Ezetimibe/Atorvastatine STADA Arzneimittel AG 10 mg/20 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ATORVASTATINE CALCIUM 3-WATER 21,7 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 20 mg/stuk ; EZETIMIB 10 mg/stuk

INN (Algemene Internationale Benaming):

ATORVASTATINE CALCIUM 3-WATER 21,7 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 20 mg/stuk ; EZETIMIB 10 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CALCIUMCARBONAAT (E 170) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2022-05-23

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
EZETIMIBE/ATORVASTATINE STADA ARZNEIMITTEL AG 10 MG/10 MG FILMOMHULDE
TABLETTEN
EZETIMIBE/ATORVASTATINE STADA ARZNEIMITTEL AG 10 MG/20 MG FILMOMHULDE
TABLETTEN
EZETIMIBE/ATORVASTATINE STADA ARZNEIMITTEL AG 10 MG/40 MG FILMOMHULDE
TABLETTEN
EZETIMIBE/ATORVASTATINE STADA ARZNEIMITTEL AG 10 MG/80 MG FILMOMHULDE
TABLETTEN
ezetimibe and atorvastatin
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 is and what it is used for
2. What you need to know before you take
3. How to take
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
is a medicine to lower increased levels of cholesterol.
contains
ezetimibe and atorvastatin.
is used in adults to lower levels of total cholesterol,
“bad” cholesterol (LDL cholesterol),
and fatty substances called triglycerides in the blood. In addition,
raises levels of “good”
cholesterol (HDL cholesterol).
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.
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

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ezetimibe/Atorvastatine STADA Arzneimittel AG 10 mg/10 mg filmomhulde
tabletten
Ezetimibe/Atorvastatine STADA Arzneimittel AG 10 mg/20 mg filmomhulde
tabletten
Ezetimibe/Atorvastatine STADA Arzneimittel AG 10 mg/40 mg filmomhulde
tabletten
Ezetimibe/Atorvastatine STADA Arzneimittel AG 10 mg/80 mg filmomhulde
tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg / 10 mg film-coated tablets
Each tablet contains 10 mg of ezetimibe and 10 mg of atorvastatin (as
atorvastatin calcium trihydrate).
10 mg / 20 mg film-coated tablets
Each tablet contains 10 mg of ezetimibe and 20 mg of atorvastatin (as
atorvastatin calcium trihydrate).
10 mg / 40 mg film-coated tablets
Each tablet contains 10 mg of ezetimibe and 40 mg of atorvastatin (as
atorvastatin calcium trihydrate).
10 mg / 80 mg film-coated tablets
Each tablet contains 10 mg of ezetimibe and 80 mg of atorvastatin (as
atorvastatin calcium trihydrate).
Excipients with known effect
Each 10 mg / 10 mg tablet contains 2.74 mg of lactose.
Each 10 mg / 20 mg tablet contains 3.76 mg of lactose.
Each 10 mg / 40 mg tablet contains 5.81 mg of lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
10 mg / 10 mg film-coated tablet
White, round, biconvex film-coated tablets, with diameter 8.1 mm
approximately
10 mg / 20 mg film-coated tablet
White, ovaloid, biconvex film-coated tablets, with dimensions 11.6 x
7.1 mm approximately
10 mg / 40 mg film-coated tablet
White, capsule shape, biconvex film-coated tablets, with dimensions
16.1 x 6.1 mm approximately
10 mg / 80 mg film-coated tablet
Yellow, oblong, biconvex film-coated tablets, with dimensions 19.1 x
7.6 mm approximately
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypercholesterolaemia
as an adjunct to diet is indicated as s