Ezetimibe/Atorvastatine Heumann 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(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POLYSORBAAT 80 (E 433) ; 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 PATIENT
EZETIMIBE/ATORVASTATINE HEUMANN 10 MG/10 MG FILMOMHULDE TABLETTEN
EZETIMIBE/ATORVASTATINE HEUMANN 10 MG/20 MG FILMOMHULDE TABLETTEN
EZETIMIBE/ATORVASTATINE HEUMANN 10 MG/40 MG FILMOMHULDE TABLETTEN
EZETIMIBE/ATORVASTATINE HEUMANN 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 Ezetimibe/Atorvastatine Heumann is and what it is used for
2.
What you need to know before you take Ezetimibe/Atorvastatine Heumann
3.
How to take Ezetimibe/Atorvastatine Heumann
4.
Possible side effects
5.
How to store Ezetimibe/Atorvastatine Heumann
6.
Contents of the pack and other information
1.
WHAT EZETIMIBE/ATORVASTATINE HEUMANN IS AND WHAT IT IS USED FOR
Ezetimibe/Atorvastatine Heumann is a medicine to lower increased
levels of cholesterol.
Ezetimibe/Atorvastatine Heumann contains ezetimibe and atorvastatin.
Ezetimibe/Atorvastatine Heumann is used in adults to lower levels of
total cholesterol, “bad”
cholesterol (LDL cholesterol), and fatty substances called
triglycerides in the blood. In addition,
Ezetimibe/Atorvastatine Heumann raises levels of “good”
cholesterol (HDL cholesterol).
Ezetimibe/Atorvastatine Heumann 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 cho

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ezetimibe/Atorvastatine Heumann 10 mg/10 mg filmomhulde tabletten
Ezetimibe/Atorvastatine Heumann 10 mg/20 mg filmomhulde tabletten
Ezetimibe/Atorvastatine Heumann 10 mg/40 mg filmomhulde tabletten
Ezetimibe/Atorvastatine Heumann 10 mg/80 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg ezetimibe and 10, 20, 40 or 80
mg atorvastatin (as atorvastatin
calcium trihydrate).
Excipient(s) with known effect:
Each 10 mg/10 mg film-coated tablet contains 153,83 mg of lactose (as
monohydrate).
Each 10 mg/20 mg film-coated tablet contains 180,79 mg of lactose (as
monohydrate).
Each 10 mg/40 mg film-coated tablet contains 234,71 mg of lactose (as
monohydrate).
Each 10 mg/80 mg film-coated tablet contains 342,55 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
10 mg/10 mg tablet: White to off white, capsule shaped with the
dimensions of approximately 13
mm
x 5
m, biconvex, film-coated tablets with one side debossed “1T” and
plain on the other side.
10 mg/20 mg tablet: White to off white, capsule shaped with the
dimensions of approximately 15
mm
x 6
mm, biconvex, film-coated tablets with one side debossed “2T and
plain on the other side.
10 mg/40 mg tablet: White to off white, capsule shaped with the
dimensions of approximately 16
mm
x 6
mm, biconvex, film-coated tablets with one side debossed “4T” and
plain on the other side.
10 mg/80 mg tablet: White to off white, capsule shaped with the
dimensions of approximately 19
mm
x 8
mm, biconvex, film-coated tablets with one side debossed “8T” and
plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Prevention of Cardiovascular Events _
Ezetimibe/Atorvastatine Heumann is indicated to reduce the risk of
cardiovascular events (see section
5.1) in patients with coronary heart disease (CHD) and a history of
acute coronary syndrome (ACS),
either prev