Land: Holland
Sprog: hollandsk
Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ATORVASTATINE CALCIUM 3-WATER SAMENSTELLING overeenkomend met ; ATORVASTATINE ; EZETIMIB
ATORVASTATIN CALCIUM 3-WATER COMPOSITION equivalent to ; ATORVASTATIN ; EZETIMIB
Filmomhulde tablet
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
2021-11-19
PACKAGE LEAFLET BIJSLUITER: INFORMATIE VOOR DE PATIËNT TOVASTIBE 10 MG/ 10 MG, FILMOMHULDE TABLETTEN TOVASTIBE 10 MG/ 20 MG, FILMOMHULDE TABLETTEN TOVASTIBE 10 MG/ 40 MG, FILMOMHULDE TABLETTEN TOVASTIBE 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. 1. What Tovastibe is and what it is used for 2. What you need to know before you take Tovastibe 3. How to take Tovastibe 4. Possible side effects 5. How to store Tovastibe 6. Contents of the pack and other information 1. WHAT TOVASTIBE IS AND WHAT IT IS USED FOR _ _ Tovastibe is a medicine to lower increased levels of cholesterol. Tovastibe contains ezetimibe and atorvastatin. Tovastibe is used in adults to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Tovastibe raises levels of “good” cholesterol (HDL cholesterol). Tovastibe 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 can slow or block blood flow to vital organs such as the heart and brain. This Læs hele dokumentet
SAMENVATTING VAN DE PRODUCTKENMERKEN 1. NAAM VAN HET GENEESMIDDEL Tovastibe 10 mg/ 10 mg, filmomhulde tabletten Tovastibe 10 mg/ 20 mg, filmomhulde tabletten Tovastibe 10 mg/ 40 mg, filmomhulde tabletten Tovastibe 10 mg/ 80 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tovastibe 10 mg/ 10 mg film-coated tablets Each film-coated tablet contains 10 mg of ezetimibe and 10 mg of atorvastatin (as calcium trihydrate). Tovastibe 10 mg/ 20 mg film-coated tablets Each film-coated tablet contains 10 mg of ezetimibe and 20 mg of atorvastatin (as calcium trihydrate). Tovastibe 10 mg/ 40 mg film-coated tablets Each film-coated tablet contains 10 mg of ezetimibe and 40 mg of atorvastatin (as calcium trihydrate). Tovastibe 10 mg/ 80 mg film-coated tablets Each film-coated tablet contains 10 mg of ezetimibe and 80 mg of atorvastatin (as calcium trihydrate). Excipients with known effect Each Tovastibe 10 mg/ 10 mg film-coated tablet contains 2.74 mg of lactose. Each Tovastibe 10 mg/ 20 mg film-coated tablet contains 3.76 mg of lactose. Each Tovastibe 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 Tovastibe 10 mg/ 10 mg film-coated tablets White, round, biconvex film-coated tablets, with diameter 8.1 mm approximately Tovastibe 10 mg/ 20 mg film-coated tablets White, ovaloid, biconvex film-coated tablets, with dimensions 11.6 x 7.1 mm approximately Tovastibe 10 mg/ 40 mg film-coated tablets White, capsule shape, biconvex film-coated tablets, with dimensions 16.1 x 6.1 mm approximately Tovastibe 10 mg/ 80 mg film-coated tablets Yellow, oblong, biconvex film-coated tablets, with dimensions 19.1 x 7.6 mm approximately 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia Tovastibe as an adjunct to diet is indicated as substitution therapy for treatment of adults with primary (heterozygous and homozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia already con Læs hele dokumentet