Ezetimibe/Simvastatine Genepharm 10 mg/40 mg, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

EZETIMIB 10 mg/stuk ; SIMVASTATINE 40 mg/stuk

Beschikbaar vanaf:

Genepharm S.A. 18th km Marathonos Avenue 153 51 PALLINI (GRIEKENLAND)

ATC-code:

C10BA02

INN (Algemene Internationale Benaming):

EZETIMIB 10 mg/stuk ; SIMVASTATINE 40 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

BUTYLHYDROXYANISOL (E 320) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CITROENZUUR 1-WATER (E 330) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; PROPYLGALLAAT (E 310)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Simvastatin And Ezetimibe

Autorisatie datum:

2019-07-08

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
EZETIMIBE/SIMVASTATINE GENEPHARM 10 MG/10 MG, TABLETTEN
EZETIMIBE/SIMVASTATINE GENEPHARM 10 MG/20 MG, TABLETTEN
EZETIMIBE/SIMVASTATINE GENEPHARM 10 MG/40 MG, TABLETTEN
EZETIMIBE/SIMVASTATINE GENEPHARM 10 MG/80 MG, TABLETTEN
EZETIMIBE AND SIMVASTATIN
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

contains
the
active
substances
ezetimibe
and
simvastatin.
is a medicine used
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.
The
active
ingredient ezetimibe
reduces the cholesterol absorbed in your digestive tract. The active
ingredient
simvastatin
belonging to the class of “statins” inhibits the production of 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.

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ezetimibe/Simvastatine Genepharm 10 mg/10 mg, tabletten
Ezetimibe/Simvastatine Genepharm 10 mg/20 mg, tabletten
Ezetimibe/Simvastatine Genepharm 10 mg/40 mg, tabletten
Ezetimibe/Simvastatine Genepharm 10 mg/80 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg ezetimibe and 10, 20, 40 or 80 mg of
simvastatin.
Excipient(s) with known effect:
Each 10/10 mg tablet contains 51 mg of lactose monohydrate.
Each 10/20 mg tablet contains 113 mg of lactose monohydrate.
Each 10/40 mg tablet contains 236 mg of lactose monohydrate.
Each 10/80 mg tablet contains 482 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
10mg/10mg:
White to Off white capsule shaped uncoated tablets debossed with
“G” on one side and “321”
on other side, approx.8.5 mm in length and 4.25 mm in width.
10mg/20mg:
White to Off white capsule shaped uncoated tablets debossed with
“G” on one side and
“322” on other side, approx.10.7 mm in length and 5.3 mm in width.
10mg/40mg:
White to Off white capsule shaped uncoated tablets debossed with
“G” on one side and
“323” on other side, approx.14.0 mm in length and 6.0 mm in width.
10mg/80mg:
White to Off white capsule shaped uncoated tablets debossed with
“G” on one side and
“324” on other side, approx.17.5 mm in length and 7.5 mm in width.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of Cardiovascular Events
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 previously treated with a statin or not.
Hypercholesterolaemia
is indicated as adjunctive therapy to diet for use in
patients with
primary (heterozygous familial and non-familial) hypercholesterolaemia
or mixed
hyperlipidaemia where use of a combination product is appropriate:
•
patients not appropr