País: Países Bajos
Idioma: neerlandés
Fuente: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
PRASUGRELHYDROBROMIDE SAMENSTELLING overeenkomend met ; PRASUGREL
Sigillata Limited Block A, 15 Castleforbes Square, Sheriff Street DUBLIN 1 (IERLAND)
B01AC22
PRASUGRELHYDROBROMIDE COMPOSITION corresponding to ; PRASUGREL
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; GLYCEROLDIBEHENAAT ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 3350 ; MANNITOL (D-) (E 421) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SUCROSESTEARAAT (E 473) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Prasugrel
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); GLYCEROLDIBEHENAAT; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); MACROGOL 3350; MANNITOL (D-) (E 421); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); SUCROSESTEARAAT (E 473); TALK (E 553 B); TITAANDIOXIDE (E 171);
2018-04-25
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DRULLUB 5 MG FILMOMHULDE TABLETTEN DRULLUB 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 Drullub is and what it is used for 2. What you need to know before you take Drullub 3. How to take Drullub 4. Possible side effects 5. How to store Drullub 6. Contents of the pack and other information 1. WHAT DRULLUB IS AND WHAT IT IS USED FOR Drullub, which contains the active substance prasugrel, belongs to a group of medicines called anti- platelet 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). Drullub inhibits the clumping of platelets and so reduces the chance of a blood clot forming. You have been prescribed Drullub 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 a blocked or narrowed artery supplying blood to the heart. Drullub reduces the cha Leer el documento completo
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Drullub 5 mg filmomhulde tabletten Drullub 10 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _5 mg:_ Each film-coated tablet contains 5 mg prasugrel (as hydrobromide). Excipient with known effect: Each film-coated tablet contains 2.75 mg sucrose stearate which contains 0.11 mg sucrose. _10 mg:_ Each film-coated tablet contains 10 mg prasugrel (as hydrobromide). Excipient with known effect: Each film-coated tablet contains 5.5 mg sucrose stearate which contains 0.22 mg sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. _5 mg:_ Yellow, oval film-coated tablets, debossed with "P5" on one side and plain on the other side of the tablet. Dimensions: approx. 9 x 4 mm. _10 mg:_ Beige, oval film-coated tablets, debossed with "P10" on one side and a score line on the other side of the tablet. Dimensions: approx. 11 x 6 mm. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Drullub, 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 _ Drullub 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 Drullub 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 Dr Leer el documento completo