Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
prasugrel besilate
Mylan Pharmaceuticals Limited
B01AC22
prasugrel
Antithrombotic agents
Myocardial Infarction; Acute Coronary Syndrome; Angina, Unstable
Prasugrel Mylan, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (i.e. unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).
Revision: 8
Authorised
2018-05-15
37/44 B. PACKAGE LEAFLET 38/44 PACKAGE LEAFLET: INFORMATION FOR THE USER PRASUGREL VIATRIS 5 MG FILM-COATED TABLETS PRASUGREL VIATRIS 10 MG FILM-COATED TABLETS prasugrel 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 Prasugrel Viatris is and what it is used for 2. What you need to know before you take Prasugrel Viatris 3. How to take Prasugrel Viatris 4. Possible side effects 5. How to store Prasugrel Viatris 6. Contents of the pack and other information 1. WHAT PRASUGREL VIATRIS IS AND WHAT IT IS USED FOR Prasugrel Viatris, which contains the active substance prasugrel, belongs to a group of medicines called antiplatelet agents. Platelets are very small cell particles that circulate in the blood. When a blood vessel is damaged, for example if it is cut, platelets clump together to help form a blood clot (thrombus). Therefore, platelets are essential to help stop bleeding. If clots form within a hardened blood vessel such as an artery they can be very dangerous as they can cut off the blood supply, causing a heart attack (myocardial infarction), stroke or death. Clots in arteries supplying blood to the heart may also reduce the blood supply, causing unstable angina (a severe chest pain). Prasugrel Viatris inhibits the clumping of platelets and so reduces the chance of a blood clot forming. You have been prescribed Prasugrel Viatris because you have already had a heart attack or unstable angina and you have been treated with a procedure to open blocked arteries in the heart. You may also Læs hele dokumentet
1/44 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2/44 1. NAME OF THE MEDICINAL PRODUCT Prasugrel Viatris 5 mg film-coated tablets Prasugrel Viatris 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Prasugrel Viatris 5 mg _ _ Each tablet contains prasugrel besilate equivalent to 5 mg prasugrel. Prasugrel Viatris 10 mg _ _ Each tablet contains prasugrel besilate equivalent to 10 mg prasugrel. Excipient with known effect Each tablet contains 0.016 mg of sunset yellow FCF aluminium lake (E110). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Prasugrel Viatris 5 mg Yellow film-coated, capsule shaped, biconvex tablet, of dimensions 8.15 mm × 4.15 mm, debossed with ‘PH3’ on one side and ‘M’ on the other side. Prasugrel Viatris 10 mg Beige film-coated, capsule shaped, biconvex tablet, of dimensions 11.15 mm × 5.15 mm, debossed with ‘PH4’ on one side and ‘M’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prasugrel Viatris, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (i.e. unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI). For further information please refer to section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ Prasugrel Viatris should be initiated with a single 60 mg loading dose and then continued at 10 mg once a day. In UA/NSTEMI patients, where coronary angiography is performed within 48 hours after 3/44 admission, the loading dose should only be given at the time of PCI (see sections 4.4, 4.8 and 5.1). Patients taking Prasugrel Viatris should also take ASA daily (75 mg to 325 mg). In patients with acute coronary syndrome (ACS) who are managed with PCI, premature discontinuation of any antiplatelet agent, including Prasugrel Viatris, Læs hele dokumentet