Valsts: Nīderlande
Valoda: holandiešu
Klimata pārmaiņas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ATORVASTATINE CALCIUM 3-WATER 86,8 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 80 mg/stuk ; EZETIMIB 10 mg/stuk
ATORVASTATINE CALCIUM 3-WATER 86,8 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 80 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) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; 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) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
1900-01-01
Ezetimibe/Atorvastatin, NL/H/5238/001-004, 07.02.2023 1 PACKAGE LEAFLET: INFORMATION FOR THE USER EZEAT 10 MG/10 MG, FILMOMHULDE TABLETTEN EZEAT 10 MG/20 MG, FILMOMHULDE TABLETTEN EZEAT 10 MG/40 MG, FILMOMHULDE TABLETTEN EZEAT 10 MG/80 MG, FILMOMHULDE TABLETTEN ezetimibe/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 Izlasiet visu dokumentu3. 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 arteries forming plaque. Eventually this plaque build-up can lead to a narrowing of the arteries. This narrowing
Ezetimibe/Atorvastatin, NL/H/5238/001-004, 07.02.2023 1 rvg 127269-70-71-72 EU SPC IA/005 met NL info-tracked SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Ezeat 10 mg/10 mg, filmomhulde tabletten Ezeat 10 mg/20 mg, filmomhulde tabletten Ezeat 10 mg/40 mg, filmomhulde tabletten Ezeat 10 mg/80 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION10 mg/10 mg film-coated tablets Each film-coated tablet contains 10 mg of ezetimibe and 10 mg of atorvastatin (as atorvastatin calcium trihydrate). Izlasiet visu dokumentu10 mg/20 mg film-coated tablets Each film-coated tablet contains 10 mg of ezetimibe and 20 mg of atorvastatin (as atorvastatin calcium trihydrate). 10 mg/40 mg film-coated tablets Each film-coated tablet contains 10 mg of ezetimibe and 40 mg of atorvastatin (as atorvastatin calcium trihydrate). 10 mg/80 mg film-coated tablets Each film-coated tablet contains 10 mg of ezetimibe and 80 mg of atorvastatin (as atorvastatin calcium trihydrate). Excipients with known effect Each 10 mg/10 mg film-coated tablet contains 2.74 mg of lactose. Each 10 mg/20 mg film-coated tablet contains 3.76 mg of lactose. Each 10 mg/40 mg film-coated 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 2 rvg 127269-70-71-72 EU SPC IA/005 met NL info-tracked 4.1 THERAPEUTIC INDICATIONS