Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
WARFARIN SODIUM CLATHRATE
Taro Pharmaceuticals UK Ltd.
0.5 Milligram
Tablets
2008-07-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Warfarin Teva 0.5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains warfarin sodium clathrate equivalent to 0.5mg warfarin sodium. For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Oblong, flat, white tablet with ‘WARFARIN’ engraved on one side and ‘TARO 0.5’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of venous thrombosis and pulmonary embolism, and for use in the treatment of these conditions to prevent their extension. Prophylaxis of systemic embolisation in patients with rheumatic heart disease and atrial fibrillation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Warfarin Tablets are for oral administration. Adults: The usual induction dose of warfarin is 10mg daily for 2 days, but this should be tailored to individual requirements. A baseline coagulation screen and liver function tests should be performed before initiating warfarin therapy. Subsequent daily doses should be adjusted according to the results of the prothrombin time, usually reported as the INR (international normalised ratio). The daily maintenance dose of warfarin is usually in the range 3 to 9mg, taken at the same time each day. The maintenance dose is omitted if the INR is excessively high. Elderly patients: The elderly are generally more sensitive to the effects of warfarin and often require a smaller dose on a weight-for-weight basis than younger patients. Children: The safety and efficacy of warfarin in children have not been established. 4.3 CONTRAINDICATIONS Pregnancy (see section 4.6 Pregnancy and lactation). Warfarin should not be given within 3 days of surgery. Known hypersensitivity to warfarin or to any of the excipients. Use of herbal prepa Read the complete document