Země: Nizozemsko
Jazyk: nizozemština
Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
EZETIMIB 10 mg/stuk ; ROSUVASTATINE CALCIUM 0-WATER 20,8 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 20 mg/stuk
Aurora Biofarma S.R.L. Via Nicola Antonio Porpora 127 20131 MILAAN (ITALIË)
EZETIMIB 10 mg/stuk ; ROSUVASTATINE CALCIUM 0-WATER 20,8 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 20 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
2020-12-24
PACKAGE LEAFLET: INFORMATION FOR THE USER ROZEMIB 5 MG/10 MG, FILMOMHULDE TABLETTEN ROZEMIB 10 MG/10 MG, FILMOMHULDE TABLETTEN ROZEMIB 20 MG/10 MG, FILMOMHULDE TABLETTEN ROZEMIB 40 MG/10 MG, FILMOMHULDE TABLETTEN ROSUVASTATIN & EZETIMIBE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Rozemib is and what it is used for 2. What you need to know before you use Rozemib 3. How to use Rozemib 4. Possible side effects 5. How to store Rozemib 6. Contents of the pack and other information 1. WHAT ROZEMIB IS AND WHAT IT IS USED FOR Rozemib contains two different active substances in one film coated tablet. One of the active substances is rosuvastatin calcium, belonging to the group of so called statins, the other active substance is ezetimibe. Rozemib is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol) and fatty substances called triglycerides in your blood. In addition, it also raises levels of “good” cholesterol (HDL cholesterol). This medicine 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. For most people, high cholesterol does not affect the way they feel because it does not produce any symptoms. However, if it is left untreated, fatty deposits can build up in the walls of your blood vessels causing them to narrow. Sometimes, these narrowed blood vessels can get blocked which can cut off the blood supply to the heart or brain lea Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rozemib 5 mg/10 mg, filmomhulde tabletten Rozemib 10 mg/10 mg, filmomhulde tabletten Rozemib 20 mg/10 mg, filmomhulde tabletten Rozemib 40 mg/10 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Rozemib 5 mg/10 mg Each film-coated tablet contains 5.20 mg rosuvastatin calcium (equivalent to 5 mg rosuvastatin) and 10 mg of ezetimibe. Rozemib 10 mg/10 mg Each film-coated tablet contains 10.40 mg rosuvastatin calcium (equivalent to 10 mg rosuvastatin) and 10 mg of ezetimibe. Rozemib 20 mg/10 mg Each film-coated tablet contains 20.80 mg rosuvastatin calcium (equivalent to 20 mg rosuvastatin) and 10 mg of ezetimibe. Rozemib 40 mg/10 mg Each film-coated tablet contains 41.60 mg rosuvastatin calcium (equivalent to 40 mg rosuvastatin) and 10 mg of ezetimibe. Excipients with known effect: Rozemib 5 mg/10 mg: Each film-coated tablet contains 200.50 mg of lactose monohydrate. Rozemib 10 mg/10 mg: Each film-coated tablet contains 200.50 mg of lactose monohydrate. Rozemib 20 mg/10 mg: Each film-coated tablet contains 200.50 mg of lactose monohydrate. Rozemib 40 mg/10 mg: Each film-coated tablet contains 200.50 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablets 5 mg / 10 mg: Light yellow, round, biconvex film coated tablets with a diameter of 10mm approximately and "EL 5" embossed on one side 10 mg / 10 mg: Beige, round, biconvex film coated tablets with a diameter of 10mm approximately and "EL 4" embossed on one side 20 mg / 10 mg: Yellow, round, biconvex film coated tablets with a diameter of 10mm approximately and "EL 3" embossed on one side 40 mg / 10 mg: White, round, biconvex film coated tablets with a diameter of 10mm approximately and "EL 2" embossed on one side 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rozemib is indicated as adjunct to diet for treatment of primary hypercholesterolemiaas substitution therapy in adult patients adequately controlled with t Přečtěte si celý dokument