Ezeat 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:

2021-10-28

Bijsluiter

Ezetimibe/Atorvastatin, NL/H/5238/001-004, 07.02.2023
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EZEAT 10 MG/10 MG, FILMOMHULDE TABLETTEN
EZEAT 10 MG/20 MG, FILMOMHULDE TABLETTEN
EZEAT 10 MG/40 MG, FILMOMHULDE TABLETTEN
EZEAT 10 MG/80 MG, FILMOMHULDE TABLETTEN
ezetimibe/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 arteries
forming plaque. Eventually this plaque build-up can lead to a
narrowing of the arteries. This narrowing

Productkenmerken

Ezetimibe/Atorvastatin, NL/H/5238/001-004, 07.02.2023
1
rvg 127269-70-71-72 EU SPC IA/005 met NL info-tracked
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Ezeat 10 mg/10 mg, filmomhulde tabletten
Ezeat 10 mg/20 mg, filmomhulde tabletten
Ezeat 10 mg/40 mg, filmomhulde tabletten
Ezeat 10 mg/80 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg/10 mg film-coated tablets
Each film-coated tablet contains 10 mg of ezetimibe and 10 mg of
atorvastatin (as atorvastatin calcium
trihydrate).
10 mg/20 mg film-coated tablets
Each film-coated tablet contains 10 mg of ezetimibe and 20 mg of
atorvastatin (as atorvastatin calcium
trihydrate).
10 mg/40 mg film-coated tablets
Each film-coated tablet contains 10 mg of ezetimibe and 40 mg of
atorvastatin (as atorvastatin calcium
trihydrate).
10 mg/80 mg film-coated tablets
Each film-coated tablet contains 10 mg of ezetimibe and 80 mg of
atorvastatin (as atorvastatin calcium
trihydrate).
Excipients with known effect
Each 10 mg/10 mg film-coated tablet contains 2.74 mg of
lactose.
Each 10 mg/20 mg film-coated tablet contains 3.76 mg of
lactose.
Each 10 mg/40 mg film-coated 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
2
rvg 127269-70-71-72 EU SPC IA/005 met NL info-tracked
4.1
THERAPEUTIC INDICATIONS