Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
CLOPIDOGREL BESILATE
Pensa Pharma AB
CLOPIDOGREL BESILATE
75 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER CLOPIDOGREL PENSA 75 MG FILM-COATED TABLETS Clopidogrel 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 further questions, ask your doctor, pharmacist or nurse. - 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 get any of the side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1.What Clopidogrel Pensa is and what it is used for 2. What you need to know before you take Clopidogrel Pensa 3.How to take Clopidogrel Pensa 4.Possible side effects 5.How to store Clopidogrel Pensa 6. Contents of the pack and other information 1. WHAT CLOPIDOGREL PENSA IS AND WHAT IT IS USED FOR Clopidogrel Pensa belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood which clump together during blood clotting. By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis). Clopidogrel Pensa is taken 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 Pensa to help prevent blood clots and reduce the risk of these severe events because: - you have a condition of hardening of arteries (also known as artherosclerosis), and - you have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or - you have experienced a severe type of chest pain known as Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clopidogrel Pensa 75 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as clopidogrel besilate). Excipient with known effect: each tablet contains 2.80 mg of lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Pink, round, biconvex, film-coated tablets with '75' embossed on one side and a diameter of approximately 8.3 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and elderly_ Clopidogrel should be given as a single daily 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 infarction): clopidogrel treatment should be initiated with a single 300-mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg-325 mg daily). Since higher Lesen Sie das vollständige Dokument