国家: 荷兰
语言: 荷兰文
来源: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ATORVASTATINE CALCIUM 3-WATER 10,8 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 10 mg/stuk ; EZETIMIB 10 mg/stuk
ATORVASTATINE CALCIUM 3-WATER 10,8 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 10 mg/stuk ; EZETIMIB 10 mg/stuk
Filmomhulde tablet
CALCIUMCARBONAAT (E 170) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171), CALCIUMCARBONAAT (E 170) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171)
Oraal gebruik
1900-01-01
PACKAGE LEAFLET: INFORMATION FOR THE USER EZETIMIBE/ATORVASTATINE STADA ARZNEIMITTEL AG 10 MG/10 MG FILMOMHULDE TABLETTEN EZETIMIBE/ATORVASTATINE STADA ARZNEIMITTEL AG 10 MG/20 MG FILMOMHULDE TABLETTEN EZETIMIBE/ATORVASTATINE STADA ARZNEIMITTEL AG 10 MG/40 MG FILMOMHULDE TABLETTEN EZETIMIBE/ATORVASTATINE STADA ARZNEIMITTEL AG 10 MG/80 MG FILMOMHULDE TABLETTEN ezetimibe and atorvastatin 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 阅读完整的文件3. 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 is a medicine to lower increased levels of cholesterol. contains ezetimibe and atorvastatin. is used in adults to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, raises levels of “good” cholesterol (HDL cholesterol). works to reduce your cholesterol in two ways. It reduces the cholesterol absorbed in your digestive tract, as well as the cholesterol your body makes by itself. Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol. LDL cholesterol is often called “bad” cholesterol because it can build up in the walls of your
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ezetimibe/Atorvastatine STADA Arzneimittel AG 10 mg/10 mg filmomhulde tabletten Ezetimibe/Atorvastatine STADA Arzneimittel AG 10 mg/20 mg filmomhulde tabletten Ezetimibe/Atorvastatine STADA Arzneimittel AG 10 mg/40 mg filmomhulde tabletten Ezetimibe/Atorvastatine STADA Arzneimittel AG 10 mg/80 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION10 mg / 10 mg film-coated tablets Each tablet contains 10 mg of ezetimibe and 10 mg of atorvastatin (as atorvastatin calcium trihydrate). 阅读完整的文件10 mg / 20 mg film-coated tablets Each tablet contains 10 mg of ezetimibe and 20 mg of atorvastatin (as atorvastatin calcium trihydrate). 10 mg / 40 mg film-coated tablets Each tablet contains 10 mg of ezetimibe and 40 mg of atorvastatin (as atorvastatin calcium trihydrate). 10 mg / 80 mg film-coated tablets Each tablet contains 10 mg of ezetimibe and 80 mg of atorvastatin (as atorvastatin calcium trihydrate). Excipients with known effect Each 10 mg / 10 mg tablet contains 2.74 mg of lactose. Each 10 mg / 20 mg tablet contains 3.76 mg of lactose. Each 10 mg / 40 mg tablet contains 5.81 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 10 mg / 10 mg film-coated tablet White, round, biconvex film-coated tablets, with diameter 8.1 mm approximately 10 mg / 20 mg film-coated tablet White, ovaloid, biconvex film-coated tablets, with dimensions 11.6 x 7.1 mm approximately 10 mg / 40 mg film-coated tablet White, capsule shape, biconvex film-coated tablets, with dimensions 16.1 x 6.1 mm approximately 10 mg / 80 mg film-coated tablet Yellow, oblong, biconvex film-coated tablets, with dimensions 19.1 x 7.6 mm approximately 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia as an adjunct to diet is indicated as s