Land: Nederländerna
Språk: nederländska
Källa: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
PRASUGRELBESILAAT SAMENSTELLING overeenkomend met ; PRASUGREL
Aristo Pharma GmbH Wallenroder Strasse 8-10 13435 BERLIJN (DUITSLAND)
B01AC22
PRASUGRELBESILAAT COMPOSITION corresponding to ; PRASUGREL
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT (E 487) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
Prasugrel
2018-08-13
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PRASUGREL ARISTO 5 MG, FILMOMHULDE TABLETTEN PRASUGREL ARISTO 10 MG, FILMOMHULDE TABLETTEN 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 Aristo is and what it is used for 2. What you need to know before you take Prasugrel Aristo 3. How to take Prasugrel Aristo 4. Possible side effects 5. How to store Prasugrel Aristo 6. Contents of the pack and other information 1. WHAT PRASUGREL ARISTO IS AND WHAT IT IS USED FOR Prasugrel Aristo, 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 Aristo inhibits the clumping of platelets and so reduces the chance of a blood clot forming. You have been prescribed Prasugrel Aristo 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 have had one or more stents placed to ke Läs hela dokumentet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Prasugrel Aristo 5 mg, filmomhulde tabletten Prasugrel Aristo 10 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Prasugrel Aristo 5 mg film-coated tablets Each tablet contains 5 mg prasugrel (as besylate). Excipient with known effect: This medicine contains less than 1 mmol sodium (23 mg) per tablet. Prasugrel Aristo 10 mg film-coated tablets Each tablet contains 10 mg prasugrel (as besylate). Excipient with known effect: This medicine contains less than 1 mmol sodium (23 mg) per tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Prasugrel Aristo 5 mg film-coated tablets Yellow double-arrow shaped tablets, debossed with “5” on one side, 9.81±0.1mm in length, 4.61±0.1mm in width, 2.5±0.3mm in thickness. Prasugrel Aristo 10 mg film-coated tablets Dark-beige double-arrow shaped tablets, debossed with “10 ” on one side, 11.02±0.1mm in length, 5.20±0.1mm in width, 3.95±0.4mm in thickness. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prasugrel Aristo, 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 Aristo 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 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 Aristo should also take ASA daily (75 mg to 325 mg). 2 In patients with acute coronary syndrome (ACS) who are managed with P Läs hela dokumentet