Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Warfarin sodium
Sandoz Ltd
B01AA03
Warfarin sodium
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02080200
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Warfarin 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Warfarin Sodium 5 mg. Excipients with known effect: Each tablet contains 139.00 mg of lactose monohydrate and 8.00 mg of sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Pink coloured, circular, flat faced bevelled edged uncoated tablet with ‘5’ embossing on one side and ‘BL’ embossing on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of systemic embolism in patients with rheumatic heart disease and atrial fibrillation. Prophylaxis after insertion of prosthetic heart valves. Prophylaxis and treatment of venous thrombosis and pulmonary embolism. Transient attacks of cerebral ischaemia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults: The typical induction dose is 10 mg daily for 2 days but this should be tailored to individual requirements. The daily maintenance dose is usually 3 to 9 mg taken at the same time each day. The exact maintenance dose depends on the prothrombin time or other appropriate coagulation tests. Control tests should be made at regular intervals and the maintenance dose should be adjusted according to the results obtained. Once the maintenance dose is established, it is rarely necessary to alter it. In emergencies, anticoagulant therapy should be initiated with heparin and Warfarin together. Concomitant therapy with heparin affects the results of control tests, and should be discontinued at least six hours before the first test is carried out. Elderly: As for adults, but dosage may need to be lowered. The elderly are generally more sensitive to the effects of warfarin and often require a smaller dose. Paediatric population: Warfarin Tablets are not recommended for use in children due to insufficient data on safety and efficacy. Method of administration Oral. 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substance(s) or to any of the excipients liste Læs hele dokumentet