Rosuvastatine/Ezemtimibe S.J.A. Pharm, 10 mg + 10 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

EZETIMIB 10 mg/stuk ; ROSUVASTATINE CALCIUM 0-WATER 10,4 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 10 mg/stuk

INN (Algemene Internationale Benaming):

EZETIMIB 10 mg/stuk ; ROSUVASTATINE CALCIUM 0-WATER 10,4 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 10 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
ROSUVASTATINE/EZETIMIBE S.J.A. PHARM, 5 MG + 10 MG FILMOMHULDE
TABLETTEN
ROSUVASTATINE/EZETIMIBE S.J.A. PHARM, 10 MG + 10 MG FILMOMHULDE
TABLETTEN
ROSUVASTATINE/EZETIMIBE S.J.A. PHARM, 20 MG + 10 MG FILMOMHULDE
TABLETTEN
ROSUVASTATINE/EZETIMIBE S.J.A. PHARM, 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 Rosuvastatine/Ezetimibe S.J.A. Pharm is and what it is used for
2.
What you need to know before you use Rosuvastatine/Ezetimibe S.J.A.
Pharm
3.
How to use Rosuvastatine/Ezetimibe S.J.A. Pharm
4.
Possible side effects
5.
How to store Rosuvastatine/Ezetimibe S.J.A. Pharm
6.
Contents of the pack and other information
1.
WHAT ROSUVASTATINE/EZETIMIBE S.J.A. PHARM IS AND WHAT IT IS USED FOR
Rosuvastatine/Ezetimibe S.J.A. Pharm 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.
Rosuvastatine/Ezetimibe S.J.A. Pharm 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, hig

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rosuvastatine/Ezetimibe S.J.A. Pharm, 5 mg + 10 mg filmomhulde
tabletten
Rosuvastatine/Ezetimibe S.J.A. Pharm, 10 mg + 10 mg filmomhulde
tabletten
Rosuvastatine/Ezetimibe S.J.A. Pharm, 20 mg + 10 mg filmomhulde
tabletten
Rosuvastatine/Ezetimibe S.J.A. Pharm, 40 mg + 10 mg filmomhulde
tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Rosuvastatine/Ezetimibe S.J.A. Pharm, 5 mg+10 mg
Each film-coated tablet contains 5.20 mg rosuvastatin calcium
(equivalent to 5 mg
rosuvastatin) and 10 mg of ezetimibe.
Rosuvastatine/Ezetimibe S.J.A. Pharm, 10 mg+10 mg
Each film-coated tablet contains 10.40 mg rosuvastatin calcium
(equivalent to 10 mg
rosuvastatin) and 10 mg of ezetimibe.
Rosuvastatine/Ezetimibe S.J.A. Pharm, 20 mg+10 mg
Each film-coated tablet contains 20.80 mg rosuvastatin calcium
(equivalent to 20 mg
rosuvastatin) and 10 mg of ezetimibe.
Rosuvastatine/Ezetimibe S.J.A. Pharm, 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:
Rosuvastatine/Ezetimibe S.J.A. Pharm, 5 mg+10 mg: Each film-coated
tablet contains 200.50
mg of lactose monohydrate.
Rosuvastatine/Ezetimibe S.J.A. Pharm, 10 mg+10 mg: Each film-coated
tablet contains
200.50 mg of lactose monohydrate.
Rosuvastatine/Ezetimibe S.J.A. Pharm, 20 mg+10 mg: Each film-coated
tablet contains
200.50 mg of lactose monohydrate.
Rosuvastatine/Ezetimibe S.J.A. Pharm, 40 mg+10 mg: Each film-coated
tablet contains
205.54 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 10 mm
approximately and "EL 5" embossed on one side
10 mg + 10 mg: Beige, round, biconvex film coated tablets
with a diameter of 10 mm
approximately and "EL 4" embossed on one side
20 mg + 10 mg: Yellow, round, biconvex film coated tablets
with a diameter of 10 mm
approximately