stilnoct 10mg
 

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Stilnoct 10mg


Stilnoct 10 mg Tablets

zolpidem tartrate

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Read all of this leaflet carefully before you start taking this medicine Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you.
Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Stilnoct is and what it is used for 2. Before you take Stilnoct 3. How to take Stilnoct 4. Possible side effects 5. How to store Stilnoct 6. Further information What Stilnoct is and what it is used for

The name of your medicine is Stilnoct 10mg Tablets (called Stilnoct in this leaflet). Stilnoct contains a medicine called zolpidem tartrate. This belongs to a group of medicines called hypnotics. It works by acting on your brain to help you sleep.

Stilnoct is used for temporary sleep problems that are causing you severe distress or that are affecting your every day life. This includes sleep problems such as:

Difficulty falling asleep Waking in the middle of the night Waking too early

Stilnoct is not meant to be used every day for long periods of time. Ask your doctor for advice if you are unsure.

Before you take Stilnoct Do not take this medicine and tell your doctor if: You are allergic (hypersensitive) to zolpidem tartrate or any of the other ingredients of Stilnoct (listed in Section 6 below)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue Your lungs do not work properly (respiratory failure) You have severe liver problems You have a problem where you stop breathing for short periods at night (sleep apnoea) You have a problem that causes severe muscle weakness (myasthenia gravis) You have been told by a doctor that you have a mental illness (psychosis) You are under the age of 18

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Stilnoct.

Take special care with Stilnoct

Check with your doctor or pharmacist before taking your medicine if:

You have a history of alcohol or drug abuse You have liver problems You have depression or have had another mental illnesses in the past You have recently taken Stilnoct or other similar medicines for more than four weeks You are elderly

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Stilnoct.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

This includes medicines you buy without a prescription, including herbal medicines. This is because Stilnoct can affect the way some other medicines work. Also some medicines can affect the way Stilnoct works.

Tell your doctor if you are taking any of the following medicines:

Stilnoct may increase the effect of the following medicines:

Medicines for some mental health problems (antipsychotics) Medicines for depression such as sertraline Medicines for epilepsy (anticonvulsants) Medicines used in surgery (anaesthetics) Medicines to calm or reduce anxiety or for sleep problems Medicines for hay fever, rashes or other allergies that can make you sleepy (sedative antihistamines) such as chlorphenamine or promethazine Some medicines for moderate to severe pain (narcotic analgesics) such as codeine, methadone, morphine, oxycodone, pethidine or tramadol

The following medicines can increase the chance of you getting side effects when taken with Stilnoct. To make this less likely, your doctor may decide to lower your dose of Stilnoct:

Some antibiotics such as clarithromycin or erythromycin Some medicines for fungal infections such as ketaconazole and itraconazole Ritonavir (a protease inhibitor) - for HIV infections

The following medicines can make Stilnoct work less well:

Some medicines for epilepsy such as carbamazepine, phenobarbital or phenytoin Rifampicin (an antibiotic) - for infections St John’s Wort (a herbal medicine) - for mood swings and depression Taking Stilnoct with food and drink Do not drink alcohol while you are taking Stilnoct.
Alcohol can increase the effects of Stilnoct and make you sleep very deeply so that you do not breathe properly or have difficulty waking Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant. Taking Stilnoct during pregnancy may harm your baby.

You should not breast-feed if you are taking Stilnoct. This is because small amounts may pass into mother’s milk.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

On the day after taking Stilnoct, do not drive or use machinery or tools if you feel sleepy, dizzy or confused. For more information about possible side effects which could affect your driving see section 4 of this leaflet.

Important information about some of the ingredients of Stilnoct

Stilnoct contains:

Lactose. This is a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine How to take Stilnoct

Always take Stilnoct exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine Take this medicine by mouth Swallow the tablet whole with a drink of water Take just before bedtime. Make sure you have at least 7-8 hours for sleep after taking this medicine The usual length of treatment is 2 days to 4 weeks Adults

The usual dose is one Stilnoct tablet (10 mg) just before bedtime.

Elderly

The usual dose is half a tablet (5mg) just before bedtime.

Patients with liver problems

The usual starting dose is half a tablet (5mg) just before bedtime. Your doctor may decide to increase this to one tablet (10mg) if it is safe to do so.

Children and Adolescents

Stilnoct should not be used in people under 18 years old.

If you take more Stilnoct than you should

If you take more Stilnoct than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.

Taking too much Stilnoct can be very dangerous.

The following effects may happen:

Feeling drowsy, confused, sleeping deeply and possibly falling into a fatal coma. If you forget to take Stilnoct

Stilnoct must only be taken at bedtime. If you forget to take your tablet at bedtime, then you should not take it at any other time, otherwise you may feel drowsy, dizzy and confused during the day.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Stilnoct

Keep taking Stilnoct until your doctor tells you to stop.

Do not stop taking Stilnoct suddenly, but tell your doctor if you want to stop. Your doctor will need to lower your dose and stop your tablets over a period of time.

If you stop taking Stilnoct suddenly, your sleep problems may come back and you may get a ‘withdrawal effect’. If this happens you may get some of the effects listed below.

See a doctor straight away if you get any of the following effects:

Feeling anxious, restless, irritable or confused Headache Faster heartbeat or uneven heartbeat (palpitations) Nightmares, seeing or hearing things that are not real (hallucinations) Being more sensitive to light, noise and touch than normal Relaxed grip on reality Feeling distant from your body or feeling ‘puppet-like’ Numbness and tingling in your hands and feet Aching muscles Stomach problems Sleep problems come back worse than before

In rare cases fits (seizures) may also occur.

Stilnoct 10mg Side Effects

Like all medicines, Stilnoct can cause side effects, although not everybody gets them.

Stop taking Stilnoct and see a doctor or go to a hospital straight away if: You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue Tell your doctor as soon as possible if you have any of the following side effects:

Common (affects less than 1 in 10 people)

Poor memory while taking Stilnoct (amnesia) and strange behaviour during this time. This is more likely to affect you in the few hours after you take this medicine. By having 7-8 hours sleep after taking Stilnoct, this is less likely to cause you a problem. Sleeping problems that get worse after taking this medicine Seeing or hearing things that are not real (hallucinations)

Uncommon (affects less than 1 in 100 people)

Blurred eyesight or ‘seeing double’

Frequency unknown

Being less aware of your environment Falling, especially in the elderly

Sleep-Driving and other strange behaviour

There have been some reports of people doing things while asleep that they do not remember when waking up after taking a sleep medicine.

This includes sleep-driving, sleep walking and having sex. Alcohol and some medicines for depression or anxiety can increase the chance that this serious effect will happen.

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

Common (affects less than 1 in 10 people)

Diarrhoea Headache Feeling tired or agitated Nightmares

Uncommon (affects less than 1 in 100 people)

Feeling confused or irratable

Frequency unknown

Itching skin or skin rash Weak muscles Feeling restless, aggressive, angry or showing unusual behaviour Thinking things that are not true (delusions) Changes in sex drive (libido) Change in the amount of liver enzymes – shown up in the results of blood tests Changes in the way you walk Stilnoct having less effect than normal

Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet

How to store Stilnoct

Keep this medicine in a safe place where children cannot see or reach it.

Do not use Stilnoct after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What Stilnoct contains Each tablet of Stilnoct contains 10 mg of the active substance zolpidem tartrate Other ingredients are lactose monohydrate, microcrystalline cellulose, hypromellose, titanium dioxide (E171), sodium starch glycollate, magnesium stearate and macrogol 400. What Stilnoct looks like and contents of the pack

Stilnoct is a white to off-white film-coated oblong (rectangle) shaped tablet with a scored and engraved ‘SN 10’ on one side contained within clear PVC/ foil blisters in cartons containing 4 or 28 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS Tel:01483 505515 Fax:01483 535432 email:uk-medicalinformation@sanofi-aventis.com

Manufacturer

Sanofi Winthrop Industrie 6, Blvd. De L’Europe 21 800 Qu?tigny France

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in 08/2008

© sanofi-aventis, 1993 - 2008

209512


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Isosorbide


In the US, Isosorbide (isosorbide mononitrate systemic) is a member of the drug class miscellaneous uncategorized agents.

US matches:

Isosorbide Isosorbide Dinitrate Isosorbide Dinitrate Extended-Release Isosorbide Dinitrate/Hydralazine Isosorbide Mononitrate Isosorbide Mononitrate Sustained-Release Tablets Isosorbide dinitrate Oral, Sublingual Isosorbide Mononitrate Extended Release Isosorbide Dinitrate/Hydralazine Hydrochloride

UK matches:

Isosorbide Dinitrate Tablets 10mg, 20mgIsosorbide Mononitrate Tablets 10mg, 20mg, 40mg (Actavis UK Ltd)Isosorbide Dinitrate Injection Concentrate BP 1mg/ml (SPC)Isosorbide Dinitrate Tablets BP 10mg (SPC)Isosorbide Dinitrate Tablets BP 20mg (SPC)Isosorbide mononitrate 20mg tablets (SPC)Isosorbide Mononitrate 40mg (SPC)Isosorbide Mononitrate Tablets 40mg (SPC)Ingredient matches for Isosorbide Isosorbide

Isosorbide (BAN, JAN, USAN) is known as Isosorbide in the US.

Isosorbide Mononitrate

Isosorbide Mononitrate is reported as an ingredient of Isosorbide in the following countries:

Bosnia & Herzegowina Cyprus

International Drug Name Search

Glossary

BANBritish Approved NameJANJapanese Accepted NameSPC Summary of Product Characteristics (UK)USANUnited States Adopted Name
Click for further information on drug naming conventions and International Nonproprietary Names.
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Dibenyline Capsules 10mg / Phenoxybenzamine Capsules 10mg


1. Name Of The Medicinal Product

Dibenyline Capsules 10mg

Phenoxybenzamine 10mg Capsules

2. Qualitative And Quantitative Composition

Each capsule contains 10 mg Phenoxybenzamine hydrochloride BP.

3. Pharmaceutical Form

Capsules

4. Clinical Particulars 4.1 Therapeutic Indications

Hypertensive episodes associated with Phaeochromocytoma.

4.2 Posology And Method Of Administration

Method of Administration: Oral

Posology

Adults: The usual starting dose is 10 mg daily. This may be increased by 10 mg daily until control of hypertensive episodes is achieved, or postural hypotension occurs. Usually the dosage required is 1-2 mg/kg body weight daily in two doses. Concomitant beta-adrenergic blockade may be necessary to control tachycardia and arrythmias notably when tumours are secreting an appreciable amount of adrenaline as well as noradrenaline.

Elderly: Use with caution: 10mg daily dose should be sufficient (see Contra-Indications and Cautions below).

Children: There is little experience in children but, doses of 1 to 2 mg/kg daily have been used successfully.

4.3 Contraindications

Do not use in patients who have had a cerebrovascular accident; or in the recovery period (usually 3-4 weeks) after acute myocardial infarction.

4.4 Special Warnings And Precautions For Use

Use with great caution in patients in whom a fall in blood pressure and/or tachycardia may be undesirable, such as the elderly or those with severe heart disease, congestive heart failure, cerebrovascular disease or renal damage. The mode of action should be borne in mind, if used concurrently with ?-sympatho-mimetics or myocardial depressants.

Phenoxybenzamine is carcinogenic in the rat and has shown mutagenic activity in the bacterial Ames test and mouse lymphoma assay. It should only be used after very careful consideration of the risks, in patients in which alternative treatment is inappropriate.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

See under Special Precautions and Warnings.

4.6 Pregnancy And Lactation

There is little evidence of safety of Dibenyline in pregnancy and it should not be used in pregnancy unless essential.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Side effects are generally mild and transient, but may include postural hypotension with dizziness and compensatory tachycardia, nasal congestion, inhibition of ejaculation, miosis and lassitude. Gastro-intestinal upset has also been reported.

4.9 Overdose

The main effect of overdosage is profound hypotension, which may last several hours, tachycardia and collapse. Treatment consists of the induction of vomiting and/or gastric lavage together with appropriate symptomatic and supportive measures.

Treat hypotension with plasma expanders and the 'head down' position.

Noradrenaline is of little value when ?-adrenergic receptors are blocked.

Adrenaline should not be used since stimulation of ?-adrenergic receptors will further increase blood pressure.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Phenoxybenzamine is a non competitive long acting ?-adrenergic receptor antagonist.

5.2 Pharmacokinetic Properties

Phenoxybenzamine is incompletely absorbed from the gastrointestinal tract. The maximum effect is attained in about 1 hour after an intravenous dose. Following oral administration the onset of action is gradual over several hours and persists for 3-4 days following a single dose. The plasma half-life is about 24 hours. Phenoxybenzamine is metabolised in the liver and excreted in the urine and bile but small amounts remain in the body for several days. It has prolonged action probably owing to stable covalent bonding.

5.3 Preclinical Safety Data

No further information of relevance.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Lactose

Talc

Hard Gelatin Capsules:

Titanium Dioxide E171

Indigotin E132

Erythrosine E127

Edible grey ink.

6.2 Incompatibilities

None known.

6.3 Shelf Life

60 months.

6.4 Special Precautions For Storage

Store in a dry place and protect from light.

6.5 Nature And Contents Of Container

Polypropylene securitainers, amber glass bottles, polythene containers and blisters. (PVC/PVDC/Aluminium foil). In packs of 30 and 100.

6.6 Special Precautions For Disposal And Other Handling

No special instructions.

7. Marketing Authorisation Holder

Goldshield Pharmaceuticals Limited

NLA tower

12-16 Addiscombe Road

Croydon

Surrey

CR0 0XT

United Kingdom

8. Marketing Authorisation Number(S)

PL 12762/0224

9. Date Of First Authorisation/Renewal Of The Authorisation

28/02/1994

10. Date Of Revision Of The Text

18/07/2011


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Clarityn Allergy 10mg Tablets


1. Name Of The Medicinal Product

Clarityn Allergy 10mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 10mg loratadine.

The quantity of lactose monohydrate in the loratadine 10 mg tablet composition is 71.3 mg.

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Tablet: White to off-white, oval tablet with flask and bowl, score and “10” on one side, plain on the other side.

Tablet: The scoreline of the tablet is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

4. Clinical Particulars 4.1 Therapeutic Indications

Clarityn Allergy Tablets are indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.

4.2 Posology And Method Of Administration

Adults and children over 12 years of age:

10mg once daily (one tablet once daily).

The tablet may be taken without regard to mealtime.

Children 2 to 12 years of age are dosed by weight:

Bodyweight more than 30kg: 10mg once daily (one tablet once daily).

The 10mg strength tablet is not appropriate in children with a bodyweight less than 30kg.

Efficacy and safety of Clarityn Allergy Tablets in children under 2 years of age has not been established.

Patients with severe liver impairment should be administered a lower initial dose because they have reduced clearance of loratadine. An initial dose of 10mg every other day is recommended for adults and children weighing more than 30kg, and for children weighing 30 kg or less, 5 mg every other day is recommended.

No dosage adjustments are required in the elderly or in patients with renal insufficiency.

4.3 Contraindications

Clarityn Allergy Tablets are contraindicated in patients who are hypersensitive to the active substance or to any of the excipients in these formulations.

4.4 Special Warnings And Precautions For Use

Clarityn Allergy Tablets should be administered with caution in patients with severe liver impairment (see section 4.2).

This medicinal product contains lactose; thus patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

The administration of Clarityn Allergy Tablets should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

When administered concomitantly with alcohol, Clarityn Allergy Tablets have no potentiating effects as measured by psychomotor performance studies.

Potential interaction may occur with all known inhibitors of CYP3A4 or CYP2D6 resulting in elevated levels of loratadine (see Section 5.2), which may cause an increase in adverse events.

4.6 Pregnancy And Lactation

Loratadine was not teratogenic in animal studies. The safe use of loratadine during pregnancy has not been established. The use of Clarityn Allergy Tablets during pregnancy is therefore not recommended.

Loratadine is excreted in breast milk, therefore the use of loratadine is not recommended in breast-feeding women.

4.7 Effects On Ability To Drive And Use Machines

In clinical trials that assessed driving ability, no impairment occurred in patients receiving loratadine. However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.

4.8 Undesirable Effects

In clinical trials in a paediatric population, children aged 2 through 12 years, common adverse reactions reported in excess of placebo were headache (2.7%), nervousness (2.3%), and fatigue (1%).

In clinical trials involving adults and adolescents in a range of indications including AR and CIU, at the recommended dose of 10mg daily, adverse reactions with loratadine were reported in 2% of patients in excess of those treated with placebo. The most frequent adverse reactions reported in excess of placebo were somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%). Other adverse reactions reported very rarely during the post-marketing period are listed in the following table.

Immune system disorders

Anaphylaxis

Nervous system disorders

Dizziness

Cardiac disorders

Tachycardia, palpitation

Gastrointestinal disorders

Nausea, dry mouth, gastritis

Hepatobiliary disorders

Abnormal hepatic function

Skin and subcutaneous tissue disorders

Rash, alopecia

General disorders and administration site conditions

Fatigue

4.9 Overdose

Overdosage with loratadine increased the occurrence of anticholinergic symptoms. Somnolence, tachycardia and headache have been reported with overdoses.

In the event of overdose, general symptomatic and supportive measures are to be instituted and maintained for as long as necessary. Administration of activated charcoal as a slurry with water may be attempted. Gastric lavage may be considered. Loratadine is not removed by haemodialysis and it is not known if loratadine is removed by peritoneal dialysis. Medical monitoring of the patient is to be continued after emergency treatment.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group : antihistamines – H1 antagonist, ATC code : R06A X13.

Loratadine, the active ingredient in Clarityn Allergy Tablets, is a tricyclic antihistamine with selective, peripheral H1-receptor activity.

Loratadine has no clinically significant sedative or anticholinergic properties in the majority of the population and when used at the recommended dosage.

During long-term treatment there were no clinically significant changes in vital signs, laboratory test values, physical examinations or electrocardiograms.

Loratadine has no significant H2-receptor activity. It does not inhibit norepinephrine uptake and has practically no influence on cardiovascular function or on intrinsic cardiac pacemaker activity.

5.2 Pharmacokinetic Properties

After oral administration, loratadine is rapidly and well absorbed and undergoes an extensive first pass metabolism, mainly by CYP3A4 and CYP2D6. The major metabolite-desloratadine (DL)- is pharmacologically active and responsible for a large part of the clinical effect. Loratadine and DL achieve maximum plasma concentrations (Tmax) between 1-1.5 hours and 1.5-3.7 hours after administration, respectively.

Increase in plasma concentrations of loratadine has been reported after concomitant use with ketoconazole, erythromycin and cimetidine in controlled trials, but without clinically significant changes (including electrocardiographic).

Loratadine is highly bound (97% to 99%) and its active metabolite moderately bound (73% to 76%) to plasma proteins.

In healthy subjects, plasma distribution half-lives of loratadine and its active metabolite are approximately 1 and 2 hours, respectively. The mean elimination half-lives in healthy adult subjects were 8.4 hours (range = 3 to 20 hours) for loratadine and 28 hours (range = 8.8 to 92 hours) for the major active metabolite.

Approximately 40% of the dose is excreted in the urine and 42% in the faeces over a 10 day period and mainly in the form of conjugated metabolites. Approximately 27% of the dose is eliminated in the urine during the first 24 hours. Less than 1% of the active substance is excreted unchanged in active form, as loratadine or DL.

The bioavailability parameters of loratadine and of the active metabolite are dose proportional.

The pharmacokinetic profile of loratadine and its metabolites is comparable in healthy volunteers and in healthy geriatric volunteers.

Concomitant ingestion of food can delay slightly the absorption of loratadine but without influencing the clinical effect.

In patients with chronic renal impairment, both the AUC and peak plasma levels (Cmax) increased for loratadine and its metabolite as compared to the AUCs and peak plasma levels (Cmax) of patients with normal renal function. The mean elimination half-lives of loratadine and its metabolite were not significantly different from that observed in normal subjects. Haemodialysis does not have an effect on the pharmacokinetics of loratadine or its active metabolite in subjects with chronic renal impairment.

In patients with chronic alcoholic liver disease, the AUC and peak plasma levels (Cmax) of loratadine were double while the pharmacokinetic profile of the active metabolite was not significantly changed from that in patients with normal liver function. The elimination half-lives for loratadine and its metabolite were 24 hours and 37 hours, respectively, and increased with increasing severity of liver disease.

Loratadine and its active metabolite are excreted in the breast milk of lactating women.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.

In reproductive toxicity studies, no teratogenic effects were observed. However, prolonged parturition and reduced viability of offspring were observed in rats at plasma levels (AUC) 10 times higher than those achieved with clinical doses.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Lactose Monohydrate;

Maize Starch;

Magnesium Stearate

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

This medicinal product does not require any special storage conditions.

6.5 Nature And Contents Of Container

Blister strip consisting of a 20 ?m aluminium foil with vinyl heat coating and a 250 ?m clear, transparent polyvinylchloride film.

Pack sizes of 2, 5, 7, 10, 14, 15, 20, 21, 28, 30, 50, 60, or 100 tablets.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UK

8. Marketing Authorisation Number(S)

PL 0025/0585

9. Date Of First Authorisation/Renewal Of The Authorisation

10th June 1992/8th November 2007

10. Date Of Revision Of The Text

DECEMBER 2010

Clarityn Tablets-Final-CoO-Feb0711 CLARITYN ALLERGY 10 MG/UK/01-11/001


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Surmontil 10mg and 25mg Tablets


1. Name Of The Medicinal Product

Surmontil 10mg tablets or Trimipramine 10mg Tablets

Surmontil 25mg tablets or Trimipramine 25mg Tablets

2. Qualitative And Quantitative Composition

Each 10mg tablet contains 14mg of trimipramine maleate equivalent to 10mg of trimipramine.

Each 25mg tablet contains 34.9mg of trimipramine maleate, equivalent to 25mg of trimipramine.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet

Surmontil 10mg Tablets

White to pale yellow, circular, biconvex, film coated tablet, one face impressed 'SURMONTIL' just inside the perimeter around a centrally impressed '10', scoreline on reverse.

Trimipramine 10mg Tablets

White to pale yellow, circular, biconvex, film coated tablet embossed 'TM' above '10' on one side, scoreline on reverse.

The scoreline is only to facilitate breaking for ease of swallowing and not to divide the dose.

Surmontil 25mg Tablets

White to pale yellow, circular, biconvex, film coated tablet, one face impressed 'SURMONTIL' just inside the perimeter around a centrally impressed '25', reverse face plain.

Trimipramine 25mg Tablet

White to pale yellow, circular, biconvex, film coated tablet, embossed 'TM' above ''25' on one side, reverse side plain.

4. Clinical Particulars 4.1 Therapeutic Indications

Surmontil has a potent antidepressant action similar to that of other tricyclic antidepressants. It also possesses pronounced sedative action. It is, therefore, indicated in the treatment of depressive illness, especially where sleep disturbance, anxiety or agitation are presenting symptoms. Sleep disturbance is controlled within 24 hours and true antidepressant action follows within 7 to 10 days.

4.2 Posology And Method Of Administration

Adults

For depression 50-75 mg/day initially increasing to 150-300 mg/day in divided doses or one dose at night. The maintenance dose is 75-150 mg/day.

Elderly

10-25 mg three times a day initially. The initial dose should be increased with caution under close supervision. Half the normal maintenance dose may be sufficient to produce a satisfactory clinical response.

Children

Not recommended.

Route of administration is oral.

4.3 Contraindications

• Recent myocardial infarction

• Any degree of heart block or other cardiac arrhythmias

• Mania. Severe liver disease

• During breast feeding

• Hypersensitivity to trimipramine maleate or to any of the excipients

4.4 Special Warnings And Precautions For Use

Suicide/suicidal thoughts or clinical worsening

Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.

Other psychiatric conditions for which Surmontil is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.

Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.

Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.

The elderly are particularly liable to experience adverse reactions, especially agitation, confusion and postural hypotension.

Avoid if possible in patients with narrow angle glaucoma, symptoms suggestive of prostatic hypertrophy and a history of epilepsy.

Patients posing a high suicidal risk require close initial supervision. Tricyclic antidepressants potentiate the central nervous depressant action of alcohol.

Anaesthetics given during tri/tetracyclic antidepressant therapy may increase the risk of arrhythmias and hypotension. If surgery is necessary, the anaesthetist should be informed that a patient is being so treated.

It may be advisable to monitor liver function in patients on long term treatment with Surmontil.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Trimipramine should not be given concurrently with, or within 2 weeks of cessation of, therapy with monoamine oxidase inhibitors. Trimipramine may decrease the antihypertensive effect of guanethidine, debrisoquine, betanidine and possibly clonidine. It would be advisable to review all antihypertensive therapy during treatment with tricyclic antidepressants.

Trimipramine should not be given with sympathomimetic agents such as adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine.

Barbiturates may increase the rate of metabolism.

Surmontil should be administered with care in patients receiving therapy for hyperthyrodism.

4.6 Pregnancy And Lactation

Do not use in pregnancy especially during the first and last trimesters unless there are compelling reasons. There is no evidence from animal work that it is free from hazard.

Trimipramine is contraindicated during lactation.

4.7 Effects On Ability To Drive And Use Machines

Trimipramine may initially impair alertness. Patients should be warned of the possible hazard when driving or operating machinery.

4.8 Undesirable Effects

Cases of suicidal ideation and suicidal behaviours have been reported during trimipramine therapy or early after treatment discontinuation (see section 4.4).

Cardiac arrhythmias and severe hypotension are likely to occur with high dosage or in deliberate overdosage. They may also occur in patients with pre-existing heart disease taking normal dosage.

The following adverse effects, although not necessarily all reported with trimipramine, have occurred with other tricyclic antidepressants.

Atropine-like side effects including dry mouth, disturbance of accommodation, tachycardia, constipation and hesitancy of micturation are common early in treatment but usually lessen.

Other common adverse effects include drowsiness, sweating, postural hypotension, tremor and skin rashes. Interference with sexual function may occur.

Serious adverse effects are rare; the following have been reported: depression of bone marrow, including agranulocytosis, cholestatic jaundice, hypomania, convulsions and peripheral neuropathy. Psychotic manifestations including mania and paranoid delusions, may be excacerbated during treatment with tricyclic antidepressants.

Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to this risk is unknown.

Withdrawal symptoms may occur on abrupt cessation of therapy and include insomnia, irritability and excessive perspiration.

Adverse effects such as withdrawal symptoms, respiratory depression and agitation have been reported in neonates whose mothers had taken trimipramine during the last trimester of pregnancy.

4.9 Overdose

Acute overdosage may be accompanied by hypotensive collapse, convulsions and coma. Provided coma is not present, gastric lavage should be carried out without delay even though some time may have passed since the drug was ingested. Patients in a coma should have an endotracheal tube passed before gastric lavage is started. Absorption of trimipramine is slow but, as cardiac effects may appear soon after the drug is absorbed, a saline purge should be given. Electrocardiography monitoring is essential.

It is important to treat acidosis as soon as it appears with, for example, 20 ml per kg of M/6 sodium lactate injection by slow intravenous injection. Intubation is necessary and the patient should be ventilated before convulsions develop. Convulsions should be treated with diazepam administered intravenously.

Ventricular tachycardia or fibrillation should be treated by electrical defibrillation. If supraventricular tachycardia develops, pyridostigmine bromide 1 mg (adults) intravenously or propranolol 1mg (adults) should be administered at intervals as required.

Treatment should be continued for at least three days even if the patient appears to have recovered.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group: Psychoanaleptics; Non-selective monoamine reuptake inhibitors, ATC Code: N06AA06

Trimiparamine is a tricyclic antidepressant. It has marked sedative properties.

5.2 Pharmacokinetic Properties

Trimipramine undergoes high first-pass hepatic clearance, with a mean value for bioavailability of about 41% after oral administration.

The absolute volume of distribution is 31 litres/kg and total metabolic clearance is 16 ml/min/kg.

Plasma protein binding of trimipramine is about 95%. The plasma elimination half-life is around 23 hours. Trimipramine is largely metabolised by demethylation prior to conjugation yielding a glucuronide.

5.3 Preclinical Safety Data

No additional pre-clinical data of relevance to the prescriber.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Tablet Core:

Calcium Hydrogen Phosphate

Starch Potato

Magnesium Stearate

Talc

Tablet Coat (Opadry OY-L-28900):

Lactose Monohydrate

Hypromellose

Titanium Dioxide

Macrogol 4000

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

5 years

6.4 Special Precautions For Storage

Keep the blister in the outer carton in order to protect from light.

6.5 Nature And Contents Of Container

10mg: Cartons containing PVDC/coated UPVC/aluminium foil blister packs of 84 or 28 tablets.

25mg: Cardboard cartons containing PVDC/coated UPVC/aluminium foil blister packs of 84 or 28 tablets.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

8. Marketing Authorisation Number(S)

Surmontil 10mg tablets: PL 04425/0266

Surmontil 25mg tablets: PL 04425/0267

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first Authorisation: 6 April 1973

Date of latest Renewal: 3 May 2002

10. Date Of Revision Of The Text

7 June 2011

LEGAL CATEGORY

POM


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Zomorph capsules


1. Name Of The Medicinal Product

ZOMORPH capsules 10mg, 30mg, 60mg, 100mg, 200mg

2. Qualitative And Quantitative Composition

• Morphine sulphate BP 10mg

• Morphine sulphate BP 30mg

• Morphine sulphate BP 60mg

• Morphine sulphate BP 100mg

• Morphine sulphate BP 200mg

3. Pharmaceutical Form

Sustained-release capsules.

4. Clinical Particulars 4.1 Therapeutic Indications

Severe chronic pain and/or pain resistant to other analgesics, in particular pain associated with cancer.

4.2 Posology And Method Of Administration

Route of administration : orally.

As directed by a medical practitioner.

Recommended dosage

Adults: Recommended dosage is one capsule twice daily, at 12-hourly intervals.

Elderly: As with all narcotics, a reduction in dosage may be advisable in the elderly, as appropriate.

Children: Not recommended.

The capsules should not be chewed and should normally be swallowed whole.

The dosage varies according to the severity of pain and the previous analgesic treatments received by the patient.

If the pain persists, or if the patient develops tolerance to morphine, the dosage may be increased by prescribing the 10mg, 30mg, 60mg, 100mg and 200mg capsules in various combinations or alone to obtain the desired relief.

Patients previously treated with immediate-release oral morphine should receive the same daily dose of sustained-release capsules, but in two divided doses at 12-hourly intervals.

Patients previously treated with parenteral morphine should be given a sufficiently increased dosage to compensate for any reduction of the analgesic effect associated with oral administration. The dosage should be adjusted to meet the individual requirements of each patient.

For patients who cannot swallow the capsules, their contents can be administered directly in semi-solid food (puree, jam, yoghurt) or via gastric or gastrostomy tubes of a diameter of more than 16 F.G. with an open distal end or lateral pores. It is sufficient to rinse the tube with 30ml to 50ml of water.

4.3 Contraindications

Respiratory impairment, acute abdominal syndrome of unknown origin, severely impaired liver function, cranial trauma and raised intracranial pressure, convulsive state, acute alcoholic intoxication and delirium tremens, children, risk of paralytic ileus, known hypersensitivity to any of the ingredients contained in Zomorph, concurrent treatment with MAO (MAO = monoamine oxidase) inhibitors or within two weeks of their use.

4.4 Special Warnings And Precautions For Use

Caution should be exercised:

- in elderly subjects, in patients with impaired hepatic and/or renal functions, in patients with hypothyroidism or hypoadrenalism, in patients in a state of shock or with asthma. The dose of Zomorph should be reduced, or its use should be avoided in cases of hepatic or renal failure.

- in patients suffering from the following conditions: hypotension, convulsive disorders, dependence (severe withdrawal symptoms if withdrawn abruptly) and prostatic hypertrophy.

Urinary retention may occur in patients with urethral disease or prostatic hypertrophy.

Concomitant use of alcohol and Zomorph may increase the undesirable effects of Zomorph; concomitant use should be avoided.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

As serious and sometimes fatal reactions have occurred following administration of pethidine to patients receiving monoamine oxidase inhibitors, pethidine and related drugs are contra-indicated in patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment; morphine and other opioid analgesics should be given with extreme caution.

The depressant effects of opioid analgesics are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, antipsychotics, anxyolitics, hypnotics and sedatives, tricyclic antidepressants and phenothiazines.

Cyclizine may counteract the haemodynamic benefits of opioids.

Opioid analgesics with some antagonist activity, such as buprenorphine, butorphanol, nalbuphine or pentazocine may precipitate withdrawal symptoms in patients who have recently used pure agonists such as morphine. The actions of opioids may in turn affect the activities of other compounds. For instance, their gastro-intestinal effects may delay absorption as with mexiletine or may be counteractive as with metoclopramide, domperidone and possibly cisapride.

Plasma concentrations of morphine are possibly increased by ritonavir.

Alcohol may enhance the pharmacodynamic effects of Zomorph; concomitant use should be avoided.

4.6 Pregnancy And Lactation

Since this product rapidly crosses the placental barrier, it should not be used during the second stage of labour or in premature delivery because of the risk of secondary respiratory depression in the newborn infant. If the mother is addicted, a withdrawal syndrome is observed in the newborn infant characterised by: convulsions, irritability, vomiting, increased mortality. As with all drugs, it is not advisable to administer morphine during pregnancy.

4.7 Effects On Ability To Drive And Use Machines

Because of the decrease in vigilance induced by this drug, attention is drawn to the possible dangers incurred by drivers of vehicles or machine operators.

4.8 Undesirable Effects

The most common side effects at usual doses are nausea, constipation, confusion and occasionally vomiting.

Other possible effects include: urticaria, pruritus, rashes, decreased libido or potency, mood changes, drowsiness, dry mouth, sweating, headache, facial flushing, vertigo, bradycardia, tachycardia, palpitations, postural hypotension, dysphoria, hypotension, hypothermia, miosis, dysuria, sedation or excitation (particularly in elderly subjects in whom delirium and hallucinations may occur), increased intracranial pressure which may aggravate existing cerebral disorders, increased pressure in the main bile duct and urinary retention in cases of prostatic adenoma or urethral stenosis. Mild respiratory depression occurs even at therapeutic doses. In the event of overdosage it may be severe, serious or even fatal. Physical and psychic dependence may appear after administration of therapeutic doses for periods of 1 to 2 weeks. Some cases of dependence have been observed after only 2 to 3 days.

Withdrawal syndrome: this may occur a few hours after withdrawal of a prolonged treatment, and is maximal between the 36th and 72nd hours.

4.9 Overdose

Symptoms include respiratory depression, extreme miosis, hypotension, hypothermia, coma. Treatment is by intravenous injection of naloxone 0.4mg, repeated every 2 to 3 minutes if necessary, or by an infusion of 2mg in 500ml of normal saline or 5% dextrose (0.004mg/ml).

In subjects dependent on morphine-like drugs, withdrawal symptoms may occur following injection of a high dose of naloxone. It should therefore be injected in gradually increasing doses to such subjects.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Morphine is an opioid analgesic. It acts mainly on the central nervous system and smooth muscle.

Morphine exerts an analgesic action, and affects psychomotor behaviour: depending on the dose administered, it induces sedation (> 1cg) or, in some cases, excitation (< 1cg). At high doses, greater than those required to produce analgesia, it induces somnolence and sleep.

5.2 Pharmacokinetic Properties

Absorption

This is a sustained-release form, which makes twice-daily oral administration possible. Morphine is immediately absorbed from the digestive tract following oral administration. The maximum serum concentrations of morphine are obtained in 2 to 4 hours.

Distribution

The percentage of binding to plasma proteins after absorption is low (about 34%). There is no clearly defined correlation between the plasma concentration of morphine and the analgesic effect.

Metabolism

A considerable quantity of morphine is metabolised by the liver to glucuronides, which undergo enterohepatic recirculation.

Excretion

The product is eliminated essentially in the urine, by glomerular filtration, mainly as glucuronides. A small amount (less than 10%) is eliminated in the faeces.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sucrose, maize starch, polyethylene glycol 4000, ethyl-cellulose, cetyl alcohol, sodium lauryl sulphate, dibutyl sebacate, talc, gelatin, iron oxide ink (E172), titanium dioxide (E171) (for the 10mg, 30mg, 60mg and 100mg strengths), quinoline yellow (E104) (only for the 10mg strength), erythrosine (E127) (only for the 30mg strength), sunset yellow (E 110) (only for the 60mg strength).

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store below 25°C in a dry place protected from heat.

6.5 Nature And Contents Of Container

Blister packs (aluminium/PVC).

Boxes of 14, 30 and 60 capsules.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Archimedes Pharma UK Limited

250 South Oak Way

Green Park

Reading

Berkshire

RG2 6UG

UK

8. Marketing Authorisation Number(S)

10mg: PL 12406/0028

30mg: PL 12406/0029

60mg: PL 12406/0030

100mg: PL 12406/0031

200mg: PL 12406/0032

9. Date Of First Authorisation/Renewal Of The Authorisation

16 July 2010 (10mg, 30mg)

17 July 2010 (60mg, 100mg & 200mg)

10. Date Of Revision Of The Text

22 July 2011

ZomCapAll-SPC06

UK/ZC/11/006

OCT 2011


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Fosinopril Tablets 10mg, 20mg (Actavis UK Ltd)


Fosinopril sodium 10mg and 20mg tablets

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed on this leaflet, please tell your doctor or pharmacist. In this leaflet 1 What Fosinopril sodium is and what it is used for 2 Before you take Fosinopril sodium tablets 3 How to take Fosinopril sodium tablets 4 Possible side effects 5 How to store Fosinopril sodium tablets 6 Further Information What Fosinopril sodium is and what it is used for

Each tablet contains fosinopril sodium which is used to treat high blood pressure (hypertension) and heart failure.

Fosinopril sodium tablets belong to a group of medicines called ACE inhibitors and make it easier for the heart to pump blood around the body.

Before you take Fosinopril sodium tablets Do not take Fosinopril sodium tablets and tell your doctor if you: are allergic (hypersensitive) to fosinopril sodium, other ACE inhibitors or any of the other ingredients in the tablet. (See Section 6 for further information on the ingredients) or a member of your family have previously had swelling of the legs, arms, face, mucous membranes or tongue and/or throat (angioedema), with or without ACE inhibitor treatment have narrowing of the blood vessels in one or both kidneys are in shock due to heart problems (cardiogenic shock) are pregnant or breastfeeding. Take special care with Fosinopril sodium tablets and tell your doctor if you: have kidney problems are having dialysis are going to undergo treatment for hypersensitivity to bee or wasp stings (hyposensitisation) have problems with your immune system due to some diseases (e.g. scleroderma, lupus erythematosus), white blood cell counts will need to be monitored have high levels of sugar in your blood (diabetes) have narrowing of some blood vessels in the heart or cardiomyopathy (enlarged heart muscle) have become dehydrated from having recently suffered from vomiting or diarrhoea are on a low salt diet are Afro-Caribbean. If you are taking Fosinopril sodium tablets as the only treatment for your high blood pressure, you may have a reduced response to this medicine. This may mean that you may need a higher dose than usually recommended.

Tell your doctor or dentist before undergoing any surgery or dental treatment that you are being treated with Fosinopril, as there is a risk of your blood pressure sinking very low during the anaesthetic.

Taking other medicines

If Fosinopril is taken with certain other medicines your treatment can be affected. Tell your doctor before using other medicines at the same time as Fosinopril. Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

It is especially important for your doctor to know if you are already being treated with any of the following medicines:

other blood pressure lowering medicines including methyldopa, betablockers (e.g. atenolol), calcium antagonists (e.g. verapamil) or diuretics (water tablets) (e.g. furosemide) as it may lead to an increase in the blood pressure lowering effects potassium-sparing diuretics (e.g. spironolactone, triamterene or amiloride), potassium supplements or potassium-containing salt substitutes, as Fosinopril may increase potassium levels. Patient will need their blood potassium levels measured by their doctors painkillers and anti-inflammatory medicines of the NSAID type (e.g. aspirin or indometacin) as they can reduce the effect of Fosinopril antacids (to relieve indigestion) stop the body absorbing Fosinopril. There should be at least 2 hours between taking the antacid and Fosinopril insulin and tablets used in diabetes, as Fosinopril may increase the effect of these especially during the first week of combination treatment lithium (used for manic depression), as Fosinopril may increase the concentration of lithium in the blood immunosuppressants (these reduce the body’s natural defence system) such as azathioprine as using them together may affect some blood counts. Pregnancy and breast feeding

Do not take Fosinopril sodium tablets during pregnancy or if you might become pregnant. There is a risk of injury to the baby. Do not take Fosinopril if you are breast feeding, as Fosinopril passes into breast milk.

Driving and using machines

If you experience dizziness, low blood pressure, light-headedness or vertigo (’spinning sensation), do not drive or use machinery during treatment with Fosinopril.

Important information about some of the ingredients of Fosinopril

Fosinopril contains lactose (see section 6 for further information). If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Blood tests

Fosinopril may interfere with the results of some blood tests. Tell your doctor that you are taking Fosinopril sodium tablets.

How to take Fosinopril sodium tablets

Swallow the tablets whole with at least half a glass of water in the morning with or without food. Do not chew or crush the tablets.

Always take Fosinopril exactly as your doctor has told you. If you are not sure check with your doctor or pharmacist.

Adults: The usual dose is 10mg once daily, up to a maximum of 40mg once daily. Fosinopril sodium tablets may be taken alone or in combination with a diuretic (water tablet) or digitalis (digoxin). If you are already taking diuretics, your doctor may tell you to reduce the dose of the diuretic or to stop taking them for several days before beginning treatment with Fosinopril.

Occasionally some people start their treatment in hospital.

Children under 18 years old: Not recommended.

If you take more Fosinopril sodium than you should:

Immediately contact your doctor, the nearest hospital casualty department or the centre for poison information for advice.

If you forget to take Fosinopril sodium

Do not take the missed dose, just carry on with the next one as normal. Do not take a double dose to make up for a forgotten dose.

If you stop taking Fosinopril sodium

Do not stop taking Fosinopril unless your doctor advises you to do so. If you stop taking Fosinopril, your blood pressure may increase.

Possible side effects

Like all medicines, Fosinopril can cause side effects, although not everybody gets them. The following side effects may occur.

Stop taking Fosinopril sodium tablets and contact your doctor immediately if you experience swelling of the face, lips, tongue and/or throat, rash, itching, breathlessness or difficulty swallowing (angioedema).

Tell your doctor if you notice any of the following side effects or they get worse:

Common (occurring in less than 1 in 10 patients): dizziness, raise in heart rate, feeling faint on standing up due to reduced blood pressure, low blood pressure, cough, feeling or being sick, diarrhoea, rash, dermatitis, weakness, chest pain (not related to the heart), increase in blood levels of alkaline, bilirubin, LDH and transaminases (as seen in blood tests). Uncommon (occurring in less than 1 in 100 patients): lack of appetite, gout, raised levels of potassium in the blood, depression, confusion, pins & needles, sleepiness, fainting, lack of blood supply to the brain, stroke, tremor, problems with sight, ear ache, vertigo (‘spinning’ sensation), tinnitus (ringing in the ear), palpitations, chest pain (due to angina), heart attack, problems with heart rhythm or heart rate, high blood pressure, shock, reduced blood flow, inflammation of the lungs, difficulty breathing, runny nose, inflamed sinus, constipation, dry mouth, weight gain, changes in taste, flatulence, excessive sweating, itchy rash, muscle pain, kidney failure, problems with sexual function, fever, water retention, sudden death, pain in the upper body. Rare (occurring in less that 1 in 1000 patients): changes in types and numbers of blood cells (you may experience sore throat, recurring infections, nose bleeds, increased bruising), memory and speech problems, flushing, bleeding, asthma or wheezing, nosebleeds, sore throat, hoarseness, damage to small blood vessels, lung infections or fluid on the lungs, stomach pain or bloating, mouth ulcers, swollen tongue, swallowing difficulties, inflammation of the pancreas, inflammation of the liver (causing fatigue, loss of appetite or weight loss, weakness, fever, stomach pains or yellowing of the skin or whites of the eyes), bruising, pain and swelling of the joint, prostate problems, weakness in one arm or leg. Very rare (occurring in less than 1 in 10,000 patients): an infection with symptoms such as fever and serious deterioration of your general condition, or fever with a sore throat/mouth or urinary problems. A blood test may be taken to check possible reduction of white blood cells (agranulocytosis).

If you have any of these side effects, they get worse or you notice any side effects not listed, please tell your doctor or pharmacist.

How to store Fosinopril sodium tablets

Keep out of the reach and sight of children.

Do not store Fosinopril above 25°C. Do not transfer to another container.

Do not use Fosinopril after the expiry date stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information What Fosinopril sodium tablets contain The active substance is fosinopril sodium. Each tablet contains either 10mg or 20mg of fosinopril sodium. The other ingredients are lactose monohydrate, croscarmellose sodium, pregelatinised starch (maize), microcrystalline cellulose and glycerol dibehenate. The sodium content is 0.67mg per 10mg tablet and 1.06mg per 20mg tablet. What Fosinopril sodium tablets look like and contents of the pack

Fosinopril sodium tablets are white to off-white, round, uncoated tablets, which come in two strengths.

Each pack contains 28 tablets.

Marketing Authorisation Holder & Manufacturer: Actavis Barnstaple EX32 8NS UK

This leaflet was last revised in: October 2007

Actavis Barnstaple EX32 8NS UK

ACTPL029


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Myotonine 25 mg (Bethanechol Chloride)


1. Name Of The Medicinal Product

Myotonine ®( bethanechol chloride).

2. Qualitative And Quantitative Composition

Each 25mg tablet weighs 440mg; total active ingredient 25mg bethanechol chloride USPXXIV

3. Pharmaceutical Form

Each 25mg tablet is white, flat with bevelled edge and with a cross score and embossed “MY25”.

4. Clinical Particulars 4.1 Therapeutic Indications

Urinary retention -indicated for the treatment of acute postoperative and postpartum non-obstructive (functional) urinary retention and neurogenic atony of the urinary bladder with retention.

Reflux oesophagitis; treatment of reflux associated with decreased pressure of the lower oesophageal sphincter or delayed gastric emptying.

4.2 Posology And Method Of Administration

Administration orally by tablets.

Adults: 10mg –25mg three or four times daily, taken half an hour before food. Occasionally it may be necessary to initiate therapy with a 50mg dose.

Children: The experience with children is limited therefore no recommended dose is given.

4.3 Contraindications

Intestinal or urinary obstruction, recent myocardial infarction, recent intestinal anastomosis.

4.4 Special Warnings And Precautions For Use

A severe cholinergic reaction is likely if bethanechol chloride is administered IV or IM. This reaction has also rarely occurred in cases of hypersensitivity or overdose.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Cholinergics, other, especially cholinesterase inhibitors.

Ganglionic blocking agents such as mecamylamine, pentolinium and trimethaphan.

Procainamide or quinidine.

4.6 Pregnancy And Lactation

Should not be used during pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

In some cases the ability to drive and operate machinery may be impaired.

4.8 Undesirable Effects

Nausea, vomiting, sweating and intestinal colic.

4.9 Overdose

The symptoms of overdose include nausea, salivation, lachrymation, eructation, involuntary defecation and urination, transient dyspnoea, palpitation, bradycardia and peripheral vasodilation leading to hypertension, transient heart block and a feeling of constriction under the sternum.

Procedure: The stomach should be emptied by aspiration or lavage. Give atropine sulphate 1-2mg intravenously, intramuscularly or subcutaneously to control muscarinic effects. The dose may be repeated every 2-4 hours as necessary.

Supportive treatment includes intravenous administration of diazepam 5-10mg: muscle twitching may be controlled by small doses of tubocararine (together with assisted respiration): oxygen may be required.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Bethanechol is a synthetic choline ester of carbamic acid which possesses a significant acetylcholine-like activity. It is active after oral administration.As a consequence of the very slow hydrolysation by acetylcholinesterase bethanechol has a prolonged action as has been demonstrated in the urinary tract. The onset of action occurs after oral administration within an hour.

The major pharmacological effects of bethanechol result from interaction of the drug with muscarinic receptor sites of smooth muscles, especially those of the urinary bladder and gastrointestinal tract.

In addition, minor but important nicotinic effects have been noted. In usual therapeutic doses, bethanechol does not cross the blood brain barrier.

5.2 Pharmacokinetic Properties

Studies not available.

5.3 Preclinical Safety Data

N/A

6. Pharmaceutical Particulars 6.1 List Of Excipients

Calcium sulphate dihydrate BP.

Maize starch BP.

Talc BP(iron free)

6.2 Incompatibilities

Major –none known.

6.3 Shelf Life

The shelf life of Myotonine tablets is currently two years from date of manufacture.

6.4 Special Precautions For Storage

Keep out of reach of children and away from direct heat or light sources.

Store below 25?C.

6.5 Nature And Contents Of Container

The container is of polypropylene with a tamper-evident polyethylene cap and closure. A filla may be inserted to reduce the risk of tablet breakage due to ullage.

Each container is filled with 100 tablets.

6.6 Special Precautions For Disposal And Other Handling 7. Marketing Authorisation Holder

Glenwood Laboratories UK Ltd.

Jenkins Dale

Chatham

Kent

ME4 5RD

8. Marketing Authorisation Number(S)

Myotonine 25mg 00245/5010R.

9. Date Of First Authorisation/Renewal Of The Authorisation

February 2003

10. Date Of Revision Of The Text

November 2003,February 2000, April 1996,July 1995.


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Soltamox 10mg / 5ml Oral Solution


SOLTAMOX 10mg/5ml Oral Solution

Tamoxifen

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

In this leaflet:

1. What Soltamox is and what it is used for 2. Before you take Soltamox 3. How to take Soltamox 4. Possible side-effects 5. Storing Soltamox 6. Further information

SOLTAMOX 10mg/5ml Oral Solution

Active substance: tamoxifen.

The active substance is 10 mg tamoxifen (as tamoxifen citrate).

The medicine is presented as 1 bottle with 150 ml of solution.

What Soltamox Is And What It Is Used For

Tamoxifen belongs to a group of medicines known as anti-oestrogens.

Soltamox is used to treat breast cancer.

Before You Take Soltamox

Do not take this medicine but speak to your doctor if:

You are allergic to tamoxifen or any of the ingredients. You are pregnant or breast feeding. You should not become pregnant while taking this medicine or within 2 months of finishing the course. If you are sexually active, you should use a barrier method or other non-hormonal method of contraception. Discuss this with your doctor. If you think you have become pregnant you should speak to your doctor immediately. You are taking anastrozole to treat breast cancer.

This medicine is not intended for use in children.

Take special care with this medicine:

Consult your doctor before taking this medicine if:

You have not yet gone through the menopause, as your doctor will have to ensure you are not pregnant before starting treatment. You have a family history of strokes or blood clots.

Tamoxifen can cause absence of or change in the regularity of periods.

Driving and using machines

As tamoxifen can cause changes in eyesight and light headedness, you should take care when driving or using machines.

Important information about some of the ingredients of Soltamox

This product contains 19% v/v ethanol. Each 5 ml dose contains 0.75g of alcohol equivalent to 19ml of beer or 8ml of wine. It is harmful for those suffering from alcoholism. Speak to the doctor before taking this medicine if you suffer from liver disease or epilepsy. It may also modify or increase the effect of other medicines.

This product contains glycerol which may cause headache, stomach upset and diarrhoea.

It also contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, speak to your doctor before taking this product.

Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

Consult your doctor before using this medicine if you are taking:

anastrozole, used to treat breast cancer anticoagulants e.g. warfarin or anti-platelets e.g. aspirin or clopidogrel that prevent blood clots forming other cytotoxic medicines or are undergoing chemotherapy bromocriptine rifampicin hormone preparations (e.g. oral contraceptives). How To Take Soltamox

Always take Soltamox exactly as your doctor has instructed you.

This medicine is only to be taken by mouth. Do not exceed or take less than the stated dose. Do not take this medicine more or less often than prescribed.

You should check with your doctor or pharmacist if you are unsure.

When not prescribed otherwise by the doctor, the usual dose is:

Adults (including the elderly): 20 mg to 40 mg as a single dose or in divided doses.

Children: Not applicable.

If you take too much medicine a doctor or hospital should be contacted immediately.

If you forget to take a dose, take the missed dose as soon as you remember then carry on as before. Never take two doses together.

Possible Side-Effects

The frequency of side effects is assessed on the following basis:

Very common: in more than 1 in 10 subjects treated

Common: in more than 1 in 100 subjects treated

Uncommon: in more than 1 in 1000 subjects treated

Rare: in more than 1 in 10,000 subjects treated

Very rare: in 1 or fewer than 1 in 10,000 subjects treated, including isolated cases.

Very common

Hot flushes, vaginal discharge, genital itching, abnormal vaginal bleeding.

Common

Bone and tumour pain, fluid retention, an increased risk of blood clots, deep vein thrombosis, pulmonary embolism (a blood clot in the lungs), light headedness, headache, changes in vision as a result of cataracts or changes to the cornea or retina, nausea, thinning of hair, leg cramps.

If you develop sudden shortness of breath, chest pain, coughing up blood, calf or thigh pain or swelling in the legs, seek medical attention immediately.

Uncommon

Vomiting.

If you notice you have excessive thirst, nausea or vomiting you should contact your doctor as you may have too much calcium in your blood and the doctor may want to perform tests.

Rare

Temporary disorders of the blood system which may show as a tendency to bruise more easily and which can disappear on stopping treatment, skin rash and liver problems such as jaundice and hepatitis.

Rarely an allergic reaction may occur which may show as difficulty in breathing and generalised swelling. If this happens, seek medical help immediately.

Menstrual disturbances, vaginal discharge, cancer of the womb, changes in the lining of the womb which may be seen as pain or pressure in the pelvis and abnormal vaginal bleeding and swollen ovaries. If you notice abnormal bleeding or pain and pressure in the pelvis you should speak to your doctor straight away.

Very rare

Severe blood disorders which may show as a tendency to bruise more easily, very high cholesterol levels, pancreatitis which may result in stomach pain radiating to the back, fever and nausea, liver cell damage, Stevens-Johnson syndrome with severe skin rashes, which may also include ring-shaped rashes and the formation of large blisters.

Inflammation of the lungs may occur. This may show as a dry cough, progressive difficulty in breathing, swelling of the ends of the fingers, bluish discolouration of the skin and fever. If this happens, seek medical help immediately.

Cases of optic nerve diseases, which cause problems with your sight, have been reported. In a small number of cases blindness has occurred.

If you have any of the symptoms listed or other effects it is advisable to speak to your doctor.

Storing Soltamox

Keep out of the reach and sight of children.

Do not use after the expiry date stated on the bottle and outer packaging.

Discard 3 months after first opening.

Soltamox should not be stored above 25°C. Do not refrigerate or freeze. Store in the original package in order to protect from light.

Always keep the medicine in the bottle in which it was originally given to you.

Do not keep outdated medicine or medicine that is no longer wanted. Take it to your pharmacist for safe disposal.

If you notice any defects, or signs of deterioration in the medicine you should consult your pharmacist.

Further Information

The other ingredients are: ethanol (19% v/v), glycerol (E422), propylene glycol (E1520), sorbitol liquid (non-crystallising) (E420), natural aniseed flavouring (flavouring preparations, isopropyl alcohol, water), liquorice flavouring (flavouring preparations, natural flavouring substances, artificial flavouring substances, propylene glycol E1520, isopropyl alcohol) and purified water.

The marketing authorisations (PL 00427/0121 – UK, PA 312/8/1 – Eire) are held by and the product is manufactured by

Rosemont Pharmaceuticals Ltd Rosemont House Yorkdale Industrial Park Braithwaite Street Leeds LS11 9XE UK

This leaflet was prepared in April 2009.

P0451


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Ikorel Tablets


1. Name Of The Medicinal Product

Ikorel 10mg and 20mg Tablet

2. Qualitative And Quantitative Composition

Nicorandil 10mg or 20mg

3. Pharmaceutical Form

Tablet

Off-white, round, with faceted edges, scored on one side and bearing the inscription IK10 (10mg) or IK20 (20mg).

4. Clinical Particulars 4.1 Therapeutic Indications

Ikorel tablets are indicated for the following:

• The prevention and long term treatment of chronic stable angina pectoris

• A reduction in the risk of acute coronary syndromes in patients with chronic stable angina and at least one of the following risk factors:

Previous MI

Previous CABG

CHD on angiography or a positive exercise test together with one of the following: LVH on ECG, left ventricular dysfunction, Age

4.2 Posology And Method Of Administration

Route of administration: oral.

Adults: The recommended starting dose is 10mg nicorandil twice daily, although 5mg twice daily may be employed in patients particularly susceptible to headache. Subsequently the dosage should be titrated upward depending on the clinical response. The usual therapeutic dosage is in the range 10 to 20mg nicorandil twice daily, although up to 30mg twice daily may be employed if necessary.

Elderly:

For elderly patients use of the lowest effective dose is recommended.

Children:A paediatric dosage has not been established and use of nicorandil is not recommended.

4.3 Contraindications

Ikorel is contraindicated in patients with hypersensitivity to nicorandil or any of the excipients.

Nicorandil must not be used in the case of cardiogenic shock, hypotension or left ventricular failure with low filling pressure.

Concurrent use of nicorandil and phosphodiesterase 5 inhibitors (e.g. sildenafil, tadalafil, vardenafil) is contraindicated since it can lead to a serious drop in blood pressure.

4.4 Special Warnings And Precautions For Use

Gastrointestinal ulcerations, skin and mucosal ulceration have been reported with nicorandil. These are refractory to treatment and most only respond to withdrawal of nicorandil treatment. If ulcerations develop, it is recommended to discontinue the nicorandil treatment.

Gastrointestinal perforations in context of concomitant use of nicorandil and corticosteroids have been reported. Caution is advised when concomitant use is considered.

Nicorandil must be used with caution in patients who may have blood volume depletion or in those who present, low systolic blood pressure (e.g below 100 mm Hg), acute pulmonary oedema or acute myocardial infarction with acute left ventricular failure and low filling pressures.

Caution is advised if nicorandil is used in combination with other medicinal products with blood pressure lowering effect (see section 4.5).

The tablets are sensitive to moisture; hence the patients should be advised to keep the tablets in their blister until intake. Besides the nicorandil tablets, each blister contains active substance-free silica gel tablets as desiccant in a separate blister segment which is marked accordingly. The patients should be advised not to take these tablets. Although any accidental intake of this desiccant is usually harmless, it may alter the scheduled intake of the active tablets.

Paediatric patients

Ikorel is not recommended in paediatric patients since its safety and efficacy have not been established in this patient group.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Gastrointestinal perforations in the context of concomitant use of nicorandil and corticosteroids have been reported. Caution is advised when concomitant use is considered.

Concurrent use of nicorandil and phosphodiesterase 5 inhibitors, e.g. sildenafil, tadalfil, vardenafil, is contraindicated, since it can lead to a serious drop in blood pressure.

Therapeutic doses of nicorandil may lower the blood pressure of hypotensive patients. If nicorandil is used concomitantly with antihypertensive agents or other medicinal products with blood-pressure-lowering effect (e.g vasodilators, tricyclic antidepressants, alcohol) the blood-pressure-lowering effect may be increased.

4.6 Pregnancy And Lactation

Pregnancy: Although animal studies have not shown any teratogenic effect of nicorandil, the medicinal product has not been studied in human pregnancy; therefore, Ikorel must only be used in pregnant women if the anticipated benefit outweighs any potential risks.

Lactation: Animal studies have shown that nicorandil is excreted in small amounts into the breast milk. It is not known whether nicorandil is excreted in human milk, therefore Ikorel is not recommended during breastfeeding.

4.7 Effects On Ability To Drive And Use Machines

Blood pressure-lowering effects of nicorandil can reduce the ability to drive or to use machines. This effect can be increased in conjunction with alcohol or other products with blood-pressure-lowering effect (e.g. vasodilators, tricyclic antidepressants). (see section 4.5).

Patients should be warned not to drive or operate machinery until it is established that their performance is unimpaired by nicorandil.

4.8 Undesirable Effects

The following definitions apply to the frequency terminology used hereafter:

Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000).

SOC

FREQUENCY

ADR

     

Nervous system disorders

Very common

Headache,particularly during the first few days of treatment.

 

Common

Dizziness

Cardiac disorders

Common

Increase in heart rate, following the administration of high doses

Vascular disorders

Common

Cutaneous vasodilation with flushing

 

Uncommon

Decrease in blood pressure.

Gastrointestinal disorders

Common

Nausea and vomiting

 

Rare

Gastrointestinal ulcerations such as aphtosis, mouth ulcers, tongue ulcers, intestinal and anal ulcers. These ulcers, if advanced, may develop into perforation, fistula, or abscess formation. (see section 4.4).

     

Hepato-biliary disorders

Very rare

Liver disorders such as hepatitis, cholestasis, or jaundice.

Skin and subcutaneous tissue disorders

Rare

Different types of rash, pruritis.

 

Very rare

Angio-oedema. Skin and muscosal ulcerations (mainly peri-anal ulcerations, genital ulcerations and parastomal ulcerations (see section 4.4).

Musculoskeletal & connective tissue disorders

Rare

Myalgia

General disorders and administration site conditions

Common

Feeling of weakness

Additional Information

In addition, the following events have been reported at a different frequency in the IONA (Impact of Nicorandil in Angina) study which was conducted in subjects at high risk of cardiovascular events only.

Skin and subcutaneous tissue disorders

Uncommon – angio-oedema

Gastrointestinal disorders

Common – rectal bleeding.

Uncommon – mouth ulcers

Very rare – abdominal pain

Musculoskeletal & connective tissue disorders

Uncommon - myalgia

4.9 Overdose

Symptoms

In case of acute overdose, the likely symptomatology may be peripheral vasodilation with a fall in blood pressure and reflex tachycardia.

Management

Monitoring cardiac function and general supportive measures are recommended. If not successful, increase in circulating plasma volume by substitution of fluid is recommended. In life-threatening situations, administration of vasopressors must be considered. There is no experience of massive overdosage in humans, although the LD50 in dogs is in the range 62.5 to 125 mg/kg and in rodents it is in the order of 1200 mg/kg.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Other vasodilators used in cardiac disease, ATC code: C01DX16

Nicorandil provides a dual mode of action leading to relaxation of vascular smooth muscle. A potassium channel opening action provides arterial vasodilation, thus reducing afterload, while the nitrate component promotes venous relaxation and a reduction in preload. Nicorandil has a direct effect on coronary arteries without leading to a steal phenomenon. The overall action improves blood flow to post-stenotic regions and the oxygen balance in the myocardium.

A reduction of coronary heart disease complications has been shown in patients suffering from angina pectoris who were treated with nicorandil in the IONA study.

The study was a randomised, double blind, placebo controlled, cardiovascular endpoint study carried out in 5126 patients to determine if Nicorandil could reduce the frequency of coronary events in men and women with chronic stable angina and standard anti anginal treatment at high risk of cardiovascular events defined by either: 1) previous myocardial infarction, or 2) coronary artery bypass grafting , or 3) coronary artery disease confirmed by angiography, or a positive exercise test in the previous two years, together with one of the following: left ventricular hypertrophy on the ECG, left ventricular ejection fraction

The primary endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction, or unplanned hospital admission for cardiac chest pain, occurred in 13.1% of patients treated with nicorandil compared with 15.5% of patients receiving placebo (hazard ratio 0.83, p=0.014). The rate of acute coronary syndrome (CHD death, non fatal MI or unstable angina) was 6.1% in patients treated with nicorandil compared with 7.6% in patients receiving placebo (hazard ratio 0.79, p=0.028). All cardiovascular events were significantly less in the nicorandil than placebo group 14.7% vs 17.0% (hazard ratio 0.86 p=0.027). The validity of these finding was confirmed by re-analysing the primary endpoint using all cause rather than cardiovascular mortality (nicorandil 14.9% compared with placebo 17.3%, hazard ratio 0.85, p=0.021). The study was not expressly powered to, nor did it detect any statistically significant reduction in any individual component endpoints.

5.2 Pharmacokinetic Properties

Nicorandil is well absorbed with no significant first-pass metabolism. Maximum plasma concentrations are achieved in 30 to 60 minutes and are directly related to the dosage. Metabolism is mainly by denitration of the molecule into the nicotinamide pathway with less than 20% of an administered dose being excreted in the urine. The main phase of elimination has a half-life of about 1 hour. Nicorandil is only slightly bound to plasma proteins.

No clinically relevant modifications in the pharmacokinetic profile have been seen in the elderly or in patients with liver disease or chronic renal failure.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Maize starch, croscarmellose sodium, stearic acid and mannitol.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

18 months.

Each blister strip should be used within 30 days of opening.

6.4 Special Precautions For Storage

Store in a dry place below 25°C.

6.5 Nature And Contents Of Container

Ikorel tablets 10mg and 20mg are presented in hard tempered aluminium foil/ (Polyamide/aluminium/PVC) blister strips of 10 tablets, in which each tablet is linked to a silica gel capsule dessicant.

The blister strips are packaged in cartons of 60 tablets.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey, GU1 4YS, UK

8. Marketing Authorisation Number(S)

Ikorel tablets 10mg: PL 04425/0327

Ikorel tablets 20mg: PL 04425/0328

9. Date Of First Authorisation/Renewal Of The Authorisation

24 February 2009

10. Date Of Revision Of The Text

22 February 2011

LEGAL STATUS

POM


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Reductil 10mg and 15mg


REDUCTIL 10mg & 15mg Capsules

(sibutramine)

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not give it to others. If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What REDUCTIL is and what it is used for 2. Before you take REDUCTIL 3. How to take REDUCTIL 4. Possible side effects 5. How to store REDUCTIL 6. Further information What Reductil Is And What It Is Used For

Reductil, which contains sibutramine is a medicine to help you lose weight if your doctor has determined you are obese, or over-weight with additional risk factors for obesity such as diabetes and/or elevated lipids. Your doctor may start you on Reductil if diet and exercise for three months didn’t help you lose enough weight. This medicine makes you feel full sooner so you eat less food. By eating less you should be able to lose and control your weight. This medicine is part of your weight loss plan you set up with your doctor.

This medicine should be used together with a low calorie diet and an increase in your physical activity. The combination will also help you lose weight. Your doctor will guide you with your weight loss program and will give you regular check-ups.

Before You Take Reductil Do Not Take REDUCTIL if you have obesity that is not related to overeating if your blood pressure is above 145/90 mmHg whether or not you take blood pressure medicines. if you have, or have had in the past, an eating disorder, such as anorexia or bulimia. if you are allergic to sibutramine or any of the other ingredients of Reductil (please refer to Section 6 or the list of ingredients for this medicine) if you have a mental illness such as manic depression (bipolar disorder) if you are currently using or have used in the past 2 weeks MAOI medicines (to treat depression or Parkinson’s disease) or you have used other medicines to treat depression, psychosis or weight loss or tryptophan to treat sleep disorders. These medicines can affect the amount of the chemical called serotonin in your brain. This can be a problem if you also use Reductil at the same time. if you have Tourette’s syndrome if you have or have ever had heart problems, a raised heart rate, an uneven heart beat, heart failure, hardening of the arteries or strokes if you have an overactive thyroid gland if you have severe kidney disease, are on dialysis or have severe liver disease. if you are a male patient and you notice problems with your prostate. An enlarged prostate may make it hard to empty your bladder even if you feel an urge to urinate. if you have a certain kind of tumours on the adrenal glands (phaeochromocytoma) if you have an eye problem called narrow angle glaucoma. if you abuse drugs, medicines or alcohol or have done so in the past if you are pregnant or planning to become pregnant or if you are breastfeeding. if you are under 18 or over 65 years old. Take Special Care with REDUCTIL

Your doctor will check your progress regularly, measuring your weight, blood pressure and pulse rate to be sure that this medicine is the right treatment for you.

Talk to your doctor: if your blood pressure or heart rate goes up or gets too high. It is very important to have your blood pressure checked if you have a sleeping problem called sleep apnoea. if you experience symptoms such as shortness of breath, chest pain and swollen ankles due to pulmonary hypertension. if you have epilepsy (seizures). if you have kidney or liver problems if you have a family history of tics. if you have depression. if you have a condition that makes you prone to bleeding or if you are taking any medicines that may thin your blood or may increase bleeding. if you have an eye problem called wide angle glaucoma (increase of pressure in your eyes) or if you are at risk because you have a relative who has had this condition.

Your doctor will decide if you should continue taking this medicine.

Important information about some of the ingredients of REDUCTIL

Reductil contains lactose. If you have been told by your doctor that you are have an intolerance to some sugars, tell your doctor taking this medicinal product.

Using Other Medicines

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.

Several medicines can cause unwanted reactions if used with Reductil. Ask your doctor or pharmacist for advice before taking this medicine. In particular tell your doctor if you are using any of the following medicines:

if you are currently using or have used in the past 2 weeks MAOI medicines (to treat depression or Parkinson’s disease) or you have used other medicines to treat depression, psychosis or weight loss or tryptophan to treat sleep disorders (see Do Not Take REDUCTIL). medicines to treat migraine headaches e.g. sumatriptan, ergot (dihydroergotamine) some kinds of strong pain-killers: for example, fentanyl and pethidine, pentazocine. certain medicines that can increase blood pressure, such as cold or allergy medications e.g. dextromethorphan, ephedrine, pseudoephedrine. cimetidine (a medicine used to treat ulcers) some medicines to treat infections including antibiotics, such as rifampicin, erythromycin, troleandomycin and clarithromycin, or antifungal medicines, such as itraconazole and ketoconazole. Talk to your doctor if you are using any medicine to treat an infection. some epilepsy (seizure) medicines: carbamazepine, phenobarbitone and phenytoin. some medicines called steroids and medicines that affect your body’s ability to fight disease: such as dexamethasone and cyclosporin. Taking REDUCTIL with Food and Drink It doesn’t matter if you have eaten or not when you take this medicine. This medicine should be swallowed whole with a full glass of water. Pregnancy and Breast-feeding

You shouldn’t use Reductil if you are pregnant or planning to become pregnant. Take measures to avoid becoming pregnant while using this medicine. Do not breast-feed if you are taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and Using Machines

If you find that this medicine affects your judgment, your thinking or your coordination, you should not drive or use tools or machinery.

How To Take Reductil

Always take this medicine exactly as your doctor has told you. If you are not sure, you should check with your doctor.

The starting dose is one 10mg capsule of Reductil every morning, swallowed whole with a glass of water. Do not chew or break open the capsule. It doesn’t matter if you have eaten or not when you take this medicine.

If you haven’t lost about four pounds (two kilograms) of weight during the first four weeks you take Reductil, your doctor may want to increase your dose of this medicine to one 15 mg capsule taken once a day. Reductil must be taken as prescribed by your doctor.

If you take more REDUCTIL than you should

If you took more Reductil than you should, immediately tell your doctor or pharmacist. Taking too much Reductil may make you feel dizzy. Your heart may beat faster and your blood pressure may increase. You may also get a headache.

If you forget to take REDUCTIL

If you do forget to take a dose, just skip it. Do not take a double dose to make up for the one you have missed. Talk to your doctor or pharmacist if you have any questions about how to take this medicine.

If you stop taking REDUCTIL

If you stop taking this medicine, you might get a headache or want to eat more. If this happens, talk to your doctor.

Possible Side Effects

Like all medicines, Reductil can cause side effects, although not everyone gets them. Most side effects occur during the first four weeks of treatment. Most of these are not serious, occur less often and became less marked over time or go away when this medicine is stopped.

The following side effects have been seen with Reductil. Some of these may become serious. You should talk to your doctor and/or pharmacist if you notice any of the following.

An increase in blood pressure or heart rate. An irregular heart beat such as a fluttering of the heart A rare but serious problem called serotonin syndrome. This is a combination of symptoms that can include feeling confused, sweating, shaking, nausea, hallucinations, sudden jerking of the muscles or a fast heart beat. This may occur when people take other medicines that affect a brain chemical called serotonin along with this medicine. If you get breathing problems, chest pains or swollen ankles. Unusual bleeding or unusual bruising, or if it takes you longer than usual to stop bleeding. If you get a rash or hives, trouble breathing, fainting and swelling of the face and throat. You may be having an allergic reaction which may need emergency treatment. If you get any of these symptoms, stop taking this medicine and talk to your doctor right away.

Very common side effects (in more than 1 in 10 patients taking this medicine in clinical trials) include:

trouble sleeping, constipation, dry mouth

Common side effects (in less than 1 in 10 patients taking this medicine in clinical trials) include:

a fast heart beat, increased blood pressure, awareness of the heart beat (palpitations), nausea, headache, anxiety, a “pins-and-needles” feeling, dizziness, hot flushes or sweating. If you have haemorrhoids (piles), they could become worse.

Foods and drinks may taste different than they used to or you may have a different taste in your mouth.

Other side effects include (less common or with an unknown frequency): seizures, trouble remembering things, blurred vision, diarrhoea, vomiting, thinning hair, erectile dysfunction/abnormal orgasms, menstrual disorders, bleeding into the skin with joint pain, feeling agitated or depressed, bleeding in the stomach, kidney problems, inability to empty the bladder and increases in certain liver tests.

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Reductil

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package in order to protect from moisture.

Do not use this medicine if you notice the capsules are damaged or don’t look right in some other way.

Do not use this medicine after the expiry date which is stated on the blister strip and the carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or with household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What REDUCTIL Contains

The active substance is sibutramine, as sibutramine hydrochloride monohydrate.

Reductil Capsules also contain the following non active ingredients: Lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica.

Capsule shell and markings contain: Indigo carmine (E132), titanium dioxide (E171), gelatin, sodium lauryl sulphate, dimethicone, propylene glycol, iron oxide black (E172), shellac glaze, lecithin (E322).

Reductil 10 mg capsules also contain quinilone yellow (E104).

What REDUCTIL looks like and contents of the pack

Reductil 10mg Capsules are immediate release hard gelatin capsules with a blue cap and yellow body

Reductil 15mg Capsules are immediate release hard gelatin capsules with a blue cap and white body

Reductil capsules are available in a PVC/PVDC blister strip calendar packs.

Calendar packs containing 28 capsules (4 weeks), 56 capsules (8 weeks) and 98 capsules (14 weeks) Hospital packs (calendar packs) containing 28 capsules and 280 (10 x 28) capsules Marketing Authorisation Holder and Manufacturer Abbott Laboratories Ltd. Queenborough Kent ME11 5EL United Kingdom

Reductil is made by

Abbott GmbH & Co. KG Knollstrasse 67061 Ludwigshafen Germany

This leaflet was last approved in November 2007


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Morphgesic 10mg Tablets


1. Name Of The Medicinal Product

Rhotard Morphine SR 10 mg Tablets

Morphgesic SR 10 mg Tablets

2. Qualitative And Quantitative Composition

Rhotard Morphine SR 10 mg Tablets/ Morphgesic SR 10 mg Tablets contain 10mg Morphine Sulphate.

Each 10mg tablet is a buff coloured biconvex round film coated tablet.

3. Pharmaceutical Form

Controlled release tablets

4. Clinical Particulars 4.1 Therapeutic Indications

For the prolonged relief of severe pain.

4.2 Posology And Method Of Administration

Route of administration: Oral

Rhotard Morphine SR/ Morphgesic SR tablets should be swallowed whole and not chewed.

Adults:

The dosage is dependent upon the severity of the pain and the patient's previous history of analgesic requirements. The tablets should normally be administered twice daily at 12 hourly intervals. One or two 10 mg tablets (10mg) twice daily is the recommended starting dosage for a patient presenting with severe pain. With increasing severity of pain it is recommended that the dosage of morphine be increased to achieve the desired relief. The dosage may be varied by choosing combinations of available strengths (10, 30, 60, and 100 mg) or by using higher strength tablets alone.

It is recommended that a patient transferred from another oral morphine preparation, having similar bioavailability to oral morphine liquid, should receive the same total morphine dose in one 24-hour period. This total dose should be divided between the morning and evening administration. Dosage titration and clinical assessment may be appropriate.

Where a patient had previously received parenteral morphine prior to being transferred to Rhotard Morphine SR/ Morphgesic SR tablets, a higher dosage of morphine may be required. Individual dosage adjustment will be necessary to compensate for any reduction in analgesic effect associated with oral administration.

When Rhotard Morphine SR/ Morphgesic SR tablets is to be given for the relief of post-operative pain, it is not advisable to administer it during the first 24 hours. Following this initial period, the dosage should be at the physician's discretion.

Some patients may require supplemental parenteral morphine which is perfectly acceptable. Careful attention should be paid to the total morphine dosage however, and the prolonged effects of morphine in the Rhotard Morphine SR/ Morphgesic SR formulation should also be borne in mind.

Rhotard Morphine SR/ Morphgesic SR tablets should be used with caution post-operatively (as with all morphine preparations) but especially in cases of 'acute abdomen' and following abdominal surgery.

Gastric motility should have returned and be maintained.

Children:

Rhotard Morphine SR/ Morphgesic SR tablets are not recommended for paediatric use.

4.3 Contraindications

Respiratory depression, paralytic ileus, delayed gastric emptying, obstructive airways disease, known morphine sensitivity or acute hepatic disease. It is also contra-indicated in the presence of hypersensitivity to any of the constituents, acute alcoholism, head injuries and conditions in which intracranial pressure is raised. Neither should it be given during an attack of bronchial asthma nor heart failure secondary to chronic lung disease.

Not recommended for pre-operative use or for the first 24 hours post-operatively.

Not recommended during pregnancy and lactation.

Concurrent administration of monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuation of their use.

4.4 Special Warnings And Precautions For Use

Rhotard Morphine SR/ Morphgesic SR tablets should be given with caution or in reduced doses to patients with hypothyroidism, adrenocortical insufficiency, impaired kidney or liver function, prostatic hypertrophy or shock. It should be used with caution in patients with either obstructive bowel disorders or myasthenia gravis.

Caution in patients with convulsive disorders, hypotension with hypovolaemia, the elderly, opioid dependent patients, diseases of the biliary tract, pancreatitis and inflammatory bowel disorders.

Should not be used where there is a possibility of paralytic ileus occurring. Should paralytic ileus be suspected to occur during use, treatment should be discontinued immediately.

As with all morphine preparations, patients who are to undergo cordotomy or other pain relieving surgical procedures should not receive Rhotard Morphine SR/ Morphgesic SR tablets for 24 hours prior to surgery. If further treatment is then indicated, the dosage should be adjusted to the new post-operative requirement.

It is not possible to ensure bio-equivalence between different brands of controlled release morphine products. Therefore, it should be emphasised that patients, once titrated to an effective dose should not be changed from Rhotard Morphine SR/ Morphgesic SR tablets to other slow, sustained or controlled release morphine or other potent narcotic analgesic preparations without retitration and clinical assessment.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Rhotard Morphine SR/ Morphgesic SR tablets should not be concurrently administered with monoamine oxidase inhibitors (MAOI's) or used within two weeks of discontinuation of MAOI use. The depressant effects of morphine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, tricyclic antidepressants and phenothiazines. The action of morphine may in turn affect the activities of other compounds, for example its gastro-intestinal effects may delay absorption as with mexilitine or may be counteractive as with metoclopramide.

Cimetidine inhibits the metabolism of morphine.

Morphine potentiates the effects of tranquillisers, muscle relaxants and anti-hypertensives.

Mixed agonist/antagonist opioid analgesics (e.g. Buprenorphine, nalbuphine, pentazocine) should not be administered to a patient who has received a course of therapy with a pure opioid agonist analgesic.

4.6 Pregnancy And Lactation

Rhotard Morphine SR/ Morphgesic SR tablets are contraindicated during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

Patients taking Rhotard Morphine SR/ Morphgesic SR tablets should not operate machines.

4.8 Undesirable Effects

The commonest side-effects of morphine when administered at normal doses are nausea, vomiting, constipation, drowsiness and confusion. Micturition may be difficult and there may be ureteric or biliary spasm. There is also an antidiuretic effect. Dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypothermia, restlessness, changes of mood and miosis also occur. These effects occur more commonly in ambulant patients than in those at rest in bed. Raised intracranial pressure occurs in some patients. Larger doses of morphine produce respiratory depression and hypotension with circulatory failure and deepening coma. Death may occur from respiratory failure. Toxic doses vary considerably with the individual. Tolerance and dependence may occur.

Paralytic ileus may be associated with opioid usage. Other effects include bronchospasm, headache, disorientation, hallucinations, rash, myoclonus, decreased libido and colic.

Morphine has histamine releasing effects which may be responsible in part for reactions such as urticaria and pruritus.

4.9 Overdose

In acute poisoning by Rhotard Morphine SR/ Morphgesic SR tablets, the stomach should be emptied by aspiration and lavage. A laxative may be given to aid peristalsis. Signs of morphine toxicity and overdose are likely to consist of pin-point pupils, respiratory depression and hypotension. Circulatory failure and deepening coma may occur in more severe cases.

Treatment of respiratory failure and shock may require intensive supportive therapy. In addition to this the specific antagonist naloxone hydrochloride should be administered at a dose of 0.4 to 2 mg iv. This dose should be repeated at intervals of 2 to 3 minutes if required, up to a total dose of 10mg.

The physician should be aware that Rhotard Morphine SR/ Morphgesic SR tablets remaining in the intestine will continue to release morphine sulphate for a period of hours.

Rhabdomyolysis progressing to renal failure has been reported in opioid overdosage.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Morphine is an opioid analgesic. It acts mainly on the central nervous system and on smooth muscle. Although morphine is predominantly a central nervous system depressant it has some central stimulant actions which results in nausea and vomiting and miosis. Morphine generally increases smooth muscle tone, especially the sphincters of the gastro-intestinal tract.

Morphine and related analgesics may produce both physical and psychological dependence and should therefore be used with discrimination. Tolerance may also develop.

Morphine is an analgesic used for the symptomatic relief of moderate to severe pain, especially that associated with neoplastic disease, myocardial infarction and surgery. When pain is likely to be short of duration, a short-acting analgesic is usually preferred in addition to relieving pain, morphine also alleviates the anxiety associated with severe pain. It is useful as a hypnotic where sleeplessness is due to pain and may also relieve the pain of biliary or renal colic, although an antispasmodic may also be required since morphine may increase smooth muscle tone.

Morphine reduces intestinal motility and is used in the symptomatic treatment of diarrhoea. It also relieves the dyspnoea of left ventricular failure and of pulmonary oedema. It is effective for the suppression of cough, but codeine is usually preferred as there is less risk of dependence. Morphine has been used pre-operatively as an adjunct to anaesthesia for pain relief and to allay anxiety. It has also been used in high doses as a general anaesthetic in specialised procedures. Morphine is usually administered as the sulphate, although the hydrochloride and the tartrate are used in similar doses; the acetate has also been used. Routes of administration include the oral, subcutaneous, intramuscular, intravenous, intraspinal and rectal routes. Parenteral doses may be intermittent injections or continuous or intermittent infusions adjusted according to individual analgesic requirements.

5.2 Pharmacokinetic Properties

Morphine has a plasma half life of about 2 to 3 hours and if given IV must be administered frequently. Rhotard Morphine SR/ Morphgesic SR, being a sustained release preparation of morphine, has the advantage that it is only administered twice daily.

A summary of the morphine pharmacokinetic parameters is given below:

(a) Half life; plasma half life; about 2-3 hours

(b) Volume of distribution; about 3-5 litres/KG

(c) Clearance; plasma clearance; about 15 to 20 ml/min/kg

(d) Protein binding; in plasma 20-35%

Pharmacokinetic parameters pertinent to Rhotard Morphine SR/ Morphgesic SR tablets are summarised in the following table:

Parameters

Rhotard Morphine SR/ Morphgesic SR Tablets

Fasting (A)

Rhotard Morphine SR/ Morphgesic SR Tablets

Food (B)

AUC (0-t)

(ng.h/ml)

46.02 ± 18.85

59.88 ± 20.52

Cmax

(ng/ml)

9.2 ± 3.6

13.6 ± 4.6

T max

hours

2.5 ± 1.7

3.9 ± 1.6

5.3 Preclinical Safety Data

No preclinical safety data are available which are additional to the experience gained in man with morphine over many years.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Lactose, Hydroxyethylcellulose, Hypromellose (E464), Povidone, Talc, Magnesium Stearate, Macrogol and Industrial Methylated Spirits 99% BP.

Rhotard Morphine SR 10 mg Tablets/ Morphgesic SR 10 mg Tablets contain the colourants listed below:

Titanium Dioxide (E171)

Iron Oxide Yellow (172)

Iron Oxide Red (E172)

6.2 Incompatibilities

None.

6.3 Shelf Life

36 Months

6.4 Special Precautions For Storage

Do not store above 25°C. Store in the original package.

6.5 Nature And Contents Of Container

Each pack contains either 10 or 60 tablets in PVC blister packs with aluminium foil lidding.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Waymade plc

Trading as Sovereign Medical

Sovereign House

Miles Gray Road

Basildon

Essex.

SS14 3FR

United Kingdom

And trading as Amdipharm

Regency House

Miles Gray Road

Basildon

Essex

SS14 3AF

United Kingdom

8. Marketing Authorisation Number(S)

PL 06464/1651

9. Date Of First Authorisation/Renewal Of The Authorisation

28 June 2002

10. Date Of Revision Of The Text

April 2003


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Ramipril 1.25mg, 2.5mg, 5mg & 10mg Capsules


Ramipril 1.25mg, 2.5mg, 5mg and 10mg Capsules

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect In this leaflet: 1. What ramipril is and what it is used for. 2. Before you take ramipril. 3. How to take ramipril. 4. Possible side effects. 5. How to store ramipril. 6. Further Information. What Ramipril Is And What It Is Used For

The name of your medicine is Ramipril 1.25mg, 2.5mg, 5mg or 10mg Capsules (called ramipril throughout this leaflet). It belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).

Ramipril works by:

Decreasing your body’s production of substances that could raise your blood pressure Making your blood vessels relax and widen Making it easier for your heart to pump blood around your body.

Ramipril can be used:

To treat high blood pressure (hypertension) To reduce the risk of you having a heart attack or stroke To reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes) To treat your heart when it cannot pump enough blood to the rest of your body (heart failure) As treatment following heart attack (myocardial infarction) complicated with heart failure. Before You Take Ramipril Do not take ramipril: If you are allergic (hypersensitive) to ramipril, any other ACE inhibitor medicine or any of the other ingredients of ramipril capsules (see Section 6).
Signs of an allergic reaction may include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. If you have ever had a serious allergic reaction called “angioedema”. The signs include itching, hives (urticaria), red marks on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing. If you are having dialysis or any other type of blood filtration. Depending on the machine that is used, ramipril may not be suitable for you If you have kidney problems where the blood supply to your kidney is reduced (renal artery stenosis) During the last 6 months of pregnancy (see section below on “Pregnancy and breast-feeding”) If your blood pressure is abnormally low or unstable. Your doctor will need to make this assessment.

Do not take ramipril if any of the above apply to you. If you are not sure, talk to your doctor before taking ramipril.

Take special care with ramipril

Check with your doctor or pharmacist before taking your medicine :

If you have heart, liver or kidney problems If you have lost a lot of body salts or fluids (through being sick (vomiting), having diarrhoea, sweating more than usual, being on a low salt diet, taking diuretics (water tablets) for a long time or having had dialysis) If you are going to have treatment to reduce your allergy to bee or wasp stings (desensitisation) If you are going to receive an anaesthetic. This may be given for an operation or any dental work. You may need to stop your ramipril treatment one day beforehand; ask your doctor for advice If you have high amounts of potassium in your blood (shown in blood test results) If you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus You must tell your doctor if you think that you are (or might become) pregnant. Ramipril is not recommended in the first 3 months of pregnancy and may cause serious harm to your baby after 3 months of pregnancy, see section “Pregnancy and breast-feeding”. Children

Ramipril is not recommended for use in children and adolescents below 18 years of age because there is no information available in this population.

If any of the above apply to you (or you are not sure), talk to your doctor before taking ramipril.

Taking ramipril with other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (including herbal medicines). This is because ramipril can affect the way some other medicines work. Also some medicines can affect the way ramipril works.

Please tell your doctor if you are taking any of the following medicines. They can make ramipril work less well:

Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indometacin and aspirin) Medicines used for the treatment of low blood pressure, shock, cardiac failure, asthma or allergies such as ephedrine, noradrenaline or adrenaline. Your doctor will need to check your blood pressure.

Please tell your doctor if you are taking any of the following medicines. They can increase the chance of getting side effects if you take them with ramipril:

Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indometacin and aspirin) Medicines for cancer (chemotherapy) Medicines to stop the rejection of organs after a transplant such as ciclosporin Diuretics (water tablets) such as furosemide Medicines which can increase the amount of potassium in your blood such as spironolactone, triamterene, amiloride, potassium salts and heparin (for thinning blood) Steroid medicines for inflammation such as prednisolone Allopurinol (used to lower the uric acid in your blood) Procainamide (for heart rhythm problems).

Please tell your doctor if you are taking any of the following medicines. They may be affected by ramipril:

Medicines for diabetes such as oral glucose lowering medicines and insulin. Ramipril may lower your blood sugar. Check your blood sugar closely while taking ramipril Lithium (for mental health problems). Ramipril may increase the amount of lithium in your blood. Your lithium levels will need to be closely checked by your doctor.

If any of the above apply to you (or you are not sure), talk to your doctor before taking ramipril.

Taking ramipril with food and alcohol Drinking alcohol with ramipril may make you feel dizzy or light-headed. If you are concerned about how much you can drink while you are taking ramipril, discuss this with your doctor as medicines used to reduce blood pressure and alcohol can have additive effects. Ramipril may be taken with or without food. Pregnancy and breast-feeding

You must tell your doctor if you think that you are (or might become) pregnant
You should not take ramipril in the first 12 weeks of pregnancy, and you must not take them at all after the 13th week as their use during pregnancy may possibly be harmful to the baby.

If you become pregnant while on ramipril, tell your doctor immediately. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy.

You should not take ramipril if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You may feel dizzy, while taking ramipril. This is more likely to happen when you start taking ramipril or start taking a higher dose. If this happens, do not drive or use any tools or machines.

How To Take Ramipril

Always take ramipril exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine Take this medicine by mouth at the same time of the day each day. Swallow the capsules whole with liquid. Do not crush or chew the capsules. How much to take

Treatment of high blood pressure

The usual starting dose is 1.25mg or 2.5mg once daily. Your doctor will adjust the amount you take until your blood pressure is controlled. The maximum dose is 10 mg once daily. If you are already taking diuretics (water tablets), your doctor may stop or reduce the amount of the diuretic you take before beginning treatment with ramipril.

To reduce the risk of you having a heart attack or stroke

The usual starting dose is 2.5 mg once daily. Your doctor may then decide to increase the amount you take. The usual dose is 10 mg once daily.

Treatment to reduce or delay the worsening of kidney problems

You may be started on a dose of 1.25 mg or 2.5 mg once daily. Your doctor will adjust the amount you are taking. The usual dose is 5 mg or 10 mg once daily.

Treatment of heart failure

The usual starting dose is 1.25 mg once daily. Your doctor will adjust the amount you take. The maximum dose is 10 mg daily. Two administrations per day are preferable.

Treatment after you have had a heart attack

The usual starting dose is 1.25 mg once daily to 2.5 mg twice daily. Your doctor will adjust the amount you take. The usual dose is 10 mg daily. Two administrations per day are preferable.

Elderly

Your doctor will reduce the initial dose and adjust your treatment more slowly.

If you take more ramipril than you should

Tell a doctor or go to the nearest hospital casualty department straight away. Do not drive to the hospital, get somebody else to take you or call for an ambulance. Take the medicine pack with you. This is so the doctor knows what you have taken.

If you forget to take ramipril If you miss a dose, take your normal dose when it is next due. Do not take a double dose to make up for a forgotten capsule.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, ramipril can cause side effects, although not everybody gets them.

Stop taking ramipril and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment: Swelling of the face, lips or throat which make it difficult to swallow or breathe, as well as itching and rashes. This could be a sign of a severe allergic reaction to ramipril capsules Severe skin reactions including rash, ulcers in your mouth, worsening of a pre-existing skin disease, reddening, blistering or detachment of skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiform). Tell your doctor immediately if you experience: Faster heart rate, uneven or forceful heartbeat (palpitations), chest pain, tightness in your chest or more serious problems including heart attack and stroke Shortness of breath or a cough. These could be signs of lung problems Bruising more easily, bleeding for longer than normal, any sign of bleeding (e.g. bleeding from the gums), purple spots, blotching on the skin or getting infections more easily than usual, sore throat and fever, feeling tired, faint, dizzy or having pale skin. These can be signs of blood or bone marrow problems Severe stomach pain which may reach through to your back. This could be a sign of pancreatitis (inflammation of the pancreas). Fever, chills, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of your skin or eyes (jaundice). These can be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage. Other side effects include:

Please tell your doctor if any of the following gets serious or lasts longer than a few days.

Common (affects less than 1 in 10 people)

Headache or feeling tired Feeling dizzy. This is more likely to happen when you start taking ramipril or start taking a higher dose Fainting, hypotension (abnormally low blood pressure), especially when you stand or sit up quickly Dry tickly cough, inflammation of your sinuses (sinusitis) or bronchitis, shortness of breath Stomach or gut pain, diarrhoea, indigestion, feeling or being sick Skin rash with or without raised area Chest pain Cramps or pain in your muscles Blood tests showing more potassium than usual in your blood.

Uncommon (affects less than 1 in 100 people)

Balance problems (vertigo) Itching and unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paraesthesia) Loss of or change in the way things taste Sleep problems Feeling depressed, anxious, more nervous than usual or restless Blocked nose, difficulty breathing or worsening of asthma A swelling in your gut called “intestinal angioedema” presenting with symptoms like abdominal pain, vomiting and diarrhoea Heartburn, constipation or dry mouth Passing more water (urine) than usual over the day Sweating more than usual Loss or decrease of appetite (anorexia) Increased or irregular heartbeat Swollen arms and legs. This may be a sign of your body holding onto more water than usual Flushing Blurred vision Pain in your joints Fever Sexual inability in men, reduced sexual desire in men or women An increased number of certain white blood cells (eosinophilia) found during a blood test Blood tests showing changes in the way your liver, pancreas or kidneys are working.

Rare (affects less than 1 in 1,000 people)

Feeling shaky or confused Red and swollen tongue Severe flaking or peeling of the skin, itchy, lumpy rash Nail problems (e.g. loosening or separation of a nail from its bed) Skin rash or bruising Blotches on your skin and cold extremities Red, itchy, swollen or watery eyes Disturbed hearing and ringing in your ears Feeling weak Blood tests showing a decrease in the number of red blood cells, white blood cells or platelets or in the amount of haemoglobin.

Very rare (affects less than 1 in 10,000 people)

Being more sensitive to the sun than usual. Other side effects reported:

Please tell your doctor if any of the following gets serious or lasts longer than a few days.

Difficulty concentrating Swollen mouth Blood tests showing too few blood cells in your blood Blood tests showing less sodium than usual in your blood Fingers and toes changing colour when you are cold and then tingling or feeling painful when you warm up (Raynaud’s phenomenon) Breast enlargement in men Slowed or impaired reactions Burning sensation Change in the way things smell Hair loss.

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Ramipril Keep out of the reach and sight of children. Do not use Ramipril Capsules after the expiry date which is stated on the label of the carton. Store below 25°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Further Information What Ramipril Capsules contain. The active substance is ramipril. The other ingredients are pregelatinised starch and gelatin. The 1.25mg capsules also contain titanium dioxide (E171) and yellow ferric oxide (E172). The 2.5mg capsules also contain erythrosine (E127), titanium dioxide (E171) and yellow ferric oxide (E172). The 5mg capsules also contain erythrosine (E127), patent blue (E131) and titanium dioxide (E171). The 10mg capsules also contain erythrosine (E127), indigo carmine (E132), titanium dioxide (E171) and black ferric oxide (E172). What Ramipril Capsules look like and contents of the pack Ramipril 1.25mg Capsules are yellow and white hard capsules. Ramipril 2.5mg Capsules are orange and white hard capsules. Ramipril 5mg Capsules are scarlet and white hard capsules. Ramipril 10mg Capsules are blue and white hard capsules.

All strengths are supplied in blister (calendar) packs of 28 capsules.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aventis Pharma Ltd 50 Kings Hill Avenue Kings Hill West Malling ME19 4AH UK

Manufacturer

Sanofi Winthrop Industrie 6 Boulevard de L’Europe F-21800 Qu?tigny France

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in April 2009


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Diazepam 5mg / 5ml Forte Syrup (Sandoz Limited)


1. Name Of The Medicinal Product

Diazepam Forte Syrup 5mg/5ml

2. Qualitative And Quantitative Composition

Each 5ml contains 5mg of Diazepam B.P.

3. Pharmaceutical Form

Oral Solution

4. Clinical Particulars 4.1 Therapeutic Indications

Diazepam has anticonvulsant, anxiolytic, sedative, muscle relaxant and amnesic properties.

Diazepam Forte Syrup 5mg/5ml is indicated for

Adults

i) For the short-term relief (2-4 weeks only) of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic or psychotic illness;

ii) As a sedative and premedicant;

iii) As an anticonvulsant in the management of status epilepticus, febrile convulsions and poisoning;

iv) In the control of muscle spasms as in tetanus;

v) In the management of alcohol withdrawal symptoms;

vi) In selected cases it may be useful in the management of cerebral spasticity;

Children

i) Night terrors and somnambulism;

ii) Premedication;

iii) In the control of muscle spasms as in tetanus;

iv) In selected cases, it may be useful in controlling tension and irritability in cerebral spasticity;

The use of diazepam to treat short term anxiety is inappropriate and unsuitable. Diazepam should be used to treat insomnia only when it is severe, disabling or subjecting the individual to extreme stress.

4.2 Posology And Method Of Administration

Adults:

Anxiety States: 2mg three times daily up to 30mg daily in divided doses.

Insomnia associated with Anxiety: 5mg to 15mg before retiring.

Muscle Spasms: 2mg to 15mg daily in divided doses up to 60mg in severe spastic disorders such as cerebral spasticity, epilepsy and muscle spasms associated with upper-motor neurone disease.

In the control of muscle spasms as in tetanus: 3mg to 10mg/kg bodyweight daily.

Alcohol Withdrawal Symptoms: 5mg to 20mg repeated within 2 to 4 hours if necessary.

Premedication in Dental Patients: 5mg the night before, 5mg on waking and another 5mg 2 hours before the appointment.

Elderly or Debilitated patients: The dosage should be half that recommended in adults.

Children:

Night Terrors and Somnambulism: 1mg to 5mg daily before retiring.

Premedication: 2mg to 10mg.

Management of Cerebral Spasticity: 2mg to 40mg daily in divided doses.

In the control of Muscle spasms as in Tetanus: 3mg to 10mg/kg bodyweight daily.

Doses should be repeated only on medical advice. Long-term chronic use is not recommended and treatment should always be tapered off gradually. When a benzodiazepine is used as a hypnotic, treatment should, if possible, be intermittent.

Route of administration

Oral.

4.3 Contraindications

Patients with a known sensitivity to benzodiazepines, acute pulmonary insufficiency; respiratory depression.

4.4 Special Warnings And Precautions For Use

The lowest dose that can control the symptoms should be used and treatment should not be continued beyond 4 weeks. The risk of dependence increases when high dosages are attained, especially when given over long periods. This is particularly so in patients with a history of alcoholism, drug abuse or in patients with marked personality disorders.

Treatment should always be tapered off gradually. Sudden cessation of treatment can result in symptoms such as depression, nervousness, rebound insomnia, irritability, sweating and diarrhoea even in patients receiving normal therapeutic doses for short periods of time. Abrupt withdrawal following high dosage may produce confusion, toxic psychosis, convulsions or a condition resembling delirium tremens.

Diazepam should not be used to treat chronic psychoses or phobic or obsessional states. Because diazepam-induced disinhibition may precipitate suicidal or aggressive behaviour, it should not be used alone to treat depression or anxiety related depression. Caution must be exercised when treating patients with personality disorders.

Elderly or debilitated patients may be more prone to adverse effects and care must be taken in patients with impaired liver or kidney function. Care is also required in patients with organic brain disease (particularly arteriosclerosis).

Diazepam should be avoided in cases of loss or bereavement as psychological adjustment may be inhibited by benzodiazepines.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Sedation, or respiratory or cardiovascular depression may be enhanced if diazepam is combined with centrally acting drugs such as alcohol, anaesthetics, analgesics, antidepressants, hypnotics, neuroleptics and tranquillisers. Concomitant intake with alcohol is not recommended since the sedative effect is increased. Diazepam is primarily metabolised by hepatic microsomal oxidation and drugs which affect liver enzymes, such as cimetidine and phenobarbitone, may alter its pharmacokinetics. Diazepam has been reported to be displaced from protein-binding sites by sodium valproate.

4.6 Pregnancy And Lactation

If the product is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuance of the product if she intends to become or suspects that she is pregnant.

If, for compelling medical reasons, the product is administered during the late phase of pregnancy or during labour at high doses, effects on the neonate such as hypothermia, hypotonia and moderate respiratory depression can be expected owing to the pharmacological action of the compound.

Infants born to mothers who took benzodiazepines chronically during the latter stages of pregnancy may have developed physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period.

Since benzodiazepines are found in the breast milk, benzodiazepines should not be given to breast feeding mothers.

4.7 Effects On Ability To Drive And Use Machines

The side-effects of diazepam, such as sedation and impaired muscle function, may adversely affect the ability to drive or use machines. Insufficient sleep may also increase the likelihood of impaired alertness. (see also interactions, Section 4.5)

4.8 Undesirable Effects

Diazepam may cause drowsiness, sedation, blurring of vision, unsteadiness and ataxia. These may occur after single as well as repeated doses and persist to the following day. Less common effects include vertigo, headache, confusion, slurred speech, visual disturbance, tremor, change in libido, skin rashes and gastro-intestinal upset. Jaundice or blood dyscrasias have been reported rarely. High doses may be associated with respiratory depression or hypotension.

Abnormal psychological reactions to benzodiazepines have been reported. Rare behavioural adverse effects including paradoxical aggressive outbursts, excitement, confusion and the uncovering of depression with suicidal tendencies.

4.9 Overdose

Symptoms

Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Coma, hypotension and respiratory depression occasionally occur but are seldom serious if these drugs are taken alone. Coma usually lasts only a few hours but in elderly people it may be more protracted and cyclical. Benzodiazepine respiratory depressant effects are more serious in patients with severe chronic respiratory disease.

Benzodiazepines potentiate the effects of other central nervous system depressants, including alcohol.

Management

Consider activated charcoal in adults or children who have taken more than 1 mg/kg within 1 hour, provided they are not too drowsy. Gastric lavage is unnecessary if these drugs have been taken alone. Patients who are asymptomatic at four hours are unlikely to develop symptoms. Institute supportive measures as indicated by the patient's clinical state.

If CNS depression is severe consider the use of flumazenil (Anexate), a benzodiazepine antagonist. This should rarely be required. It has a short half-life (about an hour) and should NOT TO BE USED IN MIXED OVERDOSE OR AS A "DIAGNOSTIC" TEST. It is contraindicated in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants).

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Diazepam has potent anxiolytic anti-convulsant and central muscle relaxant properties, these effects are probably mediated through special areas of the CNS. Diazepam has little autonomic activity.

5.2 Pharmacokinetic Properties

The following results were obtained following a pharmacokinetic study with healthy volunteers

 

 

Diazepam 5mg/5ml Syrup (Lagap)

cmax (mean ± S.D.)

275 ± 73

tmax (mean)

1 hour

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars 6.1 List Of Excipients

Glycerin, sucrose, microcrystalline cellulose, methyl hydroxybenzoate, propyl hydroxybenzoate, alcohol (96%), sodium carboxymethylcellulose, Flavouring Agent (Framboise/raspberry 50969A), Ponceau 4R (E124), potassium sorbate and purified water.

6.2 Incompatibilities

None Known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Store below 25?C. Protect from light.

6.5 Nature And Contents Of Container

Amber glass bottles with screw caps and plastic inserts.

Pack sizes: 50ml, 100ml, 150ml, 200ml, 250ml, 300ml and 500ml

6.6 Special Precautions For Disposal And Other Handling

Shake well before use.

7. Marketing Authorisation Holder

Sandoz Ltd

Woolmer Way

Bordon

Hampshire

GU35 9QE

8. Marketing Authorisation Number(S)

PL 4416/0067

9. Date Of First Authorisation/Renewal Of The Authorisation

16th April 1984 / 30th January 1995

10. Date Of Revision Of The Text

6 July 2005


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Ismelin ampoules 10mg / ml


1. Name Of The Medicinal Product

Ismelin®ampoules l0mg/ml

2. Qualitative And Quantitative Composition

Guanethidine monosulphate Ph.Eur. 10mg/ml

3. Pharmaceutical Form

A colourless solution in a clear glass l ml ampoule, for intramuscular administration.

4. Clinical Particulars 4.1 Therapeutic Indications

Control of hypertensive crises, and to obtain more rapid blood pressure control.

4.2 Posology And Method Of Administration

Adults:

Ismelin should be given by intramuscular injection. One injection of 10 to 20mg will generally cause a fall in blood pressure within 30 minutes which reaches a maximum in one to two hours and is maintained for four to six hours. If a further dose of 10 to 20mg is deemed necessary, then three hours should be allowed to elapse between doses.

In hypertensive patients with moderate renal insufficiency, the intervals between dosing should be extended or the dosage reduced to avoid accumulation as the drug is renally excreted. (For patients with renal failure, see Section 4.3, "Contra

Children: not recommended.

Elderly: Clinical evidence would indicate that no special dosage regime is necessary, but concurrent coronary or cerebral insufficiency should be taken into account.

4.3 Contraindications

Cases of phaeochromocytoma and patients previously treated with monoamine oxidase inhibitors (see Section 4.5, "Interactions with other medicaments and other forms of interaction"); in such cases, Ismelin may lead to the release of large quantities of catecholamines, which may cause a hypertensive crisis.

Patients with known hypersensitivity to guanethidine and related derivatives. Heart failure due to causes other than hypertension. Renal failure (creatinine clearance 10 to 40ml/min).

4.4 Special Warnings And Precautions For Use

Heat and physical exertion may increase the antihypertensive effect of Ismelin.

Ismelin should be used with caution in patients with moderate renal insufficiency (creatinine clearance 41 to 65ml/min), or with coronary and/or cerebral arteriosclerosis; abrupt lowering of blood pressure should be avoided. Caution should be exercised in asthmatic patients or in patients with a history of gastro

The concurrent administration of guanethidine and ?

When patients have to undergo surgery, it is recommended that treatment with Ismelin be withdrawn a few days before the operation. To avoid excessive bradycardia during anaesthesia, it is advisable to premedicate with larger than usual doses of atropine.

After prolonged treatment with Ismelin, latent heart failure may develop. This is due to salt and water retention, and mild negative inotropic and chronotropic effects. Concomitant administration of diuretics can readily correct this condition.

If patients develop fever, the dose of Ismelin should be lowered.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Monoamine oxidase inhibitors should be withdrawn at least fourteen days before starting treatment with Ismelin (See Section 4.3, "Contra

Concurrent administration of Ismelin with anti

The anti-hypertensive action of Ismelin may be enhanced by other anti-hypertensive agents such as reserpine, methyldopa, vasodilators (especially minoxidil), calcium antagonists, ?

The anti-hypertensive action of Ismelin may be reduced by chlorpromazine, phenothiazine derivatives, tricyclic antidepressants and related anti-psychotic drugs, and oral contraceptives. Consequently if larger doses of Ismelin are prescribed, care must be taken upon the withdrawal of any of the drugs listed, as severe hypotension may ensue if the dose of Ismelin is not adjusted in advance.

After prolonged treatment with Ismelin, it may be necessary to adjust the dosage of insulin or oral anti

Patients on Ismelin may become hypersensitive to adrenaline, amphetamines or other sympathomimetic agents. Therefore caution should be exercised when taking or using preparations containing these drugs.

4.6 Pregnancy And Lactation

No foetal toxicity or fertility studies have been carried out in animals. Therefore the drug should only be used if there is no safer alternative. However, in particular, it should not be used during the first trimester of pregnancy nor within at least two weeks prior to the birth or during labour since it may induce paralytic ileus in the newborn infant.

In mothers receiving Ismelin in therapeutic doses, the active substance passes into the breast milk, but in quantities so small that no undesirable effects on the infant are to be expected.

4.7 Effects On Ability To Drive And Use Machines

Patients should be warned of the potential hazards of driving or operating machinery if they experience side effects such as dizziness, blurred vision or drowsiness.

4.8 Undesirable Effects

Side effects are often an indication of excessive dosage. The following effects may occur:

Central nervous system: Particularly at the start of treatment: dizziness, tiredness, lethargy, paraesthesia and headache. Occasional: blurred vision and depression. Rare: myalgia and muscular tremor.

Cardiovascular system: Postural hypotension (which may be associated with cerebral or myocardial ischaemia in severe cases) especially when getting up in the morning or after physical exertion, sick

Gastro Diarrhoea and gaseous distension. Occasional: vomiting, nausea and dry mouth. Rare: swelling of parotid glands.

Respiratory tract: Nasal congestion. Rare: asthma.

Urogenital system: Raised BUN levels or uraemia in patients with latent or manifest renal failure, and ejaculation disturbances.

Skin and hair: Occasional: dermatitis. Rare: hair loss.

Blood: Isolated reports of anaemia, leucopenia, and/or thrombocytopenia.

4.9 Overdose

Symptoms: may include postural hypotension which may cause syncope, sinus bradycardia (although tachycardia has been observed), tiredness, dizziness, blurring of vision, muscular weakness, nausea, vomiting, severe diarrhoea and oliguria.

Treatment: Postural hypotension may be overcome by keeping the patient recumbent, or by instituting fluid and electrolyte replacement, and if necessary, by cautious administration of pressor agents (see Section 4.5, "Interactions with other medicaments and other forms of interaction"). Sinus bradycardia can be treated with atropine, and diarrhoea with an anticholinergic agent.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Ismelin is a peripheral sympathetic blocking drug which lowers blood pressure by depleting and inhibiting reformation of noradrenaline in postganglionic nerve endings. Guanethidine, being highly polar, does not cross the blood

5.2 Pharmacokinetic Properties

Guanethidine may be excreted more slowly in those patients with moderate to severely compromised renal function, therefore the potential for accumulation of the drug will be higher.

5.3 Preclinical Safety Data

There are no pre

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium chloride, sulphuric acid and water for injections.

6.2 Incompatibilities

None known.

6.3 Shelf Life

5 years.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Clear glass type I, l ml ampoules containing l0mg/ml: Boxes of 5.

6.6 Special Precautions For Disposal And Other Handling

None

Administrative Data 7. Marketing Authorisation Holder

Amdipharm Plc

Regency House

Miles Gray Road

Basildon

Essex SS14 3AF

United Kingdom

8. Marketing Authorisation Number(S)

PL 20072/0027

9. Date Of First Authorisation/Renewal Of The Authorisation

18th April 2005

10. Date Of Revision Of The Text Legal Status

POM


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Nicorette 10 mg Patch


1. Name Of The Medicinal Product

Nicorette 10mg Patch or Boots NicAssist 10 mg Patch

2. Qualitative And Quantitative Composition

Nicotine, 10mg released over 16 hours use. Each patch is 20 sq.cm, containing nicotine 0.83mg/sq.cm.

For excipients see section 6.1

3. Pharmaceutical Form

Transdermal Patch

4. Clinical Particulars 4.1 Therapeutic Indications

Nicorette Patch is indicated for the relief of nicotine withdrawal symptoms as an aid to smoking cessation in adults and children over 12 years of age. It is also indicated in pregnant and lactating women (see section 4.6).

If possible, Nicorette Patch should be used in conjunction with a behavioural support programme.

4.2 Posology And Method Of Administration

The patient should make every effort to stop smoking completely during treatment with Nicorette Patch.

Behavioural therapy, advice and support will normally improve the success rate.

Nicorette Patch should be applied to clean, dry intact areas of hairless skin, for example on the hip, upper arm, or chest. These areas should be varied each day and the same site should not be used on consecutive days.

There is no clinically significant difference in bioavailability of nicotine when the patch is applied to either the hip, upper arm or chest.

Adults (over 18 years of age)

The daily dose is one patch delivering 15mg, 10mg or 5mg nicotine as appropriate, with application limited to 16 hours in a 24 hour period in each case.

Daily treatment commences with one 15mg (30cm2) patch, applied on waking (usually in the morning) and removed 16 hours later (usually at bedtime).

After removal, used patches should be disposed of carefully (see warnings).

Treatment should continue at this dose for an initial period of 8 weeks. Patients who have successfully abstained from smoking during this 8 week period should be supported through a further 4 week weaning period, using the lower strength patches. Downward titration of dose is achieved by applying one 10mg (20cm2) patch daily for 2 weeks followed by one 5mg (10cm2) patch daily for a further 2 weeks.

Adults who use NRT beyond 9 months are recommended to seek additional help and advice from a healthcare professional.

Adolescents (12 to 18 years)

The dose and method of use are as for adults however as data are limited in this age group, the recommended treatment duration is 12 weeks. If longer treatment is required, advice from a healthcare professional should be sought.

4.3 Contraindications

Nicorette Patches should not be administered to patients with known hypersensitivity to nicotine or any component of the patch.

4.4 Special Warnings And Precautions For Use

Any risks that may be associated with NRT are substantially outweighed by the well established dangers of continued smoking.

Underlying cardiovascular disease: In stable cardiovascular disease Nicorette Patch presents a lesser hazard than continuing to smoke. However dependent smokers currently hospitalised as a result of myocardial infarction, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, Nicorette Patch may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision.

Diabetes mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

Renal or hepatic impairment: Nicorette Patch should be used with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.

Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. After removal, the patch should be folded in half, adhesive side innermost, and placed inside the opened sachet, or in a piece of aluminium foil. The used patch should then be disposed of carefully, away from the reach of children or animals.

Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes release of catecholamines, Nicorette Patch should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma.

Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e.g. theophylline, clozapine and ropinirole.

Generalised dermatological disorders :Patients with chronic generalised dermatological disorders such as psoriasis, chronic dermatitis or urticaria should not use Nicorette Patch.

Erythema may occur. If it is severe or persistent, treatment should be discontinued.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically relevant interactions between nicotine replacement therapy and other drugs has definitely been established. However nicotine may possibly enhance the haemodynamic effects of adenosine i.e. increase in blood pressure and heart rate and also increase pain response (angina-pectoris type chest pain) provoked by adenosine administration.

4.6 Pregnancy And Lactation

Pregnancy

NRT is not contraindicated in pregnancy. The decision to use NRT should be made on a risk-benefit assessment as early on in the pregnancy as possible with the aim of discontinuing use as soon as possible.

Smoking during pregnancy is associated with risks such as intra-uterine growth retardation, premature birth or stillbirth. Stopping smoking is the single most effective intervention for improving the health of both pregnant smoker and her baby. The earlier abstinence is achieved the better.

Ideally smoking cessation during pregnancy should be achieved without NRT. However for women unable to quit on their own, NRT may be recommended to assist a quit attempt.

Nicotine passes to the fetus affecting breathing movements and has a dose-dependent effect on placental/fetal circulation. However the risk of using NRT to the fetus is lower than that expected with tobacco smoking, due to lower maximal plasma nicotine concentration and no additional exposure to polycyclic hydrocarbons and carbon monoxide.

Intermittent dosing products may be preferable as these usually provide a lower daily dose of nicotine than patches. However, patches may be preferred if the women is suffering from nausea during pregnancy. If patches are used they should be removed before going to bed.

Lactation

NRT is not contraindicated in lactation. Nicotine from smoking and NRT is found in breast milk. However the amount of nicotine the infant is exposed to is relatively small and less hazardous than the second-hand smoke they would otherwise be exposed to.

Using intermittent dose NRT preparations, compared with patches, may minimize the amount of nicotine in the breast milk as the time between administrations of NRT and feeding can be more easily prolonged.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can include; irritability/aggression, dysphoria/depressed mood, anxiety, restlessness, poor concentration, increased appetite/weight gain, urges to smoke (cravings), night-time awakenings/sleep disturbance and decreased heart rate.

Increased frequency of aphthous ulcer may occur after abstinence from smoking. The causality is unclear.

Nicorette Patch may cause adverse reactions similar to those associated with nicotine given by other means, including smoking, and these are mainly dose-dependent. At recommended doses Nicorette Patch has not been found to cause any serious adverse effects. Excessive use of Nicorette Patch by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.

About 20% of Nicorette patch users experience mild local skin reactions, during the first weeks of treatment.

Reported adverse events associated with Nicorette 5mg, 10mg and 15mg patch include:

Body System

Incidence*

Reported adverse event

 

Nervous system disorders:

Common:

Dizziness, headache

Cardiac disorders:

Uncommon:

Palpitations

 

 

Very rare:

Reversible atrial fibrillation

Gastrointestinal disorders:

Common:

Gastrointestinal discomfort, nausea, vomiting

Skin and subcutaneous tissue disorders:

Uncommon:

Urticaria

General disorders and administration site disorders:

Very common:

Itching

 

 

Common:

Erythema

*Very common >1/10); common >1/100, <1/10); uncommon >1/1 000, <1/100); rare >1/10 000, <1/1 000); very rare (<1/10 000), including isolated reports.

4.9 Overdose

Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.

Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Nicotine has no therapeutic uses except as replacement therapy for the relief of abstinence symptoms in nicotine-dependent smokers.

Owing to its many actions, the overall effects of nicotine are complex. A wide variety of stimulant and depressant effects are observed that involve the central and peripheral nervous, cardiovascular, endocrine, gastro-intestinal and skeletal motor systems. Nicotine acts on specific binding sites or receptors throughout the nervous system.

5.2 Pharmacokinetic Properties

Taking into account the residual concentration of nicotine in the transdermal system, the nicotine released from the system is efficiently absorbed: a bioavailability of between 80-100% has been reported. There is no clinically significant difference in bioavailability of nicotine when the patch is applied to either the hip, upper arm or chest.

Steady state concentrations of plasma nicotine in volunteers were examined during a study period of six days. Although nicotine was detectable 24 hours after the first dose, the data did not indicate any accumulation.

Tmax of nicotine after application of a 30cm2 nicotine transdermal system has been shown to vary between 6 ± 2 and 9 ± 3 hours: Cmax has been shown to vary between 13 ± 3 and 16 ± 5 ng/ml. No differences in these pharmacokinetic parameters have been observed between males and females.

All Nicorette Patches are labelled by the average amount of nicotine absorbed by the patient over 16 hours.

5.3 Preclinical Safety Data

Preclinical data indicate that nicotine is neither mutagenic nor genotoxic.

There are no other findings derived from preclinical testing of relevance to the prescriber in determining the safety of the product which have not been considered in other relevant sections of this Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Medium molecular weight polyisobutylene

Low molecular weight polyisobutylene

Polybutylene

Polyester non- woven

Backing film

Siliconised polyester release liner

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Do not store at above 30oC.

6.5 Nature And Contents Of Container

Heat sealed multilaminate pouch containing one patch. Cartons of 1, 2, 3, 7*, 14 and 28 pouches (*pack presently marketed).

6.6 Special Precautions For Disposal And Other Handling

Cut open the pouch with scissors along the line, as indicated. A clean, dry intact area of skin is selected which is hairless, such as the hip, upper arm or chest. The transparent plastic backing is peeled away and the patch pressed carefully onto the skin. The fingers should be rubbed firmly round the edge to ensure that the patch sticks properly. The patch will normally resist bathing, showering, or swimming, but if it does come off it should be replaced with a new one. Use of skin oils or talc can prevent proper adhesion of the patch.

It is intended that the patch is worn through the waking hours (approximately 16 hours) being applied on waking and removed at bedtime. Nicotine residues in the used patches may present a hazard to children and pets, thus used patches should be folded, sticky sides together, put back in an empty pouch and placed in household rubbish.

7. Marketing Authorisation Holder

Pharmacia Ltd.

Ramsgate Road

Sandwich

Kent CT13 9NJ

UK

8. Marketing Authorisation Number(S)

PL 0032/0293

9. Date Of First Authorisation/Renewal Of The Authorisation

1 May 2001/ 1st January 2002

10. Date Of Revision Of The Text

04 November 2005


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Amiloride Tablets BP 5mg


1. Name Of The Medicinal Product

AMILORIDE TABLETS BP 5mg

2. Qualitative And Quantitative Composition

Each tablet contains Amiloride Hydrochloride BP equivalent to 5mg anhydrous amiloride hydrochloride.

3. Pharmaceutical Form

Yellow uncoated tablets.

4. Clinical Particulars 4.1 Therapeutic Indications

Potassium-conserving agent; diuretic. Although amiloride may be used alone, its principal indication is as concurrent therapy with thiazides or more potent diuretics to conserve potassium during periods of vigorous diuresis and during long-term maintenance therapy. It is indicated for use in:

1) Congestive heart failure.

2) Hypertension.

3) Hepatic cirrhosis with ascites.

4.2 Posology And Method Of Administration

Monotherapy: Initially 10mg which may be given as a single or divided dose. This may be increased if necessary to a maximum of 20mg daily. When diuresis has been achieved, the dosage may be reduced by 5mg increments to the least amount required.

In conjunction with other diuretic therapy: When amiloride is used with a diuretic which is given on an intermittent basis, it should be given at the same time as the diuretic.

Congestive heart failure: Initially 5-10mg daily, together with the usual dosage of the diuretic concurrently employed. Where diuresis is not achieved dosage of both agents may be increased if necessary, however, the maximum dose for amiloride is 20mg a day. Once diuresis is achieved, reduction in dosage of both agents may be attempted for maintenance therapy. The dosage of both drugs is determined by diuresis and the level of plasma potassium.

Hypertension: 5-10mg daily, together with the usual antihypertensive dosage of the thiazide concurrently employed. It is not usually necessary to exceed 10mg of amiloride daily; in any event, not more than 20mg a day should be given.

Hepatic cirrhosis with ascites: When used in conjunction with another diuretic, treatment should be commenced with a small amiloride dose of 5mg, plus a low dosage of the other diuretic agent. If necessary, dosage of both agents may gradually be increased until there is effective diuresis. The maximum dose for amiloride is 20mg daily. Maintenance doses may be lower than those required to initiate diuresis; reduction in the daily dosage should therefore be attempted when the patient's weight is stabilised.

Elderly: Dosage in the elderly should be carefully adjusted according to renal function, blood electrolytes and diuretic response. The elderly are more susceptible to electrolyte imbalance and more likely to experience hyperkalaemia since renal reserve may be reduced.

Children: The use of amiloride in children is contraindicated.

For oral administration.

4.3 Contraindications

Hyperkalaemia (plasma potassium over 5.5mmol/l); other potassium-conserving agents or potassium supplements; anuria, acute renal failure, severe progressive renal disease, diabetic nephropathy; known sensitivity to amiloride; use in children as safety has not been established.

4.4 Special Warnings And Precautions For Use

Diabetes mellitus: To minimise the risk of hyperkalaemia in known or suspected diabetic patients, the status of renal function should be determined before initiating therapy. Amiloride should be discontinued for at least three days before a glucose-tolerance test.

Metabolic or respiratory acidosis: Potassium-conserving therapy should be initiated only with caution in severely ill patients in whom metabolic or respiratory acidosis may occur, eg patients with cardiopulmonary disease of decompensated diabetes. Shifts in acid-base balance alter the balance of extracellular-intracellular potassium, and the development of acidosis may be associated with rapid increase in plasma potassium.

Hyperkalaemia: This has been observed in some patients receiving amiloride, alone or with other diuretics. These patients should be observed carefully for clinical, laboratory, and ECG evidence of hyperkalaemia. Some deaths have been reported in this group of patients. Hyperkalaemia has been noted particularly in the elderly and in hospital patients with hepatic cirrhosis or cardiac oedema who have known renal involvement, who were seriously ill, or were undergoing vigorous diuretic therapy.

Neither potassium-conserving agents nor a diet rich in potassium should be used with amiloride except in severe and/or refractory cases of hypokalaemia. If the combination is used, plasma potassium levels must be continuously monitored.

Treatment of hyperkalaemia: If hyperkalaemia occurs, amiloride should be discontinued immediately and, if necessary, active measures taken to reduce the plasma potassium level.

Impaired renal function: Patients with blood urea over 10mmol/l, serum creatinine over 130µmol/l, or with diabetes mellitus require careful monitoring of serum electrolytes and blood urea levels. In renal impairment, use of a potassium-conserving agent may result in rapid development of hyperkalaemia.

Electrolyte imbalance and blood urea increases: Hyponatraemia and hypochloraemia may occur when amiloride is used with other diuretics. Reversible increases in blood urea levels have been reported accompanying vigorous diuresis, especially when diuretics were used in seriously ill patients, such as those with hepatic cirrhosis with ascites and metabolic alkalosis, or those with resistant oedema. Careful monitoring of serum electrolytes and blood urea levels should therefore be carried out when amiloride is given with oral diuretics to such patients.

Cirrhotic patients: Oral diuretic therapy is more frequently accompanied by side-effects in patients with hepatic cirrhosis with or without ascites, because these patients are intolerant of acute shifts in electrolyte balance, and because they often already have hypokalaemia as a result of associated aldosteronism.

Reports suggest that patients with pre-existing severe liver disease treated with diuretics, including amiloride hydrochloride, may experience hepatic encephalopathy, manifested by tremors, confusion and coma, and increased jaundice.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Lithium should not generally be given with diuretics because they reduce it renal clearance and add a high risk of lithium toxicity.

When combined with thiazide diuretics, amiloride can act synergistically with chlorpropamide to increase the risk of hyponatraemia.

When amiloride is administered concurrently with an angiotensin-converting enzyme inhibitor, NSAIDs or ciclosporin the risk of hyperkalaemia may be increased. Therefore, if concomitant use of these agents is indicated because of demonstrated hypokalaemia, they should be used with caution and with frequent monitoring of serum potassium.In patients receiving amiloride with NSAIDs or ciclosporin the risk of nephrotoxcity may also be increased.

4.6 Pregnancy And Lactation

Amiloride is not recommended for use during pregnancy due to limited clinical experience. The potential benefits must be weighed against the possible hazard to the foetus if administered to a woman of childbearing age.

The routine use of diuretics in otherwise healthy pregnant women with or without mild oedema is not indicated because they may be associated with hypovolaemia, increased blood viscosity and decreased placental perfusion. Foetal and neonatal jaundice, foetal bone depression and thrombocytopenia have also been described.

It is not known whether amiloride is excreted in human milk. Therefore, due to the risk that it may take this route of excretion, and possibly cause serious adverse reactions to the nursing infant, the mother should either stop breast-feeding or cease taking the drug.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Amiloride is usually well tolerated, although minor side-effects are reported relatively frequently. Apart from hyperkalaemia, significant adverse reactions have been infrequently reported. Nausea/anorexia, abdominal pain, flatulence and mild skin rash are probably due to amiloride; but other side-effects are generally associated with diuresis or with the underlying disease being treated.

Body as a whole: Headache, weakness, fatigue, back pain, chest pain, neck/shoulder ache, pain in the extremities.

Cardiovascular: Angina pectoris, orthostatic hypotension, arrhythmias, palpitation, one patient with partial heart block developed complete heart block.

Digestive: Anorexia, nausea, vomiting, diarrhoea, constipation, abdominal pain, GI bleeding, jaundice, thirst, dyspepsia, flatulence.

Metabolic: Elevated plasma potassium levels above 5.5mmol/l, hyponatraemia.

Musculoskeletal: Muscle cramps, joint pain.Serum uric acid levels may rise during treatment with amiloride and acute attacks of gout may be precipitated.

Nervous: Dizziness, vertigo, paraesthesia, tremors, encephalopathy.

Psychiatric: nervousness, mental confusion, insomnia, decreased libido, depression, somnolence.

Respiratory: Cough, dyspnoea.

Special senses: Nasal congestion, visual disturbances, increased intra-ocular pressure, tinnitus.

Urogenital: Impotence, polyuria, dysuria, bladder spasms, frequency of micturition.

Reactions in which no causal relationship could be established were activation of probable pre-existing peptic ulcer, aplastic anaemia, neutropenia and abnormal liver function tests. In a few cirrhotic patients, jaundice associated with the underlying disease has deepened, but the drug relationship is unknown.

4.9 Overdose

No data are available; it is not known whether the drug is dialysable. No specific antidote is available.

The most likely signs and symptoms are dehydration and electrolyte imbalance which should be treated by established methods. Therapy should be discontinued and the patient closely observed. Emesis should be induced or gastric lavage performed if ingestion is recent. Treatment is symptomatic and supportive. If hyperkalaemia occurs, active measures should be taken to reduce plasma potassium levels.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Amiloride hydrochloride is a diuretic.

5.2 Pharmacokinetic Properties

Amiloride is incompletely absorbed from the gastrointestinal tract. Peak serum concentrations are achieved about 3-4 hours after administration by mouth. It is excreted unchanged in the urine. Amiloride has been estimated to have a serum half-life of about 6 hours.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Also contains: lactose, magnesium stearate, maize starch, E172, E460.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Shelf-life

Three years from the date of manufacture.

Shelf-life after dilution/reconstitution

Not applicable.

Shelf-life after first opening

Not applicable.

6.4 Special Precautions For Storage

Store below 25°C in a dry place.

Protect from light.

6.5 Nature And Contents Of Container

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene tablet containers with and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass bottles with screw caps and polyfoam wad or cotton wool.

The product may also be supplied in blister packs in cartons:

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-7g/M? PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack sizes: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s, 250s, 500s, 1000s

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material.

Maximum size of bulk packs: 50,000.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

Administrative Data 7. Marketing Authorisation Holder

Name or style and permanent address of registered place of business of the holder of the Marketing Authorisation:

Actavis UK Limited

(Trading style: Actavis)

Whiddon Valley

BARNSTAPLE

N Devon EX32 8NS

8. Marketing Authorisation Number(S)

PL 0142/0210

9. Date Of First Authorisation/Renewal Of The Authorisation

August 1986; August 1991

10. Date Of Revision Of The Text

May 2007


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Strong Pholcodine Linctus BP


1. Name Of The Medicinal Product

Strong Pholcodine Linctus BP

2. Qualitative And Quantitative Composition

Each 5ml contains Pholcodine BP 10mg

3. Pharmaceutical Form

Oral solution: Clear, colourless, raspberry and cola flavoured syrup.

4. Clinical Particulars 4.1 Therapeutic Indications

Suppression of non-productive cough.

4.2 Posology And Method Of Administration

Adults:

5ml spoonful 3-4 times daily

Children:

Not recommended.

4.3 Contraindications

Liver disease, ventilatory failure, asthma, bronchitis, bronchiectasis. Use in patients with hypersensitivity or idiosyncratic response to the active ingredient, use in children.

4.4 Special Warnings And Precautions For Use

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Depressant effects may occur with concurrent alcohol ingestion; concurrent (or within 2 weeks) use of MAOIs may lead to excitation; the depressant effects might be increased by phenothiazines, MAOIs and tricyclic anti-depressants.

4.6 Pregnancy And Lactation

This product should not be used during pregnancy or lactation unless it is considered essential by the physician.

4.7 Effects On Ability To Drive And Use Machines

Pholcodine may induce drowsiness. Patients receiving this medication should not drive or operate machinery unless it has been shown not to affect mental or physical ability.

4.8 Undesirable Effects

Constipation, nausea and drowsiness occasionally occur.

Immune system disorders: hypersensitivity reactions, anaphylaxis.

4.9 Overdose

Restlessness, excitement and ataxia may occur after large doses. A toxic dose in children is reported to be about 200mg.

Treatment: Gastric lavage with supportive and symptomatic measures. In severe cases, and where respiratory depression occurs an opioid antagonist such as Naloxone – should be considered.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Morphine or codeine derivatives. By tradition used mainly as an antitussive. It suppresses the cough reflex by a direct central action, probably in the medulla or pons. It has little or no analgesic or euphorigenic activity.

5.2 Pharmacokinetic Properties

Metabolised in the liver.

5.3 Preclinical Safety Data

Not stated

6. Pharmaceutical Particulars 6.1 List Of Excipients

Citric Acid BP

Sodium Carboxymethylcellulose 7HOF BP

Glycerol BP

Sodium Benzoate BP

Saccharin Sodium BP

Lycasin 80/55 HSE

Ethanol 96% BP

Raspberry/Cola flavour

Purified Water BP to volume

6.2 Incompatibilities

None known

6.3 Shelf Life

Amber glass bottles – 2 years

High density polyethylene bottles – 2 years

6.4 Special Precautions For Storage

Store below 20°C. Protect from light.

6.5 Nature And Contents Of Container

Amber Grade III glass bottle with pilfer proof screw cap, 100ml, 125ml, 200ml and 500ml.

Virgin HDPE bottle with tamper evident screw cap, 500ml, 1 Litre, 2 Litres.

6.6 Special Precautions For Disposal And Other Handling

As for all medicines – no special requirements.

Administrative Data 7. Marketing Authorisation Holder

Pinewood Laboratories Ltd.,

Ballymacarbry, Clonmel,

Co. Tipperary, Ireland

8. Marketing Authorisation Number(S)

PL 04917/0005

9. Date Of First Authorisation/Renewal Of The Authorisation

15 August 1991

10. Date Of Revision Of The Text

February 2008


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Atenolol 50mg Tablets


1. Name Of The Medicinal Product

Atenolol 50 mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 50mg of Atenolol

3. Pharmaceutical Form

White, slightly biconvex, film coated debossed tablets, marked with AT/50 on one side and company logo on the other side of the tablet, intended for oral administration to human beings.

4. Clinical Particulars 4.1 Therapeutic Indications

Management of hypertension.

Management of angina pectoris.

Management of cardiac arrhythmias.

Early intervention in the acute phase of myocardial infarction.

4.2 Posology And Method Of Administration

Adults:Hypertension: One tablet (50mg) daily. Higher doses rarely necessary. A further reduction in blood pressure may be achieved by combining atenolol with other antihypertensive agents. For example, co-administration of atenolol with a diuretic provides a highly effective and convenient antihypertensive therapy.

Angina: Most patients with angina pectoris will respond to 100mg daily given orally once daily or 50mg given twice daily. It is unlikely that additional benefit will be gained by increasing the dose.

Dysrhythmias: A suitable initial dose of atenolol is 2.5mg (5ml) injected intravenously over a 2.5 minute period (i.e. 1mg/minute). This may be repeated at 5 minute intervals until a response is observed up to a maximum dosage of 10mg. If atenolol is given by infusion, 0.15mg/kg bodyweight may be administered over a 20 minute period. If required, the injection or infusion may be repeated every 12 hours. Having controlled the dysrhythmias with intravenous 'atenolol' a suitable oral maintenance dosage is 50-100mg daily, given as a single dose.

Myocardial infarction: For patients suitable for treatment with intravenous beta-blackade and presenting within 12 hours of the onset of chest pain, atenolol 5-10mg should be given by slow intravenous injection (1mg/minute) followed by atenolol 50mg orally about 15 minutes later provided no untoward effects occur from the intravenous dose. This should be followed by a further 50mg orally 12 hours after the intravenous dose and then 12 hours later by 100mg orally to be given once daily. If bradycardia and/or hypotension requiring treatment, or any other untoward effects occur, atenolol should be discontinued.

Elderly patients: Dosage requirements may be reduced, especially in patients with impaired renal function.

Children: There is no paediatric experience with atenolol and for this reason it is not recommended for use in children.

Renal failure: No significant accumulation of atenolol occurs in patients with a creatinine clearance greater than 35ml/min/1.73m? (normal range is 100-150ml/min/1.73?). For patients with a creatinine clearance of 15-35ml/min/1.73m? (equivalent to serum creatinine of 300-600mcmol/litre) the oral dose should be 50mg daily and the intravenous dose should be 10mg once every two days. For patients with a creatinine clearance of <15ml/min/1.73m? (equivalent to serum creatinine of>600mcmol/litre) the oral dose should be 25mg daily or 50mg on alternate days and the intravenous dose should be 10mg once every four days.

Patients on haemodialysis should be given 50mg orally after each dialysis. This should be done under hospital supervision as marked falls in blood pressure can occur.

Route of administration: Oral

4.3 Contraindications

As with other beta-blocking drugs, atenolol should not be used in patients with any of the following conditions: known hypersensitivity to atenolol or any of the excipients, bradycardia, cardiogenic shock, hypotension, metabolic acidosis, severe peripheral arterial circulatory disturbances, second or third degree heart block, sick sinus syndrome, untreated phaeochromocytoma or uncontrolled heart failure.

4.4 Special Warnings And Precautions For Use

Atenolol as with other beta-blocking drugs:

- Should not be withdrawn abruptly. The dosage should be withdrawn gradually over a period of 7–14 days, to facilitate a reduction in beta-blocker dosage. Patients should be followed during withdrawal, especially those with ischaemic heart disease.

- When a patient is scheduled for surgery, and a decision is made to discontinue beta-blocker therapy, this should be done at least 24 hours prior to the procedure. The risk-benefit assessment of stopping beta-blockade should be made for each patient. If treatment is continued, an anaesthetic with little negative inotropic activity should be selected to minimise the risk of myocardial depression. The patient may be protected against vagal reactions by intravenous administration of atropine.

-although contra-indicated in uncontrolled heart failure (see Contra-indications above), may be used in patients whose signs of heart failure has been controlled. Caution must be exercised in patients with poor cardiac reserve.

-may increase the number and duration of angina attacks in patients with Prinzmetal's angina due to unopposed alpha-receptor mediated coronary artery vasoconstriction. Atenolol is a beta1-selective beta-blocking drug, therefore, its use may be considered although utmost caution must be exercised.

-although contra-indicated in severe peripheral arterial circulatory disturbances (see Contra-indications above), may also aggravate less severe peripheral arterial circulatory disturbances.

-because of its negative effect on conduction time, must be used with caution in patients with first degree heart block.

-May mask the symptoms of hypoglycaemia, in particular, tachycardia.

-may mask the signs of thyrotoxicosis.

-will reduce heart rate as a result of its pharmacological action. In the rare instances when a treated patient develops symptoms which may be attributable to a slow heart rate, and the pulse rate drops to less than 50–55 bpm at rest, the dose may be reduced.

-may cause a more severe reaction to various allergens when given to patients with a history of anaphylactic reaction to such allergens. Such patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reaction.

-should be used only after careful consideration in patients with anamnestically known psoriasis.

• May cause a hypersensitivity reaction including angioedema and urticaria.

• Should be used with caution in the elderly, starting with a lesser dose (see Section 4.2).

Since Atenolol is excreted via the kidneys, dosage should be reduced in patients with a creatinine clearance of below 35 ml/min/1.73 m2.

Although cardioselective (beta1) beta-blocking drugs may have less effect on lung function than non-selective beta-blockers, these should be avoided in patients with reversible obstructive airways disease unless there are compelling clinical reasons for their use. If such reasons exist, atenolol may be used with caution. Occasionally, some increase in airways resistance may occur in asthmatic patients. However, this may usually be reversed by commonly used dosage of a bronchodilator such as salbutamol or isoprenaline.

As with other beta-blockers, in patients with a phaeochromocytoma, an alpha-blocker should be given concomitantly.

The label shall contain the following statement:

'Do not take this medicine if you have a history of wheezing or asthma'.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Class I anti-arrhythmic drugs (e.g. disopyramide) and amiodarone may have a potentiating effect on atrial-conduction time and induce negative inotropic effect.

Combined use of beta-adrenoceptor blocking drugs and calcium channel blockers with negative inotropic effects e.g. verapamil, diltiazem can lead to an exaggeration of these effects, particularly in patients with impaired ventricular function and/or SA or AV conduction abnormalities. This may result in severe hypotension, bradycardia and cardiac failure. Neither the beta-adrenoceptor blocking drug nor the calcium channel blocker should be administered intravenously within 48 hours of discontinuing the other.

Concomitant therapy with dihydropyridines e.g. nifedipine, may increase the risk of hypotension, and cardiac failure may occur in patients with latent cardiac insufficiency.

Beta-adrenoceptor blocking drugs may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are co-administered, the beta-adrenoceptor blocking drug should be withdrawn several days before discontinuing clonidine. If replacing clonidine by beta-adrenoceptor blocking drug therapy, the introduction of beta-adrenoceptor blocking drugs should be delayed for several days after clonidine administration has stopped.

Digitalis glycosides, in association with beta-blocking drugs may increase AV conduction time.

Concomitant use of sympathomimetics e.g. adrenaline, may counteract the effect of beta-blocking drugs.

Concomitant use of alcohol with a beta-blocker may increase the risk of hypotension.

Beta-blockers (especially non-selective ones) may intensify the blood sugar-lowering effects of insulin and oral antidiabetic drugs. Symptoms of hypoglycaemia, particularly tachycardia, may be masked (see section 4.4).

Concomitant use of prostaglandin synthetase-inhibiting drugs, e.g. ibuprofen and indometacin, may decrease the hypotensive effects of beta-blockers.

. Anaesthesia: Care should be taken when using anaesthetic agents with atenolol. The anaesthetist should be informed and the choice of anaesthetic should be the agent with as little negative inotropic activity as possible. Concomitant use of beta-adrenoceptor blocking drugs with anaesthetic drugs may result in attentuation of the reflex tachycardia and increase the risk of hypotension. Anaesthetic agents causing myocardial depression are best avoided.

4.6 Pregnancy And Lactation

Beta-blockers reduce placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries. In addition, adverse effects (especially hypoglycaemia and bradycardia) may occur in foetus and neonate. There is an increased risk of cardiac and pulmonary complications in the neonate in the postnatal period. Most beta-blockers, particularly lipophilic compounds, will pass into breast milk although to a variable extent.

Breast-feeding is therefore not recommended.

Atenolol crosses the placental barrier and appears in the cord blood. No studies have been performed on the use of atenolol in the first trimester and the possibility of foetal injury cannot be excluded. Atenolol has been used under close supervision for the treatment of hypertension in the third trimester. Administration of atenolol for longer periods to pregnant women in the management of mild to moderate hypertension has been associated with intra-uterine growth retardation. The use of atenolol in women who are, or may become pregnant, requires that the anticipated benefit be weighed against the possible risks, particularly in the first and second trimesters.

Neonates born to mothers who are receiving Atenolol at parturition or breast-feeding may be at risk of hypoglycaemia and bradycardia

4.7 Effects On Ability To Drive And Use Machines

Atenolol is unlikely to impair the ability of patients to drive or to operate machinery. However, it should be taken into account that occasional dizziness or fatigue may occur.

4.8 Undesirable Effects

Atenolol is well tolerated. The undesirable effects reported in clinical studies are usually attributable to the pharmacological actions of atenolol.

The following undesired events, listed by body system, have been reported with the following frequencies: very common (

Blood and lymphatic system disorders:

Rare: Purpura, thrombocytopenia.

Psychiatric disorders:

Uncommon: Sleep disturbances of the type noted with other beta-blockers.

Rare: Mood changes, nightmares, confusion, psychoses and hallucinations.

Nervous system disorders:

Rare: Dizziness, headache, paraesthesia.

Eye disorders:

Rare: Dry eyes, visual disturbances.

Cardiac disorders:

Common: Bradycardia.

Rare: Heart failure deterioration, precipitation of heart block.

Vascular disorders:

Common: Cold extremities.

Rare: Postural hypotension which may be associated with syncope, intermittent claudication may be increased if already present, in susceptible patients Raynaud's phenomenon.

Respiratory, thoracic and mediastinal disorders:

Rare: Bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints.

Gastrointestinal disorders:

Common: Gastrointestinal disturbances.

Rare: Dry mouth.

Hepato-biliary disorders:

Uncommon: Elevations of transaminase levels.

Rare: Hepatic toxicity including intrahepatic cholestasis.

Skin and subcutaneous tissue disorders:

Rare: Alopecia, psoriasiform skin reactions, exacerbation of psoriasis, skin rashes.

Not known: Hypersensitivity reactions, including angioedema and urticaria.

Reproductive system and breast disorders:

Rare: Sexual dysfunction (Impotence).

General disorders and administration site conditions:

Common: Fatigue.

Investigations:

Very rare: An increase in ANA (Antinuclear Antibodies) has been observed, however the clinical relevance of this is not clear.

Discontinuance of the drug should be considered if it is the clinical judgement that the well-being of the patient is adversely affected by any of the above reactions.

4.9 Overdose

Symptoms of overdose may include bradycardia, hypotension, acute cardiac insufficiency and bronchospasm.

General treatment should include close supervision, treatment in an intensive care ward, gastric lavage, activated charcoal and a laxative to prevent absorption of any drug still present in the GI tract, use of plasma or plasma substitutes to treat hypotension and shock. The possible use of haemodialysis or haemoperfusion may be considered.

Excessive bradycardia may be countered with atropine 1-2mg intravenously and/or a cardiac pacemaker. If necessary, this may be followed by a bolus dose of glucagon 10mg intravenously and/or a cardiac pacemaker. If necessary, this may be followed by a bolus dose of glucagon 10mg intravenously.

If required, this may be repeated or followed by an intravenous infusion of glucagon 1-10mg/hour depending on response. If no response to glucagon occurs or if glucagon is unavailable, a beta-adrenoceptor stimulant such as dobutamine 2.5 to 10 micrograms/kg/minute by intravenous infusion may be given. Because of its inotropic effect, dobutamine could also be used to treat hypotension and acute cardiac insufficiency. It is likely that these doses would be inadequate to reverse the cardiac effects of beta-adrenoceptor blockade if a large overdose has been taken. The dose of dobutamine should therefore be increased if necessary to achieve the required response according to the clinical condition of the patient.

Bronchospasm can usually be reversed by bronchodilators.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Atenolol is a beta-adrenoceptor blocking drug which is beta? selective (i.e. acts preferentially on beta?adrenergic receptors in the heart). Selectivity decreases with increasing dose. It does not possess intrinsic sympathomimetic activity nor membrane stabilising properties. As with other beta-adrenoceptor blocking drugs, atenolol has negative inotropic effects (and is therefore contra-indicated in uncontrolled heart failure).

Like other beta-adrenoceptor blocking drugs, the mode of action of atenolol in the treatment of hypertension is unclear. Atenolol reduces cardiac rate and contractility and these actions probably account for its effectiveness in the symptomatic relief of angina.

Atenolol is effective and well tolerated in most ethnic populations, although the response may be less in black patients.

Atenolol is compatible with diuretics, other anti-hypertensive drugs and anti-anginal agents (see Interactions section).

5.2 Pharmacokinetic Properties

Absorption of atenolol following oral dosing is consistent but incomplete (approximately 40-50%) with peak plasma concentrations occurring 2-4 hours after dosing.

There is no significant hepatic metabolism of atenolol and more than 90% of the absorbed drug reaches the systemic circulation. The plasma half life is about six hours but this may rise in severe renal impairment since the kidney is the major route of elimination. Due to its hydrophilic structure atenolol penetrates tissues poorly and its concentration in brain tissue is low. Plasma protein binding is also low (approximately 3%).

5.3 Preclinical Safety Data

No further relevant information other than that which is included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Tablet core

Lactose

Microcrystalline Cellulose

Sodium Lauryl Sulphate

Sodium Starch Glycollate

Maize Starch

Gelatin

Purified Water

Magnesium Stearate

Tablet coat

Opadry Y-1 –7000

6.2 Incompatibilities

Nil

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store below 25°C.

Protect from light.

6.5 Nature And Contents Of Container

Blister packs which consist of strips made from hard PVC with a foil back packed in cardboard cartons to contain 2 x 14 tablets or 4 x 14 tablets.

6.6 Special Precautions For Disposal And Other Handling

Use as directed by the physician.

Keep out of reach of children.

7. Marketing Authorisation Holder

Goldshield Pharmaceuticals Ltd.,

NLA Tower,

12-16 Addiscombe Road,

Croydon, CR0 0XT,

United Kingdom.

8. Marketing Authorisation Number(S)

PL 12762/0103

9. Date Of First Authorisation/Renewal Of The Authorisation

25/07/2001

10. Date Of Revision Of The Text

December 2009


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Metharose Sugar Free 1mg / 1ml Oral Solution


Metharose Sugar Free 1mg/1ml Oral Solution

Methadone hydrochloride

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your pharmacist. This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet 1. What is Metharose and what is it used for? 2. Before you take Metharose 3. How to take Metharose 4. Possible side effects 5. How to store Metharose 6. Further information What is Metharose and what is it used for?

The name of your medicine is Metharose. It contains methadone hydrochloride. This belongs to a group of medicines called Narcotic Analgesics.

Metharose is used:

to treat opioid drug addiction to treat moderate to severe pain Before you take Metharose Do not take Metharose and tell your doctor if: you are allergic (hypersensitive) to methadone or any other ingredients in this liquid (see section 6 below). An allergic reaction can include a rash, itching or shortness of breath you have severe breathing problems or a history of asthma. You must not use this medicine during an asthma attack. If you give this medicine to yourself (self-administration), wait until the asthma attack has passed and you are fully recovered you are taking Monoamine Oxidase Inhibitors (MAOIs) used to treat depression or if you have taken a MAOI medicine in the past two weeks (see ‘Taking other medicines’) you are dependent on any other drugs you are in labour children must not be given this medicine.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking Metharose.

Take special care with Metharose

Before you take this medicine, tell your doctor if:

you have liver or kidney problems you have epilepsy you are addicted to alcohol you have or have recently had a head injury you have low thyroid function (hypothyroid) you have problems with your adrenal glands. These are linked to your kidneys you have an enlarged prostate gland you have low blood pressure you are in shock you have a muscle weakness disease called myasthenia gravis you have bowel problems you have a history of irregular heart beat you have a history of heart disease you have a family history of people dying suddenly without cause you have low potassium, sodium or magnesium levels you are pregnant or breast feeding you are extremely ill or an older person. You may be more sensitive to the medicine.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Metharose.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines bought without a prescription, including herbal medicines. This is because Metharose can affect the way some other medicines work. Also some medicines can affect the way Metharose works.

You must not take Metharose

at the same time or within 2 weeks of taking Monoamine Oxidase Inhibitors (MAOIs).

Some medicines can increase the risk of heart problems when used with Metharose. Talk to your doctor before taking Metharose if you are taking:

medicines for heart problems such as verapamil and enalapril medicines which affect electrolyte balance such as diuretics (water tablets) or lithium.

Tell your doctor if you are taking any of the following medicines:

medicines that dull your senses such as medicine for depression (for example, fluvoxamine, fluoxetine), medicines to help you sleep (including anaesthetics) and medicines to calm you down called tranquillisers cimetidine, used to treat stomach ulcers rifampicin, used to treat tuberculosis (TB) medicines used to treat epilepsy such as phenytoin, carbamazepine, phenobarbital and primidone medicines that make your urine acidic such as ascorbic acid (vitamin C) narcotic painkillers such as codeine and pentazocine naloxone used to reverse the effects of opioid drugs medicines used to stop opioid drugs working such as naltrexone and buprenorphine medicines used to treat HIV such as nevirapine, efavirenz and nelfinavir. The doctor may have to change the amount of methadone you take whilst on these medicines antibiotics such as ciprofloxacin or macrolide antibiotics for example erythromycin medicines used to treat fungal infections such as ketoconazole or fluconazole St. John’s Wort - a herbal preparation for depression.

If any of the above apply to you, talk to your doctor before taking Metharose.

Taking Metharose with food and drink

Do not drink alcohol whilst taking Metharose. This is because Metharose can make you feel sleepy and drinking alcohol will make you even more sleepy.

Pregnancy and breast-feeding talk to your doctor before taking Metharose if you are pregnant or likely to become pregnant take care if you are taking a pregnancy test as the methadone may interfere with the results you should not take this medicine whilst you are in labour do not breast-feed if you are taking Metharose Driving and using machines

Metharose will severely affect your ability to drive or use machines, whilst taking it and afterwards.

You should only start doing these activities again with the permission of your doctor.

Important information about what is in Metharose:

This medicine contains:

methyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This allergy may happen some time after starting the medicine liquid maltitol. If your doctor has told you that you cannot tolerate some sugars, see your doctor before taking this medicine. How to take Metharose

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask your doctor or pharmacist if you are not sure.

Taking this medicine this medicine contains 1mg of methadone in each 1ml take this medicine by mouth Adults

For addiction

the starting dose is 10mg to 20mg (10ml to 20ml) each day the doctor can increase this to 40mg to 60mg (40ml to 60ml) each day.

For pain

the usual dose is 5mg to 10mg (5ml to 10ml) every 6 to 8 hours the dose may be changed by your doctor Older people and very ill people if you have to have repeated doses of this medicine, the doctor may want to monitor you more closely. Children

Children must not take this medicine.

If you take more Metharose than you should

If you take more of this medicine than you should, talk to a doctor or go to your nearest hospital straight away. Take the medicine pack with you.

If you forget to take Metharose if you forget a dose do not take it. Wait until the next dose is due and take only that amount do not take a double dose (two doses at the same time) to make up for a forgotten dose. If you stop taking Metharose do not stop taking this medicine unless your doctor tells you to as you may suffer withdrawal effects your doctor will tell you how to lower the dose gradually.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Metharose can cause side effects although not everybody gets them.

Stop taking this medicine and see a doctor straight away if you have an allergic reaction to Metharose.

An allergic reaction may include:

swelling of your face, lips, tongue or throat or difficulty breathing or swallowing severe itching of your skin with raised lumps. Stop taking this medicine and see a doctor straight away if you have any of the following: heart problems. The signs of this may include changes in the way your heart beats, such as it beating faster or missed heart beats, breathing difficulties and dizziness if your breathing becomes slow and shallow. Keep taking the medicine but tell your doctor straight away if you get any of the following side effects: if you have asthma and it gets worse worsening of the pressure inside your head if you already have this condition following an injury to your brain or brain disease. Tell your doctor if you get any of these side effects: feeling sick (nausea) or being sick (vomiting) constipation sweating a lot more than usual feeling dizzy, particularly when standing up. This may be a sign that you have low blood pressure small pupils breast growth and production of breast milk difficulty in passing water (urine), pain in the lower back and abdomen caused by muscle spasms dry mouth, eyes or nose, facial flushing feeling drowsy, confused or restless changes in your mood, feeling ”high” or over excited seeing or hearing things that are not there (hallucinations) headache, rashes low body heat (hypothermia) lower sexual urge or desire painful periods or lack of periods.

You may notice that some of the side effects become less severe with time as you get used to the methadone

When taken for a long period of time, it is possible that you may become dependent on Metharose.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Metharose keep out of the reach and sight of children store below 25°C. Protect from light do not use after the expiry date (month, year) stated on the label and carton if it is out of date or you no longer want it, take it back to the pharmacy do not use Metharose if you notice anything wrong with the medicine. Talk to your pharmacist medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicine no longer required. These measures will help to protect the environment. Further information What Metharose contains The active ingredient is methadone hydrochloride The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), propylene glycol (E1520), caramel (E150), liquid maltitol (E965) and purified water. What Metharose looks like and contents of the pack

A brown solution

It comes in a brown glass bottle holding 500ml of solution.

Marketing Authorisation Holder and Manufacturer Rosemont Pharmaceuticals Ltd Yorkdale Industrial Park Braithwaite Street Leeds LS11 9XE UK

This leaflet was last approved in May 2009.

P0459


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