Rosuvastatine/Ezetimibe Gebro 40 mg/10 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

EZETIMIB ; ROSUVASTATINE CALCIUM 0-WATER SAMENSTELLING overeenkomend met ; ROSUVASTATINE

Beschikbaar vanaf:

Gebro Pharma GmbH Bahnhofbichl 13 A-6391 FIEBERBRUNN (OOSTENRIJK)

ATC-code:

C10BA06

INN (Algemene Internationale Benaming):

EZETIMIB ; ROSUVASTATIN CALCIUM 0-WATER COMPOSITION corresponding to ; ROSUVASTATIN

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Rosuvastatin and ezetimibe

Autorisatie datum:

2019-09-20

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
ROSUVASTATINE/EZETIMIBE GEBRO 5 MG/10 MG FILMOMHULDE TABLETTEN
ROSUVASTATINE/EZETIMIBE GEBRO 10 MG/10 MG FILMOMHULDE TABLETTEN
ROSUVASTATINE/EZETIMIBE GEBRO 20 MG/10 MG FILMOMHULDE TABLETTEN
ROSUVASTATINE/EZETIMIBE GEBRO 40 MG/10 MG FILMOMHULDE TABLETTEN
Rosuvastatine & 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 [Product Name] is and what it is used for
2.
What you need to know before you use [Product Name]
3.
How to use [Product Name]
4.
Possible side effects
5.
How to store [Product Name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
{Product Name} 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.
{Product Name} 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 causin

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rosuvastatine/Ezetimibe Gebro 5 mg/10 mg filmomhulde tabletten
Rosuvastatine/Ezetimibe Gebro 10 mg/10 mg filmomhulde tabletten
Rosuvastatine/Ezetimibe Gebro 20 mg/10 mg filmomhulde tabletten
Rosuvastatine/Ezetimibe Gebro 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
i