देश: नीदरलैंड
भाषा: डच
स्रोत: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
EZETIMIB ; ROSUVASTATINE CALCIUM 0-WATER SAMENSTELLING overeenkomend met ; ROSUVASTATINE
Ferrer International S.A. Gran Via Carlos III, 94 08028 BARCELONA (SPANJE)
C10BA06
EZETIMIB ; ROSUVASTATIN CALCIUM 0-WATER COMPOSITION corresponding to ; ROSUVASTATIN
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (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
Rosuvastatin and ezetimibe
2020-01-16
PACKAGE LEAFLET: INFORMATION FOR THE USER ROSUVASTATINE/EZETIMIBE FERRER 5 MG/10 MG FILMOMHULDE TABLETTEN ROSUVASTATINE/EZETIMIBE FERRER 10 MG/10 MG FILMOMHULDE TABLETTEN ROSUVASTATINE/EZETIMIBE FERRER 20 MG/10 MG FILMOMHULDE TABLETTEN ROSUVASTATINE/EZETIMIBE FERRER 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. Whatis and what it is used for 2. What you need to know before you use पूरा दस्तावेज़ पढ़ें3. How to use 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 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. 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 cau
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rosuvastatine/Ezetimibe Ferrer 5 mg/10 mg filmomhulde tabletten
Rosuvastatine/Ezetimibe Ferrer 10 mg/10 mg filmomhulde tabletten
Rosuvastatine/Ezetimibe Ferrer 20 mg/10 mg filmomhulde tabletten
Rosuvastatine/Ezetimibe Ferrer 40 mg/10 mg filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mg/10 mg
Each film-coated tablet contains 5.20 mg rosuvastatin calcium
(equivalent to 5 mg
rosuvastatin) and 10 mg of ezetimibe.
10 mg/10 mg
Each film-coated tablet contains 10.40 mg rosuvastatin calcium
(equivalent to 10 mg
rosuvastatin) and 10 mg of ezetimibe.
20 mg/10 mg
Each film-coated tablet contains 20.80 mg rosuvastatin calcium
(equivalent to 20 mg
rosuvastatin) and 10 mg of ezetimibe.
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:
5 mg/10 mg: Each film-coated tablet contains 200.50 mg
of lactose
monohydrate.
10 mg/10 mg: Each film-coated tablet contains 200.50 mg
of lactose
monohydrate.
20 mg/10 mg: Each film-coated tablet contains 200.50 mg
of lactose
monohydrate.
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
पूरा दस्तावेज़ पढ़ें