Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
PRASUGRELHYDROCHLORIDE SAMENSTELLING overeenkomend met ; PRASUGREL
Centrafarm B.V. Nieuwe Donk 3 4879 AC ETTEN LEUR
B01AC22
PRASUGRELHYDROCHLORIDE COMPOSITION corresponding to ; PRASUGREL
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; TITAANDIOXIDE (E 171)
Oraal gebruik
Prasugrel
2019-04-15
1 PACKAGE LEAFLET: INFORMATION FOR THE USER Prasugrel HCl CF 5 mg, filmomhulde tabletten Prasugrel HCl CF 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. Whatis and what it is used for 2. What you need to know before you take Lees het volledige document3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR , 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). inhibits the clumping of platelets and so reduces the chance of a blood clot forming. You have been prescribed 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 keep open
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Prasugrel HCl CF 5 mg, filmomhulde tabletten Prasugrel HCl CF 10 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg prasugrel (as hydrochloride). Excipient with known effect: Each tablet contains 1.21 mg lactose (as monohydrate). Each tablet contains 10 mg prasugrel (as hydrochloride). Excipient with known effect: Each tablet contains 2.42 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet).5 mg tablets are oval, biconvex, yellow film-coated tablets with a length of approximately 8.0 mm and a width of approximately 4.2 mm. Lees het volledige document10 mg tablets are oval, biconvex, beige film-coated tablets with a length of approximately 10.0 mm and a width of approximately 5.1 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prasugrel, 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 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 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, could result in an increased risk of thrombosis, myocardial infarction or death due to the patient’s underly