Ezetimibe/Simvastatine ratiopharm 10 mg/20 mg, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

EZETIMIB 10 mg/stuk ; SIMVASTATINE 20 mg/stuk

Beschikbaar vanaf:

Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)

ATC-code:

C10BA02

INN (Algemene Internationale Benaming):

EZETIMIB 10 mg/stuk ; SIMVASTATINE 20 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

ASCORBINEZUUR (L-) (E 300) ; BUTYLHYDROXYANISOL (E 320) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CITROENZUUR 0-WATER (E 330) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; PROPYLGALLAAT (E 310),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Simvastatin And Ezetimibe

Product samenvatting:

Hulpstoffen: ASCORBINEZUUR (L-) (E 300); BUTYLHYDROXYANISOL (E 320); CELLULOSE, MICROKRISTALLIJN (E 460); CITROENZUUR 0-WATER (E 330); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); PROPYLGALLAAT (E 310);

Autorisatie datum:

2018-04-23

Bijsluiter

Ezetimibe/Simvastatin, tablets, DE/H/6643/001-004
PRAC (EPITT 19824), 06.02.23
1
rvg 120536-8-9 EU PIL IA/018 met NL info-clean
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EZETIMIBE/SIMVASTATINE RATIOPHARM 10 MG/20 MG, TABLETTEN
EZETIMIBE/SIMVASTATINE RATIOPHARM 10 MG/40 MG, TABLETTEN
EZETIMIBE/SIMVASTATINE RATIOPHARM 10 MG/80 MG, TABLETTEN
ezetimibe/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. Eventually this p

Productkenmerken

Ezetimibe/Simvastatin, tablets, DE/H/6643/001-004
PRAC (EPITT 19824), 06.02.23
1
rvg 120536_8_9 EU SPC IA/018 met NL info-clean
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Ezetimibe/Simvastatine ratiopharm 10 mg/20 mg, tabletten
Ezetimibe/Simvastatine ratiopharm 10 mg/40 mg, tabletten
Ezetimibe/Simvastatine ratiopharm 10 mg/80 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg ezetimibe and 10 mg simvastatin.
Each tablet contains 10 mg ezetimibe and 20 mg simvastatin.
Each tablet contains 10 mg ezetimibe and 40 mg simvastatin.
Each tablet contains 10 mg ezetimibe and 80 mg simvastatin.
Excipient with known effect:
Each 10 mg/10 mg tablet contains 51.631 mg of lactose monohydrate.
Each 10 mg/20 mg tablet contains 113.262 mg of lactose monohydrate.
Each 10 mg/40 mg tablet contains 236.524 mg of lactose monohydrate.
Each 10 mg/80 mg tablet contains 483.048 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
/…/ 10 mg/10 mg tablets: Light tan, mottled, round, 6 mm in
diameter, biconvex tablets, plain on one
side and “511” on the other side.
/…/ 10 mg/20 mg tablets: Light tan, mottled, round, 8 mm in
diameter, biconvex tablets, plain on one
side and “512” on the other side.
/…/ 10 mg/40 mg tablets: Light tan, mottled, round, 10 mm in
diameter, biconvex tablets, plain on one
side and “513” on the other side.
/…/ 10 mg/80 mg tablets: Light tan, mottled, capsule shaped, 17.5 x
7.55 mm, biconvex tablets, plain
on one side and “515” on the other side.
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-fa