国家: 荷兰
语言: 荷兰文
来源: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
AMLODIPINEBESILAAT 13,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 10 mg/stuk ; HYDROCHLOORTHIAZIDE 12,5 mg/stuk ; OLMESARTANMEDOXOMIL 40 mg/stuk
Menarini International Operations Luxembourg S.A. 1,Avenue de la Gare L-1611 LUXEMBURG (LUXEMBURG)
C09DX03
AMLODIPINEBESILAAT 13,9 mg/stuk SAMENSTELLING overeenkomend met ; AMLODIPINE 10 mg/stuk ; HYDROCHLOORTHIAZIDE 12,5 mg/stuk ; OLMESARTANMEDOXOMIL 40 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYVINYLALCOHOL (E 1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYVINYLALCOHOL (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Olmesartan medoxomil, amlodipine and hydrochlorothiazide
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POLYVINYLALCOHOL (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER NISTIK 20 MG/5 MG/12,5 MG FILMOMHULDE TABLETTEN NISTIK 40 MG/5 MG/12,5 MG FILMOMHULDE TABLETTEN NISTIK 40 MG/10 MG/12,5 MG FILMOMHULDE TABLETTEN NISTIK 40 MG/5 MG/25 MG FILMOMHULDE TABLETTEN NISTIK 40 MG/10 MG/25 MG FILMOMHULDE TABLETTEN OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE 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 Nistik is and what it is used for 2. What you need to know before you take Nistik 3. How to take Nistik 4. Possible side effects 5. How to store Nistik 6. Contents of the pack and other information 1. WHAT NISTIK IS AND WHAT IT IS USED FOR Nistik contains three active substances called olmesartan medoxomil, amlodipine (as amlodipine besilate) and hydrochlorothiazide. All three substances help to control high blood pressure. • Olmesartan medoxomil belongs to a group of medicines called “angiotensin-II receptor antagonists”, which lowers blood pressure by relaxing the blood vessels. • Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine also lowers blood pressure by relaxing blood vessels. • Hydrochlorothiazide is one of a group of medicines called thiazide diuretics (“water tablets”). It lowers blood pressure by helping the body to get rid of extra fluid by making your kidneys produce more urine. The actions of these substances contribute to decrease your blood pressure. Nistik is used for the treatment of high blood pressure: • in adult patients whose blood 阅读完整的文件
1 SAMENVATTING VAN DE PRODUCTKENMERKEN 1. NAAM VAN HET GENEESMIDDEL Nistik 20 mg/5 mg/12,5 mg filmomhulde tabletten Nistik 40 mg/5 mg/12,5 mg filmomhulde tabletten Nistik 40 mg/10 mg/12,5 mg filmomhulde tabletten Nistik 40 mg/5 mg/25 mg filmomhulde tabletten Nistik 40 mg/10 mg/25 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Nistik 20 mg/5 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 20 mg olmesartan medoxomil, 5 mg amlodipine (as amlodipine besilate) and 12.5 mg hydrochlorothiazide. Nistik 40 mg/5 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 40 mg olmesartan medoxomil, 5 mg amlodipine (as amlodipine besilate) and 12.5 mg hydrochlorothiazide. Nistik 40 mg/10 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 40 mg olmesartan medoxomil, 10 mg amlodipine (as amlodipine besilate) and 12.5 mg hydrochlorothiazide. Nistik 40 mg/5 mg/25 mg film-coated tablets: Each film-coated tablet contains 40 mg olmesartan medoxomil, 5 mg amlodipine (as amlodipine besilate) and 25 mg hydrochlorothiazide. Nistik 40 mg/10 mg/25 mg film-coated tablets: Each film-coated tablet contains 40 mg olmesartan medoxomil, 10 mg amlodipine (as amlodipine besilate) and 25 mg hydrochlorothiazide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Nistik 20 mg/5 mg/12.5 mg film-coated tablets: Light orange, round, film-coated tablet of 8 mm debossed C51 on one side. Nistik 40 mg/5 mg/12.5 mg film-coated tablets: Light yellow, round, film-coated tablet of 9.5 mm debossed C53 on one side. Nistik 40 mg/10 mg/12.5 mg film-coated tablets: Greyish red, round, film-coated tablet of 9.5 mm debossed C55 on one side. Nistik 40 mg/5 mg/25 mg film-coated tablets: Light yellow, oval, film-coated tablet of 15 x 7 mm debossed C54 on one side. Nistik 40 mg/10 mg/25 mg film-coated tablets: Greyish red, oval, film-coated tablet of 15 x 7 mm debossed C57 on one side. 2 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertens 阅读完整的文件