Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Warfarin sodium
Bristol Laboratories Ltd
B01AA03
Warfarin sodium
3mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02080200; GTIN: 5060013941740
Warfarin insert mock two SAME SIZE ARTWORK 420 x 136 MM Front XXXXXXX PACKAGE LEAFLET: INFORMATION FOR THE USER WARFARIN 1 MG, 3 MG OR 5 MG TABLETS Warfarin Sodium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any questions, ask your doctor or 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. • It is important to take the correct dose. If you have difficulty, ask someone to help you. If you take the wrong dose or too much, contact your doctor or pharmacist (see section 3). • Carry your warfarin record card with you at ALL times. Always tell any doctors, surgeons, nurses, dentists pharmacists that you are taking warfarin. • Warfarin can be affected by many other medicines including non prescription medicines, herbal remedies, vitamin and food supplements (see section 2 ‘OTHER MEDICINES AND WARFARIN TABLETS’). Do not start taking any new medicine without checking it is safe to take it with warfarin; especially aspirin, ibuprofen and other NSAIDS (non steroidal anti- inflammatory drugs), as these can make you more likely to bleed. • Some foods and illness can affect warfarin treatment. Follow the advice in section 2 ‘Things which affect warfarin’. • If you have any signs or symptoms of bleeding, contact a doctor straight away (See Section 4). • Seek medical help at once if you are unable to stop any bleeding, you fall, get hurt or hit your head. WHAT IS IN THIS LEAFLET: 1. What Warfarin Tablets are and what they are used for 2. What you need to know before you take Warfarin Tablets 3. How to take Warfarin Tablets 4. Possible Side Effects 5. How to store Warfarin tablets 6. Contents of the pack and other information 1. WHAT WARFARIN TABLETS ARE AND WHAT THEY ARE USED FOR Warfarin belongs to a group of medicines called anticoagulants. It is used to reduce the clotti Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Warfarin 3 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Warfarin Sodium 3 mg. Excipients with known effect: Each tablet contains 141.00 mg of lactose monohydrate and 8.00 mg of sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Blue coloured, circular, flat faced bevelled edged uncoated tablet with ‘3’ debossed on one side and ‘BL’ debossed 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 listed Прочетете целия документ