Land: Den europeiske union
Språk: engelsk
Kilde: EMA (European Medicines Agency)
clopidogrel, Acetylsalicylic acid
Sanofi Winthrop Industrie
B01AC30
clopidogrel, acetylsalicylic acid
Antithrombotic agents
Acute Coronary Syndrome; Myocardial Infarction
DuoPlavin is indicated for the secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). DuoPlavin is a fixed-dose combination medicinal product for continuation of therapy in: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 (PCI);ST segment elevation acute myocardial infarction (STEMI) in patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy.For further information please refer to section 5.1.
Revision: 30
Authorised
2010-03-14
41 B. PACKAGE LEAFLET 42 PACKAGE LEAFLET: INFORMATION FOR THE USER DUOPLAVIN 75 MG/75 MG FILM-COATED TABLETS DUOPLAVIN 75 MG/100 MG FILM-COATED TABLETS clopidogrel/acetylsalicylic acid 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What DuoPlavin is and what it is used for 2. What you need to know before you take DuoPlavin 3. How to take DuoPlavin 4. Possible side effects 5 How to store DuoPlavin 6. Contents of the pack and other information 1. WHAT DUOPLAVIN IS AND WHAT IT IS USED FOR DuoPlavin contains clopidogrel and acetylsalicylic acid (ASA) and 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 in some types of blood vessels (called arteries), antiplatelet medicinal products reduce the chances of blood clots forming (a process called atherothrombosis). DuoPlavin is taken by adults to prevent blood clots forming in hardened arteries which can lead to atherothrombotic events (such as stroke, heart attack, or death). You have been prescribed DuoPlavin in place of the two separate medicines, clopidogrel and ASA, to help prevent blood clots because you have experienced a severe type of chest pain known as ‘unstable angina’ or heart attack (myocardial infarction). For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DUOPLAV Les hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT DuoPlavin 75 mg/75 mg film-coated tablets DuoPlavin 75 mg/100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DuoPlavin 75 mg/75 mg film-coated tablets Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid (ASA). _Excipients with known effect: _ Each film-coated tablet contains 7 mg of lactose and 3.3 mg of hydrogenated castor oil. DuoPlavin 75 mg/100 mg film-coated tablets Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid (ASA). _Excipients with known effect: _ Each film-coated tablet contains 8 mg of lactose and 3.3 mg of hydrogenated castor oil. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). DuoPlavin 75 mg/75 mg film-coated tablets Yellow, oval, slightly biconvex, engraved with «C75» on one side and «A75» on the other side. DuoPlavin 75 mg/100 mg film-coated tablets Light pink, oval, slightly biconvex, engraved with «C75» on one side and «A100» on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DuoPlavin is indicated for the secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). DuoPlavin is a fixed-dose combination medicinal product for continuation of therapy in: • 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 (PCI) • ST segment elevation acute myocardial infarction (STEMI) in patients undergoing PCI (including patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/ fibrinolytic therapy For further information please refer to section 5.1. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and elderly _ DuoPlavin 75 mg/75 mg film-coated ta Les hele dokumentet