Land: Israel
Språk: engelsk
Kilde: Ministry of Health
WARFARIN SODIUM
TARO PHARMACEUTICAL INDUSTRIES LTD
B01AA03
TABLETS
WARFARIN SODIUM 1 MG
PER OS
Required
TARO PHARMACEUTICAL INDUSTRIES LTD
WARFARIN
WARFARIN
Coumadin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, and pulmonary embolism. Coumadin is indicated for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement. Coumadin is indicated to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
2023-06-30
Page 1 of 7 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only COUMADIN 1 MG TABLETS COUMADIN 2 MG TABLETS Active ingredient and its quantity: Active ingredient and its quantity: Each tablet contains: Each tablet contains: warfarin sodium 1 mg warfarin sodium 2 mg COUMADIN 2.5 MG TABLETS COUMADIN 5 MG TABLETS Active ingredient and its quantity: Active ingredient and its quantity: Each tablet contains: Each tablet contains: warfarin sodium 2.5 mg warfarin sodium 5 mg Inactive ingredients and allergens: see section 2 under ‘Important information about some of this medicine’s ingredients’ and section 6, ‘Additional information'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Prophylaxis and treatment of thrombosis. THERAPEUTIC GROUP: Anticoagulants, vitamin K antagonists. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient (warfarin sodium) or to any of the other ingredients in this medicine (listed in section 6). • You are pregnant, may become pregnant or gave birth within the last 48 hours. • You have or have ever had any bleeding problems. • You recently had a stroke caused by bleeding in the brain. • You had surgery within the last 72 hours or are going to have surgery within the next 72 hours. • You are taking non-steroidal anti-inflammatory drugs (NSAIDs), aspirin or anticoagulants, since using them in combination with Coumadin may increase the risk of bleeding (see section ‘Drug interactions’). If any of these conditions applies to you, do not take this medicine and go back Les hele dokumentet
Page 1 of 13 PRESCRIBING INFORMATION COUMADIN TABLETS 1. NAME OF THE MEDICINAL PRODUCT COUMADIN 1 mg COUMADIN 2 mg COUMADIN 2.5 mg COUMADIN 5 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Coumadin 1 mg contains 1 mg warfarin sodium. Each tablet of Coumadin 2 mg contains 2 mg warfarin sodium. Each tablet of Coumadin 2.5 mg contains 2.5 mg warfarin sodium. Each tablet of Coumadin 5 mg contains 5 mg warfarin sodium. Excipients with known effect: Lactose: Each tablet contains 196.5-198.6 mg lactose per tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. Presentation: COUMADIN 1 mg tablets are pink, flat capsule shaped, beveled tablets, one side engraved with “WARFARIN” and "TARO", and other side scored and engraved with “1”. COUMADIN 2 mg tablets are lavender, flat capsule shaped, beveled tablets, one side engraved with “WARFARIN” and "TARO", and other side scored and engraved with “2”. COUMADIN 2.5 mg tablets are green, flat capsule shaped, beveled tablets, one side engraved with “WARFARIN” and "TARO", and other side scored and engraved with “2½”. COUMADIN 5 mg tablets are peach, flat capsule shaped, beveled tablets, one side engraved with “WARFARIN” and "TARO", and other side scored and engraved with “5”. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS COUMADIN is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, and pulmonary embolism. COUMADIN is indicated for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement. COUMADIN is indicated to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction. Page 2 of 13 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage and administration of COUMADIN must be individualized for each patient according to the particular patient's Les hele dokumentet