1. Name Of The Medicinal Product

UTROGESTAN 100MG CAPSULES

2. Qualitative And Quantitative Composition

Each capsule contains 100 mg micronised progesterone (INN). For excipients, see 6.1.

3. Pharmaceutical Form

Capsules, soft

White

4. Clinical Particulars 4.1 Therapeutic Indications

Adjunctive use with estrogen in post-menopausal women with an intact uterus. (HRT)

4.2 Posology And Method Of Administration

Posology

In women receiving estrogen replacement therapy there is an increased risk of endometrial cancer which can be countered by progesterone administration. The recommended dose is 200 mg daily at bedtime, for twelve days in the last half of each therapeutic cycle (beginning on day 15 of the cycle and ending on day 26). Withdrawal bleeding may occur in the following week. Alternatively 100 mg can be given at bedtime from day 1 to day 25 of each therapeutic cycle, withdrawal bleeding being less with this treatment schedule.

Children: Not applicable.

Elderly: As for adults

Method of Administration: Oral. Utrogestan 100mg Capsules should not be taken with food

4.3 Contraindications

Known allergy or hypersensitivity to progesterone or to any of the excipients. The capsules contain arachis oil (peanut oil) and should never be used by patients allergic to peanuts. Severe hepatic dysfunction. Undiagnosed vaginal bleeding. Mammary or genital tract carcinoma. Thrombophlebitis. Thromboembolic disorders. Cerebral haemorrhage. Porphyria.

4.4 Special Warnings And Precautions For Use

Warnings:

Utrogestan 100mg Capsules are not a treatment for premature labour.

Prescription of progesterone beyond the first trimester of pregnancy may reveal gravidic cholestasis.

Utrogestan 100mg Capsules are not suitable for use as a contraceptive.

If unexplained, sudden or gradual, partial or complete loss of vision, proptosis or diplopia, papilloedema, retinal vascular lesions or migraine occur during therapy, the drug should be discontinued and appropriate diagnostic and therapeutic measures instituted.

Utrogestan 100mg Capsules are intended to be co-prescribed with an estrogen product as HRT. Epidemiological evidence suggests that the use of HRT is associated with an increased risk of developing deep vein thrombosis (DVT) or pulmonary embolism. The prescribing information for the co-prescribed estrogen product should be referred to for information about the risks of venous thromboembolism.

There is suggestive evidence of a small increased risk of breast cancer with estrogen replacement therapy. It is not known whether concurrent progesterone influences the risk of cancer in post-menopausal women taking hormone replacement therapy. The prescribing information for the co-prescribed estrogen product should be referred to for information about the risks of breast cancer.

Precautions

Prior to taking hormone replacement therapy (and at regular intervals thereafter) each woman should be assessed. A personal and family medical history should be taken and physical examination should be guided by this and by the contraindications and warnings for this product.

Utrogestan 100mg Capsules should not be taken with food and should be taken at bedtime. Concomitant food ingestion increases the bioavailability of Utrogestan 100mg Capsules.

Utrogestan 100mg Capsules should be used cautiously in patients with conditions that might be aggravated by fluid retention (e.g. hypertension, cardiac disease, renal disease, epilepsy, migraine, asthma); in patients with a history of depression, diabetes, mild to moderate hepatic dysfunction, migraine or photosensitivity and in breast-feeding mothers.

Clinical examination of the breasts and pelvic examination should be performed where clinically indicated rather than as a routine procedure. Women should be encouraged to participate in the national breast cancer screening programme (mammography) and the national cervical cancer screening programme (cervical cytology) as appropriate for their age. Breast awareness should also be encouraged and women advised to report any changes in their breasts to their doctor or nurse.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Utrogestan 100mg Capsules may interfere with the effects of bromocriptine and may raise the plasma concentration of ciclosporin. Utrogestan 100mg Capsules may affect the results of laboratory tests of hepatic and/or endocrine functions.

Metabolism of Utrogestan 100mg Capsules is accelerated by rifamycin an antibacterial agent.

The metabolism of progesterone by human liver microsomes was inhibited by ketoconazole (IC50 <0.1 ?M Ketoconazole is a known inhibitor of cytochrome P450 3A4. These data therefore suggest that ketoconazole may increase the bioavailability of progesterone. The clinical relevance of the in vitro findings is unknown.

4.6 Pregnancy And Lactation

Pregnancy

Utrogestan 100mg Capsules are not indicated during pregnancy. If pregnancy occurs during medication, Utrogestan 100mg Capsules should be withdrawn immediately.

Lactation

Detectable amounts of progesterone enter the breast milk. There is no indication for prescribing HRT during lactation.

4.7 Effects On Ability To Drive And Use Machines

Utrogestan 100mg Capsules may cause drowsiness and/or dizziness in a minority of patients; therefore caution is advised in drivers and users of machines. Taking the capsules at bedtime should reduce these effects during the day.

4.8 Undesirable Effects

Somnolence or transient dizziness may occur 1 to 3 hours after intake of the drug. Bedtime dosing and reduction of the dose may reduce these effects.

Shortening of the cycle or breakthrough bleeding may occur. If this occurs, the dose of Utrogestan 100mg Capsules can be reduced and taken at bedtime from day 1 to day 26 of each therapeutic cycle.

Acne, urticaria, rashes, fluid retention, weight changes, gastro-intestinal disturbances, changes in libido, breast discomfort, premenstrual symptoms, menstrual disturbances; also chloasma, depression, pyrexia, insomnia, alopecia, hirsutism; rarely jaundice.

Venous thromboembolism, i.e. deep leg or pelvic venous thrombosis and pulmonary embolism, is more frequent among hormone replacement therapy users than among non-users.

4.9 Overdose

Symptoms of overdosage may include somnolence, dizziness, euphoria or dysmenorrhoea. Treatment is observation and, if necessary, symptomatic and supportive measures should be provided.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group (ATC code: G03D)

Progesterone is a natural progestogen, the main hormone of the corpus luteum and the placenta. It acts on the endometrium by converting the proliferating phase to the secretory phase. Utrogestan 100mg Capsules have all the properties of endogenous progesterone with induction of a full secretory endometrium and in particular gestagenic, antiestrogenic, slightly anti-androgenic and antialdosterone effects.

5.2 Pharmacokinetic Properties

Absorption

Micronised progesterone is absorbed by the digestive tract. Pharmacokinetic studies conducted in healthy volunteers have shown that after oral administration of 2 capsules (200mg), plasma progesterone levels increased to reach the Cmax of 13.8ng/ml +/- 2.9ng/ml in 2.2 +/- 1.4 hours. The elimination half-life observed was 16.8+/- 2.3 hours.

Although there were inter-individual variations, the individual pharmacokinetic characteristics were maintained over several months, indicating predictable responses to the drug.

Distribution

Progesterone is approximately 96%-99% bound to serum proteins, primarily to serum albumin (50%-54%) and transcortin (43%-48%).

Elimination

Urinary elimination is observed for 95% in the form of glycuroconjugated metabolites, mainly 3 ?, 5 ?–pregnanediol (pregnandiol).

Metabolism

Progesterone is metabolised primarily by the liver. The main plasma metabolites are 20 ? hydroxy- ? 4 ?- prenolone and 5 ?-dihydroprogesterone. Some progesterone metabolites are excreted in the bile and these may be deconjugated and further metabolised in the gut via reduction, dehydroxylation and epimerisation. The main plasma and urinary metabolites are similar to those found during the physiological secretion of the corpus luteum.

5.3 Preclinical Safety Data

Preclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology and toxicity.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Arachis oil

Soya lecithin

Gelatin

Glycerol

Titanium dioxide

6.2 Incompatibilities

None.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

No special precautions for storage.

6.5 Nature And Contents Of Container

The product is supplied in PVC/Aluminium blisters contained in cartons.

Pack size: 30 capsules

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Laboratoires BESINS INTERNATIONAL

3, rue du Bourg l'Abb?

75003

Paris

France

8. Marketing Authorisation Number(S)

PL 16468/0001

9. Date Of First Authorisation/Renewal Of The Authorisation

10 January 2003

10. Date Of Revision Of The Text

Feburary 2006

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1. Name Of The Medicinal Product

Vitamin E Suspension 100mg/ml

2. Qualitative And Quantitative Composition

Each 5ml of suspension contains 500mg of DL-alpha-tocopheryl acetate.

3. Pharmaceutical Form

Oral Suspension

4. Clinical Particulars 4.1 Therapeutic Indications

For the correction of Vitamin E deficiency occurring in malabsorption disorders ie. cystic fibrosis, chronic cholestasis and abetalipoproteinaemia.

4.2 Posology And Method Of Administration

Route of administration: For oral use.

Adults (including the elderly)

For the treatment of malabsorption disorders the following doses should be administered:

Cystic fibrosis 100-200mg/day

Abetalipoproteinaemia 50-100mg/kg/day

Children

For the treatment of cystic fibrosis a dose of 50mg/day should be given to children less than 1 year and 100mg/day to children 1 year and over.

The adult dosage should be used for the treatment of abetalipoproteinaemia (50-100mg/kg/day).

Infants with vitamin E deficiency which is secondary to chronic cholestasis may be treated with doses of 150-200mg/kg/day.

4.3 Contraindications

Use in patients with a known hypersensitivity to Vitamin E.

4.4 Special Warnings And Precautions For Use

Vitamin E has been reported to increase the risk of thrombosis in patients predisposed to this condition, including patients taking oestrogens. This finding has not been confirmed but should be borne in mind when selecting patients for treatment, in particular women taking oral contraceptives containing oestrogens.

A higher incidence of necrotising enterocolitis has been noted in lower weight premature infants (less than 1.5kg) treated with vitamin E.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Vitamin E may increase the risk of thrombosis in patients taking oestrogens (see 4.4 above).

4.6 Pregnancy And Lactation

There is no evidence of the safety of high doses of vitamin E in pregnancy nor is there evidence from animal work that it is free from hazard, therefore do not use in pregnancy especially in the first trimester. No information is available on excretion in breast milk, therefore it is advisable not to use during lactation.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Diarrhoea and abdominal pain may occur with doses greater than 1g daily.

4.9 Overdose

Transient gastro-intestinal disturbances have been reported with doses greater than 1g daily and where necessary, general supportive measures should be employed.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

The exact role of vitamin E in the animal organism has not yet been established. Vitamin E is known to exert an important physiological function as an antioxidant for fats, with a sparing action on vitamin A, carotenoids and on unsaturated fatty acids. Other work has demonstrated that vitamin E is connected with the maintenance of certain factors essential for the normal metabolic cycle.

5.2 Pharmacokinetic Properties

Vitamin E is absorbed from the gastrointestinal tract. Most of the vitamin appears in the lymph and is then widely distributed to all tissues. Most of the dose is slowly excreted in the bile and the remainder is eliminated in the urine as glucuronides of tocopheronic acid or other metabolites.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Castor oil polyethylene glycol ether

Benzoic acid

Sorbic acid

Glycerol

Syrup

Flavour raspberry

Purified Water

6.2 Incompatibilities

None.

6.3 Shelf Life

Unopened: Two years.

After first opening: One month (The product will be stable after opening for the normal duration of treatment providing the cap is replaced after use and the recommended storage conditions on the label are observed).

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

Amber glass bottles with aluminium screw caps or Vistop tamper-evident caps.

6.6 Special Precautions For Disposal And Other Handling

Vitamin E Suspension may be diluted with Syrup BP but should be used immediately and not stored.

7. Marketing Authorisation Holder

Cambridge Laboratories Limited

Deltic House

Kingfisher Way

Silverlink Business Park

Wallsend

Tyne & Wear

NE28 9NX

8. Marketing Authorisation Number(S)

PL 12070/0010

9. Date Of First Authorisation/Renewal Of The Authorisation

8 March 1993

10. Date Of Revision Of The Text

March 2000

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Flecainide Acetate 50mg and 100mg 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, 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. Index 1 What Flecainide Acetate tablets are and what they are used for 2 Before you take 3 How to take 4 Possible side effects 5 How to store 6 Further information What Flecainide Acetate tablets are and what they are used for

Flecainide Acetate tablets belong to a group of medicines called anti-arrhythmics. They work by regulating the heart rate.

Flecainide Acetate tablets may be used to treat the following conditions when other drugs are not effective: irregular beats of the upper heart chambers (atria) including Wolff-Parkinson-White Syndrome irregular beats of the lower heart chambers (ventricles). Before you take

Do not take Flecainide Acetate tablets and tell your doctor if you:

are allergic (hypersensitive) to flecainide acetate or any of the other ingredients (see section 6) suffer from conduction problems of the heart, such as a slow or fast heart beat or heart block suffer from heart failure have severely low blood pressure have had a heart attack (myocardial infarction) are in shock due to heart problems (cardiogenic shock) have rapid and irregular heart beat (atrial fibrillation) are taking disopyramide (medicine to treat irregular heart rhythms).

Take special care with Flecainide Acetate tablets and tell your doctor if you:

suffer from low or high levels of potassium in the blood have liver or kidney disease have a pacemaker have any heart disease or an enlarged heart have rapid or irregular heart beats after heart surgery have been told you have disturbances in heart rhythm known as sick sinus syndrome. Taking other medicines

Before taking Flecainide Acetate tablets, tell your doctor if you are taking or have recently taken the following medicines, or are taking any non-prescribed medicines:

verapamil or beta blockers (e.g. propranolol to treat heart diseases) laxatives (to treat constipation) diuretics (‘water tablets’) steroids (e.g. betamethasone, hydrocortisone or prednisolone) sodium channel blockers (e.g. lidocaine to treat irregular heartbeat (arrhythmia) or as a local anaesthetic) phenytoin, phenobarbital or carbamazepine (to treat epilepsy) digoxin (to treat heart conditions) amiodarone, quinidine or disopyramide (to treat irregular heart rhythms) cimetidine (to treat stomach ulcers) fluoxetine or tricyclic antidepressants (e.g. amitriptyline to treat depression) terfenadine or astemizole (to treat allergic reactions) quinine or halfantrine (to treat or prevent malaria) Pregnancy and breast-feeding

Your doctor will only prescribe Flecainide Acetate tablets if it is absolutely necessary. Breast feeding is not recommended whilst taking Flecainide Acetate tablets. Check with your doctor if you are unsure.

Driving and using machines

Flecainide Acetate tablets may cause dizziness or affect your vision. Make sure you are not affected before you drive or operate machinery.

Tests

Your doctor will monitor your progress on a regular basis with ECG (electrocardiogram) and blood tests, and may alter the dose if necessary.

If you see another doctor or go into hospital, let them know what medicines you are taking.

How to take

Always take Flecainide Acetate tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Treament may be started in hospital.

Swallow these tablets whole with water on an empty stomach or one hour before food.

Doses: Adults and adolescents (13-17 years of age) treatment of irregular beats of the upper heart chambers (atria) : starting dose is 50mg twice a day up to a maximum dose of 300mg per day. treatment of irregular heart beats of the lower heart chambers (ventricular) : starting dose is 100mg twice a day up to a maximum dose of 400mg per day. Children under 12 years of age - not recommended Elderly patients or those fitted with pacemakers, with kidney or liver problems or taking amiodarone or cimetidine - a lower dose of flecainide may be given. If you take more Flecainide Acetate tablets than you should

If you have accidentally taken more than the prescribed dose, contact your nearest casualty department or tell your doctor or pharmacist at once.

If you forget to take Flecainide Acetate tablets

If you forget to take a dose take it as soon as you remember, unless it is nearly time to take the next dose. Then go on as before. Never double up on the next dose to make up for the one missed.

If you stop taking the tablets

Talk to your doctor before you stop taking the tablets and follow their advice.

Possible side effects

Like all medicines, Flecainide Acetate tablets can cause side effects, although not everybody gets them.

Stop taking Flecainide Acetate tablets and contact your doctor at once if the following allergic reaction happens: skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

Very common (occurs in more than 1 in 10 users): dizziness, giddiness, light headedness, headache, double or blurred vision

Common (occurs in less than 1 in 10 users): signs of your heart condition getting worse or development of new heart symptoms, a change in heart beat pattern (especially in patients with existing heart problems)

Uncommon (occurs in less than 1 in 100 users): changes in the numbers and types of your blood cells, difficulty breathing, feeling or being sick

Rare (occurs in less than 1 in 1,000 users): affects on your immune system which may be associated with inflammation, hallucinations, depression, confusion, memory loss, nervousness, anxiety, disturbances of movement, convulsions, ‘pins and needles’ or numbness, problems with co-ordination, raised liver enzyme levels or jaundice (yellow skin and/or whites of the eyes)

Very rare (occurs in less than 1 in 10,000 users): particles in the front of the eye (corneal deposits), lung disease (pneumonitis), sensitivity of the skin to light, flushing or increased sweating, allergic skin reactions (which may be itchy), dry mouth, impairment of taste, joint and muscle pain, impotence.

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

How to store

Keep out of the reach and sight of children.

Do not store the tablets above 25°C and store in the original packaging.

Do not use Flecainide Acetate tablets after the expiry date stated on the label/carton/bottle. 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 Flecainide Acetate tablets contain The active substance (the ingredient that makes the tablets work) is flecainide acetate. Each tablets contains either 50mg or 100mg of the active ingredient. The other ingredients are croscarmellose sodium, magnesium stearate, maize starch, pregelatinised maize starch, microcrystalline cellulose (E460). What Flecainide Acetate tablets look like and contents of the pack

Flecainide Acetate tablets are white, uncoated tablets.

Pack sizes are 60 tablets

Marketing Authorisation Holder and Manufacturer Actavis Barnstaple EX32 8NS UK

Date of last revision: July 2008.

If you would like a leaflet with larger text, please contact 01271 311257.

Actavis Barnstaple EX32 8NS UK

50134525

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Orelox 100mg Tablets

Cefpodoxime proxetil

Is this leaflet hard to see or read?

Phone 01483 505515 for help

Read all of this leaflet carefully before 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 for you. Do not pass it on to others. It may harm them, even if their symptoms are the same 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 your pharmacist. In this leaflet: 1. What Orelox Tablets are and what they are used for 2. Before you take Orelox Tablets 3. How to take Orelox Tablets 4. Possible side effects 5. How to store Orelox Tablets 6. Further information What Orelox Tablets are and what they are used for

Orelox Tablets contains a medicine called cefpodoxime proxetil. This belongs to a group of antibiotics called ‘cephalosporins’.

Orelox Tablets are used to treat infections caused by bacteria. These include infections of the:

nose, sinuses (such as sinusitis) throat (such as tonsillitis, pharyngitis) chest and lungs (such as bronchitis, pneumonia) skin (such as an abscess, ulcer, infected wound, inflamed hair follicles, carbuncles, furuncles, infections around the finger nails, a type of skin infection called cellulitis) urinary system (such as cystitis, and kidney infections) the sexually transmitted infection, gonorrhoea Before you take Orelox Tablets Do not take this medicine and tell your doctor or pharmacist if: You are allergic (hypersensitive) to cefpodoxime, any other antibiotics including penicillin or to any of the other ingredients of this medicine (see Section 6: Further Information).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat and tongue.

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

Take special care with Orelox Tablets

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

Have ever had colitis Have kidney problems

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

Taking other medicines

Please tell your doctor or your 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 Orelox Tablets can affect the way some other medicines work. Also some medicines can affect the way Orelox Tablets works.

In particular, tell your doctor if you are taking any of the following:

antacids (used to treat indigestion) medicines for treating ulcers (such as ranitidine or cimetidine) water tablets or injections (diuretics) used to increase the flow of your water (urine) aminoglycoside antibiotics (used to treat infections) probenecid (used with a medicine called cidofovir to stop kidney damage) coumarin anti-coagulants such as warfarin (used to thin the blood) oestrogens such as in the contraceptive pill

Take antacids and medicines for ulcers 2-3 hours after Orelox Tablets.

Tests

If you require any tests (such as blood or urine tests) while taking this medicine, please make sure your doctor knows that you are taking Orelox Tablets.

Pregnancy and breast-feeding

Talk to your doctor before taking Orelox Tablets if you are pregnant, might become pregnant or think you may be pregnant.

Do not breast-feed if you are taking Orelox Tablets. This is because small amounts may pass into the mother’s milk.

If you are pregnant or breast-feeding talk to your doctor or pharmacist before taking any medicine.

Driving and using machinery

You may feel dizzy while you are taking this medicine. If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of Orelox Tablets

Orelox Tablets contain:

Lactose: This is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars talk to your doctor before taking this medicine. How to take Orelox Tablets

Always take Orelox Tablets 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. Take this medicine with or straight after food If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor. How much to take

The dose of Orelox Tablets depends on your needs and the illness being treated. Your doctor will advise you:

Adults

Infections of the nose/throat

One tablet twice each day

Infection of the sinuses

Two tablets twice each day

Infections of the chest and lungs

One or two tablets, twice each day

Infections of the lower urinary system e.g. cystitis

One tablet twice each day

Gonorrhoea

Two tablets as a single dose

Infections of the upper urinary system such as kidney infections

Two tablets twice each day

Skin infections

Two tablets twice each day People with kidney problems

Your doctor may need to give you a lower dose

Children

Children should be given Orelox Paediatric Granules

Your doctor will advise you of the best way to take your medicine. Always follow his advice about when and how to take your medicine and always read the label on the box. Your pharmacist will also be able to help you if you are not sure.

Blood tests

If you take this medicine for more than 10 days, the doctor or nurse may do a blood test. This is routine and nothing to worry about.

If you take more Orelox Tablets than you should

If you have too much of this medicine, talk to your doctor straight away. The following effects may happen: confusion, lack of emotion or interest in anything and agitation.

If you forget to take Orelox Tablets

If a dose is missed, do not worry. Just wait until the next dose is due. Do not take a double dose to make up for a forgotten dose.

If you stop taking Orelox Tablets

Do not stop taking your medicine without talking to your doctor. You should not stop taking Orelox Tablets just because you feel better. This is because the infection may come back or get worse again.

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

Possible side effects

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

Tell your doctor straight away or go to the nearest hospital casualty department if you notice any of the following serious side effects – you may need urgent medical treatment: You have an allergic reaction. The signs may include: a rash, joint pain, swallowing or breathing problems, swelling of your lips, face, throat or tongue. Blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also flu-like symptoms and fever. This may be something called ‘Stevens-Johnson syndrome’. Severe blistering rash where layers of the skin may peel off to leave large areas of raw exposed skin over the body. Also a feeling of being generally unwell, fever, chills and aching muscles. This may be something called ‘Toxic epidermal necrolysis’. You have a skin rash or skin lesions with a pink/red ring and a pale centre which may be itchy, scaly or filled with fluid. The rash may appear especially on the palms or soles of your feet. These could be signs of a serious allergy to the medicine called ‘erythema multiforme’. You get infections more easily than usual. This could be because of a blood disorder. This is more likely if you are taking the tablets for a long time. Yellowing of the skin, eyes or mouth and feeling tired. You may also be more pale than normal. This could be because of a serious type of anaemia. Stop taking your medicine and you contact your doctor without delay if you get: Severe diarrhoea Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days Feeling sick (nausea) or being sick (vomiting) Stomach pains Headaches Feeling dizzy Ringing in the ears Feeling tired or weak Itching skin without rash Pins and needles Numbness or tingling feelings

Tell your doctor if any of these side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.

Blood tests

Orelox Tablets can change the levels of liver enzymes shown up in blood tests. This can mean that your liver is not working properly.

If you think you are reacting badly to the medicine or having any problems, then discuss it with your doctor or your pharmacist.

How to store Orelox Tablets

Keep out of the reach and sight of children.

Store below 25°C.

Do not use Orelox 100mg Tablets after the expiry date which is stated on the label or carton 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 Orelox Tablets contain Each tablet contains 130mg of the active ingredient cefpodoxime proxetil (equivalent to 100mg cefpodoxime). The other ingredients are lactose, magnesium stearate, carboxymethylcellulose calcium, hydroxypropylcellulose, sodium lauryl sulphate. The tablets are film coated with titanium dioxide, talc and hydroxypropylmethylcellulose 6CP. What Orelox Tablets looks like and content of the pack

Orelox 100mg Tablets are biconvex cylindrical white tablets with “208” and beneath “A” engraved on one side.

Orelox is available in blister packs of 10 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS UK Tel:01483 505515 Fax:01483 535432

Manufacturer

Sanofi Winthrop Industrie 56, Route de Choisy–au–bac 60205 Compiegne 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 July 2008.

© sanofi-aventis, 1998 - 2008

R752320

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Ciprofibrate 100mg Tablets

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Phone 01483 505515 for help

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 ciprofibrate is and what it is used for 2. Before you take ciprofibrate 3. How to take ciprofibrate 4. Possible side effects 5. How to store ciprofibrate 6. Further information What ciprofibrate is and what it is used for

The name of your medicine is Ciprofibrate 100mg Tablets (called ciprofibrate throughout this leaflet).

It contains a medicine called ciprofibrate. This belongs to a group of medicines called ‘fibrates’. It works by lowering the amount of fat in your blood.

Ciprofibrate is used to treat something called ‘hyperlipidaemia’.

This is where you have high levels of fat in your blood It is usually given after a low fat diet has failed to reduce these high levels People with high levels of fat in their blood have a higher chance of getting the early signs of heart disease Before you take ciprofibrate Do not take ciprofibrate if: You are allergic (hypersensitive) to ciprofibrate or any of the other ingredients of ciprofibrate (see Section 6: Further information)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue You are pregnant, might become pregnant or think you may be pregnant (see “Pregnancy and breast-feeding” section below) You are breast-feeding (see “Pregnancy and breast-feeding” section below) You have severe liver or kidney problems You are taking 'fibrates' (such as clofibrate, bezafibrate, fenofibrate or gemfibrozil)- used to treat high blood fat levels

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

Take special care with ciprofibrate. Check with your doctor or pharmacist before taking ciprofibrate if: You have unexpected muscle pains, tenderness or weakness You have liver or kidney problems You have an under-active thyroid gland

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

Blood Tests Taking ciprofibrate may affect the results of some blood tests. During treatment your doctor may do blood tests to check how your liver is working If you are going to have any other blood tests, it is important to tell the person taking the test that you are taking ciprofibrate 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 ciprofibrate can affect the way some other medicines work. Also some medicines can affect the way ciprofibrate works.

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

Statins (such as simvastatin, atorvastatin, pravastatin, fluvastatin and rosuvastatin)- used to treat high blood fat levels Warfarin - used for thinning the blood Insulin or Metformin - used for diabetes Contraceptive medicines (such as 'The Pill) or hormone replacement therapy (HRT) Taking ciprofibrate with alcohol

One of the side effects of this medicine is muscle problems. Drinking a lot of alcohol may increase the chance of muscle problems. This means that you must limit the amount of alcohol you drink while you are taking ciprofibrate. Ask your doctor for more advice.

Pregnancy and breast-feeding

Do not take ciprofibrate if you are:

Pregnant, might become pregnant, or think you may be pregnant Breast-feeding or planning to breast-feed. This is because small amounts of ciprofibrate may pass into the 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

If you get dizzy, drowsy and tired while taking ciprofibrate, then you should not drive or use any tools or machinery.

Important information about some of the ingredients of ciprofibrate

If you have been told by your doctor that you cannot tolerate some sugars, contact your doctor before taking ciprofibrate.

How to take ciprofibrate

Always take ciprofibrate 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 Do not give to children under 12 years It is important while you are taking ciprofibrate to keep to any special diet you have been given If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor How much to take The usual dose for adults is 1 tablet every day Do not take any more than 1 tablet each day If you have kidney problems, only take 1 tablet every other day If you take more ciprofibrate than you should

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

If you forget to take ciprofibrate If you forget a dose, take it as soon as you remember it However, if it is time for the next dose, skip the missed dose Do not take a double dose to make up for a forgotten dose If you stop taking ciprofibrate

Keep taking your medicine until your doctor tells you to stop. Do not stop taking ciprofibrate just because you feel better. If you stop, your illness may get worse.

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

Possible side effects

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

Stop taking your medicine and see a doctor or go to a hospital straight away - you may need urgent medical treatment. Muscle problems, such as cramps, pain or tenderness.This can lead to kidney failure Tell your doctor as soon as possible if you have any of the following side effects: An allergic reaction. The signs may include: a rash (which may be itchy and lumpy), itching and being more sensitive to the sun than usual Feeling breathless Liver problems. This may cause the eyes or skin to go yellow (jaundice) Other side effects are: Hair loss, balding Headache, balance problems Feeling dizzy, drowsy or tired Impotence The following side effects can happen at the start of your treatment. You are less likely to get them as treatment continues: Feeling sick (nausea) or being sick (vomiting) Diarrhoea, indigestion or stomach pains

Tell your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days. Also tell them if you notice any side effects not listed in this leaflet

How to store ciprofibrate

Keep out of the reach and sight of children.

Do not use ciprofibrate after the expiry date which is 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 ciprofibrate contains The active substance is ciprofibrate The other ingredients are maize starch, lactose monohydrate, microcrystalline cellulose, hypromellose, powdered vegetable stearine, sodium laurilsulfate What ciprofibrate looks like and contents of the pack

Ciprofibrate tablets are long and white with S170 stamped on one side. They are supplied in cartons of 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Winthrop Pharmaceuticals PO Box 611 Guildford Surrey GU1 4YS UK

Manufacturer

Fawdon Manufacturing Centre Edgefield Avenue Fawdon Newcastle-upon-Tyne NE3 3TT

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 February 2009.

‘Winthrop’ is a registered trademark.

©2009 Winthrop Pharmaceuticals.

30338600

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1. Name Of The Medicinal Product

Praxilene 100mg Capsules

2. Qualitative And Quantitative Composition

100mg naftidrofuryl oxalate equivalent to 81.0 mg naftidrofuryl and 19.0 mg oxalate.

3. Pharmaceutical Form

Capsule

4. Clinical Particulars 4.1 Therapeutic Indications

Peripheral vascular disorders - intermittent claudication, night cramps, rest pain, incipient gangrene, trophic ulcers, Raynaud's Syndrome, diabetic arteriopathy and acrocyanosis.

Cerebral vascular disorders - cerebral insufficiency and cerebral atherosclerosis, particularly where these manifest themselves as mental deterioration and confusion in the elderly.

4.2 Posology And Method Of Administration

Peripheral vascular disorders - one or two capsules three times daily for a minimum of three months, or at the discretion of the physician.

Cerebral vascular disorders - one 100mg capsule three times daily for a minimum of three months, or at the discretion of the physician.

There is no recommended use for children.

Administration:

For oral administration. The capsules should be swallowed whole during meals with a sufficient amount of water (minimum) of one glass.

4.3 Contraindications

Hypersensitivity to the drug. Patients with a history of hyperoxaluria or recurrent calcium-containing stones.

4.4 Special Warnings And Precautions For Use

A sufficient amount of liquid should be taken during treatment to maintain an adequate level of diuresis.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Pregnancy: There is no, or inadequate, evidence of the safety of naftidrofuryl oxalate in human pregnancy, but it has been in wide use for many years without apparent ill consequence, animal studies having shown no hazard. If drug therapy is needed in pregnancy, this drug can be used if there is no safer alternative.

Lactation: No information is available.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Naftidrofuryl oxalate is normally well tolerated in the dosage recommended. Occasionally nausea, epigastric pain and rashes have been noted.

Rarely, hepatitis has been reported. Very rarely, calcium oxalate kidney stones have been reported.

4.9 Overdose

Signs and symptoms: Depression of cardiac conduction and convulsions may occur.

Treatment: The stomach should be emptied by gastric lavage and emesis. Activated charcoal may be employed if necessary. Cardiovascular function and respiration should be monitored and, in severe cases, electrical pacemaking or the use of isoprenaline should be considered. Convulsions may be managed by diazepam.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Naftidrofuryl oxalate has been shown to exert a direct effect on intracellular metabolism. Thus it has been shown in man and animals that it produces an increase of ATP levels and a decrease of lactic acid levels in ischaemic conditions, evidence for an enhancement of cellular oxidative capacity. Furthermore, naftidrofuryl oxalate is a powerful spasmolytic agent.

5.2 Pharmacokinetic Properties

Naftidrofuryl oxalate is well absorbed when given orally. Peak plasma levels occur about 30 minutes after dosing and the half life is about an hour, although inter subject variation is relatively high. Accumulation does not occur at a dose level of 200mg three times daily.

The drug becomes extensively bound to plasma proteins and is excreted principally via the urine, all in the form of metabolites.

5.3 Preclinical Safety Data

No toxic effects were seen in animal studies which provide additional information to that obtained in man. In repeated dose studies the no effect level was 25mg/kg/day or greater. There was no evidence of effects on reproduction below doses which caused maternal toxicity.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Talc

Magnesium Stearate

Purified Water*

Denatured Ethanol*

Capsule Shells:

Erythrosine (E127)

Titanium Dioxide (E171)

Gelatine

Printing ink:

Black iron oxide (E172)

*Not present in final product

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store below 20°C in a dry place away from light.

6.5 Nature And Contents Of Container

Pack size 10 (medical sample), 21 and 84 capsules:-

Cardboard carton containing blister strips comprising heat-sealable PVC (250?m) and aluminium foil (30?m).

Pack size 100 and 500:

Polyethylene securitainers with tamper evident closures.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Merck Serono Ltd

Bedfont Cross

Stanwell Road

Feltham

Middlesex

TW14 8NX, UK

8. Marketing Authorisation Number(S)

PL 11648/0064

9. Date Of First Authorisation/Renewal Of The Authorisation

24 March 2009

10. Date Of Revision Of The Text

24 March 2009

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1. Name Of The Medicinal Product

NAFTIDROFURYL CAPSULES BP 100mg

2. Qualitative And Quantitative Composition

Each hard gelatin capsule contains 100mg Naftidrofuryl oxalate PhEur.

3. Pharmaceutical Form

Pink hard gelatin capsules.

Pink hard gelatin capsules (size 2) printed “C” and “NL” in black.

4. Clinical Particulars 4.1 Therapeutic Indications

1) Peripheral vascular disorders (intermittent claudication, night cramps, rest pain, incipient gangrene, trophic ulcers, Raynaud's syndrome, diabetic arteriopathy and acrocyanosis).

2) Cerebral vascular disorders (cerebral insufficiency and cerebral atherosclerosis, particularly where these manifest themselves as mental deterioration and confusion in the elderly).

4.2 Posology And Method Of Administration

Posology

The capsules should be administered with a sufficient amount of water (one glass) during or after food.

Adults and the elderly:

Peripheral vasular disorders: One or two 100mg capsules three times daily for a minimum of three months, or at the discretion of the physician.

In patients with renal impairment a dose adjustment may be considered.

Cerebral vasular disorders: One 100mg capsule three times daily for a minimum of three months, or at the discretion of the physician.

Method of Administration

For oral use (swallowing).

4.3 Contraindications

Known hypersensitivity to naftidrofuryl oxalate or other ingredients in the capsule.

Patients with a history of hyperoxaluria or recurrent calcium-containing stones.

Contains soya lecithin. Purified soya oil may contain peanut protein. Therefore, Naftidrofuryl capsules are contraindicated in patients who are allergic to peanut of soya.

4.4 Special Warnings And Precautions For Use

Should be used with caution in patients with renal or hepatic disorders as the drug is metabolised in the liver and excreted mainly in the urine.

A sufficient amount of liquid should be taken during treatment to maintain an adequate level of diuresis.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is no, or inadequate evidence of safety of naftidrofuryl oxalate in human pregnancy, but it has been in wide use for many years without apparent ill consequence, animal studies having shown no hazard. If drug therapy is needed in pregnancy, the benefits should be weighed against the potential risks.

There is no information available on the secretion of this drug in breast milk, and its use is therefore best avoided.

4.7 Effects On Ability To Drive And Use Machines

As Naftidrofuryl can cause dizziness patient should make sure they are not affected before driving or operating machinery.

4.8 Undesirable Effects

Naftidrofuryl is normally well tolerated in the dosage recommended. Occasionally nausea, epigastric pain, diarrhoea and rashes have been noted. Rarely has hepatitis and hepatic failure been reported.

Central Nervous System symptoms of dizziness, headache, agitation and sleep disorders have been reported.

Very rarely the presence of calcium oxalate kidney stones has been reported.

4.9 Overdose

Depression of cardiac conduction and convulsions may occur. The stomach should be emptied by gastric lavage and emesis. Activated charcoal may be employed if necessary. Cardiovascular function and respiration should be monitored and, in severe cases, electrical pacemaking or the use of isoprenaline should be considered. Convulsions may be managed with diazepam.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC code: C04A X 21

Naftidrofuryl oxalate is a powerful vasodilator agent with an antagonist effect on 5-HT2 receptors of the smooth muscle cells. The vasodilator effect, which occurs in both the cerebral and peripheral circulation, is probably the main action. However, the drug has also been shown to activate intracellular aerobic metabolism as demonstrated by a reduction in the level of lactic acid level and an increased level of ATP. It is claimed that this action protects cells against the metabolic effects of ischaemia.

5.2 Pharmacokinetic Properties

Peak plasma levels are attained at 0.5-0.75 hours after oral dose. Some 24% of the drug (range 17-32%) is absorbed from the gastrointestinal tract. There is some pre-systemic metabolism. The plasma half life is approximately 1 hour (range 0.8-1.6 hours). The drug penetrates brain and other tissues. It is, however, 80% bound to albumin. Cumulation does not occur at a dose level of 200mg three times daily.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

The capsule contains: maize starch, microcrystalline cellulose (E460), sodium starch glycollate, colloidal silica, stearic acid, magnesium stearate, water.

The capsule shell contains: erythrosine (E127), titanium dioxide (E171), water, gelatin.

The printing ink contains: IMS 74OP, shellac (E904), iron oxide black (E172), N-Butyl alcohol, soya lecithin MC thin (E322), antifoam DC 1510, water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Shelf-life

Two 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 containers with snap-on polyethylene lids.

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/PVdC. (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

Al/PVC/PVDC: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s

PP Tablet Container: 100s, 250s, 500s, 1000s

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 0142/0429.

9. Date Of First Authorisation/Renewal Of The Authorisation

22.12.98

10. Date Of Revision Of The Text

09/09/2010

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1. Name Of The Medicinal Product

Modalim Tablets 100 mg

2. Qualitative And Quantitative Composition

Each tablet contains 100mg ciprofibrate as the active ingredient.

For excipients, see 6.1

3. Pharmaceutical Form

Tablet.

4. Clinical Particulars 4.1 Therapeutic Indications

Modalim tablets are recommended for the treatment of primary dyslipoproteinaemias, including types IIa, IIb, III and IV (hypercholesterolaemia, hypertriglyceridaemia and combined forms) - refractory to appropriate dietary treatment.

Dietary measures should be continued during therapy.

4.2 Posology And Method Of Administration

Adults

The recommended dosage is one tablet (100mg ciprofibrate) per day. This dose should not be exceeded (see Precautions).

Elderly Patients

As for adults, but see Precautions and Warnings.

Use in Case of Impaired Renal Function

In moderate renal impairment it is recommended that dosage be reduced to one tablet every other day. Patients should be carefully monitored. Modalim should not be used in severe renal impairment.

Use in Children

Not recommended since safety and efficacy in children has not been established.

Modalim tablets are for oral administration only.

4.3 Contraindications

Severe hepatic impairment.

Severe renal impairment.

Pregnancy and lactation.

Concurrent use with another fibrate.

Hypersensitivity to the active substance or to any component of the product.

4.4 Special Warnings And Precautions For Use

4.4.1 Special warnings

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

-Myalgia/myopathy:

- Patients should be advised to report unexplained muscle pain, tenderness or weakness immediately.

CPK levels should be assessed immediately in patients reporting these symptoms. Treatment should be discontinued if CPK levels are greater than ten times the upper limit of the normal range, if levels rise progressively or if there is other evidence of myopathy.

- Doses of 200mg Modalim per day or greater have been associated with a high risk of rhabdomyolysis. Therefore the daily dose should not exceed 100mg.

- Impaired renal function and any situation of hypoalbuminaemia such as nephrotic syndrome, high alcohol intake or hypothyroidism may increase the risk of myopathy.

- As with other fibrates, the risk of rhabdomyolysis and myoglobinuria may be increased if ciprofibrate is used in combination with other fibrates or HMG CoA reductase inhibitors (see section 4.3 Contraindications and section 4.5 Interaction with other Medicinal Products and Other Forms of Interaction).

Use with caution in patients with impaired hepatic function.

Periodic hepatic function tests are recommended. Modalim treatment should be discontinued if significant transaminases abnormalities persist or if cholestatic liver injury is evidenced.

Secondary causes of dyslipidaemia, such as hypothyroidism, should be excluded or corrected prior to commencing any lipid lowering drug treatment.

4.4.2 Special precautions for use

Association with oral anticoagulant therapy: concomitant oral anticoagulant therapy should be given at reduced dosage and adjusted according to INR (see section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction).

If after a period of administration lasting several months, a satisfactory reduction in serum lipid concentrations has not been obtained, additional or different therapeutic measures must be considered.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

•Contra-indicated combination

Other fibrates: As with other fibrates, the risk of rhabdomyolysis and myoglobinuria may be increased if ciprofibrate is used in combination with other fibrates (see section 4.3 Contra-indications and section 4.4.1 Special warnings).

•Not recommended combinations

HMG CoA reductase inhibitors: As with other fibrates, the risk of myopathy, rhabdomyolysis and myoglobinuria may be increased if ciprofibrate is used in combination with HMG CoA reductase inhibitors (see section 4.4.1 Special warnings). The benefits of combined use should be carefully weighed against the risks. Physicians contemplating concomitant therapy with HMG CoA reductase inhibitors should consult the SPC of the relevant HMG CoA reductase inhibitor as some higher doses are contraindicated / not recommended with fibrates.

•Combination requiring caution

Oral anticoagulant therapy: Ciprofibrate is highly protein bound and therefore likely to displace other drugs from plasma protein binding sites. Ciprofibrate has been shown to potentiate the effect of warfarin, indicating that concomitant oral anticoagulant therapy should be given at reduced dosage and adjusted according to INR (see section 4.4.2 Special precautions for use).

•Combination to be taken into account

Oral hypoglycaemics: A possible interaction should be considered.

Oestrogens: Oestrogens can raise lipid levels. Although a pharmacodynamic interaction may be suggested, no clinical data are currently available.

4.6 Pregnancy And Lactation

There is no evidence that ciprofibrate is teratogenic but signs of embryotoxicity were observed at high doses in animals. Ciprofibrate is excreted in the breast milk of lactating rats. There are no data on the use of the drug in human pregnancy or lactation. Therefore the use of ciprofibrate is contraindicated during pregnancy and in nursing mothers.

4.7 Effects On Ability To Drive And Use Machines

Dizziness, drowsiness, and tiredness have only rarely been reported in association with ciprofibrate. Patients should be warned that if they are affected they should not drive or operate machinery.

4.8 Undesirable Effects

Cutaneous disorders:

Cutaneous reactions mainly allergic have been reported: rashes, urticaria and pruritus, and very rarely photosensitivity.

As with other drugs in this class, a low occurrence of alopecia has been reported.

Muscular disorders:

As with other fibrates, elevation of serum creatine phosphokinase (CPK), myalgia and myopathy including myositis and rare cases of rhabdomyolysis have been reported. In the majority of cases muscle toxicity is reversible when treatment is withdrawn (see section 4.4 Special Warnings and Special Warnings for Use).

Neurological disorders:

Occasional reports of headache, vertigo.

Dizziness, drowsiness have only rarely been reported in association with ciprofibrate.

As with other drugs of this class, a low occurrence of impotence has been reported.

Gastro-intestinal disorders:

There have been occasional reports of gastrointestinal symptoms including nausea, vomiting, diarrhoea, dyspepsia, and abdominal pain. Generally, these side effects were mild to moderate in nature and occurred early on, becoming less frequent as treatment progressed.

Hepato-biliary disorders:

As with other fibrates, abnormal liver function tests have been observed occasionally. Very rare cases of cholestasis or cytolysis have been reported (see section 4.4 Special Warnings and Special Precautions for Use). Exceptional cases with chronic evolution have been observed.

Pulmonary disorders:

Isolated cases of pneumonitis or pulmonary fibrosis have been reported.

General disorders:

Tiredness has only rarely been reported in association with ciprofibrate.

4.9 Overdose

Overdosage with ciprofibrate has been rarely reported. Associated adverse events reflect those seen in routine use. There are no specific antidotes to ciprofibrate. Treatment of overdosage should be symptomatic. Gastric lavage and appropriate supportive care may be instituted if necessary. Ciprofibrate is non-dialysable.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC Code: C10A B08

Pharmacotherapeutic group: Serum lipid reducing agents - fibrates.

Ciprofibrate is a new derivative of phenoxyisobutyric acid which has a marked hypolipidaemic action. It reduces both LDL and VLDL and hence the levels of triglyceride and cholesterol associated with these lipoprotein fractions. It also increases levels of HDL cholesterol.

Ciprofibrate is effective in the treatment of hyperlipidaemia associated with high plasma concentrations of LDL and VLDL (types IIa, IIb, III and IV according to the Fredrickson Classification). In clinical studies ciprofibrate has been shown to be effective in complementing the dietary treatment of such conditions.

5.2 Pharmacokinetic Properties

Ciprofibrate is readily absorbed in man, with maximum plasma concentrations occurring mainly between one and four hours following an oral dose. Following a single dose of 100mg, in volunteers, maximum plasma concentration of ciprofibrate was between 21 and 36?g/ml. In patients on chronic therapy, maximum levels from 53 to 165?g/ml have been measured.

Terminal elimination half-life in patients on long term therapy varies from 38 to 86 hours. The elimination half-life in subjects with moderate renal insufficiency was slightly increased compared with normal subjects (116.7h compared with 81.1h). In subjects with severe renal impairment, a significant increase was noted (171.9h).

Approximately 30-75% of a single dose administered to volunteers was excreted in the urine in 72 hours, either as unchanged ciprofibrate (20-25% of the total excreted) or as a conjugate. Subjects with moderate renal impairment excreted on average 7.0% of a single dose as unchanged ciprofibrate over 96 hours, compared with 6.9% in normal subjects. In subjects with severe insufficiency this was reduced to 4.7%.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars 6.1 List Of Excipients

Maize starch, Lactose monohydrate, Microcrystalline cellulose, Hypromellose, Powdered vegetable stearine, Sodium laurilsulfate.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

5 years when packed in blister strips

6.4 Special Precautions For Storage

There are no special storage precautions.

6.5 Nature And Contents Of Container

Clear PVC / Aluminium blister strips in packs of 28 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

8. Marketing Authorisation Number(S)

PL 11723/0050

9. Date Of First Authorisation/Renewal Of The Authorisation

13 June 2002

10. Date Of Revision Of The Text

October 2006

11. Legal Category

POM

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1. Name Of The Medicinal Product

Furadantin® tablets 100mg

Nitrofurantoin 100mg tablets

2. Qualitative And Quantitative Composition

Furadantin tablets contain 100mg Nitrofurantoin Ph Eur.

3. Pharmaceutical Form

Furadantin tablets are yellow and pentagonal. Each tablet has a break line on one face and the tablet strength on the opposite face.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of and prophylaxis against acute or recurrent, uncomplicated lower urinary tract infections or pyelitis either spontaneous or following surgical procedures.

Nitrofurantoin is specifically indicated for the treatment of infections, when due to susceptible strains of Escherichia co/i, Enterococci, Staphylococci, Citrobacter, Kiebsiella and Enterobacter.

4.2 Posology And Method Of Administration

Dosage:

Adults

Acute Uncomplicated Urinary Tract Infections: 50mg four times daily for seven days

Severe Chronic Recurrence: 100mg four times day for seven days

Long Term Suppression: 50mg - 100mg once a day.

Pophylaxis: 50mg four times daily for the duration of procedure and 3 days thereafter.

Children and Infants over three months of age

Acute Urinary Tract Infections: 3mg/kg/day in four divided doses for seven days.

Suppressive: 1mg/kg, once a day.

For children under 25kg body weight consideration should be given to the use of Furadantin® Suspension.

Elderly

Provided there is no significant renal impairment, in which Nitrofurantoin is contraindicated, the dosage should be that for any normal adult. See precaution and risks to elderly patients associated with long-term therapy (Section 4.8).

4.3 Contraindications

Patients suffering from renal dysfunction with a creatinine clearance of less than 60ml/minute or elevated serum creatinine.

In infants under three months of age as well as pregnant patients at term (during labour and delivery) because of the theoretical possibility of haemolytic anaemia in the foetus or in the new-born infant, due to immature erythrocyte enzyme systems.

Patients with known hypersensitivity to Nitrofurantoin or other nitrofurans.

4.4 Special Warnings And Precautions For Use

Nitrofurantoin is not effective for the treatment of parenchymal infections of unilaterally non-functioning kidney. A surgical cause for infection should be excluded in recurrent or severe cases.

Since pre-existing conditions may mask adverse reactions, Nitrofurantoin should be used with caution in patients with pulmonary disease, hepatic dysfunction, neurological disorders, and allergic diathesis.

Peripheral neuropathy and susceptibility to peripheral neuropathy, which may become severe or irreversible, has occurred and may be life threatening. Therefore, treatment should be stopped at the first signs of neural involvement (paraesthesiae).

Nitrofurantoin should be used in caution with patients with anaemia, diabetes mellitus, electrolyte imbalance, debilitating conditions and vitamin B (particularly folate) deficiency.

Acute, subacute and chronic pulmonary reactions have been observed in patients treated with nitrofurantoin. If these reactions occur, nitrofurantoin should be discontinued immediately.

Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonitis) can develop insidiously, and may occur commonly in elderly patients. Close monitoring of the pulmonary condition of patients receiving long-term therapy is warranted (especially in the elderly).

Patients should be monitored closely for signs of hepatitis (particularly in long-term use). Urine may be coloured yellow or brown after taking Nitrofurantoin. Patients on Nitrofurantoin are susceptible to false positive urinary glucose (If tested for reducing substances)

Nitrofurantoin should be discontinued at any sign of haemolysis in those with suspected glucose-6-phosphate dehydogenase deficiency.

Gastrointestinal reactions may be minimised by taking the drug with food or milk, or by adjustment of dosage.

For long-term treatment, monitor patients closely for evidence of hepatitis or pulmonary symptoms or other evidence of toxicity.

Discontinue treatment with Nitrofurantoin if otherwise unexplained pulmonary, hepatic, haematological or neurological syndromes occur.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

1. Increased absorption with food or agents delaying gastric emptying.

2. Decreased absorption with magnesium trisilicate.

3. Decreased renal excretion of Nitrofurantoin by probenecid and sulphinpyrazone.

4. Decreased anti-bacterial activity by carbonic anhydrase inhibitors and urine alkalisation.

5. Anti-bacterial antagonism by quinolone anti-infectives.

6. Interference with some tests for glucose in urine

4.6 Pregnancy And Lactation

Animal studies with Nitrofurantoin have shown no teratogenic effects. Nitrofurantoin has been in extensive use since 1952, and its suitability in human pregnancy has been well documented. However, as with all other drugs, the maternal side effects may adversely affect course of pregnancy. The drug should be used at the lowest dose as appropriate for specific indication, only after careful assessment.

Nitrofurantoin is however contraindicated in infants under three months of age and in pregnant women during labour and delivery, because of the possible risk of haemolysis of the infants' immature red cells. Caution should be exercised while breast-feeding an infant known or suspected to have an erythrocyte enzyme deficiency, since Nitrofurantoin is detected in trace amounts in breast milk.

4.7 Effects On Ability To Drive And Use Machines

Nitrofurantoin may cause dizziness and drowsiness and the patient should not drive or operate machinery if affected this way.

4.8 Undesirable Effects

Respiratory

If any of the following respiratory reactions occur the drug should be discontinued.

Acute pulmonary reactions usually occur within the first week of treatment and are reversible with cessation of therapy. Acute pulmonary reactions are commonly manifested by fever, chills, cough, chest pain, dyspnoea, pulmonary infiltration with consolidation or pleural effusion on chest x-ray, and eosinophilia. In subacute pulmonary reactions, fever and eosinophilia occur less often than in the acute form.

Chronic pulmonary reactions occur rarely in patients who have received continuous therapy for six months or longer and are more common in elderly patients. Changes in ECG have occurred, associated with pulmonary reactions.

Minor symptoms such as fever, chills, cough and dyspnoea may be significant. Collapse and cyanosis have been reported rarely. The severity of chronic pulmonary reactions and their degree of resolution appear to be related to the duration of therapy after the first clinical signs appear. It is important to recognise symptoms as early as possible. Pulmonary function may be impaired permanently, even after cessation of therapy.

Hepatic

Hepatic reactions including cholestatic jaundice and chronic active hepatitis occur rarely. Fatalities have been reported. Cholestatic jaundice is generally associated with short-term therapy (usually up to two weeks). Chronic active hepatitis, occasionally leading to hepatic necrosis is generally associated with long-term therapy (usually after six months). The onset may be insidious. Treatment should be stopped at the first sign of hepatotoxicity.

Neurological

Peripheral neuropathy (including optical neuritis) with symptoms of sensory as well as motor involvement, which may become severe or irreversible, has been reported infrequently. Less frequent reactions of unknown causal relationship are depression, euphoria, confusion, psychotic reactions, nystagmus, vertigo, dizziness, asthenia, headache and drowsiness. Treatment should be stopped at the first sign of neurological involvement.

Gastrointestinal

Nausea and anorexia have been reported. Emesis, abdominal pain and diarrhoea are less common gastrointestinal reactions.

Haematological

Agranulocytosis, leucopenia, granulocytopenia, haemolytic anaemia, thrombocytopenia, megaloblastic anaemia, glucose-6-phosphate dehydrogenase deficiency anaemia, and eosinophilia have been reported. Aplastic anaemia has been reported rarely. Cessation of therapy has generally returned the blood picture to normal.

Hypersensitivity

Allergic skin reactions manifesting as angioneurotic oedema, maculopapular, erythematous or eczematous eruptions, urticaria, rash, and pruritis have occurred.

Lupus-like syndrome associated with pulmonary reactions to Nitrofurantoin has been reported.

Exfoliative dermatitis and erythema multiforme (including Stevens- Johnson Syndrome) have been reported rarely.

Other hypersensitivity reactions include anaphylaxis, sialadenitis, pancreatitis, drug fever and arthralgia.

Miscellaneous

Transient alopecia and benign intracranial hypertension. As with other antimicrobial agents, superinfections by fungi or resistant organisms such as Pseudomonas may occur.

However, these are limited to the genitourinary tract because suppression of normal bacterial flora does not occur elsewhere in the body.

4.9 Overdose

Symptoms and signs of overdose include gastric irritation, nausea and vomiting. There is no known specific antidote. However, Nitrofurantoin can be haemodialysed in cases of recent ingestion. Standard treatment is by induction of emesis or by gastric lavage. Monitoring of full blood count, liver function, and pulmonary function tests are recommended. A high fluid intake should be maintained to promote urinary excretion of the drug.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Furadantin is a broad-spectrum antibacterial agent, active against the majority of urinary pathogens. The wide range of organisms sensitive to the bactericidal activity include:

Escherichia coli

Enterococcus Faecalis

Klebsiella Species

Enterobacter Species

Staphylococcus Species, e.g. S.Aureus, S.Saprophyticus, S.Epidermidis

Citrobacter Species

Clinically most common urinary pathogens are sensitive to Nitrofurantoin. Most strains of Proteus and Serratia are resistant. All pseudomonas strains are resistant.

5.2 Pharmacokinetic Properties

Orally administered Nitrofurantoin is readily absorbed in the upper gastrointestinal tract and is rapidly excreted in the urine. Blood concentrations at therapeutic dosages are usually low with an elimination half-life of about 30 minutes.

Maximum urinary excretion usually occurs 2-4 hours after administration of Nitrofurantoin. Urinary drug dose recoveries of about 40-45% are obtained.

5.3 Preclinical Safety Data

Carcinogenic effect of Nitrofurantoin in animal studies was observed. However, human data and extensive use of Nitrofurantoin over 50 years do not support such observation.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Furadantin tablets also contain lactose, maize starch, talc, alginic acid and magnesium stearate and purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

The tablets are packaged in light-proof and moisture-resistant containers. Storage temperatures must not exceed 25°C.

6.5 Nature And Contents Of Container

Furadantin tablets are supplied in packs of 30 and 100 tablets.

6.6 Special Precautions For Disposal And Other Handling

Used as directed by physician. A Patient Information Leaflet is provided with details of use and handling of the product.

7. Marketing Authorisation Holder

Goldshield Pharmaceuticals Limited

NLA Tower

12-16 Addiscombe Road

Croydon

CR0 0XT

United Kingdom.

8. Marketing Authorisation Number(S)

PL 12762/0051 (100mg tablets)

9. Date Of First Authorisation/Renewal Of The Authorisation

31/03/2000.

10. Date Of Revision Of The Text

13/08/2010

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1. Name Of The Medicinal Product

PERSANTIN Tablets 100 mg

2. Qualitative And Quantitative Composition

Dipyridamole 100 mg.

For excipients, see 6.1.

3. Pharmaceutical Form

Coated Tablets.

Round, white, biconvex, shiny, sugar-coated tablets.

4. Clinical Particulars 4.1 Therapeutic Indications

An adjunct to oral anti-coagulation for prophylaxis of thrombo-embolism associated with prosthetic heart valves.

4.2 Posology And Method Of Administration

Adults: 300-600 mg daily in three or four doses.

Children: PERSANTIN is not recommended for children.

PERSANTIN should usually be taken before meals.

4.3 Contraindications

Hypersensitivity to any of the components of the product.

4.4 Special Warnings And Precautions For Use

Among other properties, dipyridamole acts as a vasodilator. It should be used with caution in patients with severe coronary artery disease, including unstable angina and/or recent myocardial infarction, left ventricular outflow obstruction or haemodynamic instability (e.g. decompensated heart failure).

Patients being treated with regular oral doses of PERSANTIN should not receive additional intravenous dipyridamole. Clinical experience suggests that patients being treated with oral dipyridamole who also require pharmacological stress testing with intravenous dipyridamole, should discontinue drugs containing oral dipyridamole for twenty-four hours prior to stress testing.

In patients with myasthenia gravis, readjustment of therapy may be necessary after changes in dipyridamole dosage (see Drug Interactions).

PERSANTIN should be used with caution in patients with coagulation disorders.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Dipyridamole increases plasma levels and cardiovascular effects of adenosine. Adjustment of adenosine dosage should be considered if use with dipyridamole is unavoidable.

There is evidence that the effects of aspirin and dipyridamole on platelet behaviour are additive.

The administration of antacids may reduce the efficacy of PERSANTIN. It is possible that PERSANTIN may enhance the effects of oral anti-coagulants.

When dipyridamole is used in combination with anticoagulants and acetylsalicylic acid, the statements on intolerance and risks for these preparations must be observed. Addition of dipyridamole to acetylsalicylic acid does not increase the incidence of bleeding events. When dipyridamole was administered concomitantly with warfarin, bleeding was no greater in frequency or severity than that observed when warfarin was administered alone.

Dipyridamole may increase the hypotensive effect of drugs which reduce blood pressure and may counteract the anticholinesterase effect of cholinesterase inhibitors thereby potentially aggravating myasthenia gravis.

4.6 Pregnancy And Lactation

There is inadequate evidence of safety in human pregnancy, but PERSANTIN has been used for many years without apparent ill-consequence. Animal studies have shown no hazard. Medicines should not be used in pregnancy, especially the first trimester unless the expected benefit is thought to outweigh the possible risk to the foetus.

Dipyridamole is excreted in breast milk at levels approximately 6% of the plasma concentration. Therefore PERSANTIN should only be used during lactation if considered essential by the physician.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

If these occur, it is usually during the early part of treatment. The vasodilating properties of PERSANTIN may occasionally produce a vascular headache which normally disappears with long-term use. Vomiting, diarrhoea and symptoms such as dizziness, faintness, nausea, dyspepsia and myalgia have been observed.

As a result of its vasodilator properties, PERSANTIN may cause hypotension, hot flushes and tachycardia. Worsening of symptoms of coronary heart disease such as angina and arrhythmias.

Hypersensitivity reactions such as rash, urticaria, severe bronchospasm and angio-oedema have been reported.

In very rare cases, increased bleeding during or after surgery has been observed. Isolated cases of thrombocytopenia have been reported in conjunction with treatment with PERSANTIN.

Dipyridamole has been shown to be incorporated into gallstones.

4.9 Overdose

Symptoms

Due to the low number of observations, experience with dipyridamole overdose is limited. Symptoms such as a warm feeling, flushes, sweating, restlessness, feeling of weakness, dizziness and anginal complaints can be expected. A drop in blood pressure and tachycardia might be observed.

Therapy

Symptomatic therapy is recommended. Administration of xanthine derivatives (e.g. aminophylline) may reverse the haemodynamic effects of dipyridamole overdose. Due to its wide distribution to tissues and its predominantly hepatic elimination, dipyridamole is not likely to be accessible to enhanced removal procedures.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Dipyridamole has an antithrombotic action based on its ability to modify various aspects of platelet function, such as platelet aggregation, adhesion and survival, which have been shown to be factors associated with the initiation of thrombus formation. Dipyridamole also has coronary vasodilator properties.

5.2 Pharmacokinetic Properties

Oral administration of dipyridamole gives a peak plasma level 1-2 hours after dosing. The drug has an apparent bioavailability of 37-66%.

In man the volume of distribution is 2.43±1.1 l/kg. When given orally, the elimination half life is 30-50 minutes. In man the major route of excretion of dipyridamole is in the bile.

5.3 Preclinical Safety Data

None

6. Pharmaceutical Particulars 6.1 List Of Excipients

Core:

Calcium hydrogen phosphate, anhydrous

Maize starch, dried

Maize starch, soluble

Colloidal silica

Magnesium stearate

Coating:

Sucrose

Talc

Acacia

Titanium dioxide, E171

Macrogol 6000

Wax, bleached

Carnauba Wax

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

5 years.

6.4 Special Precautions For Storage

Do not store above 30°C. Protect from light.

6.5 Nature And Contents Of Container

Marketed packs: Blister pack containing 84 white sugar coated tablets

Non-marketed packs: Blister packs of 100 and 112 white sugar coated tablets.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

United Kingdom

8. Marketing Authorisation Number(S)

PL 0015/5016R

9. Date Of First Authorisation/Renewal Of The Authorisation

24 November 1988 / 01 May 2007

10. Date Of Revision Of The Text

01/05/2007

11. Legal category

POM

P2c/100mg/UK/SPC/7

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Class: Genitourinary Smooth Muscle Relaxants
ATC Class: G04BD02
VA Class: GU201
Chemical Name: 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate hydrochloride
CAS Number: 3717-88-2
Brands: Urispas

Introduction

Genitourinary antispasmodic.a b

Uses for Flavoxate Hydrochloride Overactive Bladder

Symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence associated with cystitis, prostatitis, urethritis, urethrocystitis, or urethrotrigonitis. b Not indicated as definitive treatment, but is compatible with drugs used for treatment of urinary tract infections.a

Has not been shown to be more effective in the treatment of these conditions than antimuscarinic agents.a

Flavoxate Hydrochloride Dosage and Administration Administration Oral Administration

Administer orally 3 or 4 times daily.a b

Dosage

Available as flavoxate hydrochloride; dosage expressed in terms of the salt.b

Pediatric Patients Oral

Children ?12 years of age: 100 or 200 mg 3 or 4 times daily. a b May reduce dosage as symptoms improve.a b

Adults Oral

100 or 200 mg 3 or 4 times daily. a b May reduce dosage as symptoms improve.a b

Special Populations

No special population dosage recommendations at this time.b

Cautions for Flavoxate Hydrochloride Contraindications

Pyloric or duodenal obstruction. a b

Obstructive intestinal lesions or ileus.a b

Achalasia.a b

GI hemorrhage.a b

Obstructive uropathies of the lower urinary tract.a b

Warnings/Precautions Warnings Glaucoma

Use with caution in patients with suspected glaucoma. a b

Specific Populations Pregnancy

Category B.b

Lactation

Not known whether flavoxate is distributed into milk.a b Caution if used in nursing women.b

Pediatric Use

Safety and efficacy not established in children <12 years of age. a b

Geriatric Use

Possible increased incidence of mental confusion compared with younger adults.b

Common Adverse Effects

Nausea, vomiting, dry mouth, vertigo, headache, mental confusion, drowsiness, nervousness, blurred vision.b

Interactions for Flavoxate Hydrochloride

No formal drug interaction studies to date.a b

Flavoxate Hydrochloride Pharmacokinetics Absorption Bioavailability

Appears to be well absorbed from the GI tract. a

Onset

Following oral administration in healthy males, onset of action was 55 minutes.a

Duration

Following oral administration in healthy males, peak effect occurred at 112 minutes.a

Distribution Extent

Not known whether flavoxate is distributed into milk.a

Elimination Elimination Route

57% of an oral dose of flavoxate is excreted in urine within 24 hours.a b

Special Populations

Not known whether flavoxate is dialyzable.a

Stability Storage Oral Tablets

15–30°C.a b

ActionsActions

Exerts a direct spasmolytic (papaverine-like) action on smooth muscle of the urinary tract.a b

Increases urinary bladder capacity in patients with evidence of bladder spasticity, possibly as a result of action on the detrusor muscle.a

Advice to Patients

Risk of drowsiness or blurred vision; use caution when driving, operating machinery, or participating in activities where alertness is required.b

Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.b

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.b

Importance of informing patients of other important precautionary information.b (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Flavoxate Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

100 mg*

Urispas

Ortho-McNeil

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Flavoxate HCl 100MG Tablets (GLOBAL PHARMACEUTICAL CORP): 100/$99.99 or 300/$279.96

Urispas 100MG Tablets (MCNEIL): 28/$51.99 or 84/$145.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS drug information 2004. McEvoy GK, ed. Flavoxate. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 3600-1.

b. Ortho-McNeil Pharmaceutical, Inc. Urispas (flavoxate hydrochloride) prescribing and patient information. Raritan, NJ; 2004 Aug.

More Flavoxate Hydrochloride resources Flavoxate Hydrochloride Side Effects (in more detail) Flavoxate Hydrochloride Dosage Flavoxate Hydrochloride Use in Pregnancy & Breastfeeding Drug Images Flavoxate Hydrochloride Drug Interactions Flavoxate Hydrochloride Support Group 1 Review for Flavoxate Hydrochloride - Add your own review/rating Flavoxate MedFacts Consumer Leaflet (Wolters Kluwer) Flavoxate Prescribing Information (FDA) Flavoxate Professional Patient Advice (Wolters Kluwer) Urispas Prescribing Information (FDA) flavoxate Concise Consumer Information (Cerner Multum) flavoxate Advanced Consumer (Micromedex) - Includes Dosage Information Compare Flavoxate Hydrochloride with other medications Dysuria Overactive Bladder Urinary Incontinence
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1. Name Of The Medicinal Product

Provera Tablets 100 mg or Medroxyprogesterone Acetate Tablets 100 mg.

Provera Tablets 200 mg or Medroxyprogesterone Acetate Tablets 200 mg.

Provera® Tablets 400 mg

2. Qualitative And Quantitative Composition

1 tablet contains 100mg medroxyprogesterone acetate.

1 tablet contains 200 mg medroxyprogesterone acetate.

1 tablet contains 400 mg medroxyprogesterone acetate.

For excipients, see 6.1.

3. Pharmaceutical Form

Tablet.

4. Clinical Particulars 4.1 Therapeutic Indications

Progestogen indicated for the treatment of certain hormone dependant neoplasms, such as:

1. Endometrial carcinoma.

2. Renal cell carcinoma.

3. Carcinoma of breast in post menopausal women.

4.2 Posology And Method Of Administration

Route of administration: Oral.

Adults

Endometrial and renal cell carcinoma

200 - 600 mg daily

Breast carcinoma

400 - 1500 mg daily

The incidence of minor side-effects, such as indigestion and weight gain, increase with the increase in dose.

Response to hormonal therapy may not be evident until after at least 8-10 weeks of therapy.

Elderly patients : This product has been used primarily in the older age group for the treatment of malignancies. There is no evidence to suggest that the older age group is any less prepared to handle the drug metabolically than is the younger patient. Therefore the same dosage, contra-indications, and precautions would apply to either age group.

Children:The product is not anticipated for paediatric use in the indications recommended.

4.3 Contraindications

Medroxyprogesterone acetate is contraindicated in the following conditions:

• thrombophlebitis, thrombo-embolic disorders, and where there is a high risk of developing such manifestations [presence or history of atrial fibrillation, valvular disorders, endocarditis, heart failure, pulmonary embolism; thrombo-embolic ischaemic attack (TIA), cerebral infarction; atherosclerosis; immediate post surgery period]

• hypercalcaemia in patients with osseous metastases

• known sensitivity to medroxyprogesterone acetate or any component of the drug.

• impaired liver function or active liver disease.

• missed abortion, metrorrhagia, known or suspected pregnancy.

• undiagnosed vaginal bleeding.

• previous idiopathic or current venous thromboembolism (deep vein thrombosis, pulmonary embolism).

• active or recent arterial thromboembolic disease (e.g., angina, myocardial infarction).

• suspected or early breast carcinoma

Progestogens are known to be porphyrogenic. Patients with a history of attacks or aged under 30 are at greatest risk of an acute attack while on progesterone treatment. A careful assessment of potential benefit should be made where this risk is present.

4.4 Special Warnings And Precautions For Use

Warnings:

In the treatment of carcinoma of breast occasional cases of hypercalcaemia have been reported.

Unexpected vaginal bleeding during therapy with medroxyprogesterone acetate should be investigated.

Medication should not be readministered pending examination if there is sudden partial or complete loss of vision or if there is a sudden onset of proptosis, diplopia or migraine. If examination reveals papilloedema or retinal vascular lesions, medication should not be readministered.

Medroxyprogesterone acetate may produce Cushingoid symptoms.

Some patients receiving medroxyprogesterone acetate may exhibit suppressed adrenal function. Medroxyprogesterone acetate may decrease ACTH and hydrocortisone blood levels.

Treatment with medroxyprogesterone acetate should be discontinued in the event of:

• jaundice or deterioration in liver function

• significant increase in blood pressure

• new onset of migraine-type headache

Precautions:

Animal studies show that Provera possesses adrenocorticoid activity. This has also been reported in man, therefore patients receiving large doses continuously and for long periods should be observed closely for signs normally associated with adrenocorticoid therapy, such as hypertension, sodium retention, oedema, etc. Care is needed in treating patients with diabetes and/or arterial hypertension.

Before using Provera the general medical condition of the patient should be carefully evaluated.

This product should be used under the supervision of a specialist and the patient kept under regular surveillance.

Patients with the following conditions should be carefully monitored while taking progestogens:

• Conditions which may be influenced by potential fluid retention

o Epilepsy

o Migraine

o Asthma

o Cardiac dysfunction

o Renal dysfunction

• History of mental depression

• Diabetes (a decrease in glucose tolerance has been observed in some patients).

• Hyperlipidaemia

The pathologist (laboratory) should be informed of the patient's use of medroxyprogesterone acetate if endometrial or endocervical tissue is submitted for examination.

The physician/laboratory should be informed that medroxyprogesterone acetate may decrease the levels of the following endocrine biomarkers:

• Plasma/urinary steroids (e.g., cortisol, oestrogen, pregnanediol, progesterone, testosterone)

• Plasma/urinary gonadotrophins (e.g., LH and FSH)

• Sex-hormone-binding-globulin

The use of medroxyprogesterone acetate in oncology indications may also cause partial adrenal insufficiency (decrease in pituitary-adrenal axis response) during Metyrapone testing. Thus the ability of adrenal cortex to respond to ACTH should be demonstrated before metyrapone is administered.

Although medroxyprogesterone acetate has not been causally associated with the induction of thromboembolic disorders, any patient with a history or who develops this kind of event while undergoing therapy with medroxyprogesterone acetate should have her status and need for treatment carefully assessed before continuing therapy.

Risk of venous thromboembolism (VTE)

The risk of VTE has not been assessed for progesterone alone. However, VTE is a known risk factor of oestrogen-only and combined hormone replacement therapy. When prescribing medroxyprogesterone acetate for oncology indications the following precautions and risk factors should be considered in the light of the patient's condition, the dose of medroxyprogesterone acetate and the duration of therapy:

• Generally recognised risk factors for VTE include a personal or family history of VTE or known thromboembolic states, severe obesity (BMI > 30 kg/m2) and systemic lupus erythematosus

• The risk of VTE may be temporarily increased with prolonged immobilisation, major trauma or major surgery.

• If VTE develops after initiating therapy, medroxyprogesterone acetate should be discontinued. Patients should be told to contact their doctor immediately if they become aware of a symptom suggestive of potential thromboembolism (e.g. painful swelling of a leg, sudden pain in the chest, dyspnoea).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Interaction with other medicaments

The metabolism of progestogens may be increased by concomitant administration of compounds known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes. These compounds include anticonvulsants (e.g., phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g., rifampicin, rifabutin, nevirapine, efavirenz,).

Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones. Herbal preparations containing St John's Wort (Hypericum Perforatum) may induce the metabolism of progestogens. Progestogen levels may therefore be reduced.

Aminoglutethimide has been reported to decrease plasma levels of some progestogens.

Concurrent administration of ciclosporin and MPA has been reported to lead to increased plasma ciclosporin levels and/or decreased plasma MPA levels.

Interactions with oral anti-coagulants have been reported rarely, but causality has not been established.

When used in combination with cytotoxic drugs, it is possible that progestogens may reduce the haematological toxicity of chemotherapy.

Special care should be taken when progestogens are administered with other drugs which also cause fluid retention, such as NSAIDs and vasodilators.

Other forms of interaction

Progestogens can influence certain laboratory tests (e.g., tests for hepatic function, thyroid function and coagulation).

4.6 Pregnancy And Lactation

Pregnancy

Medroxyprogesterone acetate is contraindicated in women who are pregnant. If medroxyprogesterone acetate is used during pregnancy, or if the patient becomes pregnant while using this drug, the patient should be apprised of the potential hazard to the foetus.

Some reports suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and genital abnormalities in male and female foetuses.

Infants from unintentional pregnancies that occur 1 to 2 months after injection of medroxyprogesterone acetate injectable suspension may be at an increased risk of low birth weight, which, in turn, is associated with an increased risk of neonatal death. The attributable risk is low because pregnancies while on medroxyprogesterone acetate are uncommon.

Lactation

Medroxyprogesterone acetate and/or its metabolites are secreted in breast milk. Therefore, the use of Provera whilst breast-feeding is not recommended.

4.7 Effects On Ability To Drive And Use Machines

No adverse effect has been reported.

4.8 Undesirable Effects

Reactions occasionally associated with the use of progestogens, particularly in high doses, are:

Breast: Tenderness, mastodynia or galactorrhoea.

Genitourinary: Abnormal uterine bleeding (irregular, increase, decrease), amenorrhoea, alterations of cervical secretions, cervical erosions, prolonged anovulation.

Central nervous system: Confusion, euphoria, loss of concentration, nervousness, insomnia, somnolence, fatigue, dizziness, depression, vision disorders and headache.

Skin and mucous membranes: Sensitivity reactions ranging from pruritus, urticaria, angioneurotic oedema, to generalised rash and anaphylaxis have occasionally been reported. Acne, alopecia or hirsutism have been reported in a few cases.

Allergy: Hypersensitivity reactions (e.g., anaphylaxis or anaphylactoid reactions, angioedema).

Gastro-intestinal/hepatobiliary: Constipation, diarrhoea, dry mouth, disturbed liver function, jaundice, vomiting, nausea and indigestion .

Metabolic and nutritional: Adrenergic-like effects (e.g., fine hand tremors, sweating, tremors, cramps in calves at night), corticoid-like effects (e.g., Cushingoid Syndrome), decreased glucose tolerance, diabetic cataract, exacerbation of diabetes mellitus, glycosuria.

Cardiovascular: Cerebral and myocardial infarction, congestive heart failure, increased blood pressure, palpitations, pulmonary embolism, retinal thrombosis, tachycardia, thromboembolic disorders, thrombophlebitis.

Haematological: Elevation of white blood cells and platelet count.

Miscellaneous: Change in appetite, change in libido, oedema/fluid retention, hypercalcaemia, malaise, hyperpyrexia, weight gain, moon facies.

4.9 Overdose

No action required other than cessation of therapy.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Progestogens. ATC Code: L02A B

Medroxyprogesterone acetate has the pharmacological action of a progestogen.

5.2 Pharmacokinetic Properties

Medroxyprogesterone acetate is absorbed from the gastro intestinal tract with a single oral dose of 10-250 mg. The time taken to reach the peak serum concentration (Tmax) was 2-6 hours and the average peak serum concentration (Cmax) was 13-46.89 mg/ml.

Unmetabolised medroxyprogesterone acetate is highly plasma protein bound. Medroxyprogesterone acetate is metabolised in the liver.

Medroxyprogesterone acetate is primarily metabolised by faecal excretion as glucuronide conjugated metabolite.

Metabolised medroxyprogesterone acetate is excreted more rapidly and in a greater percentage following oral doses than after aqueous intramuscular injection

400 mg only:

The comparative bioavailability of medroxyprogesterone acetate (MPA) in sixteen healthy male volunteers was determined following the oral ingestion of 400 mg MPA as two Provera 200 mg tablets or as one Provera 400mg tablet. It is concluded that the bioavailability appeared to be equivalent in this group of volunteers.

5.3 Preclinical Safety Data

No further preclinical safety data available.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Microcrystalline cellulose

Maize Starch

Byco C

Macrogol 400

Sodium starch glycollate

Docusate sodium

Sodium benzoate

Magnesium stearate

Isopropyl alcohol

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Provera 100mg: 36 months if stored in glass/HDPE bottles, or 24 month in blister packs.

Provera 200mg: 36 months if stored in glass/HDPE bottles, or 24 month in blister packs.

Provera 400mg: The shelf-life for Provera Tablets 400 mg is 36 months

6.4 Special Precautions For Storage

Provera 100mg: Store below 25°C. Bottle packs only: keep in a well closed container.

Provera 200mg: Store below 25°C.Bottle packs only: keep in a well closed container.

Provera 400mg: Store at controlled room temperature (15 - 30?C).Bottle packs only: keep in a well closed container.

6.5 Nature And Contents Of Container

Provera 100mg: Amber glass bottle with screw cap containing 100 tablets. HDPE bottle with tamper evident cap containing 100 tablets. PVC/aluminium strip containing 30, 60 or 100 tablets.

Provera 200mg: Amber glass bottle with screw cap containing 100 tablets. HDPE bottle with tamper evident cap containing 100 tablets. PVC/aluminium strip containing 30, 60 or 100 tablets.

Provera 400mg: Glass/HDPE bottles of 60 tablets. PVC aluminium blisters of 30 tablets

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Pharmacia Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UK

8. Marketing Authorisation Number(S)

Provera 100mg: PL 0032/0111

Provera 200mg: PL 0032/0112

Provera 400mg: PL 0032/0131

9. Date Of First Authorisation/Renewal Of The Authorisation

Provera 100mg: 7 November 1983/30 January 1996

Provera 200mg: 7 November 1983/30 January 1996

Provera 400mg: Date of first authorisation: 29 April 1986. Date of renewal of authorisation: 21 May 1998

10. Date Of Revision Of The Text

August 2007

LEGAL CATEGORY

POM

Company Reference: PVB1_0

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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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Dosage Form: FOR ANIMAL USE ONLY
Drug Facts Active Ingredient

100mg Piperazine base as Piperazine Dihydrochloride, per each tablet.

Use

Effective against large roundworms (Toxocara cati and Toxascaris leonina)

Warnings

Do not worm a kitten under six weeks of age.

Never worm a sick cat or kitten.

Consult your veterinarian in the diagnosis, treatment and control of parasitism.

Not recommended for cats under 2 lbs. of body weight.

Not recommended for pregnant or nursing females.

Pets over 1 year old should have a recent negative heartworm blood test before de-worming.

Cautions

Although piperazine has a high degree of safety, an ocassional animal may show nausea, vomiting, or muscular tremors. Such side effects are usually associated with over dosage, therefore, the recommended dosage should be followed carefully. If symptoms occur, consult a veterinarian immediatelty.

Keep this product out of reach of children and pets to avoid unintended consumption.

Directions

Administer as follows:

Treatment should be given shortly after pet has eaten or with food. Dosage may be fed directly or added to food. For multiple pet households, feed directly to individual pet to ensure proper dosage.

Cats and kittens ( 6 weeks or older)

kittens 2-4lbs. administer 1/2 tablet, cats and kittens over 4 lbs., 1 tablet per 4 lbs. of body weight.

After initial dose on day one, do not administer again until day 10. On day 10, repeat initial dose. Then administer every 30 days to prevent reinfestation.

Other Information

Store between 20-25C (68-77F)

Inactive Ingredients

Dicalcium phosphate Dihydrate, FD C Blue #1, Isopropyl  Alcohol, magnesium Stearate, Microcrystalline Cellulose, Polyvinylpyrrolidone, Water, USP Purified.

Excel Roundworm De-Wormer

Effectively Removes Roundworms

For Cats and Kittens

30 Tasty

Chew Tabs

EXCEL 
roundworm de-wormer for cats and kittens  tablet, chewable Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 24730-706 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PIPERAZINE (PIPERAZINE) PIPERAZINE 3 g  in 7.5 g Inactive Ingredients Ingredient Name Strength DIBASIC CALCIUM PHOSPHATE DIHYDRATE   FD&C BLUE NO. 1   ISOPROPYL ALCOHOL   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POVIDONE K30   WATER   Product Characteristics Color blue Score 2 pieces Shape ROUND Size 9mm Flavor Imprint Code NONE Contains          Packaging # NDC Package Description Multilevel Packaging 1 24730-706-08 1 BOX In 1 BOX contains a BLISTER PACK (24730-706-17) 1 24730-706-17 7.5 g In 1 BLISTER PACK This package is contained within the BOX (24730-706-08)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/17/2010
Labeler - United Pet Group (931135730) Establishment Name Address ID/FEI Operations Lloyd Inc. 791573233 manufacture Revised: 04/2010United Pet Group

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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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Vifor (International) Inc.

VENOFER 20 mg/ml injection

[Iron sucrose (iron (III) hydroxide sucrose complex)]

Please read this leaflet carefully. It contains a summary of the information available on Venofer 20 mg/ml injection which is part of your hospital treatment. If after reading this you have any questions ask the doctor or nurse.

In this leaflet 1. What Venofer is and what it is used for. 2. Before you receive Venofer. 3. How Venofer is administered. 4. Possible side effects of Venofer. 5. Storing Venofer. What Venofer is and what it is used for

Venofer is a sterile, dark brown, non transparent, aqueous solution of iron intended to be used only for intravenous injection or as a concentrate for solution for infusion which contains the active ingredient iron as a solution of iron sucrose (iron(III)-hydroxide sucrose complex). The solution also contains sodium hydroxide and water for injection.

Venofer is supplied in glass ampoules which contain 5ml of solution which is equivalent to 100mg of iron. The product is supplied in cardboard boxes each containing 5 ampoules.

Marketing authorisation holder: Vifor France SA 123, rue Jules Guesde 92300 Levallois-Perret France Manufacturer: ALTANA Pharma AG Byk-Gulden-Str. 2 D-78467 Konstanz Germany

Venofer provides a source of iron that can help to replenish a shortage of iron in patients with iron deficiency.

The product is intended for use only in the following circumstances:

in a patient known to be intolerant to iron preparations taken by mouth, in a patient where there is a specific clinical need to deliver iron rapidly to the iron stores, in a patient with active inflammatory bowel disease where iron preparations taken by mouth are ineffective or not tolerated. Before you receive Venofer You should be aware that: a blood test should have been carried out to ensure treatment with this medicine is appropriate, the product should not be given at the same time as other iron preparations taken by mouth, Venofer should not be administered during the first three months of pregnancy and it should be administered with caution during the fourth to ninth month. intramuscular or intravenous iron preparations can cause severe allergic or anaphylactoid reactions which may be potentially fatal. Therefore the medicine should only be given if there are appropriate medical facilities immediately available, allergic reactions, sometimes involving joint pain, have been more commonly observed when the recommended dose is exceeded. the product is not approved for use in children. You should not receive Venofer if: you are known to be sensitive (allergic) to any iron preparations intended for intramuscular or intravenous administration, you have a history of asthma, eczema or other atopic allergies because then you are more susceptible to experience allergic reactions, your anaemia is not due to a shortage of iron, you have a history of cirrhosis or hepatitis or have increased liver enzymes, you have any acute or chronic infections because these may be worsened by giving intramuscular or intravenous iron. How Venofer is administered

Venofer should only be administered by the intravenous route by slow intravenous injection or by intravenous drip infusion which is the preferred route. The product must not be administered by intramuscular or subcutaneous injection. For intravenous infusion the 5ml ampoule (100mg iron) should be diluted in 0.9% saline. No other intravenous dilution solutions or therapeutic agents should be used.

Before receiving your first dose, you should receive a small "test dose" which may help reduce the chance of a serious reaction occurring.

The total dose of Venofer you require is given in single doses of one ampoule not more than three times per week. This may be increased to two ampoules not more than three times per week depending on the severity of your iron deficiency. Your doctor will take responsibility for calculating the appropriate dose and frequency of injections.

Possible side effects of Venofer

The most commonly reported side effects of Venofer are temporary changes in taste, low blood pressure, fever, shivering, injection site reactions and nausea. Non-serious allergic reactions occurred rarely. In general, allergic reactions are potentially the most serious side effects. In these reactions, very rarely symptoms of low blood pressure, facial swelling and difficulty in breathing can be involved. See ‘Before you receive Venofer’ section 2.

The following possible side effects have been reported following the administration of Venofer:

Nervous system disorders

Common (greater than or equal to 1% and less than 10%): temporary changes in taste (in particular metallic taste).

Uncommon (greater than or equal to 0.1% and less than 1%) : headache; dizziness.

Rare (greater than or equal to 0.01% and less than 0.1%): tingling, “pins and needles”

Isolated cases: decreased alertness, light-headed feeling, confusion.

Heart and blood vessel disorders

Uncommon: low blood pressure and collapse; rapid heart beat, palpitations.

Lungs and airways disorders

Uncommon: wheezing, difficulty in breathing.

Stomach and intestine disorders

Uncommon: nausea; vomiting; abdominal (e.g. stomach) pain; diarrhoea.

Skin disorders

Uncommon: itching; hives; rash, redness.

Muscle, bone and joint disorders

Uncommon: muscle cramps, muscle pain.

Isolated cases: swelling of joints.

General disorders and administration site disorders

Uncommon: fever, shivering, flushing; chest pain and chest tightness. Burning, swelling and similar reactions (sometimes involving veins) around the site of injection.

Rare: allergic reactions (rarely involving joint pain); swelling of hands and feet; tiredness, weakness; general feeling of illness.

Isolated cases: face and tongue swelling.

Storing Venofer

Venofer is to be kept out of the reach and sight of children.

The product should not be used after the expiry date printed on the label. The ampoules should be stored below 25°C in the original cartons. The product should not be frozen. Once the ampoules have been opened they should be used immediately. After dilution with 0.9% saline the solution should be used immediately or within 3 hours if stored at room temperature.

Further information

This leaflet does not tell you everything about Venofer. If you have any questions or are not sure about receiving treatment with this medicine, then ask your doctor. Please keep this leaflet until your course of treatment with Venofer has been completed.

This Leaflet was approved:

United Kingdom: December 2003

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COZAAR COMP 50mg/12.5mg Film-coated Tablets

COZAAR COMP 100mg/12.5mg Film-coated Tablets

COZAAR COMP 100mg/25mg Film-coated Tablets

losartan potassium and hydrochlorothiazide

Read all of this leaflet carefully before 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 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 Cozaar Comp is and what it is used for
2. Before you take Cozaar Comp
3. How to take Cozaar Comp
4. Possible side effects
5. How to store Cozaar Comp
6. Further information

What Cozaar Comp Is And What It Is Used For

Cozaar Comp is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Hydrochlorothiazide works by making the kidneys pass more water and salt. This also helps to reduce blood pressure.

Cozaar Comp is indicated for the treatment of essential hypertension (high blood pressure).

Before You Take Cozaar Comp Do not take Cozaar Comp if you are allergic (hypersensitive) to losartan, hydrochlorothiazide or to any of the other ingredients in this medicine if you are allergic (hypersensitive) to other sulfonamide-derived substances (e. g. other thiazides, some antibacterial drugs such as co-trimoxazole, ask your doctor if you are not sure) if you are more than 3 months pregnant. (It is also better to avoid Cozaar Comp in early pregnancy - See Pregnancy.) if you have severely impaired liver function if you have severely impaired kidney function or your kidneys are not producing any urine if you have low potassium, low sodium or high calcium levels which cannot be corrected by treatment if you are suffering from gout. Take special care with Cozaar Comp

You must tell your doctor if you think you are (or might become) pregnant. Cozaar Comp is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

It is important to tell your doctor before taking Cozaar Comp:

if you have previously suffered from swelling of the face, lips, throat or tongue if you take diuretics (water pills) if you are on a salt-restricted diet if you have or have had severe vomiting and/or diarrhoea if you have heart failure if your liver function is impaired (see section 2 “Do not take Cozaar Comp”) if you have narrow arteries to your kidneys (renal artery stenosis) or only have one functioning kidney, or you have recently had a kidney transplant if you have narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to poor heart function) if you have ‘aortic or mitral valve stenosis’ (narrowing of the valves of the heart) or ‘hypertrophic cardiomyopathy’ (a disease causing thickening of heart muscle) if you are diabetic if you have had gout if you have or have had an allergic condition, asthma or a condition that causes joint pain, skin rashes and fever (systemic lupus erythematodus) if you have high calcium or low potassium levels or you are on a low potassium diet if you need to have an anaesthetic (even at the dentist) or before surgery, or if you are going to have tests to check your parathyroid function, you must tell the doctor or medical staff that you are taking losartan potassium and hydrochlorothiazide tablets if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality within the gland). Taking 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.

Diuretic agents such as the hydrochlorothiazide contained in Cozaar Comp may interact with other medicines.

Preparations containing lithium should not be taken with Cozaar Comp without close supervision by your doctor.

Special precautionary measures (e.g. blood tests) may be appropriate if you take potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines, other diuretics (“water tablets”), some laxatives, medicines for the treatment of gout, medicines to control heart rhythm or for diabetes (oral agents or insulins).

It is also important for your doctor to know if you are taking

other medicines to reduce your blood pressure steroids medicines to treat cancer pain killers drugs for treatment of fungal infections arthritis medicines resins used for high cholesterol, such as colestyramine medicines which relax your muscles sleeping tablets opioid medicines such as morphine ‘pressor amines’ such as adrenaline or other drugs from the same group oral agents for diabetes or insulins.

Please also inform your doctor you are taking Cozaar Comp if you will be undergoing a radiographic procedure and will be given iodine contrast media.

Taking Cozaar Comp with food and drink

You are advised not to drink alcohol whilst taking these tablets: alcohol and Cozaar Comp tablets may increase each other’s effects.

Dietary salt in excessive quantities may counteract the effect of Cozaar Comp tablets.

Cozaar Comp tablets may be taken with or without food.

Pregnancy and breast feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Cozaar Comp before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Cozaar Comp. Cozaar Comp is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast feeding. Cozaar Comp is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast feed. Especially if your baby is a newborn, or born prematurely.

Ask your doctor or pharmacist for advice before taking any medicine.

Use in children and adolescents

There is no experience with the use of Cozaar Comp in children. Therefore, Cozaar Comp should not be given to children.

Use in elderly patients

Cozaar Comp works equally well in and is equally well tolerated by most older and younger adult patients. Most older patients require the same dose as younger patients.

Driving and using machines

When you begin treatment with this medication, you should not perform tasks which may require special attention (for example, driving an automobile or operating dangerous machinery) until you know how you tolerate your medicine.

Important information about some of the ingredients of Cozaar Comp

Cozaar Comp contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How To Take Cozaar Comp

Always take Cozaar Comp exactly as your doctor has instructed you. Your doctor will decide on the appropriate dose of Cozaar Comp depending on your condition and whether you are taking other medicines. It is important to continue taking Cozaar Comp for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.

High Blood Pressure

The usual dose of Cozaar Comp for most patients with high blood pressure is 1 tablet of Cozaar Comp 50 mg/12.5 mg per day to control blood pressure over the 24-hour period. This can be increased to 2 tablets once daily of Losartan / Hydrochlorothiazide 50 mg/12.5 mg Film-Coated Tablets or changed to 1 tablet daily of Losartan / Hydrochlorothiazide 100 mg/25 mg Film-Coated Tablets (a stronger strength) per day. The maximum daily dose is 2 tablets per day of Losartan / Hydrochlorothiazide 50 mg/12.5 mg Film-Coated Tablets or 1 tablet daily of Losartan / Hydrochlorothiazide 100 mg/25 mg Film-Coated Tablets

If you take more Cozaar Comp than you should

In case of an overdose, contact your doctor immediately so that medical attention may be given promptly. Overdose can cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

If you forget to take Cozaar Comp

Try to take Cozaar Comp daily as prescribed. However, if you miss a dose, do not take an extra dose. Just resume your usual schedule.

Possible Side Effects

Like all medicines, Cozaar Comp tablets can cause side effects, although not everybody gets them.

If you experience the following, stop taking Cozaar Comp tablets and tell your doctor immediately or go to the casualty department of your nearest hospital:

A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing).

This is a serious but rare side effect, which affects more than 1 out of 10,000 patients but fewer than 1 out of 1,000 patients. You may need urgent medical attention or hospitalisation.

The following side effects have been reported:

Common (affecting less than one person in 10 but more than one person in 100):

Cough, upper airway infection, congestion in the nose, sinusitis, sinus disorder, Diarrhoea, abdominal pain, nausea, indigestion, Muscle pain or cramps, leg pain, back pain, Insomnia, headache, dizziness, Weakness, tiredness, chest pain, Increased potassium levels (which can cause an abnormal heart rhythm), decreased haemoglobin levels.

Uncommon (affecting less than one person in 100 but more than one person in 1,000):

Anaemia, red or brownish spots on the skin (sometimes especially on the feet, legs, arms and buttocks, with joint pain, swelling of the hands and feet and stomach pain), bruising, reduction in white blood cells, clotting problems and bruising, Loss of appetite, increased uric acid levels or frank gout, increased blood sugar levels, abnormal blood electrolyte levels, Anxiety, nervousness, panic disorder (recurring panic attacks), confusion, depression, abnormal dreams, sleep disorders, sleepiness, memory impairment, Pins and needles or similar sensations, pain in the extremities, trembling, migraine, fainting, Blurred vision, burning or stinging in the eyes, conjunctivitis, worsening eyesight, seeing things in yellow, Ringing, buzzing, roaring or clicking in the ears, Low blood pressure, which may be associated with changes in posture (feeling light-headed or weak when you stand up), angina (chest pain), abnormal heartbeat, cerebrovascular accident (TIA, “mini-stroke”), heart attack, palpitations, Inflammation of blood vessels, which is often associated with a skin rash or bruising, Sore throat, breathlessness, bronchitis, pneumonia, water on the lungs (which causes difficulty breathing), nosebleed, runny nose, congestion, Constipation, wind, stomach upsets, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache, Jaundice (yellowing of the eyes and skin), inflammation of the pancreas, Hives, itching, inflammation of the skin, rash, redness of the skin, sensitivity to light, dry skin, flushing, sweating, hair loss, Pain in the arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness, Frequent urination including at night, abnormal kidney function including inflammation of the kidneys, urinary infection, sugar in the urine, Decreased sexual appetite, impotence, Swelling of the face, fever.

Rare (more than 1 out of 10000 patients and less than 1 out of 1000 patients)

Hepatitis (inflammation of the liver), abnormal liver function tests

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

How To Store Cozaar Comp

Keep out of the reach and sight of children.

Do not use Cozaar Comp after the expiry date which is stated on the container. The expiry date refers to the last day of that month.

Blisters

Store Cozaar Comp in the original package in order to protect from light and moisture. Do not store the package above 30°C. Do not open the blister pack until you are ready to take the medicine.

Bottle

Store in the original container. Keep the bottle tightly closed in order to protect from light and moisture. Do not store the bottle above 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 Cozaar Comp contains

The active substances are losartan potassium and hydrochlorothiazide.

Cozaar Comp 50 mg/12.5 mg contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.

Cozaar Comp 100 mg/12.5 mg contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.

Cozaar Comp 100 mg/25 mg contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide as the active ingredients.

Cozaar Comp 50 mg/12.5 mg, Cozaar Comp 100 mg/12.5 mg and Cozaar Comp 100 mg/25 mg contain the following inactive ingredients:

microcrystalline cellulose, lactose monohydrate, pregelatinized maize starch, magnesium stearate, hydroxypropyl cellulose, hypromellose.

Cozaar Comp 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium.

Cozaar Comp 100 mg/12.5 mg and Cozaar Comp 100 mg/25 mg contain 8.48 mg (0.216 mEq) of potassium.

Cozaar Comp 50 mg/12.5 mg and Cozaar Comp 100 mg/25 mg also contain titanium dioxide (E171), quinoline yellow aluminum lake (E104) and carnauba wax (E903).

Cozaar Comp 100 mg/12.5 mg also contains: titanium dioxide (E171) and carnauba wax (E903).

What Cozaar Comp looks like and contents of the pack

Cozaar Comp 50 mg/12.5 mg is supplied as yellow, oval film-coated tablets marked 717 on one side and plain or scored on the other. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Cozaar Comp 100 mg/12.5 mg is supplied as white, oval film-coated tablets marked 745 on one side and plain on the other.

Cozaar Comp 100 mg/25 mg is supplied as light yellow, oval film-coated tablets marked 747 on one side and plain on the other.

Cozaar Comp is supplied in the following pack sizes:

Cozaar Comp 50 mg/12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 tablets and unit-dose packages of 28, 56 and 98 tablets for hospital use. HDPE bottles of 100 tablets.

Cozaar Comp 100 mg/12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 14, 15, 28, 30, 50, 56, 84, 90, 98, 280 tablets. HDPE bottles of 100 tablets.

Cozaar Comp 100 mg/25 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in cartons containing 7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 tablets and unit-dose packages of 28,56 and 98 tablets for hospital use.. HDPE bottles of 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder in the UK and Malta is

Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU UK

Manufacturers:

50mg/12.5mg strength:

Merck Manufacturing Division Shotton Lane Cramlington Northumberland NE23 3JU UK

100mg/12.5mg and 100mg/25mg strengths:

Merck Sharp & Dohme BV Waarderweg 39 2031 BN Haarlem Netherlands

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria Cosaar Plus – Filmtabletten, Fortzaar-Filmtabletten
Belgium COZAAR PLUS FORTE, COZAAR PLUS, LOORTAN PLUS FORTE, LOORTAN PLUS
Bulgaria Hyzaar
Cyprus FORTZAAR, HYZAAR
Denmark Cozaar Comp, . Cozaar Comp Forte, Fortzaar
Estonia HYZAAR, FORTZAAR
Finland Cozaar Comp, Cozaar Comp Forte
France Fortzaar, Hyzaar
Germany LORZAAR PLUS, CARDOPAL PLUS, LORZAAR VARIPHARM PLUS, FORTZAAR, FORTZAAR VARIPHARM< LORZAAR PLUS FORTE
Greece HYZAAR
Hungary Hyzaar, Hyzaar Forte.
Ireland ‘Cozaar’ Comp
Italy HIZAAR, FORZAAR, NEOLOTAN PLUS, LOSAZID
Latvia HYZAAR, Fortzaar
Lithuania FORTZAAR, HYZAAR
Luxembourg COZAAR PLUS FORTE , COZAAR PLUS, LOORTAN PLUS< LOORTAN PLUS FORTE
Malta "Cozaar Comp"
Netherlands Cozaar Plus, Fortzaar, Hyzaar
Poland HYZAAR, HYZAAR FORTE
Portugal COZAAR Plus, FORTZAAR, SIAARA, LORTAAN PLUS, Losartan + Hidrochlorotiazide Fross
Romania HYZAAR, FORTZAAR
Slovenia HYZAAR, FORTZAAR
Spain Cozaar Plus, Fortzaar
Sweden Cozaar Comp, Cozaar Comp Forte
United Kingdom COZAAR-COMP
Iceland COZAAR-COMP , COZAAR COMP FORTE
Norway Cozaar Comp, Cozaar Comp Forte

This leaflet was last approved in (07/2010)

PIL.HYZ.10.UK.3278.REN

Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU UK

Registered trademark of EI du Pont de Nemours and Company, Wilmington, Delaware, USA.

© Merck Sharp & Dohme Limited 2010. All rights reserved.

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1. Name Of The Medicinal Product

Adult Meltus for Chesty Coughs and Catarrh.

2. Qualitative And Quantitative Composition

Guaifenesin 100mg / 5ml

Cetylpyridinium Chloride 2.5mg / 5ml

Sucrose 1.75g / 5ml

Purified Honey 0.5g / 5ml

3. Pharmaceutical Form

Oral liquid

4. Clinical Particulars 4.1 Therapeutic Indications

For the symptomatic relief of coughs and catarrh associated with influenza, colds and mild throat infections.

4.2 Posology And Method Of Administration

Oral.

Adults and children over 12 years:

One or two 5ml spoonfuls to be taken and swallowed slowly every three or four hours. Not recommended for children under 12 years.

4.3 Contraindications

No known contraindications.

4.4 Special Warnings And Precautions For Use

Not suitable for children under 12 years.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Can cause transient abnormality in platelet aggregation patterns determined one hour after ingestion.

4.6 Pregnancy And Lactation

No known contraindications.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Some gastrointestinal discomfort. Very large doses may cause nausea and vomiting.

4.9 Overdose

Very large doses may cause nausea and vomiting, it is however rapidly metabolised and excreted in the urine. The patient should be kept under observation and treated symptomatically.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

A cough linctus containing an expectorant and an oral antiseptic in a honey and syrup demulcent base. The expectorant, guaifenesin, is employed to produce a thinning of mucous secretions and thus gives relief in bronchial catarrh. The antiseptic, cetylpyridinium chloride, is used for the treatment of superficial mouth and throat infections.

5.2 Pharmacokinetic Properties

None stated.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Glycerin

Alcohol (96%)

Aniseed oil

Menthol crystals

Chloroform

Caramel (E150)

Glucose Liquid

Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf Life

Five years.

6.4 Special Precautions For Storage

Store below 25oC.

6.5 Nature And Contents Of Container

Glass amber sirop bottle with tamper evident cap with fitted ploycone liner in an individual carton containing 100ml or 200 ml of product, including a 5ml CE marked polystyrene measuring spoon.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Cupal Limited, Venus, 1 Old Park Lane, Trafford Park, Manchester, M41 7HA

8. Marketing Authorisation Number(S)

PL 0338/5026R

9. Date Of First Authorisation/Renewal Of The Authorisation

14/09/90 / 07/09/99

10. Date Of Revision Of The Text

July 2006

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The wording of leaflets is regularly updated. This electronic text is the most up-to-date version and may differ from the leaflet in your pack. If you have any questions about the information provided, please ask your doctor or pharmacist.

VELOSEF FOR INJECTION

Cefradine

Your doctor has prescribed Velosef for Injection for you. This leaflet gives a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.

What Is In Velosef Injection?

The active ingredient in Velosef is cefradine. Velosef is available in two strengths and each vial contains either 500mg or 1g cefradine. Cefradine is an antibiotic and a member of the family of medicines called cephalosporins. The other ingredient is L-arginine. The powder in the vial is dissolved in water for injections or another infusion fluid before administration.

Who Supplies Velosef Injection? U.K. PRODUCT LICENCE held by: E.R. Squibb & Sons Limited Uxbridge Business Park Sanderson Road Uxbridge Middlesex UB8 1DH IRISH PRODUCT AUTHORISATION held by: Bristol-Myers Squibb Pharmaceuticals Limited Co Dublin Ireland Manufacturer Bristol-Myers Squibb Srl Via Del Murillo Sermoneta Latina Italy What Is This Medicine For?

Velosef is used to treat bacterial infections in the chest, urinary tract or skin. The injection is given when patients are unable to take an oral antibiotic medicine or when the infection needs to be treated quickly. Velosef is also used to treat infections after surgery.

Before Your Medicine Is Administered What Should My Doctor Know Before I Receive Velosef Injection?

Tell your doctor if you are allergic to any of the ingredients in Velosef or similar medicines such as other cephalosporins and penicillins.

What If I Am Pregnant Or Think I Might Be Pregnant?What If Am Breast-Feeding?

If you are pregnant, planning to become pregnant or breast feeding, speak to your doctor.

What If I Have Problems With My Liver Or Kidneys?

Tell your doctor about any previous problems with your liver or kidneys, as the dose of Velosef may need to be adjusted. Your doctor may want to monitor your liver or kidney function whilst you are taking Velosef.

What If I Am A Diabetic?

If you use chemical tests to check for sugar in the urine, Velosef may cause a false positive reaction. This does not occur with dipstick type tests. Ask your doctor which type of test kit you should use.

Can I Take Other Medicines?

If you are taking any other medicines it is important to discuss this with your doctor or pharmacist. These include furosemide (‘water tablets’) or probenecid and medicines bought at a pharmacy or elsewhere e.g. supermarket.

Is It All Right To Drink Alcohol?

There is no interaction between Velosef and moderate amounts of alcohol. However, you should check with your doctor whether drinking is advisable for you.

Administration Of Your Medicine What Is The Dose Of Velosef Injection And How Will It Be Given?

Velosef will be given by injection into a large muscle, or slow injection into a vein, or as an intravenous drip. Your doctor will decide what dose is required and how long the treatment should continue, based on your symptoms and the results of blood tests. The usual dose for treatment of infections is 2-4g daily, given in four equally divided doses. The dose given for prevention of infections after surgery is 1-2g. The usual dose for children is 50-100mg/kg bodyweight/day.

Undesirable Effects What Are The Unwanted Effects Of Velosef Injection?

In a few patients, especially those with a history of allergy, asthma, hay fever or nettle rash, Velosef may cause diarrhoea or a rash. Skin and hypersensitivity reactions may include unexpected itchy red swelling on skin, fever, joint pain or fluid retention. More rarely, there have been reports of inflammation of the tongue, heartburn, headache, dizziness, shortness of breath, pins and needles, nausea, vomiting, abdominal pain, fungal infections, vaginal inflammation. Occasionally, patients complain of pain, bruising and inflammation at the injection site. Very rarely, blood/liver disorders occur and any diarrhoea with blood and mucus should be reported to your doctor, nurse or pharmacist. There have also been very rare reports of more serious allergic reactions including anaphylaxis and Stevens Johnson syndrome. If you notice any other unusual or unexpected symptoms tell your doctor or pharmacist.

Looking After Your Medicine

This medicine will be stored in the pharmacy until it is given to you by your doctor or nurse. It should not be stored above 25°C. It should not be used after the expiry date shown on the outer packaging.

DATE OF PREPARATION October 2005

PLEASE DETACH BEFORE HANDING ABOVE SECTION TO THE PATIENT

VELOSEF FOR INJECTION

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Class: Dopamine Precursors
VA Class: CN500
CAS Number: 59-92-7
Brands: Lodosyn, Parcopa, Sinemet, Sinemet CR, Stalevo

Introduction

Antiparkinsonian; levodopa is the levorotatory isomer of dihydroxyphenylalanine and the metabolic precursor of dopamine, and carbidopa is a decarboxylase inhibitor that inhibits the peripheral decarboxylation of levodopa to dopamine.104 105 106 107 108

Uses for Levodopa/Carbidopa Parkinsonian Syndrome

Symptomatic treatment of idiopathic Parkinson’s disease (paralysis agitans), parkinsonian syndrome (postencephalitic parkinsonism), and symptomatic parkinsonism resulting from carbon monoxide intoxication and/or manganese intoxication.104 105 106 107 108

Levodopa is the most effective drug for relieving the symptoms of parkinsonian syndrome.d

Levodopa provides symptomatic relief (e.g., akinesia, rigidity, tremor); does not alter the disease course.d

Drug of choice in the management of idiopathic parkinsonian syndrome, especially in patients >70 years of age, those with cognitive impairment, and those with severe disease.101 103 d

Levodopa is used in conjunction with a decarboxylase inhibitor, carbidopa.104 105 106 107 108 Levodopa-carbidopa can be used alone or in conjunction with other antiparkinsonian drugs (e.g. ergot- and nonergot-derivative dopamine receptor agonists, catechol-O-methyltransferase [COMT] inhibitor, and/or selegiline).d 106

Drug-induced Extrapyramidal Effects

Not effective in the management of extrapyramidal effects† induced by antipsychotic agents (e.g., phenothiazines).d

Levodopa/Carbidopa Dosage and Administration Administration Oral Administration

Administer extended-release tablets as whole or half tablets; do not chew or crush.105

Just prior to administration of the orally disintegrating tablet, gently remove the tablet from the bottle with dry hands.104 Place tablet on tongue to dissolve (usually within seconds) and swallow with saliva.104

Administration of orally disintegrating tablet with water is not necessary.104

Do not divide the fixed-combination preparation containing levodopa, carbidopa, and entacapone (Stalevo); administer only one tablet per dosing interval.106

Dosage

Dosage expressed in terms of levodopa and carbidopa.104 105 106 107 108

Available in combination products containing a 1:4 or 1:10 ratio of carbidopa to levodopa.104 105 106 107 Additional carbidopa can be administered separately if a higher carbidopa dosage than is available in the combination preparations is needed.108 The treatment regimen can include levodopa-carbidopa extended-release tablets, conventional tablets, and orally disintegrating tablets and carbidopa tablets based on individual requirements.104 105 107 108 Levodopa no longer is commercially available in the US as a single-entity preparation.d

Also available as a fixed-combination preparation containing levodopa, carbidopa, and entacapone (Stalevo); available in a 1:4 ratio of carbidopa to levodopa.106 Used if optimum maintenance dosage of the 3 drugs corresponds to the dosage in the combination preparation.106 No experience transferring patients receiving levodopa-carbidopa extended-release tablets or levodopa-carbidopa preparations containing the 1:10 ratio.106

For some patients (maintenance levodopa dosage ?600 mg daily, no dyskinesias), the fixed combination containing levodopa, carbidopa, and entacapone (Stalevo) can be used when initiating entacapone therapy if optimum maintenance dosage of levodopa-carbidopa corresponds to dosage in the combination preparation.106

Adjust levodopa-carbidopa dosage carefully according to individual requirements, response, and tolerance.104 105 106 107 108

Dosage adjustment may be needed when other antiparkinsonian drugs are added to or discontinued from the regimen.104 105 106 107 108

Daily dosage of carbidopa should be at least 70–100 mg daily; patients receiving <70–100 mg daily are likely to experience nausea and vomiting.104 105 107 108 d

Observe patient closely if dosage is reduced abruptly or the drug is discontinued; risk of precipitating a symptom complex resembling neuroleptic malignant syndrome (NMS).104 105 106 107 (See Neuroleptic Malignant Syndrome under Cautions.)

If general anesthesia required, continue therapy as long as patient permitted to take oral medications; resume as soon as patient is able to take oral medication.104 105 106 107 If therapy interrupted, observe for NMS.104 105 106 107 (See Neuroleptic Malignant Syndrome under Cautions.)

Adults Parkinsonian Syndrome Levodopa-Carbidopa Conventional Tablets or Orally Disintegrating Tablets Oral

Initially, levodopa 100 mg/carbidopa 25 mg (as 1 tablet) 3 times daily.104 107 109

Increase dosage by levodopa 100 mg/carbidopa 25 mg (1 tablet) daily or every other day until a daily dosage of levodopa 800 mg/carbidopa 200 mg is reached or adverse effects prevent further increases or necessitate discontinuance.104 107 109 d

Alternatively, initiate with levodopa 100 mg/carbidopa 10 mg (as 1 tablet) 3 or 4 times daily; this dosage will not provide an adequate dose of carbidopa for most patients.104 107 109 Increase dosage by levodopa 100 mg/carbidopa 10 mg (1 tablet) daily or every other day until a daily dosage of levodopa 800 mg/carbidopa 80 mg is reached.104 107 109

Levodopa-Carbidopa Extended-release Tablets Oral

Initially, levodopa 200 mg/carbidopa 50 mg (as 1 extended-release tablet) twice daily; initial dosage should not be given at intervals <6 hours.105 Adjust dosage based on response and tolerance at intervals ?3 days.105 Most patients are treated adequately with levodopa 400 mg to 1.6 g daily and carbidopa 100–400 mg daily, administered in divided doses at intervals ranging from 4–8 hours while awake.105 Higher dosages (levodopa 2.4 g/carbidopa 600 mg) and shorter intervals (<4 hours) have been used but usually are not recommended.105 If the dosing interval is <4 hours and/or the divided doses are not equal, the smaller doses can be given at the end of the day.105

Dosage may be initiated, titrated, and stabilized initially with conventional (immediate-release) tablets.105 107

Transfer to extended-release tablets: initial dosage should provide 10% more levodopa daily than dosage previously received as conventional tablets; levodopa dosage may need to be increased up to 30% more daily, depending on response.105 (See Bioavailability under Pharmacokinetics.)

Carbidopa

Carbidopa: 25 mg with first dose of levodopa/carbidopa each day for patients who need additional carbidopa; additional 12.5- or 25-mg doses may given during the day with each dose of levodopa/carbidopa.108

Prescribing Limits Adults Parkinsonian Syndrome Oral

Experience with carbidopa dosages >200 mg daily limited.104 105 107 108

If fixed-combination preparations containing levodopa 50–150 mg, carbidopa 12.5–37.5 mg, and entacapone 200 mg (Stalevo 50, 75, 100, 125, and 150) are used, maximum of 8 tablets daily.106

If fixed-combination preparation containing levodopa 200 mg, carbidopa 50 mg, and entacapone 200 mg (Stalevo 200) is used, maximum of 6 tablets daily.106

Cautions for Levodopa/Carbidopa Contraindications

Concomitant use with a nonselective MAO inhibitor.104 105 106 107 (See Specific Drugs and Foods under Interactions.)

Angle-closure glaucoma.104 105 106 107 d

Known hypersensitivity to levodopa, carbidopa, or any ingredient in the formulation.104 105 106 107

Malignant melanoma, history of melanoma, or suspicious undiagnosed skin lesions.104 105 106 107

Warnings/Precautions Warnings Nervous System and Muscular Effects

Therapy associated with dyskinesias; dosage reduction may be needed.104 105 106 107

Mental disturbances reported.104 105 106 107 d Observe patients for depression with concomitant suicidal tendencies.104 105 106 107 d Use with caution in patients with current or past psychoses.104 105 106 107 d

Bradykinetic Episodes

“On-off” phenomenon: Sudden loss of effectiveness with abrupt onset of akinesia (“off” effect; persists 1–60 minutes) followed by sudden return of effectiveness (“on” effect); may recur many times daily and respond to increased dosing frequency.d

Akinesia Paradoxica (“start hesitation”): Sudden hypotonic freezing (patient falls frequently while attempting to walk); may respond to decreased dosage.d

Cardiovascular Effects

Risk of orthostatic hypotension; usually asymptomatic and tolerance usually develops within a few months.d

Use with care in patients with a history of MI who have residual atrial, nodal, or ventricular arrhythmias; monitor cardiac function in a facility with intensive cardiac care immediately available during the initial dosage adjustment.104 105 106 107 d

Use with caution in patients with severe cardiovascular disease.104 105 106 107 d

Respiratory Effects

Caution in patients with pulmonary disease (e.g., emphysema) or asthma who may require use of sympathomimetics.104 105 106 107 d

GI Effects

Use with caution in patients with a history of peptic ulcers; possibility of upper GI hemorrhage in these patients.d 104 105 106 107

Neuroleptic Malignant Syndrome (NMS)

Symptom complex resembling NMS reported following dosage reduction or abrupt withdrawal of levodopa.104 105 106 107 d

Observe closely when dosage is reduced or the drug discontinued; especially important in patients receiving concomitant therapy with an antipsychotic agent.d 104 105 106 107

General Precautions

Evaluate hepatic, hematopoietic, cardiovascular, and renal function periodically.d 104 105 106 107

Use of Fixed Combinations

When the fixed-combination preparation containing levodopa, carbidopa, and entacapone (Stalevo) is used, observe the usual precautions and contraindications associated with all drugs in the preparation.106

Glaucoma

Can be used with caution in patients with well-controlled open-angle glaucoma; monitor IOP.104 105 106 107 d (See Contraindications under Cautions.)

Endocrine Disorders

Use with caution.104 105 106 107

Closely monitor diabetic patients; levodopa may affect glycemic control.d

Somnolence

Possible somnolence and, very rarely, episodes of sudden onset of sleep, sometimes occurring without the patient’s awareness or without warning during daily activities.105 107

Patients must be informed of this risk; advise patients that they should exercise caution while driving or operating machinery and that they must refrain from such activities if they experience somnolence and/or an episode of sudden sleep onset.105 107

Melanoma

Epidemiologic studies indicate patients with parkinsonian syndrome have a twofold to approximately sixfold higher risk of developing melanoma than the general population.105 106 107 Unclear whether increased risk is due to parkinsonian syndrome or other factors (e.g., drugs used to treat the disease).105 106 107

Monitor for melanoma on a frequent and regular basis.105 106 107 Manufacturer recommends periodic skin examinations performed by appropriately qualified individuals (e.g., dermatologists).105 106 107

Intense Urges

Intense urges (e.g., urge to gamble, increased sexual urges, other intense urges) and inability to control these urges reported in some patients receiving antiparkinsonian agents that increase central dopaminergic tone (including levodopa-carbidopa).105 106 107 Although causal relationship not established, urges stopped in some cases when dosage was reduced or drug was discontinued.105 106 107

Consider reducing dosage or discontinuing levodopa-carbidopa if a patient develops such urges.105 106 107

Phenylketonuria

Levodopa-carbidopa orally disintegrating tablets contain aspartame (NutraSweet), which is metabolized in the GI tract to phenylalanine.104 110 111 112 113 114

Specific Populations Pregnancy

Category C.104 105 106 107

Lactation

Carbidopa is distributed into milk in rats;106 not known whether carbidopa distributes into human milk.108 Distribution of levodopa into human milk reported in at least one nursing woman.105 107 Caution advised.104 105 106 107

Pediatric Use

Safety and efficacy not established in children <18 years of age.104 105 106 107

Common Adverse Effects

Dyskinesias (choreiform, dystonic, other adventitious movements), nausea.104 105 106 107

Interactions for Levodopa/Carbidopa Specific Drugs and Foods

Drug or Food

Interaction

Comments

Anesthetics, general (cyclopropane, halogenated hydrocarbon general anesthetics)

Potential for cardiac arrhythmias with these anesthetic agentsd

Use alternative anesthetic agentsd

Anticholinergic agents

Potential for decreased tremor and/or exacerbation of abnormal involuntary movements104 105 106 107 d

Possible delay in levodopa absorption and increase in gastric metabolism of levodopad

Antidepressants, tricyclic

Potential for hypertension and dyskinesia104 105 106 107

Use concomitantly with cautiond

Antipsychotic agents (phenothiazines, butyrophenones, risperidone)

Possible reduction in the therapeutic effects of levodopa104 105 106 107

Possible increased risk of NMS104 105 106 107 (see Neuroleptic Malignant Syndrome under Cautions)

Observe patient for loss of therapeutic effect104 105 106 107

Benzodiazepines

Possible reduction in the therapeutic effects of levodopa with chlordiazepoxide or diazepamd

Use concomitantly with cautiond

Hypotensive agents

Potential for symptomatic postural hypotension104 105 106 107

Potential for toxic CNS effects such as psychosis with methyldopad

Dosage adjustment of the hypotensive agent may be needed104 105 106 107

Iron preparations

Decreased absorption of levodopa and carbidopa104 105 106 107

Clinical importance unknown104 105 106 107

Isoniazid

Possible reduction in the therapeutic effects of levodopa104 105 106 107

Observe patient for loss of therapeutic effect104 105 106 107

MAO inhibitors

Potential for hypertension, headache, hyperexcitability with nonselective MAO inhibitorse

Possible severe orthostatic hypotension with selegiline104 105 106 107

Contraindicated with nonselective MAO inhibitors;104 105 106 107 discontinue nonselective MAO inhibitor at least 2 weeks prior to initiation of levodopa104 105 106 107

May be administered concomitantly with a selective MAO inhibitor (e.g., selegiline) with caution104 105 106 107

Metoclopramide

Possible increase in bioavailability of levodopa104 105 106 107

Possible reduction in the therapeutic effects of levodopa104 105 106 107

Papaverine

Possible reduction in the therapeutic effects of levodopa104 105 106 107

Observe patient for loss of therapeutic effect104 105 106 107

Phenytoin

Possible reduction in the therapeutic effects of levodopa104 105 106 107

Observe patient for loss of therapeutic effect104 105 106 107

Protein

High protein diet may impair absorption104 105 106 107

Levodopa/Carbidopa Pharmacokinetics Absorption Bioavailability

Well absorbed from the GI tract; peak plasma levodopa concentrations achieved within 0.5 or 2 hours following administration of conventional tablets or extended-release tablets, respectively.105

Bioavailability of levodopa from extended-release tablets 70–75% of that from conventional tablets.105

Extended-release tablets result in less fluctuation in plasma concentrations between doses than conventional tablets.105

Levodopa-carbodopa conventional tablets and orally disintegrating tablets begin to release the drugs within 30 minutes of administration.104 107 109 Pharmacokinetic values for orally disintegrating tablet are similar to those for the conventional tablet.109

Food

High protein diet may interfere with absorption of levodopa.104 105 106 107

Extended-release tablets: Food increases bioavailability and peak plasma concentrations of levodopa.105

Distribution Extent

Widely distributed.d

<1% of levodopa penetrates the CNS;d carbidopa does not cross the blood-brain barrier.104 105 106 107

Plasma Protein Binding

Levodopa: 10–30%.106

Carbidopa: About 36%.106 d

Elimination Metabolism

Levodopa is metabolized in the stomach and intestine and on first pass through the liver; absorbed levodopa decarboxylated to dopamine.d

Carbidopa inhibits peripheral decarboxylation of levodopa, thus increasing availability of levodopa for distribution into the CNS.104 105 106 107

Elimination Route

Levodopa is excreted in urine as metabolites.d

Half-life

Levodopa: 1.5 hours when administered with carbidopa.104 105

Stability Storage Oral Conventional Tablets

25°C (may be exposed to 15–30°C).106 107 108 Protect from light.107

Extended-release Tablets

Tight container; <30°C.105

Orally Disintegrating Tablets

Tight, light-resistant container; 20–25°C (may be exposed to 15–30°C).104

ActionsActions

Manifestations of parkinsonian syndrome related to depletion of dopamine in the corpus striatum.104 105 106 107

Levodopa relieves symptoms of parkinsonism presumably by increasing dopamine concentrations in the brain.104 105 106 107

Advice to Patients

Importance of taking levodopa/carbidopa at regular intervals as scheduled by the clinician.104 105 106 107 Importance of not altering the prescribed dosage regimen or adding other antiparkinsonian drugs.104 105 106 107

Advise patient not to chew or crush extended-release tablets; however, tablets may be halved.105

For patients taking orally disintegrating tablets, advise to gently remove the tablet from the bottle with dry hands just before administering a dose and then placing the tablet on the tongue to dissolve and be swallowed with saliva.104

Importance of informing patients with phenylketonuria that the orally disintegrating tablets contain aspartame.104

Advise patient to notify clinician if abnormal involuntary movements appear or get worse; dosage adjustment may be needed.104 105 106 107

Advise patient of expected onset and duration of effect.104 105 106 107

Possibility that dark color (red, brown, black) may appear in saliva, urine, or sweat; garments may be discolored.104 105 106 107

Advise patient that a change in diet to food high in protein may delay absorption of levodopa and reduce systemic availability.104 105 106 107 Excess acidity may delay absorption.104 105 106 107

Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products.104 105 106 107

Risk of somnolence and episodes of sudden sleep onset; importance of exercising caution when driving or operating machinery and of refraining from such activities if somnolence and/or an episode of sudden sleep onset occurs.105 107

Importance of asking patients whether they have developed any new or increased gambling urges, sexual urges, or other urges while receiving levodopa-carbidopa and of advising them of the importance of reporting such urges.105 106 107

Importance of frequent monitoring for melanoma and periodic dermatologic examinations by a dermatologist.105 106 107

Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.104 105 106 107

Importance of advising patients of other important precautionary information.104 105 106 107 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Carbidopa

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

25 mg (of anhydrous carbidopa)

Lodosyn (scored)

Bristol-Myers Squibb

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Carbidopa-Levodopa (Co-careldopa)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

Carbidopa 10 mg (of anhydrous carbidopa) and Levodopa 100 mg*

Carbidopa and Levodopa Tablets

Sinemet (scored)

Bristol-Myers Squibb

Carbidopa 25 mg (of anhydours carbidopa) and Levodopa 100 mg*

Carbidopa and Levodopa Tablets

Sinemet (scored)

Bristol-Myers Squibb

Carbidopa 25 mg (of anhydrous carbidopa) and Levodopa 250 mg*

Carbidopa and Levodopa Tablets

Sinemet (scored)

Bristol-Myers Squibb

Tablets, extended-release

Carbidopa 50 mg (of anhydrous carbidopa) and Levodopa 200 mg*

Carbidopa and Levodopa Extended-release Tablets

Sinemet CR (scored)

Bristol-Myers Squibb

Carbidopa 25 mg (of anhydrous carbidopa) and Levodopa 100 mg*

Carbidopa and Levodopa Extended-release Tablets (scored)

Sinemet CR

Bristol-Myers Squibb

Tablets, orally disintegrating

Carbidopa 10 mg (of anhydrous carbidopa) and Levodopa 100 mg

Parcopa (scored)

Azur

Carbidopa 25 mg (of anhydrous carbidopa) and Levodopa 100 mg

Parcopa (scored)

Azur

Carbidopa 25 mg (of anhydrous carbidopa) and Levodopa 250 mg

Parcopa (scored)

Azur

Other Carbidopa Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

Carbidopa 12.5 mg (of anhydrous carbidopa) with Entacapone 200 mg and Levodopa 50 mg

Stalevo

Novartis

Carbidopa 18.75 mg (of anhydrous carbidopa) Entacapone 200 mg and Levodopa 75 mg

Stalevo

Novartis

Carbidopa 25 mg (of anhydrous carbidopa) with Entacapone 200 mg and Levodopa 100 mg

Stalevo

Novartis

Carbidopa 31.25 mg (of anhydrous carbidopa) Entacapone 200 mg and Levodopa 125 mg

Stalevo

Novartis

Carbidopa 37.5 mg (of anhydrous carbidopa) with Entacapone 200 mg and Levodopa 150 mg

Stalevo

Novartis

Carbidopa 50 mg (of anhydrous carbidopa) Entacapone 200 mg and Levodopa 200 mg

Stalevo

Novartis

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Carbidopa-Levodopa 10-100MG Tablets (TEVA PHARMACEUTICALS USA): 90/$34.99 or 180/$65.97

Carbidopa-Levodopa 25-100MG Tablets (ACTAVIS ELIZABETH): 90/$39.98 or 270/$101.98

Carbidopa-Levodopa 25-250MG Tablets (TEVA PHARMACEUTICALS USA): 60/$33.99 or 180/$82.98

Carbidopa-Levodopa CR 25-100MG Controlled-release Tablets (MYLAN): 60/$40.99 or 180/$116.98

Carbidopa-Levodopa CR 50-200MG Controlled-release Tablets (MYLAN): 60/$80.99 or 180/$221.98

Parcopa 25-100MG Dispersible Tablets (AZUR PHARMA): 30/$97.64 or 90/$234.33

Sinemet 10-100MG Tablets (MERCK SHARP &amp; DOHME): 90/$91.16 or 270/$256.57

Sinemet 25-100MG Tablets (MERCK SHARP &amp; DOHME): 90/$113.41 or 270/$305.96

Sinemet 25-250MG Tablets (MERCK SHARP &amp; DOHME): 60/$88.99 or 180/$255.97

Sinemet CR 25-100MG Controlled-release Tablets (MERCK SHARP &amp; DOHME): 60/$78.99 or 180/$225.96

Sinemet CR 50-200MG Controlled-release Tablets (MERCK SHARP &amp; DOHME): 60/$145.5 or 180/$417.26

Stalevo 100 25-100-200MG Tablets (NOVARTIS): 90/$318 or 270/$898.92

Stalevo 150 37.5-150-200MG Tablets (NOVARTIS): 30/$113.99 or 90/$334.97

Stalevo 200 50-200-200MG Tablets (NOVARTIS): 100/$363.99 or 300/$1043.97

Stalevo 50 12.5-50-200MG Tablets (NOVARTIS): 30/$110.98 or 90/$317.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 01, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

101. Olanow CW, Watts RL, Koller WC. An algorithm (decision tree) for the management of Parkinson’s disease (2001): treatment guidelines. Neurology. 2001; 56:S1-S88.

102. Chong BS, Mersfelder TL. Entacapone. Ann Pharmacother. 2000; 34:1056-65. [IDIS 452302] [PubMed 10981253]

103. Anon. Initial treatment of Parkinson’s disease: wait just a minute. Med Lett Drugs Ther. 2001; 43:59-60. [PubMed 11445778]

104. Azur Pharma. Parcopa (carbidopa-levodopa) orally disintegrating tablets prescribing information. Philadelphia, PA; 2009 Sep.

105. Bristol-Myers Squibb. Sinemet CR (carbidopa-levodopa) sustained-release tablets prescribing information. Princeton, NJ; 2009 Jan.

106. Novartis. Stalevo 50, Stalevo 75, Stalevo 100, Stalevo 125, Stalevo 150, Stalevo 200 (carbidopa, levodopa and entacapone) tablets prescribing information. East Hanover, NJ; 2009 Mar.

107. Bristol-Myers Squibb. Sinemet (carbidopa-levodopa) tablets prescribing information. Princeton, NJ; 2009 Jan.

108. Bristol-Myers Squibb. Lodosyn (carbidopa) tablets prescribing information. Princeton, NJ; 2006 Sep.

109. Anon. Parcopa: a rapidly dissolving formulation of carbidopa/levodopa. Med Lett Drugs Ther. 2005; 47:12.

110. American Medical Association Council on Scientific Affairs. Aspartame: review of safety issues. JAMA. 1985; 254:400 2. [IDIS 202002] [PubMed 2861297]

111. Gossel TA. A review of aspartame: characteristics, safety and uses. US Pharm. 1984; 9:26,28 30.

112. Food and Drug Administration. Aspartame as an inactive ingredient in human drug products; labeling requirements. Proposed rule. [21 CFR Part 201] Fed Regist. 1983; 48:54993 5. (lDIS 178728)

113. Food and Drug Administration. Food additives permitted for direct addition to food for human consumption; aspartame. Final rule. [21 CFR Part 172] Fed Regist. 1983; 48:31376 82. (IDIS 172957)

114. Anon. Aspartame and other sweeteners. Med Lett Drugs Ther. 1982; 24:1 2. [PubMed 7054648]

d. AHFS drug information 2004. McEvoy GK, ed. Levodopa/carbidopa. Bethesda, MD: American Society of Health-System Pharmacists; 2005:2485-90.

e. AHFS drug information 2004. McEvoy GK, ed. Monoamine Oxidase Inhibitors General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2005:2174-80.

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