Nazione: Malta
Lingua: inglese
Fonte: Medicines Authority
CLOPIDOGREL
Vale Pharmaceuticals Limited 3 Anglesea Street, Clonmel, Co. Tipperary, E91 D6C5, Ireland
B01AC04
CLOPIDOGREL 75 mg
FILM-COATED TABLET
CLOPIDOGREL 75 mg
POM
ANTITHROMBOTIC AGENTS
Withdrawn
2011-02-24
PAGE 1 OF 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CLOPIDOGREL VALE PHARMACEUTICALS75 MG FILM-COATED TABLETS (CLOPIDOGREL) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you have any side effects, including any side effects not listed in this leaflet, talk to your doctor or pharmacist. See section 4. What is in this leaflet: 1. What Clopidogrel Vale Pharmaceuticals is and what it is used for 2. What you need to know before you take Clopidogrel Vale Pharmaceuticals 3. How to take Clopidogrel Vale Pharmaceuticals 4. Possible side effects 5. How to store Clopidogrel Vale Pharmaceuticals 6. Contents of the pack and other information. 1. WHAT CLOPIDOGREL VALE PHARMACEUTICALSIS AND WHAT IT IS USED FOR Clopidogrel Vale Pharmaceuticalscontains clopidogrel and belongs to a group of medicines called antiplatelet medicines. Platelets are very small structures in the blood, smaller than red or white blood cells, which clump together during blood clotting. By preventing this clumping, antiplatelet medicines reduce the chances of blood clots forming (a process called thrombosis). Clopidogrel Vale Pharmaceuticalsis taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack or death). You have been prescribed Clopidogrel Vale Pharmaceuticalsto help prevent blood clots and reduce the risk of these severe events because: - You have a condition of hardening of arteries (also known as atherosclerosis), and - You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or - You have exper Leggi il documento completo
PAGE 1 OF 17 SUMMARY OF PRODUCT CHARACTERISTICS PAGE 2 OF 17 1. NAME OF THE MEDICINAL PRODUCT Clopidogrel Vale Pharmaceuticals75 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrobromide monohydrate). Excipients with known effect: Each tablet contains 2 mg lactose monohydrate and 4.8 mg hydrogenated castor oil The full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White, round, biconvex film coated tablet approximately 8.6 mm in diameter, debossed with ‘CB’ over ‘75’ on one side and ‘G’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Prevention of atherothrombotic events _ _ _ Clopidogrel is indicated in: • Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. • Adult patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). - ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy. _Prevention of atherothrombotic and thromboembolic events in atrial fibrillation _ In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke. For further information please refer to section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults and Elderly people Clopidogrel should be given as a single daily dose of 75 mg PAGE 3 OF 17 In patients suffering f Leggi il documento completo