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Withdrawn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 7 PACKAGE LEAFLET CLOPIDOGREL 75 MG FILM-COATED TABLETS PACKAGE LEAFLET: INFORMATION FOR THE USER Clopval 75 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, tlk to your doctor or pharmacist. See section 4. In this leaflet: 1. What Clopval is and what it is used for 2. What you need to know before you take Clopval 3. How to take Clopval 4. Possible side effects 5. How to store Clopval 6. Contents of the pack and other information. 1. WHAT Clopval IS AND WHAT IT IS USED FOR Clopval contains 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). Clopval is 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 Clopval to help prevent blood clots and reduce Leggi il documento completo
PAGE 1 OF 17 SUMMARY OF PRODUCT CHARACTERISTICS CLOPIDOGREL 75 MG FILM-COATED TABLETS 1. NAME OF THE MEDICINAL PRODUCT Clopval 75 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 and 4.8 mg hydrogenated castor oil The full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White, round, bioconvex film coated tablet, 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 adults for the prevention of atherothrombotic events in: 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. 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. For further information please refer to section 5.1. PAGE 2 OF 17 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults and older people Clopidogrel should be given as a single dose of 75 mg. In patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q- wave myocardial in Leggi il documento completo