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chondroitin, glucosamine, and methylsulfonylmethane


Generic Name: chondroitin, glucosamine, and methylsulfonylmethane (kon DROI tin, gloo KOSE a meen, and METH il sul FON il METH ane)
Brand names: Glucosamine & Chondroitin with MSM, Glucosamine Chondroitin MSM Complex, Osteo Bi-Flex Advanced, Osteo Bi-Flex Plus MSM, Glucosamine & Chondroitin with MSM

What is chondroitin, glucosamine, and methylsulfonylmethane?

Chondroitin is a naturally occurring substance formed of sugar chains. Chondroitin is believed to help the body maintain fluid and flexibility in the joints.

Glucosamine is a naturally occurring substance that is believed to help develop and renew cartilage (the hard connective tissue mainly located on bones near joints in the body), and keep it lubricated for better joint movement and flexibility.

Methylsulfonylmethane is a naturally occurring form of sulfur that helps support muscles and tendons in the body.

The combination of chondroitin, glucosamine, and methylsulfonylmethane is used to aid in maintaining healthy joints. It is also used as a nutritional supplement in people with osteoarthritis or other inflammatory joint disorders.

Not all uses for chondroitin, glucosamine, and methylsulfonylmethane have been approved by the FDA. Chondroitin, glucosamine, and methylsulfonylmethane should not be used in place of medication prescribed for you by your doctor.

Chondroitin, glucosamine, and methylsulfonylmethane is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Chondroitin, glucosamine, and methylsulfonylmethane may also be used for purposes not listed in this product guide.

What is the most important information I should know about chondroitin, glucosamine, and methylsulfonylmethane? Not all uses for this product have been approved by the FDA. Chondroitin, glucosamine, and methylsulfonylmethane should not be used in place of medication prescribed for you by your doctor.

Chondroitin, glucosamine, and methylsulfonylmethane is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Before using this product, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use chondroitin, glucosamine, and methylsulfonylmethane if you have diabetes, a bleeding or blood clotting disorder such as hemophilia, if you have allergies to certain drugs, if you are overweight, or if you are on a low-salt diet.

Do not take chondroitin, glucosamine, and methylsulfonylmethane without the medical advice if you are using insulin, or a blood thinner such as warfarin (Coumadin, Jantoven). Avoid taking chitosan (usually marketed as a weight-loss product) while you are taking chondroitin, glucosamine, and methylsulfonylmethane. Chitosan can make it harder for your body to absorb chondroitin. What should I discuss with my healthcare provider before taking chondroitin, glucosamine, and methylsulfonylmethane? You should not use this product if you are allergic to it.

Ask a doctor, pharmacist, herbalist, or other healthcare provider if it is safe for you to use this product if you have:

diabetes;

a bleeding or blood clotting disorder such as hemophilia;

if you have allergies to certain drugs;

if you are overweight; or

if you are on a low-salt diet.

It is not known whether chondroitin, glucosamine, and methylsulfonylmethane will harm an unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant while using this product. It is not known whether chondroitin, glucosamine, and methylsulfonylmethane passes into breast milk or if it could harm a nursing baby. Do not use this product without telling your healthcare provider if you are breast-feeding a baby. How should I take chondroitin, glucosamine, and methylsulfonylmethane?

When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.

If you choose to use chondroitin, glucosamine, and methylsulfonylmethane, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of this product than is recommended on the label.

It may take up several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after a few weeks of treatment.

Glucosamine may increase the glucose (sugar) levels in your blood. If you have diabetes, you may need to check your blood sugar more often while taking this medication. You may also need to adjust your insulin dosage. Do not change your dose or medication schedule without advice from your doctor.

Chondroitin, glucosamine, and methylsulfonylmethane may be only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture, heat, and light. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking chondroitin, glucosamine, and methylsulfonylmethane? Avoid taking chitosan (usually marketed as a weight-loss product) while you are taking chondroitin, glucosamine, and methylsulfonylmethane. Chitosan can make it harder for your body to absorb chondroitin. Chondroitin, glucosamine, and methylsulfonylmethane side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

mild nausea, upset stomach;

heartburn; or

diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect chondroitin, glucosamine, and methylsulfonylmethane?

Tell your doctor about all other medicines you use, especially:

insulin; or

a blood thinner such as warfarin (Coumadin, Jantoven).

This list is not complete and other drugs may interact with chondroitin, glucosamine, and methylsulfonylmethane. Tell your healthcare provider about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More chondroitin, glucosamine, and methylsulfonylmethane resources Chondroitin, glucosamine, and methylsulfonylmethane Drug Interactions Chondroitin, glucosamine, and methylsulfonylmethane Support Group 1 Review for Chondroitin, glucosamine, and methylsulfonylmethane - Add your own review/rating Compare chondroitin, glucosamine, and methylsulfonylmethane with other medications Dietary Supplementation Osteoarthritis Where can I get more information? Consult with a licensed healthcare professional before using any herbal/health supplement. Whether you are treated by a medical doctor or a practitioner trained in the use of natural medicines/supplements, make sure all your healthcare providers know about all of your medical conditions and treatments.
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Vitamin D3


Generic Name: cholecalciferol (vitamin D3) (KOE le kal SIF e role)
Brand Names: D 1000 IU, D3-5, D3-50, Delta D3, Vitamin D3

What is cholecalciferol?

Cholecalciferol is a vitamin D3. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Cholecalciferol is used to treat or prevent many conditions caused by a lack of vitamin D, especially conditions of the skin or bones.

Cholecalciferol may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about cholecalciferol? Do not use this medication if you have ever had an allergic reaction to vitamin D, or if you have high levels of calcium or vitamin D in your blood, or if you have any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

Before taking cholecalciferol, tell your doctor if you are allergic to any drugs, or if you have heart disease, kidney disease, or an electrolyte imbalance.

Do not take other vitamin or mineral supplements unless your doctor has told you to.

Avoid using calcium supplements or antacids without your doctor's advice. Use only the specific type of supplement or antacid your doctor recommends. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamin D can cause serious or life-threatening side effects.

Overdose symptoms may include headache, weakness, drowsiness, dry mouth, nausea, vomiting, constipation, muscle or bone pain, metallic taste in the mouth, weight loss, itchy skin, changes in heart rate, loss of interest in sex, confusion, unusual thoughts or behavior, severe pain in your upper stomach spreading to your back, or fainting.

What should I discuss with my healthcare provider before taking cholecalciferol? Do not use this medication if you have ever had an allergic reaction to vitamin D, or if you have:

high levels of calcium in your blood (hypercalcemia);

high levels of vitamin D in your body (hypervitaminosis D); or

any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use cholecalciferol:

heart disease;

kidney disease; or

an electrolyte imbalance.

Your cholecalciferol dose needs may change if you are pregnant or breast-feeding. Tell your doctor if you are pregnant or plan to become pregnant during treatment, or if you are breast-feeding a baby. How should I take cholecalciferol?

Take this medication exactly as directed on the label, or as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Cholecalciferol is only part of a complete program of treatment that may also include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat or avoid to help control your condition.

Store this medication at room temperature away from moisture, light, and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamin D can cause serious or life-threatening side effects.

Overdose symptoms may include headache, weakness, drowsiness, dry mouth, nausea, vomiting, constipation, muscle or bone pain, metallic taste in the mouth, weight loss, itchy skin, changes in heart rate, loss of interest in sex, confusion, unusual thoughts or behavior, severe pain in your upper stomach spreading to your back, or fainting.

What should I avoid while taking cholecalciferol? Do not take other vitamin or mineral supplements unless your doctor has told you to.

Avoid using calcium supplements or antacids without your doctor's advice. Use only the specific type of supplement or antacid your doctor recommends.

Cholecalciferol side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking cholecalciferol and call your doctor at once if you have a serious side effect such as:

thinking problems, changes in behavior, feeling irritable;

urinating more than usual;

chest pain, feeling short of breath; or

early signs of vitamin D overdose (weakness, metallic taste in your mouth, weight loss, muscle or bone pain, constipation, nausea, and vomiting).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect cholecalciferol?

Before taking cholecalciferol, tell your doctor if you are taking any of the following medicines:

seizure medication;

cholestyramine (Prevalite, Questran);

colestipol (Colestid);

steroids (prednisone and others);

digoxin (digitalis, Lanoxin); or

a diuretic (water pill) such as chlorothiazide (Diuril), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others.

This list is not complete and there may be other drugs that can interact with cholecalciferol. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Vitamin D3 resources Vitamin D3 Side Effects (in more detail)Vitamin D3 Use in Pregnancy & BreastfeedingVitamin D3 Drug InteractionsVitamin D3 Support Group0 Reviews for Vitamin D3 - Add your own review/rating Delta D3 Advanced Consumer (Micromedex) - Includes Dosage Information Compare Vitamin D3 with other medications Prevention of FallsPrevention of FracturesVitamin D DeficiencyVitamin D Insufficiency Where can I get more information? Your pharmacist can provide more information about cholecalciferol.

See also: Vitamin D3 side effects (in more detail)


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Calciferol


Generic Name: ergocalciferol (vitamin D2) (ER goe kal SIF e role)
Brand Names: Calcidol, Calciferol, Drisdol, Vitamin D2

What is ergocalciferol?

Ergocalciferol is vitamin D2. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Ergocalciferol is used to treat hypoparathyroidism (decreased functioning of the parathyroid glands).

Ergocalciferol is also used to treat rickets (softening of the bones caused by vitamin D deficiency) or low levels of phosphate in the blood (hypophosphatemia).

Ergocalciferol may also be used for purposes not listed in this medication guide.

What is the most important information I should know about ergocalciferol? Do not use this medication if you have ever had an allergic reaction to vitamin D, or if you have high levels of calcium or vitamin D in your blood, or if you have any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

Before you take this medication, tell your doctor if you are allergic to any drugs or dyes, or if you have heart disease, coronary artery disease, kidney disease, or an electrolyte imbalance.

Do not take other vitamin or mineral supplements unless your doctor has told you to.

Avoid using calcium supplements or antacids without your doctor's advice. Use only the specific type of supplement or antacid your doctor recommends. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamin D can cause serious or life-threatening side effects.

Overdose symptoms may include headache, weakness, drowsiness, dry mouth, nausea, vomiting, constipation, muscle or bone pain, metallic taste in the mouth, weight loss, itchy skin, changes in heart rate, loss of interest in sex, confusion, unusual thoughts or behavior, feeling unusually hot, severe pain in your upper stomach spreading to your back, or fainting.

What should I discuss with my healthcare provider before taking ergocalciferol? Do not use this medication if you have ever had an allergic reaction to vitamin D, or if you have:

high levels of calcium in your blood (hypercalcemia);

high levels of vitamin D in your body (hypervitaminosis D); or

any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

To make sure you can safely take ergocalciferol, tell your doctor if you have any of these other conditions:

heart disease;

coronary artery disease;

kidney disease; or

an electrolyte imbalance.

FDA pregnancy category C. It is not known whether ergocalciferol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Ergocalciferol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take ergocalciferol?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

To be sure this medication is helping your condition, your blood will need to be tested often. You may also need x-rays. Visit your doctor regularly.

Ergocalciferol is only part of a complete program of treatment that may also include other medications and a special diet. It is very important to follow the medication and diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat or avoid to help control your condition.

Store at room temperature away from moisture, heat, and light. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of vitamin D can cause serious or life-threatening side effects.

Overdose symptoms may include headache, weakness, drowsiness, dry mouth, nausea, vomiting, constipation, muscle or bone pain, metallic taste in the mouth, weight loss, itchy skin, changes in heart rate, loss of interest in sex, confusion, unusual thoughts or behavior, feeling unusually hot, severe pain in your upper stomach spreading to your back, or fainting.

What should I avoid while taking ergocalciferol? Do not take other vitamin or mineral supplements unless your doctor has told you to.

Avoid using calcium supplements or antacids without your doctor's advice. Use only the specific type of supplement or antacid your doctor recommends.

Ergocalciferol side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

thinking problems, changes in behavior, feeling irritable;

urinating more than usual;

chest pain, feeling short of breath; or

early signs of vitamin D overdose (weakness, metallic taste in your mouth, weight loss, muscle or bone pain, constipation, nausea, and vomiting).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ergocalciferol?

Tell your doctor about all other medicines you use, especially:

sucralfate (Carafate);

mineral oil (sometimes taken as a laxative);

seizure medication;

steroids (prednisone and others);

digoxin (digitalis, Lanoxin); or

a diuretic (water pill) such as chlorothiazide (Diuril), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor HCT, Vasoretic, Zestoretic), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others.

This list is not complete and other drugs may interact with ergocalciferol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Calciferol resources Calciferol Side Effects (in more detail) Calciferol Use in Pregnancy & Breastfeeding Calciferol Drug Interactions Calciferol Support Group 0 Reviews for Calciferol - Add your own review/rating Calciferol Solution MedFacts Consumer Leaflet (Wolters Kluwer) Calciferol Advanced Consumer (Micromedex) - Includes Dosage Information Ergocalciferol Prescribing Information (FDA) Drisdol Prescribing Information (FDA) Drisdol Monograph (AHFS DI) Drisdol MedFacts Consumer Leaflet (Wolters Kluwer) Compare Calciferol with other medications Familial Hypophosphatemia Hypocalcemia Hypoparathyroidism Hypophosphatemia Osteomalacia Renal Osteodystrophy Rickets Vitamin D Deficiency Vitamin/Mineral Supplementation and Deficiency Where can I get more information? Your pharmacist can provide more information about ergocalciferol.

See also: Calciferol side effects (in more detail)


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Calcidol


Generic Name: ergocalciferol (vitamin D2) (ER goe kal SIF e role)
Brand Names: Calcidol, Calciferol, Drisdol, Vitamin D2

What is ergocalciferol?

Ergocalciferol is vitamin D2. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Ergocalciferol is used to treat hypoparathyroidism (decreased functioning of the parathyroid glands).

Ergocalciferol is also used to treat rickets (softening of the bones caused by vitamin D deficiency) or low levels of phosphate in the blood (hypophosphatemia).

Ergocalciferol may also be used for purposes not listed in this medication guide.

What is the most important information I should know about ergocalciferol? Do not use this medication if you have ever had an allergic reaction to vitamin D, or if you have high levels of calcium or vitamin D in your blood, or if you have any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

Before you take this medication, tell your doctor if you are allergic to any drugs or dyes, or if you have heart disease, coronary artery disease, kidney disease, or an electrolyte imbalance.

Do not take other vitamin or mineral supplements unless your doctor has told you to.

Avoid using calcium supplements or antacids without your doctor's advice. Use only the specific type of supplement or antacid your doctor recommends. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamin D can cause serious or life-threatening side effects.

Overdose symptoms may include headache, weakness, drowsiness, dry mouth, nausea, vomiting, constipation, muscle or bone pain, metallic taste in the mouth, weight loss, itchy skin, changes in heart rate, loss of interest in sex, confusion, unusual thoughts or behavior, feeling unusually hot, severe pain in your upper stomach spreading to your back, or fainting.

What should I discuss with my healthcare provider before taking ergocalciferol? Do not use this medication if you have ever had an allergic reaction to vitamin D, or if you have:

high levels of calcium in your blood (hypercalcemia);

high levels of vitamin D in your body (hypervitaminosis D); or

any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

To make sure you can safely take ergocalciferol, tell your doctor if you have any of these other conditions:

heart disease;

coronary artery disease;

kidney disease; or

an electrolyte imbalance.

FDA pregnancy category C. It is not known whether ergocalciferol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Ergocalciferol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take ergocalciferol?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

To be sure this medication is helping your condition, your blood will need to be tested often. You may also need x-rays. Visit your doctor regularly.

Ergocalciferol is only part of a complete program of treatment that may also include other medications and a special diet. It is very important to follow the medication and diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat or avoid to help control your condition.

Store at room temperature away from moisture, heat, and light. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of vitamin D can cause serious or life-threatening side effects.

Overdose symptoms may include headache, weakness, drowsiness, dry mouth, nausea, vomiting, constipation, muscle or bone pain, metallic taste in the mouth, weight loss, itchy skin, changes in heart rate, loss of interest in sex, confusion, unusual thoughts or behavior, feeling unusually hot, severe pain in your upper stomach spreading to your back, or fainting.

What should I avoid while taking ergocalciferol? Do not take other vitamin or mineral supplements unless your doctor has told you to.

Avoid using calcium supplements or antacids without your doctor's advice. Use only the specific type of supplement or antacid your doctor recommends.

Ergocalciferol side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

thinking problems, changes in behavior, feeling irritable;

urinating more than usual;

chest pain, feeling short of breath; or

early signs of vitamin D overdose (weakness, metallic taste in your mouth, weight loss, muscle or bone pain, constipation, nausea, and vomiting).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ergocalciferol?

Tell your doctor about all other medicines you use, especially:

sucralfate (Carafate);

mineral oil (sometimes taken as a laxative);

seizure medication;

steroids (prednisone and others);

digoxin (digitalis, Lanoxin); or

a diuretic (water pill) such as chlorothiazide (Diuril), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor HCT, Vasoretic, Zestoretic), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others.

This list is not complete and other drugs may interact with ergocalciferol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Calcidol resources Calcidol Side Effects (in more detail) Calcidol Use in Pregnancy & Breastfeeding Calcidol Drug Interactions Calcidol Support Group 0 Reviews for Calcidol - Add your own review/rating Ergocalciferol Prescribing Information (FDA) Calciferol Solution MedFacts Consumer Leaflet (Wolters Kluwer) Calciferol Advanced Consumer (Micromedex) - Includes Dosage Information Drisdol MedFacts Consumer Leaflet (Wolters Kluwer) Drisdol Prescribing Information (FDA) Drisdol Monograph (AHFS DI) Compare Calcidol with other medications Familial Hypophosphatemia Hypocalcemia Hypoparathyroidism Hypophosphatemia Osteomalacia Renal Osteodystrophy Rickets Vitamin D Deficiency Vitamin/Mineral Supplementation and Deficiency Where can I get more information? Your pharmacist can provide more information about ergocalciferol.

See also: Calcidol side effects (in more detail)


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methoxsalen


meth-OX-a-len

Oral route(Capsule)

Methoxsalen with UV radiation should be used only by physicians who have special competence in diagnosis and treatment of psoriasis and who have special training and experience in photochemotherapy. Photochemotherapy should be restricted to patients with severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy. Risks of therapy include ocular damage, aging of the skin, and skin cancer (including melanoma). The soft gelatin capsules should not be used interchangeably with regular methoxsalen hard gelatin capsules due to greater bioavailability and earlier photosensitization onset time .

Commonly used brand name(s)

In the U.S.

8-Mop Oxsoralen-Ultra

Available Dosage Forms:

Capsule

Therapeutic Class: Antipsoriatic

Chemical Class: Psoralen

Uses For methoxsalen

Methoxsalen belongs to the group of medicines called psoralens. It is used along with ultraviolet light (found in sunlight and some special lamps) in a treatment called PUVA to treat vitiligo, a disease in which skin color is lost, and psoriasis, a skin condition associated with red and scaly patches.

Methoxsalen is also used with ultraviolet light in the treatment of white blood cells. This treatment is called photopheresis and is used to treat the skin problems associated with mycosis fungoides, which is a type of lymphoma.

Methoxsalen may also be used for other conditions as determined by your doctor.

methoxsalen is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in the product labeling, methoxsalen is used in certain patients with the following medical conditions:

Alopecia areata Atopic dermatitis Eczema Lichen planus Skin that is abnormally sensitive to sunlight Before Using methoxsalen

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For methoxsalen, the following should be considered:

Methoxsalen is a very strong medicine that increases the skin's sensitivity to sunlight. In addition to causing serious sunburns if not properly used, it has been reported to increase the chance of skin cancer and cataracts. Also, like too much sunlight, PUVA can cause premature aging of the skin. Therefore, methoxsalen should be used only as directed and it should not be used simply for suntanning. Before using methoxsalen, be sure that you have discussed its use with your doctor.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to methoxsalen or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Some of the side effects are more likely to occur in children up to 12 years of age, since these children may be more sensitive to the effects of methoxsalen.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of methoxsalen in the elderly with use in other age groups.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking methoxsalen, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using methoxsalen with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Phenytoin Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of methoxsalen. Make sure you tell your doctor if you have any other medical problems, especially:

Allergy to sunlight (or family history of) or Infection or Lupus erythematosus or Porphyria or Skin cancer (history of) or Skin conditions (other) or Stomach problems—Use of PUVA may make the condition worse Eye problems, such as cataracts or loss of the lens of the eye—The light treatment may make the condition worse or may cause damage to the eye Heart or blood vessel disease (severe)—The heat or prolonged standing associated with each light treatment may make the condition worse Liver disease—Condition may cause increased blood levels of the medicine and cause an increase in side effects Proper Use of methoxsalen

Eating certain foods while you are taking methoxsalen may increase your skin's sensitivity to sunlight. To help prevent this, avoid eating limes, figs, parsley, parsnips, mustard, carrots, and celery while you are being treated with methoxsalen.

Methoxsalen usually comes with patient directions. Read them carefully before using methoxsalen.

methoxsalen may take 6 to 8 weeks to really help your condition. Do not increase the amount of methoxsalen you are taking or spend extra time in the sunlight or under an ultraviolet lamp. This will not make the medicine act any more quickly and may result in a serious burn.

If methoxsalen upsets your stomach:

Patients taking the hard gelatin capsules may take them with food or milk. Patients taking the soft gelatin capsules may take them with low-fat food or low-fat milk. Dosing

The dose of methoxsalen will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of methoxsalen. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (hard gelatin capsule): For treating mycosis fungoides and psoriasis: Adults and children 12 years of age and over—Dose is based on body weight and must be determined by your doctor. However, the usual dose is 0.6 mg per kilogram (kg) (0.27 mg per pound) of body weight taken two hours before UVA exposure. This treatment (methoxsalen and UVA) is given two or three times a week with the treatment spaced at least forty-eight hours apart. Children up to 12 years of age—Dose must be determined by your doctor. For vitiligo: Adults and children 12 years of age and over—20 milligrams (mg) per day taken two to four hours before ultraviolet light A (UVA) exposure. This treatment (methoxsalen and UVA) is given two or three times a week with the treatment spaced at least forty-eight hours apart. Children up to 12 years of age—Dose must be determined by your doctor. For oral dosage form (soft gelatin capsule): For psoriasis: Adults and children 12 years of age and over—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.4 mg per kg (0.18 mg per pound) of body weight taken one and one-half to two hours before UVA exposure. This treatment (methoxsalen and UVA) is given two or three times a week, with the treatment spaced at least forty-eight hours apart. Children up to 12 years of age—Dose must be determined by your doctor. Missed Dose

Call your doctor or pharmacist for instructions.

If you are late in taking, or miss taking, a dose of methoxsalen, notify your doctor so your light treatment can be rescheduled. Remember that exposure to sunlight or ultraviolet light must take place a certain number of hours after you take the medicine or it will not work. For patients taking the hard gelatin capsules, this is 2 to 4 hours. For patients taking the soft gelatin capsules, this is 1? to 2 hours. If you have any questions about this, check with your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using methoxsalen

Your doctor should check your progress at regular visits to make sure methoxsalen is working and that it does not cause unwanted effects. Eye examinations should be included.

methoxsalen increases the sensitivity of your skin and lips to sunlight. Therefore, exposure to the sun, even through window glass or on a cloudy day, could cause a serious burn. If you must go out during the daylight hours:

Before each treatment, cover your skin for at least 24 hours by wearing protective clothing, such as long-sleeved shirts, full-length slacks, wide-brimmed hat, and gloves. In addition, protect your lips with a special sun block lipstick that has a skin protection factor (SPF) of at least 15. Check with your doctor before using sun block products on other parts of your body before a treatment, since sun block products should not be used on the areas of your skin that are to be treated. After each treatment, cover your skin for at least 8 hours by wearing protective clothing. In addition, use a sun block product that has a skin protection factor (SPF) of at least 15 on your lips and on those areas of your body that cannot be covered.

If you have any questions about this, check with your health care professional.

Your skin may continue to be sensitive to sunlight for some time after treatment with methoxsalen. Use extra caution for at least 48 hours following each treatment if you plan to spend any time in the sun. In addition, do not sunbathe anytime during your course of treatment with methoxsalen.

For 24 hours after you take each dose of methoxsalen, your eyes should be protected during daylight hours with special wraparound sunglasses that totally block or absorb ultraviolet light (ordinary sunglasses are not adequate). This is to prevent cataracts. Your doctor will tell you what kind of sunglasses to use. These glasses should be worn even in indirect light, such as light coming through window glass or on a cloudy day.

methoxsalen may cause your skin to become dry or itchy. However, check with your doctor before applying anything to your skin to treat this problem.

methoxsalen Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Blistering and peeling of skin reddened, sore skin swelling (especially of feet or lower legs)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Itching of skin nausea Less common Dizziness headache mental depression nervousness trouble in sleeping

Treatment with methoxsalen usually causes a slight reddening of your skin 24 to 48 hours after the treatment. This is an expected effect and is no cause for concern. However, check with your doctor right away if your skin becomes sore and red or blistered.

There is an increased risk of developing skin cancer after use of methoxsalen. You should check your body regularly and show your doctor any skin sores that do not heal, new skin growths, and skin growths that have changed in the way they look or feel.

Premature aging of the skin may occur as a result of prolonged methoxsalen therapy. This effect is permanent and is similar to what happens when a person sunbathes for long periods of time.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More methoxsalen resources Methoxsalen Dosage Methoxsalen Use in Pregnancy & Breastfeeding Methoxsalen Drug Interactions Methoxsalen Support Group 0 Reviews for Methoxsalen - Add your own review/rating methoxsalen Concise Consumer Information (Cerner Multum) Methoxsalen Hard-Gelatin Capsules MedFacts Consumer Leaflet (Wolters Kluwer) Methoxsalen Professional Patient Advice (Wolters Kluwer) 8-MOP Prescribing Information (FDA) Oxsoralen-Ultra Soft-Gelatin Capsules MedFacts Consumer Leaflet (Wolters Kluwer) Oxsoralen-Ultra Prescribing Information (FDA) Uvadex Prescribing Information (FDA) Compare methoxsalen with other medications Cutaneous T-cell Lymphoma Psoriasis
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Ursofalk Capsules


1. Name Of The Medicinal Product

Ursofalk 250mg hard capsules

2. Qualitative And Quantitative Composition

Each capsule of Ursofalk contains the following active ingredient:

ursodeoxycholic acid 250mg

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

White, opaque, hard gelatin capsules (size0) containing a white compressed powder or granules.

4. Clinical Particulars 4.1 Therapeutic Indications

Ursofalk is indicated in the treatment of primary biliary cirrhosis (PBC) and for the dissolution of radiolucent gallstones in patients with a functioning gall bladder

4.2 Posology And Method Of Administration

There are no age restrictions on the use of Ursofalk 250mg hard capsules. For patients weighing less than 47 kg or patients who are unable to swallow Ursofalk 250mg hard capsules, Ursofalk suspension is available.

The following daily dose is recommended for the various indications:

For primary biliary cirrhosis (PBC)

The daily dose depends on body weight, and ranges from 3 to 7 capsules (14 ± 2 mg ursodeoxycholic acid per kg of body weight).

For the first 3 months of treatment, Ursofalk 250mg hard capsules should be taken divided over the day. With improvement of the liver values the daily dose may be taken once daily in the evening.

Body weight (kg)

Daily dose (mg/kg BW)

Ursofalk 250mg hard capsules

     

first 3 months

subsequently        

morning

midday

evening

evening

(1 x daily)

   

47 – 62

12 – 16

1

1

1

3

63 – 78

13 – 16

1

1

2

4

79 – 93

13 – 16

1

2

2

5

94 – 109

14 – 16

2

2

2

6

Over 110

 

2

2

3

7

The capsules should be swallowed whole with some liquid. Care should be taken to ensure that they are taken regularly.

The use of Ursofalk 250mg hard capsules in primary biliary cirrhosis may be continued indefinitely.

In patients with primary biliary cirrhosis, in rare cases the clinical symptoms may worsen at the beginning of treatment, e.g. the itching may increase. Should this occur, therapy should be continued with 1 capsule daily, and the therapy gradually increased (increase of the daily dose weekly by 1 capsule) until the dose indicated in the respective dosage regimen is reached again.

Dissolution of Gallstones:

Adults: 8-12mg ursodeoxycholic acid (UDCA) per kg per day in two divided doses. The following dosage regime is recommended:

Body Weight (kg)

Capsules Daily (in 2 divided doses)

mg (UDCA)/ kg/day

50-62

2

8.1-10.0

63-85

3

8.8-11.9

86-120

4

8.3-11.6

If doses are unequal the larger dose should be taken in late evening to counteract the rise in biliary cholesterol saturation which occurs in the early morning. The late evening dose may usefully be taken with food to help maintain bile flow overnight.

The time required for dissolution of gallstones is likely to range from 6 to 24 months depending on stone size and composition.

Follow-up cholecystograms or ultrasound investigation may be useful at 6 month intervals until the gallstones have disappeared.

Treatment should be continued until 2 successive cholecystograms and/or ultrasound investigations 4-12 weeks apart have failed to demonstrate gallstones. This is because these techniques do not permit reliable visualisation of stones less than 2mm in diameter. The likelihood of recurrence of gallstones after dissolution by bile acid treatment has been estimated as up to 50% at 5 years. The efficiency of Ursofalk in treating radio-opaque or partially radio-opaque gallstones has not been tested but these are generally thought to be less soluble than radiolucent stones. Non-cholesterol stones account for 10-15% of radiolucent stones and may not be dissolved by bile acids.

Elderly: There is no evidence to suggest that any alteration in the adult dose is needed but the relevant precautions should be taken into account.

Children: Cholesterol rich gallstones are rare in children but when they occur, dosage should be related to bodyweight.

4.3 Contraindications

Ursofalk 250mg hard capsules should not be used in patients with:

• Acute inflammation of the gall bladder or biliary tract

• occlusion of the biliary tract (occlusion of the common bile duct or a cystic duct)

• frequent episodes of biliary colic

• radio-opaque calcified gallstones

• impaired contractility of the gall bladder

• hypersensitivity to bile acids or any excipient of the formulation

4.4 Special Warnings And Precautions For Use

Ursofalk 250mg hard capsules should be taken under medical supervision.

During the first 3 months of treatment, liver function parameters AST (SGOT), ALT (SGPT) and ?-GT should be monitored by the physician every 4 weeks, thereafter every 3 months. Apart from allowing for identification of responders and non-responders in patients being treated for primary biliary cirrhosis, this monitoring would also enable early detection of potential hepatic deterioration, particularly in patients with advanced stage primary biliary cirrhosis.

When used for dissolution of cholesterol gallstones:

In order to assess therapeutic progress and for timely detection of any calcification of the gallstones, depending on stone size, the gall bladder should be visualised (oral cholecystography) with overview and occlusion views in standing and supine positions (ultrasound control) 6-10 months after the beginning of treatment.

If the gall bladder cannot be visualised on X-ray images, or in cases of calcified gallstones, impaired contractility of the gall bladder or frequent episodes of biliary colic, Ursofalk 250mg hard capsules should not be used.

When used for treatment of advanced stage of primary biliary cirrhosis:

In very rare cases decompensation of hepatic cirrhosis has been observed, which partially regressed after the treatment was discontinued.

If diarrhoea occurs, the dose must be reduced and in cases of persistent diarrhoea, the therapy should be discontinued.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Ursofalk 250mg hard capsules should not be administered concomitantly with colestyramine, colestipol or antacids containing aluminium hydroxide and/or smectite (aluminium oxide), because these preparations bind ursodeoxycholic acid in the intestine and thereby inhibit its absorption and efficacy. Should the use of a preparation containing one of these substances be necessary, it must be taken at least 2 hours before or after Ursofalk 250mg hard capsules.

Ursofalk 250mg hard capsules can increase the absorption of ciclosporin from the intestine. In patients receiving ciclosporin treatment, blood concentrations of this substance should therefore be checked by the physician and the ciclosporin dose adjusted if necessary.

In isolated cases Ursofalk 250mg hard capsules can reduce the absorption of ciprofloxacin.

Ursodeoxycholic acid has been shown to reduce the plasma peak concentrations (Cmax) and the area under the curve (AUC) of the calcium antagonist nitrendipine.

An interaction with a reduction of the therapeutic effect of dapsone was also reported.

These observations together with in vitro findings could indicate a potential for ursodeoxycholic acid to induce cytochrome P450 3A enzymes. Controlled clinical trials have shown, however, that ursodeoxcholic acid does not have a relevant induction effect on cytochrome P450 3A enzymes.

Oestrogenic hormones and blood cholesterol lowering agents such as clofibrate may increase biliary lithiasis, which is a counter –effect to ursodeoxycholic acid used for dissolution of gallstones.

4.6 Pregnancy And Lactation

There are no adequate data on the use of ursodeoxycholic acid, particularly in the first trimester of pregnancy. Animal studies have provided evidence of a teratogenic effect during the early phase of gestation (see section 5.3, Toxicity to reproduction). Ursofalk 250mg hard capsules must not be used during pregnancy unless clearly necessary. Women of childbearing potential should be treated only if they use reliable contraception: non-hormonal or low-oestrogen oral contraceptive measures are recommended. However, in patients taking Ursofalk 250mg hard capsules for dissolution of gallstones, effective non-hormonal contraception should be used, since hormonal oral contraceptives may increase biliary lithiasis.

The possibility of a pregnancy must be excluded before beginning treatment.

It is not known whether ursodeoxycholic acid passes into breast milk. Therefore, Ursofalk 250mg hard capsules should not be taken during lactation. If treatment with Ursofalk 250mg hard capsules is necessary, the infant should be weaned.

4.7 Effects On Ability To Drive And Use Machines

No effects on ability to drive and use machines have been observed.

4.8 Undesirable Effects

The evaluation of undesirable effects is based on the following frequency data:

Very common (

Common (

Uncommon (

Rare (

Very rare / Not known (< 1/10,000 /cannot be estimated from available data)

Gastrointestinal disorders:

In clinical trials, reports of pasty stools or diarrhoea during ursodeoxycholic acid therapy were common.

Very rarely, severe right upper abdominal pain has occurred during the treatment of primary biliary cirrhosis.

Hepatobiliary disorders:

During treatment with ursodeoxycholic acid, calcification of gallstones can occur in very rare cases.

During therapy of the advanced stages of primary biliary cirrhosis, in very rare cases decompensation of hepatic cirrhosis has been observed, which partially regressed after the treatment was discontinued.

Skin and subcutaneous disorders:

Very rarely, urticaria can occur.

4.9 Overdose

Diarrhoea may occur in cases of overdose. In general, other symptoms of overdose are unlikely because the absorption of ursodeoxycholic acid decreases with increasing dose and therefore more is excreted with the faeces.

No specific counter-measures are necessary and the consequences of diarrhoea should be treated symptomatically with restoration of fluid and electrolyte balance.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

UDCA is a bile acid which effects a reduction in cholesterol in biliary fluid primarily by dispersing the cholesterol and forming a liquid-crystal phase

5.2 Pharmacokinetic Properties

Ursodeoxycholic acid occurs naturally in the body. When given orally it is rapidly and completely absorbed. It is 96-98% bound to plasma proteins and efficiently extracted by the liver and excreted in the bile as glycine and taurine conjugates. In the intestine some of the conjugates are deconjugated and reabsorbed. The conjugates may also be dehydroxylated to lithocholic acid, part of which is absorbed, sulphated by the liver and excreted via the biliary tract.

5.3 Preclinical Safety Data

a) Acute toxicity

Acute toxicity studies in animals have not revealed any toxic damage.

b) Chronic toxicity

Subchronic toxicity studies in monkeys showed hepatotoxic effects in the groups given high doses, including functional changes (e.g. liver enzyme changes) and morphological changes such as bile duct proliferation, portal inflammatory foci and hepatocellular necrosis. These toxic effects are most likely attributable to lithocholic acid, a metabolite of ursodeoxycholic acid, which in monkeys – unlike humans – is not detoxified. Clinical experience confirms that the described hepatotoxic effects are of no apparent relevance in humans.

c) Carcinogenic and mutagenic potential

Long-term studies in mice and rats revealed no evidence of ursodeoxycholic acid having carcinogenic potential.

In vitro and in vivo genetic toxicology tests with ursodeoxycholic acid were negative.

The tests with ursodeoxycholic acid revealed no relevant evidence of a mutagenic effect.

d) Toxicity to reproduction

In studies in rats, tail malformations occurred after a dose of 2000 mg of ursodeoxycholic acid per kg of body weight. In rabbits, no teratogenic effects were found, although there were embryotoxic effects (from a dose of 100 mg per kg of body weight). Ursodeoxycholic acid had no effect on fertility in rats and did not affect peri-/post-natal development of the offspring.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Ursofalk 250mg hard capsules contain the following excipients:

Maize starch, colloidal anhydrous silica, magnesium stearate, gelatin, titanium dioxide

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

Clear PVC blister strips with aluminium foil backing packed in cardboard cartons. Available in cartons containing 60 capsules packaged in six blister strips of 10 capsules or 100 capsules packaged in 4 blister strips of 25 capsules.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Dr Falk Pharma UK Ltd

Unit K

Bourne End Business Park

Cores End Road

Bourne End

Buckinghamshire

SL8 5AS

8. Marketing Authorisation Number(S)

PL 10341/0006

9. Date Of First Authorisation/Renewal Of The Authorisation

31 December 2004

10. Date Of Revision Of The Text

September 2011


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Dioctyl Capsules


1. Name Of The Medicinal Product

Dioctyl 100 mg Capsules.

DulcoEase, 100 mg capsules

2. Qualitative And Quantitative Composition

Docusate sodium 100 mg.

For excipients, see Section 6.1.

3. Pharmaceutical Form

Capsules

A two colour (opaque white and opaque yellow) soft, oval, gelatin capsule with a clear, colourless liquid fill.

4. Clinical Particulars 4.1 Therapeutic Indications

a) To prevent and treat chronic constipation.

(i) to soften hard, dry stools in order to ease defaecation and reduce straining at stool; and

(ii) in the presence of haemorrhoids and anal fissure, to prevent hard, dry stools and reduce straining.

b) As an adjunct in abdominal radiological procedures.

4.2 Posology And Method Of Administration

Route of administration: Oral

Adults and elderly:

Up to 500 mg should be taken daily in divided doses. Treatment should be commenced with large doses, which should be decreased as the condition of the patient improves.

For use with barium meals:

400 mg to be taken with the meal.

Children under 12 years:

Not recommended.

4.3 Contraindications

These capsules should not be administered when abdominal pain, nausea, vomiting or intestinal obstruction is present.

This product should not be given to patients with a known hypersensitivity to Dioctyl capsules or any of the components.

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

4.4 Special Warnings And Precautions For Use

Organic disorders should be excluded prior to the administration of any laxative.

The treatment of constipation with any medicinal product is only adjuvant to a healthy lifestyle and diet, for example:

• Increased intake of fluids and dietary fibre.

• Advice on appropriate physical activity

If laxatives are needed every day, or if there is persistent abdominal pain, consult your doctor.

Contains sorbitol: do not use this medicine if you are intolerant to small quantities of sugar (sorbitol, fructose).

Contains colouring E110 which may cause allergic reactions.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

These capsules should not be taken concurrently with mineral oil.

4.6 Pregnancy And Lactation

There are no adequate data from the use of the drug in pregnant women. Animal studies are insufficient with respect to effects on pregnancy and embryonic foetal development. The potential risk for humans is unknown. During wide use, no adverse consequences have been reported.

Use in pregnancy only if the benefits outweigh the risks.

Docusate sodium is excreted in breast milk and should therefore, be used with caution in lactating mothers.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Rarely, these capsules can cause diarrhoea, nausea, abdominal cramps or skin rash.

4.9 Overdose

In rare cases of overdose, excessive loss of water and electrolytes should be treated by encouraging the patient to drink plenty of fluid. Electrolyte loss should be replenished where appropriate.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC code: A06A02 Laxatives, softeners, emollients

Docusate sodium is an anionic wetting agent, which acts as a faecal softener by lowering the surface tension and allowing penetration of accumulated hard dry faeces by water and salts.

Docusate Sodium also possesses stimulant activity.

5.2 Pharmacokinetic Properties

Docusate sodium exerts its clinical effect in the gastrointestinal tract. There is some evidence that docusate sodium is absorbed and is excreted in the bile. There is also evidence that docusate sodium is capable of enhancing absorption of certain compounds administered concomitantly.

5.3 Preclinical Safety Data

None Stated

6. Pharmaceutical Particulars 6.1 List Of Excipients

Macrogol 400

Propylene glycol

Gelatin 195 bloom

Purified water

Sorbitol special

Glycerol

Titanium dioxide E171

Quinoline yellow E104

Sunset yellow E110

6.2 Incompatibilities

None.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

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

6.5 Nature And Contents Of Container

PVC/PVdC blister packs with aluminium foil containing 10, 20, 30, 40 or 50 capsules.

Polyethylene / polypropylene containers, e.g.: securitainers / tampertainers containing 30, 100 and 250 capsules.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

UCB Pharma Limited

208 Bath Road

Slough

Berkshire

SL1 3WE

United Kingdom

8. Marketing Authorisation Number(S)

PL 00039/0737

9. Date Of First Authorisation/Renewal Of The Authorisation

28 February 2008

10. Date Of Revision Of The Text
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EMEND 80mg, 125mg hard Capsules


EMEND 125 mg hard capsules

EMEND 80 mg hard capsules

aprepitant

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your pharmacist. This medicine has been prescribed 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 EMEND is and what it is used for 2. Before you take EMEND 3. How to take EMEND 4. Possible side effects 5. How to store EMEND 6. Further information What Emend Is And What It Is Used For

EMEND is used in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment).

Before You Take Emend Do not take EMEND If you are allergic (hypersensitive) to aprepitant or any of the other ingredients of EMEND. With medicines containing pimozide (used to treat psychiatric illnesses), terfenadine and astemizole (used for hay fever and other allergic conditions), cisapride (used for treating digestive problems). Tell your doctor if you are taking these medicines since your treatment must be modified before you start taking EMEND. Take special care with EMEND if you have liver disease

EMEND is not for use in children and adolescents under 18 years.

Using other medicines

EMEND can affect other medicines both during and after treatment with EMEND. There are some medicines that should not be taken with EMEND (such as pimozide, terfenadine, astemizole, and cisapride) or that require a dosage adjustment (see also Do not take EMEND). EMEND should be used with caution when taken with other medicines.

The effects of EMEND or other medicines might be influenced if you take EMEND together with other medicines including those listed below.

cyclosporine, tacrolimus, sirolimus, and everolimus (immunosupressants), alfentanil, and fentanyl (used to treat pain), quinidine (used to treat an irregular heart beat), irinotecan (medicine used to treat cancer), medicines containing ergot alkaloid derivatives such as ergotamine and diergotamine (used for treating migraines), warfarin (a blood thinner; blood tests may be required), birth control medicines (which may not work as well; another or additional form of birth control should be used for up to 2 months after using EMEND), rifampin, clarithromycin, telithromycin (antibiotics used to treat infections), phenytoin (a medicine used to treat seizures), carbamazepine (used to treat depression and epilepsy), midazolam, triazolam, and phenobarbital (medicines used to produce calmness or help you sleep), St. John’s Wort (an herbal preparation used to treat depression), protease inhibitors (used to treat HIV infections), ketoconazole itraconazole, voriconazole, and posaconazole (antifungals), nefazodone (used to treat depression), corticosteroids (such as dexamethasone and methylprednisolone), anti-anxiety drugs (such as alprazolam), and tolbutamide (a medicine used to treat diabetes)

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

Taking EMEND with food and drink

EMEND can be taken with or without food.

Pregnancy and breast-feeding

You should not use EMEND during pregnancy unless clearly necessary. It is important that you tell your doctor if you are pregnant or are planning to become pregnant before taking EMEND.

Birth control medicines (these can include birth control pills, skin patches, implants, and certain Intrauterine devices [IUDs] that release hormones) may not work adequately; another or additional form of contraception should be used during treatment with EMEND and for up to 2 months after using EMEND.

It is not known whether EMEND is excreted in human milk; therefore, breast-feeding is not recommended during treatment with EMEND. It is important that you tell your doctor if you are breast-feeding or are planning to breast-feed before taking EMEND.

Driving and using machines

It should be taken into account that some people feel dizzy and sleepy after taking EMEND. If you feel dizzy or sleepy, you should avoid driving or operating machines after taking EMEND. (See POSSIBLE SIDE EFFECTS).

Important information about some of the ingredients of EMEND

EMEND contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How To Take Emend

Always take EMEND exactly as your doctor has instructed you.

The recommended oral dose of EMEND is

one 125 mg capsule 1 hour before you start your chemotherapy treatment on Day 1 and one 80 mg capsule each morning for the 2 days following your chemotherapy treatment.

Your doctor may substitute fosaprepitant 115 mg (which is converted to aprepitant in your body) for oral EMEND (125 mg) on Day 1 only of your treatment. Fosaprepitant is given via an intravenous infusion (a drip), 30 minutes prior to chemotherapy. You will still need to take one 80 mg capsule by mouth of EMEND each morning for the 2 days following your chemotherapy treatment.

EMEND should be swallowed whole with some liquid.

If you take more EMEND than you should

Do not take more capsules than the doctor recommends. If you do take too many capsules, contact your doctor immediately.

If you forget to take EMEND

If you have missed a dose, contact your doctor for advice.

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

Possible Side Effects

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

The frequency of possible side effects listed below is defined by the following convention:

very common (affects more than 1 in 10)

common (affects 1 to 10 users in 100)

uncommon (affects 1 to 10 users in 1,000)

rare (affects 1 to 10 users in 10,000)

very rare (affects less than 1 user in 10,000)

not known (frequency cannot be estimated from the available data).

Common side effects are:

burping, constipation, diarrhoea, indigestion, dizziness, headache, weakness, tiredness, loss of appetite hiccups, increased liver blood tests.

Uncommon side effects are:

abnormal dreaming, difficulty thinking, lack of energy, sleepiness, acne, oily skin, rash, itching, sensitivity of the skin to sun, sores on skin, excessive sweating, anxiousness, euphoria (feeling of extreme happiness), disorientation bacterial infection, fungal infection stomach ulcer, nausea, vomiting, heartburn, taste disturbance, stomach pain, bloating, severe constipation, dry mouth, inflammation of the small intestine and colon, passing wind, sores in mouth, presence of red blood cells in the urine, increased painful or burning urination, passing more urine than normal, chest discomfort, swelling, generally feeling unwell, chills, change in the manner of walking reddening of the face, hot flush cough, mucus in back of throat, throat irritation, sneezing, sore throat, eye discharge and itching, ringing in the ear, muscle cramp or pain, muscle weakness, excessive thirst, weight gain or loss, high sugar levels in the blood, slow heartbeat, fast or irregular heart beats, heart and blood vessel disease, fever with increased risk of infection, lowering of red blood cells, lowering of white blood cells, low sodium levels in the blood.

Single cases of the following have been reported:

Stevens-Johnson syndrome (rare severe skin reaction), angioedema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing), serious constipation, small bowel not working properly (sub-ileus) urticaria (hives).

Since the product has been on the market the following side effects have been reported (frequency not known):

Allergic reactions, which may be serious, and may include hives, rash and itching and cause difficulty in breathing or swallowing. If you have an allergic reaction, stop taking EMEND and call your doctor right away.

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

How To Store Emend

Keep out of the reach and sight of children.

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

Store in the original package in order to protect from moisture.

Do not remove the capsule from its blister until you are ready to take it.

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

Further Information What EMEND contains

The active substance is aprepitant. Each 125 mg hard capsule contains 125 mg of aprepitant. Each 80 mg hard capsule contains 80 mg of aprepitant.

The other ingredients are: sucrose, microcrystalline cellulose (E 460), hydroxypropyl cellulose (E 463), sodium laurilsulfate, gelatin, titanium dioxide (E 171), shellac, potassium hydroxide, and black iron oxide (E 172); the 125 mg hard capsule also contains red iron oxide (E 172) and yellow iron oxide (E 172). The capsule shell may also contain sodium laurilsulfate and silica colloidal anhydrous.

What EMEND looks like and contents of the pack

The 125 mg hard capsule is opaque with a white body and pink cap with "462" and "125 mg" printed radially in black ink on the body.

The 80 mg hard capsule is opaque with a white cap and body with "461" and "80 mg" printed radially in black ink on the body.

EMEND 125 mg and 80 mg hard capsules are supplied in the following pack sizes:

Blister packs containing one EMEND 80 mg capsule Blister packs containing five EMEND 80 mg capsules 2-day treatment pack containing two EMEND 80 mg capsules Blister packs containing one EMEND 125 mg capsule Blister packs containing five EMEND 125 capsules 3-day treatment pack containing one EMEND 125 mg capsule and two EMEND 80 mg capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder Merck Sharp & Dohme Ltd. Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Manufacturer Merck Sharp & Dohme B. V. Waarderweg 39 Postbus 581 NL-2003 PC Haarlem The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom Merck Sharp and Dohme Limited Tel: +44 (0) 1992 467272 Email:medinfo_uk@merck.com

This leaflet was last approved in January 2010.

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.

PIL.EMDO9.UK.3177 (II-024)


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Boots Paracetamol 500 mg Capsules (P -32)


Boots Paracetamol 500 mg Capsules

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

Keep this leaflet, you may need to read it again Ask your pharmacist if you need more information or advice What this medicine is for

This medicine contains a painkiller to relieve mild to moderate pain and fever.

It can be used to relieve headaches, migraine, rheumatic aches and pains, muscular pain and back pain, neuralgia, toothache, sore throat, period pain, fever and the symptoms of colds and flu.

Before you take this medicine

This medicine can be taken by adults and children aged 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take: If you are allergic to any of the ingredients Talk to your pharmacist or doctor: If you have severe kidney problems or severe liver problems (including a disease caused by drinking alcohol) If you are pregnant

You can take this medicine if you are breastfeeding.

Other important information

Information about some of the ingredients: Propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218) in this medicine may cause allergic reactions (possibly delayed).

If you take other medicines

This medicine contains paracetamol.

Do not take with any other paracetamol-containing products.

Before you take these capsules, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

Metoclopramide or domperidone (for feeling sick or being sick) Colestyramine (to reduce blood fat levels) Warfarin or other blood thinners - If you take warfarin you can take occasional amounts of this medicine, but talk to your doctor first before you take it on a regular basis

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to take this medicine

Check the foil is not broken before use. If it is, do not take that capsule.

Adults and children of 12 years and over: Take one or two capsules three or four times a day, if you need to.
Don’t take more than 8 capsules in any 24 hours. Don’t take more often than every 4 hours.

Swallow each capsule with water.

Do not give to children under 12 years.

Do not take more than the amount recommended above.

If symptoms do not go away talk to your doctor.

If you take too many capsules: Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop taking the capsules. See a doctor at once: Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions) These other effects are less serious. If they bother you talk to a pharmacist: Skin rash Unusual bruising, or infections such as sore throats - this may be a sign of very rare changes in the blood

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25°C.

Store in the original package.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

Each hard gelatin capsule contains Paracetamol 500 mg, which is the active ingredient.

As well as the active ingredient, the capsules also contain pregelatinised maize starch, magnesium stearate, sodium laurilsulfate. The capsule shell contains titanium dioxide (E171), erythrosine (E127), quinoline yellow (E104), Patent Blue V (E131), gelatin, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216).

The pack contains 32 hard gelatin capsules with a red cap and white body.

Who makes this medicine

Manufactured for

The Boots Company PLC Nottingham NG2 3AA

by the Marketing Authorisation holder

Bristol Laboratories Ltd Unit 3 Canalside Northbridge Road Berkhamsted Hertfordshire HP4 1EG

Leaflet prepared July 2007

If you would like any further information about this medicine, please contact

The Boots Company PLC Nottingham NG2 3AA

3448-32eMC-Xpil


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Dioctyl 100 mg Capsules


1. Name Of The Medicinal Product

Dioctyl Capsules.

DulcoEase 100mg Capsules

2. Qualitative And Quantitative Composition

Docusate sodium 100 mg.

For excipients, see Section 6.1.

3. Pharmaceutical Form

Capsules

A two colour (opaque white and opaque yellow) soft, oval, gelatin capsule with a clear, colourless liquid fill.

4. Clinical Particulars 4.1 Therapeutic Indications

a) To prevent and treat chronic constipation.

(i) to soften hard, dry stools in order to ease defaecation and reduce straining at stool; and

(ii) in the presence of haemorrhoids and anal fissure, to prevent hard, dry stools and reduce straining.

b) As an adjunct in abdominal radiological procedures.

4.2 Posology And Method Of Administration

Route of administration: Oral

Adults and elderly:

Up to 500 mg should be taken daily in divided doses. Treatment should be commenced with large doses, which should be decreased as the condition of the patient improves.

For use with barium meals:

400 mg to be taken with the meal.

Children under 12 years:

Not recommended.

4.3 Contraindications

These capsules should not be administered when abdominal pain, nausea, vomiting or intestinal obstruction is present.

This product should not be given to patients with a known hypersensitivity to Dioctyl capsules or any of the components.

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

4.4 Special Warnings And Precautions For Use

Organic disorders should be excluded prior to the administration of any laxative.

The treatment of constipation with any medicinal product is only adjuvant to a healthy lifestyle and diet, for example:

• Increased intake of fluids and dietary fibre.

• Advice on appropriate physical activity

If laxatives are needed every day, or if there is persistent abdominal pain, consult your doctor.

Contains sorbitol: do not use this medicine if you are intolerant to small quantities of sugar (sorbitol, fructose).

Contains colouring E110 which may cause allergic reactions.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

These capsules should not be taken concurrently with mineral oil.

4.6 Pregnancy And Lactation

There are no adequate data from the use of the drug in pregnant women. Animal studies are insufficient with respect to effects on pregnancy and embryonic foetal development. The potential risk for humans is unknown. During wide use, no adverse consequences have been reported.

Use in pregnancy only if the benefits outweigh the risks.

Docusate sodium is excreted in breast milk and should therefore, be used with caution in lactating mothers.

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

Rarely, these capsules can cause diarrhoea, nausea, abdominal cramps or skin rash.

4.9 Overdose

In rare cases of overdose, excessive loss of water and electrolytes should be treated by encouraging the patient to drink plenty of fluid. Electrolyte loss should be replenished where appropriate.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC code: A06A02 Laxatives, softeners, emollients

Docusate sodium is an anionic wetting agent, which acts as a faecal softener by lowering the surface tension and allowing penetration of accumulated hard dry faeces by water and salts.

Docusate Sodium also possesses stimulant activity.

5.2 Pharmacokinetic Properties

Docusate sodium exerts its clinical effect in the gastrointestinal tract. There is some evidence that docusate sodium is absorbed and is excreted in the bile. There is also evidence that docusate sodium is capable of enhancing absorption of certain compounds administered concomitantly.

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars 6.1 List Of Excipients

Macrogol 400

Propylene glycol

Gelatin 195 bloom

Purified water

Sorbitol special

Glycerol

Titanium dioxide E171

Quinoline yellow E104

Sunset yellow E110

6.2 Incompatibilities

None

6.3 Shelf Life

PVC/PVdC blister packs with aluminium foil: 18 months

Polyethylene / polypropylene containers: 24 months

6.4 Special Precautions For Storage

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

6.5 Nature And Contents Of Container

PVC/PVdC blister packs with aluminium foil containing 10, 20, 30, 40 or 50 capsules.

Polyethylene / polypropylene containers, e.g.: securitainers / tampertainers containing 30, 100 and 250 capsules.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

UCB Pharma Limited

208 Bath Road

Slough

Berkshire

SL1 3WE

United Kingdom

8. Marketing Authorisation Number(S)

PL 00039/0737

9. Date Of First Authorisation/Renewal Of The Authorisation

28 February 2008 / 17 June 2010

10. Date Of Revision Of The Text

August 2010


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Triveen-CF NAC


Pronunciation: meth-ill-FOE-late/meth-ill-koe-BAL-a-min/a-se-teel-SIS-teen
Generic Name: L-Methylfolate/Methylcobalamin/N-Acetylcysteine
Brand Name: Examples include Cerefolin with NAC and Triveen-CF NAC
Triveen-CF NAC is used for:

Supplying nutritional requirements of certain patients with neurovascular oxidative stress or high blood levels of homocysteine. It may also be used for other conditions as determined by your doctor.

Triveen-CF NAC is a nutritional supplement. It works by providing the body with folate, vitamin B12, and a form of antioxidant, which helps to reduce or eliminate oxidative stress and lower homocysteine levels.

Do NOT use Triveen-CF NAC if: you are allergic to any ingredient in Triveen-CF NAC you are very ill

Contact your doctor or health care provider right away if any of these apply to you.

Before using Triveen-CF NAC:

Some medical conditions may interact with Triveen-CF NAC. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have anemia, liver problems, kidney stones, or a history of ulcers

Some MEDICINES MAY INTERACT with Triveen-CF NAC. Tell your health care provider if you are taking any other medicines, especially any of the following:

Antibiotics (eg, penicillin, cephalexin, ciprofloxacin), cholestyramine, colchicine, colestipol, metformin, nitrous oxide, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), para-aminosalicylic acid, potassium chloride, or sulfasalazine because they may decrease the effectiveness of Triveen-CF NAC Fluorouracil or nitrates (eg, nitroglycerin) because their side effects may be increased Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), primidone, pyrimethamine, or valproic acid because their effectiveness may be decreased by Triveen-CF NAC

This may not be a complete list of all interactions that may occur. Ask your health care provider if Triveen-CF NAC may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Triveen-CF NAC:

Use Triveen-CF NAC as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Triveen-CF NAC may be taken with or without food. If you miss a dose of Triveen-CF NAC, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Triveen-CF NAC.

Important safety information: Diabetes patients - Triveen-CF NAC may cause incorrect test results with some ketone tests. Check with your doctor before you adjust the dose of your diabetes medicine or change your diet. Triveen-CF NAC is not recommended for use in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Triveen-CF NAC, discuss with your doctor the benefits and risks of using Triveen-CF NAC during pregnancy. Triveen-CF NAC is excreted in breast milk. Do not breastfeed while you are taking Triveen-CF NAC. Possible side effects of Triveen-CF NAC:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloated feeling; headache; itching; mild diarrhea; mild fever; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); lower back or side pain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Triveen-CF NAC:

Store Triveen-CF NAC at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, light, and moisture. Keep Triveen-CF NAC out of the reach of children and away from pets.

General information: If you have any questions about Triveen-CF NAC, please talk with your doctor, pharmacist, or other health care provider. Triveen-CF NAC is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Triveen-CF NAC. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Triveen-CF NAC resources Triveen-CF NAC Use in Pregnancy & Breastfeeding Triveen-CF NAC Drug Interactions Triveen-CF NAC Support Group 4 Reviews for Triveen-CF NAC - Add your own review/rating Compare Triveen-CF NAC with other medications Dietary Supplementation Hyperhomocysteinemia
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Diocalm Ultra Capsules


1. Name Of The Medicinal Product

Diocalm Ultra Capsules.

2. Qualitative And Quantitative Composition

Loperamide Hydrochloride Ph Eur 2.0mg / capsule.

3. Pharmaceutical Form

Capsule.

4. Clinical Particulars 4.1 Therapeutic Indications

For the symptomatic treatment of acute diarrhoea.

4.2 Posology And Method Of Administration

Oral. Adults and children aged 12 years and over:

P classification: Two capsules immediately, followed by one capsule after each further bout of diarrhoea up to a maximum of eight capsules in any 24 hours.

GSL classification: Two capsules immediately, followed by one capsule after each further bout of diarrhoea up to a maximum of six capsules in any 24 hours.

Not to be given to children under 12 years.

4.3 Contraindications

Hypersensitivity to the active ingredient. Conditions where inhibition of peristalsis is to be avoided, e.g. diverticular disease and ulcerative colitis.

4.4 Special Warnings And Precautions For Use

This product should be used with caution in cases of impaired liver function.

GSL Classification: Patients suffering Irritable Bowel Syndrome should not use this product. The first line of treatment in acute diarrhoea is the prevention or treatment of fluid and electrolyte depletion; this is of particular importance to frail and elderly patients.

The following will appear on the product labeling (P or GSL): Warning: do not exceed the stated dose. Keep out of reach of children. If symptoms persist for more than 24 hours consult your doctor. If you are pregnant, consult your doctor before use. This medicine is for the relief of the symptoms of diarrhoea and is not a substitute for oral rehydration therapy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

No teratogenic effects have been shown in animals. However safety in humans has not been established and the product should only be taken under medical supervision. Caution is advised during lactation.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Rarely, skin rashes, including urticaria, have been reported.

4.9 Overdose

The following effects may be observed in cases of overdose: constipation, ileus and neurological symptoms. Treatment would be symptomatic. In severe overdose, naloxone can be given as an antidote if required.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

By binding to opiate receptors in the gut wall, loperamide hydrochloride reduces propulsive peristalsis, increases intestinal transit time and enhances resorption of water and electrolytes.

5.2 Pharmacokinetic Properties

Following partial absorption in the gastrointestinal tract, loperamide undergoes first-pass metabolism in the liver and is excreted predominantly in the faeces. The elimination half-life is reported as about ten hours.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Lactose (DMV), Maize Starch (Dried), Microcrystalline Cellulose (Avicel PH101), Pregelatinised Starch (Dried), Croscarmellose Sodium, Dimeticone. Shell cap: Yellow Iron Oxide (E172), Black Iron Oxide (E172), Indigo Carmine (E132), Titanium Dioxide (E171), Gelatin. Shell body: Titanium Dioxide (E171), Gelatin.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months unopened.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Clear blisters of hard polyvinylchloride 250µm thick backed with aluminium foil 0.02 hard silver, smooth shiny-sided hot sealable against PVC and PVdC dull sided unprinted. 6 or 12 capsules per strip are packed in a cardboard carton.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

SSL International PLC. Venus, 1 Old Park Lane, Trafford Park, Manchester, M41 7HA.

8. Marketing Authorisation Number(S)

PL 17905/0049

9. Date Of First Authorisation/Renewal Of The Authorisation

23/03/06

10. Date Of Revision Of The Text

23/03/06


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Tetanus Toxoid Adsorbed


Generic Name: tetanus toxoid (Intramuscular route, Injection route)

TET-n-us TOX-oyd

Commonly used brand name(s)

In the U.S.

TE Anatoxal Berna

In Canada

Tetanus Toxoid Adsorbed

Available Dosage Forms:

Suspension Solution

Therapeutic Class: Toxoid

Uses For Tetanus Toxoid Adsorbed

Tetanus Toxoid is used to prevent tetanus (also known as lockjaw). Tetanus is a serious illness that causes convulsions (seizures) and severe muscle spasms that can be strong enough to cause bone fractures of the spine. Tetanus causes death in 30 to 40 percent of cases.

Immunization against tetanus is recommended for all infants 6 to 8 weeks of age and older, all children, and all adults. Immunization against tetanus consists first of a series of either 3 or 4 injections, depending on which type of tetanus toxoid you receive. In addition, it is very important that you get a booster injection every 10 years for the rest of your life. Also, if you get a wound that is unclean or hard to clean, you may need an emergency booster injection if it has been more than 5 years since your last booster. In recent years, two-thirds of all tetanus cases have been in persons 50 years of age and older. A tetanus infection in the past does not make you immune to tetanus in the future.

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using Tetanus Toxoid Adsorbed

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

In deciding to receive this vaccine, the risks of receiving the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For tetanus toxoid, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use is not recommended for infants up to 6 weeks of age. For infants and children 6 weeks of age and older, tetanus toxoid is not expected to cause different side effects or problems than it does in adults.

Geriatric

This vaccine is not expected to cause different side effects or problems in older people than it does in younger adults. However, the vaccine may be slightly less effective in older persons than in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Chloramphenicol Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

A severe reaction or a fever greater than 103 °F (39.4 °C) following a previous dose of tetanus toxoid—May increase the chance of side effects with future doses of tetanus toxoid; be sure your doctor knows about this before you receive the next dose of tetanus toxoid Bronchitis, pneumonia, or other illness involving lungs or bronchial tubes, or Severe illness with fever—Possible side effects from tetanus toxoid may be confused with the symptoms of the condition Proper Use of tetanus toxoid

This section provides information on the proper use of a number of products that contain tetanus toxoid. It may not be specific to Tetanus Toxoid Adsorbed. Please read with care.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage forms: For prevention of tetanus (lockjaw): Adults, children, and infants 6 weeks of age and older—One dose is given at your first visit, then a second dose is given four to eight weeks later. Depending on the product given, you may receive a third dose four to eight weeks after the second dose, and a fourth dose six to twelve months after that; or you may receive a third dose six to twelve months after the second dose. Everyone should receive a booster dose every ten years. The doses are injected under the skin or into a muscle. In addition, if you get a wound that is unclean or hard to clean, you may need an emergency booster injection if it has been more than 5 years since your last booster dose. Tetanus Toxoid Adsorbed Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Symptoms of allergic reaction Difficulty in breathing or swallowing hives itching, especially of feet or hands reddening of skin, especially around ears swelling of eyes, face, or inside of nose unusual tiredness or weakness (sudden and severe)

Check with your doctor as soon as possible if any of the following side effects occur:

Rare Confusion convulsions (seizures) fever over 103 °F (39.4 °C) headache (severe or continuing) sleepiness (excessive) swelling, blistering, or pain at place of injection (severe or continuing) swelling of glands in armpit unusual irritability vomiting (severe or continuing)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Redness or hard lump at place of injection Less common Chills, fever, irritability, or unusual tiredness pain, tenderness, itching, or swelling at place of injection skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Tetanus Toxoid Adsorbed side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Tetanus Toxoid Adsorbed resources Tetanus Toxoid Adsorbed Side Effects (in more detail) Tetanus Toxoid Adsorbed Use in Pregnancy & Breastfeeding Tetanus Toxoid Adsorbed Drug Interactions Tetanus Toxoid Adsorbed Support Group 0 Reviews for Tetanus Toxoid Adsorbed - Add your own review/rating Tetanus Toxoid Adsorbed Concise Consumer Information (Cerner Multum) Tetanus Toxoid Professional Patient Advice (Wolters Kluwer) Compare Tetanus Toxoid Adsorbed with other medications Tetanus Prophylaxis
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AlleRx PE


Pronunciation: FEN-il-EF-rin/METH-skoe-POL-a-meen with FEN-il-EF-rin/KLOR-fen-IR-a-meen/METH-skoe-POL-a-meen
Generic Name: Phenylephrine/Methscopolamine
Brand Name: Examples include AlleRx PE and AlleRx PE 30
AlleRx PE is used for:

Relieving congestion, sneezing, runny nose, and itchy, watery eyes due to allergies, colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

AlleRx PE is a combination pack containing a morning dose and an evening dose. The morning dose has a decongestant and an anticholinergic medicine. The evening dose has an antihistamine and an anticholinergic medicine. The decongestant relieves nasal congestion by shrinking the nasal mucous membranes, which promotes nasal drainage. The antihistamine works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. The anticholinergic dries the chest by decreasing lung secretions.

Do NOT use AlleRx PE if: you are allergic to any ingredient in AlleRx PE you are breast-feeding you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, severe heart problems, or narrow-angle glaucoma you are unable to urinate or are having an asthma attack you are taking droxidopa, sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using AlleRx PE:

Some medical conditions may interact with AlleRx PE. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of adrenal gland problems (eg, adrenal gland tumor), a hiatal hernia, heart problems (eg, fast, slow, or irregular heartbeat; heart disease), high blood pressure, low blood volume, diabetes, blood vessel problems, muscle weakness (eg, myasthenia gravis), seizures, stroke, glaucoma or increased pressure in the eye, or thyroid problems if you have a history of asthma, chronic cough, lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea), or chronic obstructive pulmonary disease (COPD) if you have a history of stomach or bowel ulcers; constipation; a blockage of your stomach, bladder, or bowel; severe bowel problems (eg, ulcerative colitis, toxic megacolon); liver or kidney problems; or trouble urinating; or if you have an enlarged prostate or other prostate problems if you will be exposed to high temperatures for a long period of time if you take potassium chloride tablets or capsules

Some MEDICINES MAY INTERACT with AlleRx PE. Tell your health care provider if you are taking any other medicines, especially any of the following:

Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, linezolid, or MAOIs (eg, phenelzine) because the risk of high or low blood pressure may be increased Anticholinergics (eg, benztropine), carbonic anhydrase inhibitors (eg, acetazolamide), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of AlleRx PE's side effects Bromocriptine, hydantoins (eg, phenytoin), potassium chloride, or sodium oxybate (GHB) because the risk of their side effects may be increased by AlleRx PE Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by AlleRx PE

This may not be a complete list of all interactions that may occur. Ask your health care provider if AlleRx PE may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use AlleRx PE:

Use AlleRx PE as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take AlleRx PE by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. This product contains 2 different tablets: one for the morning and one for the evening. Be sure you understand how to take AlleRx PE. Check with your doctor or pharmacist if you are not sure which tablet to take in the morning or in the evening. Do not take an antacid or certain medicines for diarrhea 2 to 3 hours before or after you take AlleRx PE. If you miss a dose of AlleRx PE and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use AlleRx PE.

Important safety information: AlleRx PE may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use AlleRx PE with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using AlleRx PE; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. If your symptoms do not get better within 7 days or if they get worse or you develop a high fever or persistent headache, check with your doctor. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. AlleRx PE may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute. AlleRx PE may make your eyes more sensitive to sunlight. It may help to wear sunglasses. AlleRx PE may reduce sweating. Do not become overheated in hot weather or while you are being active; heatstroke may occur. Do not take diet or appetite control medicines while you are taking AlleRx PE without checking with your doctor. Before you start any new medicine, check the label to see if it has a decongestant, antihistamine, or anticholinergic in it too. If it does or if you are not sure, check with your doctor or pharmacist. If you have trouble sleeping, ask your doctor or pharmacist about the best time of the day to take AlleRx PE. AlleRx PE may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking AlleRx PE. AlleRx PE may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking AlleRx PE for a few days before the tests. Tell your doctor or dentist that you take AlleRx PE before you receive any medical or dental care, emergency care, or surgery. Use AlleRx PE with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating. Caution is advised when using AlleRx PE in CHILDREN; they may be more sensitive to its effects, especially excitability. AlleRx PE should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using AlleRx PE while you are pregnant. AlleRx PE is found in breast milk. Do not breast-feeding while taking AlleRx PE. Possible side effects of AlleRx PE:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; increased sweating; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; confusion; difficulty swallowing; difficulty urinating or inability to urinate; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mental or mood changes; seizures; severe dizziness, drowsiness, lightheadedness, or headache; shortness of breath; tremor; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: AlleRx PE side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include deep sleep or sleep loss of consciousness; fast or irregular heartbeat; hot or cool skin; large pupils; numbness or tingling in the arms or legs; seizures; severe irritability, anxiety, or panicked feeling; slowed or shallow breathing; vomiting.

Proper storage of AlleRx PE:

Store AlleRx PE at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep AlleRx PE out of the reach of children and away from pets.

General information: If you have any questions about AlleRx PE, please talk with your doctor, pharmacist, or other health care provider. AlleRx PE is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about AlleRx PE. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More AlleRx PE resources AlleRx PE Side Effects (in more detail) AlleRx PE Use in Pregnancy & Breastfeeding AlleRx PE Drug Interactions 0 Reviews for AlleRx PE - Add your own review/rating Compare AlleRx PE with other medications Nasal Congestion Rhinitis
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VisRx Sustained-Release Tablets


Pronunciation: SOO-doe-e-FED-rin/METH-skoe-POL-a-meen with KLOR-fen-IR-a-meen/METH-skoe-POL-a-meen
Generic Name: Pseudoephedrine/Methscopolamine
Brand Name: VisRx
VisRx Sustained-Release Tablets are used for:

Relieving congestion, sneezing, runny nose, and itchy, watery eyes caused by allergies or the common cold. It may also be used for other conditions as determined by your doctor.

VisRx Sustained-Release Tablets are a combination pack containing a morning dose and an evening dose. The morning dose has a decongestant and an anticholinergic medicine. The evening dose has an antihistamine and an anticholinergic medicine. The decongestant works by shrinking swollen tissue in the nose. The antihistamine works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. The anticholinergic works by drying mucous membranes in the nose and chest.

Do NOT use VisRx Sustained-Release Tablets if: you are allergic to any ingredient in VisRx Sustained-Release Tablets you are breast-feeding you are taking droxidopa, furazolidone, a phosphodiesterase inhibitor (eg, sildenafil), sodium oxybate (GHB), or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or if you have taken an MAOI within the past 14 days you have severe heart blood vessel problems, severe high blood pressure, narrow-angle glaucoma, difficulty urinating, or peptic ulcer you are having an asthma attack

Contact your doctor or health care provider right away if any of these apply to you.

Before using VisRx Sustained-Release Tablets:

Some medical conditions may interact with VisRx Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you are taking or have taken medicine for high blood pressure or depression in the last 14 days if you have a bladder blockage, an enlarged prostate, or trouble urinating if you have blood vessel problems (eg, hardening of the arteries), diabetes, glaucoma, heart problems (eg, irregular heartbeat, heart failure), high blood pressure, kidney problems, liver problems, lung or breathing problems (eg asthma, sleep apnea), a hiatal hernia, an adrenal gland tumor (pheochromocytoma), myasthenia gravis (muscle weakness), nerve problems (eg, neuropathy), stomach or bowel problems (eg, constipation, ulcerative colitis, motility problems, blockage), trouble sleeping, or an overactive thyroid if you have a history of alcohol abuse if you take potassium chloride tablets or capsules

Some MEDICINES MAY INTERACT with VisRx Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Droxidopa or sodium oxybate (GHB) because the risk of severe drowsiness, breathing problems, seizures, irregular heartbeat, or heart attack may be increased Alkalinizers (eg, sodium bicarbonate), anticholinergics (eg, benztropine, dicyclomine), antipsychotics (eg, chlorpromazine), beta-blockers (eg, propranolol), carbonic anhydrase inhibitors (eg, acetazolamide), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, MAOIs (eg, phenelzine), phosphodiesterase inhibitors (eg, sildenafil), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of VisRx Sustained-Release Tablets's side effects Bromocriptine or digoxin because the risk of their side effects may be increased by VisRx Sustained-Release Tablets Guanadrel, guanethidine, mecamylamine, methyldopa, reserpine, or other medicines for high blood pressure because their effectiveness may be decreased by VisRx Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if VisRx Sustained-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use VisRx Sustained-Release Tablets:

Use VisRx Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take VisRx Sustained-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Swallow VisRx Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing. This product contains 2 different tablets: one for the morning and one for the evening. Be sure you understand how to take VisRx Sustained-Release Tablets. Check with your doctor or pharmacist if you are not sure which tablet to take in the morning or in the evening. Do not take VisRx Sustained-Release Tablets at the same time as antacids, certain medicines for diarrhea (eg, kaolin, pectin, attapulgite, bismuth), or ketoconazole. Take these medicines 2 or 3 hours before or after taking VisRx Sustained-Release Tablets. If you miss a dose of VisRx Sustained-Release Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use VisRx Sustained-Release Tablets.

Important safety information: VisRx Sustained-Release Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use VisRx Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using VisRx Sustained-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. VisRx Sustained-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking VisRx Sustained-Release Tablets. VisRx Sustained-Release Tablets may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking VisRx Sustained-Release Tablets for a few days before the tests. VisRx Sustained-Release Tablets may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute. VisRx Sustained-Release Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses. VisRx Sustained-Release Tablets may reduce sweating. Do not become overheated in hot weather or while you are being active; heatstroke may occur. VisRx Sustained-Release Tablets contains the stimulant pseudoephedrine. Do not take diet or appetite control medicines while you are taking VisRx Sustained-Release Tablets without checking with your doctor. VisRx Sustained-Release Tablets has a decongestant and an antihistamine in it. Before you start any new medicine, check the label to see if it has a decongestant or an antihistamine in it too. If it does or if you are not sure, check with your doctor or pharmacist. Diabetes patients - VisRx Sustained-Release Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Use VisRx Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects. VisRx Sustained-Release Tablets should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: It is not known if VisRx Sustained-Release Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using VisRx Sustained-Release Tablets while you are pregnant. VisRx Sustained-Release Tablets are found in breast milk. Do not breast-feed while taking VisRx Sustained-Release Tablets.

When used for long periods of time, VisRx Sustained-Release Tablets may not work as well. This is known as TOLERANCE. Increasing the dose may cause toxic side effects to occur.

If you suddenly stop taking VisRx Sustained-Release Tablets, WITHDRAWAL symptoms, including worsening of congestion, may occur.

Possible side effects of VisRx Sustained-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; dizziness; drowsiness; dry mouth, nose, or throat; excitability or irritability (especially in children); headache; lack of energy; lightheadedness; nausea; nervousness; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast or irregular heartbeat; flushing; hallucinations; mental or mood changes (eg, anxiety); seizures; severe or persistent drowsiness or dizziness; tremor; trouble urinating; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: VisRx side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include deep sleep or loss of consciousness; hot or cool skin; fast or irregular heartbeat; large pupils; seizures; severe irritability, anxiety, or panicked feeling; slowed or shallow breathing; vomiting.

Proper storage of VisRx Sustained-Release Tablets:

Store VisRx Sustained-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep VisRx Sustained-Release Tablets out of the reach of children and away from pets.

General information: If you have any questions about VisRx Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider. VisRx Sustained-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about VisRx Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More VisRx resources VisRx Side Effects (in more detail) VisRx Use in Pregnancy & Breastfeeding VisRx Drug Interactions VisRx Support Group 2 Reviews for VisRx - Add your own review/rating Compare VisRx with other medications Hay Fever Nasal Congestion Sinus Symptoms
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Gonak


Generic Name: hypromellose (Ophthalmic route)

hye-PROE-me-lose

Commonly used brand name(s)

In the U.S.

Genteal Genteal Mild Gonak Goniosoft Goniovisc Isopto Tears Nature's Tears Tearisol Tears Again Mc

Available Dosage Forms:

Solution Gel/Jelly

Therapeutic Class: Surgical Aid, Ocular

Uses For Gonak

Hydroxypropyl methylcellulose belongs to the group of medicines known as artificial tears. It is used to relieve dryness and irritation caused by reduced tear flow. It helps prevent damage to the eye in certain eye diseases. Hydroxypropyl methylcellulose may also be used to moisten hard contact lenses and artificial eyes. In addition, it may be used in certain eye examinations.

Some of these preparations are available only with your doctor's prescription.

Before Using Gonak

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of hydroxypropyl methylcellulose in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicine have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of hydroxypropyl methylcellulose in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of hypromellose

This section provides information on the proper use of a number of products that contain hypromellose. It may not be specific to Gonak. Please read with care.

To use:

First, wash your hands. Then tilt the head back and pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed. To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

For patients wearing hard contact lenses:

Take care not to float the lens from your eye when applying this medicine. If you have any questions about this, check with your health care professional. Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For dry eyes: For ophthalmic solution (eye drops) dosage form: Adults and children—Use 1 drop three or four times a day. Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Gonak

If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if your symptoms continue for more than 3 days or become worse, check with your doctor.

Gonak Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Eye irritation not present before use of this medicine

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common - more common with 1% solution Blurred vision matting or stickiness of eyelashes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


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Genteal Mild


Generic Name: hypromellose (Ophthalmic route)

hye-PROE-me-lose

Commonly used brand name(s)

In the U.S.

Genteal Genteal Mild Gonak Goniosoft Goniovisc Isopto Tears Nature's Tears Tearisol Tears Again Mc

Available Dosage Forms:

Solution Gel/Jelly

Therapeutic Class: Surgical Aid, Ocular

Uses For Genteal Mild

Hydroxypropyl methylcellulose belongs to the group of medicines known as artificial tears. It is used to relieve dryness and irritation caused by reduced tear flow. It helps prevent damage to the eye in certain eye diseases. Hydroxypropyl methylcellulose may also be used to moisten hard contact lenses and artificial eyes. In addition, it may be used in certain eye examinations.

Some of these preparations are available only with your doctor's prescription.

Before Using Genteal Mild

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of hydroxypropyl methylcellulose in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicine have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of hydroxypropyl methylcellulose in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of hypromellose

This section provides information on the proper use of a number of products that contain hypromellose. It may not be specific to Genteal Mild. Please read with care.

To use:

First, wash your hands. Then tilt the head back and pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed. To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

For patients wearing hard contact lenses:

Take care not to float the lens from your eye when applying this medicine. If you have any questions about this, check with your health care professional. Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For dry eyes: For ophthalmic solution (eye drops) dosage form: Adults and children—Use 1 drop three or four times a day. Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Genteal Mild

If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if your symptoms continue for more than 3 days or become worse, check with your doctor.

Genteal Mild Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Eye irritation not present before use of this medicine

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common - more common with 1% solution Blurred vision matting or stickiness of eyelashes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


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AlleRx Dose Pack Sustained-Release Tablets


Pronunciation: SOO-doe-e-FED-rin/METH-skoe-POL-a-meen with FEN-il-EF-rin/KLOR-fen-IR-a-meen/METH-skoe-POL-a-meen
Generic Name: Pseudoephedrine/Methscopolamine
Brand Name: AlleRx Dose Pack
AlleRx Dose Pack Sustained-Release Tablets are used for:

Relieving congestion, sneezing, runny nose, and itchy, watery eyes caused by allergies. It may also be used for other conditions as determined by your doctor.

AlleRx Dose Pack Sustained-Release Tablets are a combination pack containing a morning dose and an evening dose. The morning dose has a decongestant and an anticholinergic medicine. The evening dose has a decongestant, an antihistamine, and an anticholinergic medicine. The decongestant works by shrinking swollen tissue in the nose. The antihistamine works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. The anticholinergic works by drying mucous membranes in the nose and chest.

Do NOT use AlleRx Dose Pack Sustained-Release Tablets if: you are allergic to any ingredient in AlleRx Dose Pack Sustained-Release Tablets you are breast-feeding you are taking droxidopa, furazolidone, a phosphodiesterase inhibitor (eg, sildenafil), sodium oxybate (GHB), or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or you have taken an MAOI within the past 14 days you have severe heart blood vessel problems, severe high blood pressure, narrow-angle glaucoma, difficulty urinating, peptic ulcer, or uncontrolled bleeding you are having an asthma attack

Contact your doctor or health care provider right away if any of these apply to you.

Before using AlleRx Dose Pack Sustained-Release Tablets:

Some medical conditions may interact with AlleRx Dose Pack Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you are taking or have taken medicine for high blood pressure or depression in the last 14 days if you have a bladder blockage, an enlarged prostate, or trouble urinating if you have blood vessel problems (eg, hardening of the arteries), diabetes, glaucoma or increased pressure in the eye, heart problems (eg, irregular heartbeat, heart failure), high blood pressure, kidney problems, liver problems, lung or breathing problems (eg asthma, sleep apnea), a hiatal hernia, an adrenal gland tumor (pheochromocytoma), myasthenia gravis (muscle weakness), nerve problems (eg, neuropathy), stomach or bowel problems (eg, constipation, ulcerative colitis, motility problems, blockage), trouble sleeping, or an overactive thyroid if you have a history of alcohol abuse if you take potassium chloride tablets

Some MEDICINES MAY INTERACT with AlleRx Dose Pack Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Droxidopa or sodium oxybate (GHB) because the risk of severe drowsiness, breathing problems, seizures, irregular heartbeat, or heart attack may be increased Alkalinizers (eg, sodium bicarbonate), anticholinergics (eg, benztropine, dicyclomine), antipsychotics (eg, chlorpromazine), beta-blockers (eg, propranolol), carbonic anhydrase inhibitors (eg, acetazolamide), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, MAOIs (eg, phenelzine), phosphodiesterase inhibitors (eg, sildenafil), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of AlleRx Dose Pack Sustained-Release Tablets's side effects Bromocriptine or digoxin because the risk of their side effects may be increased by AlleRx Dose Pack Sustained-Release Tablets Guanadrel, guanethidine, mecamylamine, methyldopa, reserpine, or other medicine for high blood pressure because their effectiveness may be decreased by AlleRx Dose Pack Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if AlleRx Dose Pack Sustained-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use AlleRx Dose Pack Sustained-Release Tablets:

Use AlleRx Dose Pack Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take AlleRx Dose Pack Sustained-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Swallow AlleRx Dose Pack Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing. This product contains 2 different tablets; one for the morning and one for the evening. Be sure you understand how to take AlleRx Dose Pack Sustained-Release Tablets. Check with your doctor or pharmacist if you are not sure which tablet to take in the morning or in the evening. Do not take AlleRx Dose Pack Sustained-Release Tablets at the same time as antacids, certain medicines for diarrhea (eg, kaolin, pectin, attapulgite, bismuth), or ketoconazole. Take these medicines 2 or 3 hours before or after taking AlleRx Dose Pack Sustained-Release Tablets. If you miss a dose of AlleRx Dose Pack Sustained-Release Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use AlleRx Dose Pack Sustained-Release Tablets.

Important safety information: AlleRx Dose Pack Sustained-Release Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use AlleRx Dose Pack Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using AlleRx Dose Pack Sustained-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. AlleRx Dose Pack Sustained-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking AlleRx Dose Pack Sustained-Release Tablets. AlleRx Dose Pack Sustained-Release Tablets may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking AlleRx Dose Pack Sustained-Release Tablets for a few days before the tests. AlleRx Dose Pack Sustained-Release Tablets may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute. AlleRx Dose Pack Sustained-Release Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses. AlleRx Dose Pack Sustained-Release Tablets may reduce sweating. Do not become overheated in hot weather or while you are being active; heatstroke may occur. AlleRx Dose Pack Sustained-Release Tablets contains the stimulants phenylephrine and pseudoephedrine. Do not take diet or appetite control medicines while you are taking AlleRx Dose Pack Sustained-Release Tablets without checking with your doctor. AlleRx Dose Pack Sustained-Release Tablets has pseudoephedrine, phenylephrine, and an antihistamine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine, phenylephrine, or an antihistamine in it too. If it does or if you are not sure, check with your doctor or pharmacist. Diabetes patients - AlleRx Dose Pack Sustained-Release Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Use AlleRx Dose Pack Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects. AlleRx Dose Pack Sustained-Release Tablets should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: It is not known if AlleRx Dose Pack Sustained-Release Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using AlleRx Dose Pack Sustained-Release Tablets while you are pregnant. AlleRx Dose Pack Sustained-Release Tablets are found in breast milk. Do not breast-feed while taking AlleRx Dose Pack Sustained-Release Tablets.

When used for long periods of time, AlleRx Dose Pack Sustained-Release Tablets may not work as well. This is known as TOLERANCE. Increasing the dose may cause toxic side effects to occur. If you suddenly stop taking AlleRx Dose Pack Sustained-Release Tablets, WITHDRAWAL symptoms, including worsening of congestion, may occur.

Possible side effects of AlleRx Dose Pack Sustained-Release Tablets:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; constipation; dizziness; drowsiness; dry mouth, nose, or throat; excitability or irritability (especially in children); giddiness; headache; lack of energy; lightheadedness; nausea; nervousness; trouble sleeping; unusual tiredness or weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast or irregular heartbeat; flushing; hallucinations; mental or mood changes; seizures; severe drowsiness or dizziness; tremor; trouble urinating; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: AlleRx Dose Pack side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include deep sleep or loss of consciousness; hot or cool skin; fast or irregular heartbeat; large pupils; seizures; severe irritability, anxiety, or panicked feeling; slowed or shallow breathing; vomiting.

Proper storage of AlleRx Dose Pack Sustained-Release Tablets:

Store AlleRx Dose Pack Sustained-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep AlleRx Dose Pack Sustained-Release Tablets out of the reach of children and away from pets.

General information: If you have any questions about AlleRx Dose Pack Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider. AlleRx Dose Pack Sustained-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about AlleRx Dose Pack Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More AlleRx Dose Pack resources AlleRx Dose Pack Side Effects (in more detail) AlleRx Dose Pack Use in Pregnancy & Breastfeeding AlleRx Dose Pack Drug Interactions AlleRx Dose Pack Support Group 0 Reviews for AlleRx Dose Pack - Add your own review/rating Compare AlleRx Dose Pack with other medications Cold Symptoms Hay Fever
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Naftidrofuryl Capsules 100mg


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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Tums Plus Chewable Tablets


Pronunciation: KAL-see-uhm/si-METH-i-kone
Generic Name: Calcium/Simethicone
Brand Name: Examples include Titralac Plus and Tums Plus
Tums Plus Chewable Tablets are used for:

Treating acid indigestion, heartburn, gas, and sour stomach. It may also be used for other conditions as determined by your doctor.

Tums Plus Chewable Tablets are an antacid and antiflatulent. It works by neutralizing acid in the stomach. It also helps to break up gas bubbles in the stomach, allowing it to be passed through the system more comfortably.

Do NOT use Tums Plus Chewable Tablets if: you are allergic to any ingredient in Tums Plus Chewable Tablets you are also taking citrate salts (found in some calcium supplements, antacids, and laxatives) you have a history of high blood calcium levels

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tums Plus Chewable Tablets:

Some medical conditions may interact with Tums Plus Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have Alzheimer disease, kidney problems, appendicitis, diarrhea, a stomach blockage, or an ileostomy if you have recently had stomach bleeding

Some MEDICINES MAY INTERACT with Tums Plus Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Cation exchange resins (eg, sodium polystyrene sulfonate) and citrate salts (found in some calcium supplements, antacids, and laxatives) because the actions and side effects of Tums Plus Chewable Tablets may be increased Anticoagulants (eg, warfarin), quinidine, or sulfonylureas (eg, glyburide) because the actions and side effects of these medicines may be increased Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), bisphosphonates (eg, risedronate), cephalosporins (eg, cephalexin), corticosteroids (eg, hydrocortisone), cyclosporine, delavirdine, digoxin, imidazoles (eg, ketoconazole), mycophenolate, penicillamine, quinolones (eg, ciprofloxacin), tetracyclines (eg, doxycycline), thyroid hormones (eg, levothyroxine), or verapamil because the effectiveness of these medicines may be decreased, especially when taken at the same time as Tums Plus Chewable Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tums Plus Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tums Plus Chewable Tablets:

Use Tums Plus Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Tums Plus Chewable Tablets may be taken with or without food. Chew thoroughly before swallowing. Drink a glass of water after swallowing. Do not use Tums Plus Chewable Tablets within 2 hours before or after taking a beta-blocker (eg, propranolol), bisphosphonate (eg, risedronate), cephalosporin (eg, cephalexin), corticosteroid (eg, hydrocortisone), delavirdine, digoxin, imidazole (eg, ketoconazole), penicillamine, or sulfonylurea (eg, glyburide) because Tums Plus Chewable Tablets may decrease the effectiveness of these medicines. If you miss a dose of Tums Plus Chewable Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tums Plus Chewable Tablets.

Important safety information: Do not exceed the recommended dose or use the maximum dose for more than 2 weeks without checking with your doctor. If your symptoms do not improve within 2 weeks or if they become worse, or if you experience black, tarry stools or vomit that looks like coffee grounds, check with your doctor. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Tums Plus Chewable Tablets, discuss with your doctor the benefits and risks of using Tums Plus Chewable Tablets during pregnancy. If you are or will be breast-feeding while you are using Tums Plus Chewable Tablets, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Tums Plus Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); loss of appetite; muscle weakness; nausea; slow reflexes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Tums Plus side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Tums Plus Chewable Tablets:

Store Tums Plus Chewable Tablets in a tightly closed container at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tums Plus Chewable Tablets out of the reach of children and away from pets.

General information: If you have any questions about Tums Plus Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider. Tums Plus Chewable Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Tums Plus Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Tums Plus resources Tums Plus Side Effects (in more detail)Tums Plus Use in Pregnancy & BreastfeedingTums Plus Drug InteractionsTums Plus Support Group0 Reviews for Tums Plus - Add your own review/rating Compare Tums Plus with other medications GERD
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