Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Acetylsalicylic acid, clopidogrel hydrogen sulfate
Mylan Pharmaceuticals Limited
B01AC30
clopidogrel, acetylsalicylic acid
Antithrombotic agents
Acute Coronary Syndrome; Myocardial Infarction
Clopidogrel/Acetylsalicylic acid Mylan is indicated for the secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA).Clopidogrel/Acetylsalicylic acid Mylan 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 interventionST segment elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy
Revision: 5
Authorised
2020-01-09
44 B. PACKAGE LEAFLET 45 Package leaflet: Information for the patient Clopidogrel/Acetylsalicylic acid Viatris 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Viatris 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 Clopidogrel/Acetylsalicylic acid Viatris is and what it is used for 2. What you need to know before you take Clopidogrel/Acetylsalicylic acid Viatris 3. How to take Clopidogrel/Acetylsalicylic acid Viatris 4. Possible side effects 5. How to store Clopidogrel/Acetylsalicylic acid Viatris 6. Contents of the pack and other information 1. What Clopidogrel/Acetylsalicylic acid Viatris is and what it is used for Clopidogrel/Acetylsalicylic acid Viatris 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). Clopidogrel/Acetylsalicylic acid Viatris 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 Clopidogrel/Acetylsalicylic acid Viatris in place of the two separate medicines, clopidogrel and ASA, to help prevent blood clots because Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Clopidogrel/Acetylsalicylic acid Viatris 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Viatris 75 mg/100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Clopidogrel/Acetylsalicylic acid Viatris 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 48 mg of lactose. Clopidogrel/Acetylsalicylic acid Viatris 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 48 mg of lactose and 0.81 mg Allura Red AC. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film coated tablet (tablet) Clopidogrel/Acetylsalicylic acid Viatris 75 mg/75 mg film-coated tablets Yellow, oval shaped, biconvex, film-coated tablets, approximately 14.5 mm x 7.4 mm debossed with “CA2” on one side of the tablet and “M” on the other side. Clopidogrel/Acetylsalicylic acid Viatris 75 mg/100 mg film-coated tablets Pink, oval shaped, biconvex, film-coated tablets, approximately 14.8 mm x 7.8 mm debossed with “CA3” on one side of the tablet and “M” on the other side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Clopidogrel/Acetylsalicylic acid Viatris is indicated for the secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). Clopidogrel/Acetylsalicylic acid Viatris 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) 3 • ST segment elevation acute myocardial infarction (STEMI) in Read the complete document