Country: Malta
Language: English
Source: Medicines Authority
WARFARIN SODIUM
Mercury Pharma Group Limited No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, United Kingdom
B01AA03
WARFARIN SODIUM 3 mg
TABLET
WARFARIN SODIUM 3 mg
POM
ANTITHROMBOTIC AGENTS
Withdrawn
2006-08-11
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Marevan 3mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 3mg warfarin sodium BP Excipients with known effect: Lactose: contains 94.500 mg lactose per tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Blue coloured, flat, circular, bevel-edged uncoated tablets having ‘M’ breakline ‘3’ on one side and plain on other side. 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 10mg daily for 2 days but this should be tailored to individual requirements. The daily maintenance dose is usually 3 to 9mg 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. Page 2 of 14 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. _Paediatric population_:_ _ Dosage for children has not been established. Method of administration: Oral. 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Haemorrhagic stroke (see section 4.4 for further details) • Clinically significant bleeding • Within 72 hours of major surgery with risk of severe Read the complete document