Страна: Малта
Език: английски
Източник: Medicines Authority
WARFARIN SODIUM
Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta
B01AA03
WARFARIN SODIUM 1 mg
TABLET
WARFARIN SODIUM 1 mg
POM
ANTITHROMBOTIC AGENTS
Authorised
2019-03-26
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT WARFARIN TABLETS 1MG, 3MG, 5 MG READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE - Keep the 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. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. • It is important to take the correct dose. If you have difficulty, ask someone to help you. If you take the wrong dose or take too much, contact your doctor or pharmacist (See Section 3). • Carry your warfarin record card with you ALL times. Always tell any doctors, surgeons, nurses, dentists or 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. ‘Taking other medicines’). 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 medicines), as these can make you more likely to bleed. • Some foods and illnesses 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 unable to stop any bleeding, you fall, get hurt or hit your head. IN THIS LEAFLET 1. WHAT WARFARIN TABLETS ARE IS 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 use Прочетете целия документ
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Warfarin Tablets 1 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1.0 mg of warfarin sodium Contains Lactose Contains Sucrose For excipients, see 6.1 3. PHARMACEUTICAL FORM Tablets Flat bevelled edged, brown tablets engraved with company logo on one side and with a breakline, and A338 on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of systemic embolism in rheumatic heart disease and atrial fibrillation. Prophylaxis and treatment of venous thrombosis and pulmonary embolism. Transient cerebral ischaemic attacks. Prophylaxis of thromboembolism after insertion of prosthetic heart valve. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION A baseline coagulation screen and liver function tests should be performed before initiating warfarin therapy. 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. If prothrombin time, reported as the international normalised ratio (INR), is excessively prolonged, the maintenance dose should be omitted. The INR should then be measured 1 – 2 days later to ensure that it is falling. Page 2 of 11 In emergencies, anticoagulant therapy should be initiated with heparin and warfarin together. Where there is less urgency, as in patients disposed to or at special risk of thromboembolism, anticoagulant therapy may be initiated with warfarin alone. 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 Прочетете целия документ