Ülke: Hollanda
Dil: Hollandaca
Kaynak: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
EZETIMIB 10 mg/stuk ; ROSUVASTATINE CALCIUM 0-WATER 41,6 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 40 mg/stuk
Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)
EZETIMIB 10 mg/stuk ; ROSUVASTATINE CALCIUM 0-WATER 41,6 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 40 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171)
Oraal gebruik
1900-01-01
EN/NL PI_NL/H/4758/001-004_CMC 07.2023_addition of primary and secondary packaging site C2-Internal PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ROZESTA 5 MG/10 MG FILMOMHULDE TABLETTEN ROZESTA 10 MG/10 MG FILMOMHULDE TABLETTEN ROZESTA 20 MG/10 MG FILMOMHULDE TABLETTEN ROZESTA 40 MG/10 MG FILMOMHULDE TABLETTEN rosuvastatin/ezetimibe 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 Rozesta is and what it is used for 2. What you need to know before you take Rozesta 3. How to take Rozesta 4. Possible side effects 5. How to store Rozesta 6. Contents of the pack and other information 1. WHAT ROZESTA IS AND WHAT IT IS USED FOR Rozesta contains 2 different active substances in 1 tablet. One of the active substances is rosuvastatin, belonging to the group of so called statins, the other active substance is ezetimibe. Rozesta is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Rozesta raises levels of “good” cholesterol (HDL cholesterol). Rozesta works to reduce your cholesterol in 2 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 p Belgenin tamamını okuyun
EN/NL PI_NL/H/4758/001-004 – Ezetimibe+rosuvastatin FCT_PRAC recom. 02.2023 C2-Internal SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rozesta 5 mg/10 mg filmomhulde tabletten Rozesta 10 mg/10 mg filmomhulde tabletten Rozesta 20 mg/10 mg filmomhulde tabletten Rozesta 40 mg/10 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Rozesta 5 mg / 10 mg: Each film-coated tablet contains 5.20 mg rosuvastatin calcium (equivalent to 5 mg rosuvastatin) and 10 mg ezetimibe. Rozesta 10 mg / 10 mg: Each film-coated tablet contains 10.40 mg rosuvastatin calcium (equivalent to 10 mg rosuvastatin) and 10 mg ezetimibe. Rozesta 20 mg / 10 mg: Each film-coated tablet contains 20.80 mg rosuvastatin calcium (equivalent to 20 mg rosuvastatin) and 10 mg ezetimibe. Rozesta 40 mg / 10 mg: Each film-coated tablet contains 41.60 mg rosuvastatin calcium (equivalent to 40 mg rosuvastatin) and 10 mg ezetimibe. Excipients with known effect Rozesta 5 mg / 10 mg: Each film-coated tablet contains 200.50 mg lactose monohydrate (equivalent to 190.47 mg lactose anhydrous). Rozesta 10 mg / 10 mg: Each film-coated tablet contains 200.50 mg lactose monohydrate (equivalent to 190.47 mg lactose anhydrous). Rozesta 20 mg / 10 mg: Each film-coated tablet contains 200.50 mg lactose monohydrate (equivalent to 190.47 mg lactose anhydrous). Rozesta 40 mg / 10 mg: Each film-coated tablet contains 205.54 mg lactose monohydrate. (equivalent to 195.26 mg lactose anhydrous). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Rozesta 5 mg / 10 mg: Light yellow, round, biconvex film-coated tablets with a diameter of 10 mm approximately and “EL5” embossed on one side. Rozesta 10 mg / 10 mg: Beige, round, biconvex film-coated tablets with a diameter of 10 mm approximately and “EL4” embossed on one side. EN/NL PI_NL/H/4758/001-004 – Ezetimibe+rosuvastatin FCT_PRAC recom. 02.2023 C2-Internal Rozesta 20 mg / 10 mg: Yellow, round, biconvex film-coated tablets with a diameter of 10 m Belgenin tamamını okuyun