Simvezor 10 mg/10 mg tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

EZETIMIB 10 mg/stuk ; SIMVASTATINE 10 mg/stuk

Beschikbaar vanaf:

Vocate Pharmaceuticals SA 150 Gounari street 16674 GLYFADA (GRIEKENLAND)

ATC-code:

C10BA02

INN (Algemene Internationale Benaming):

EZETIMIB 10 mg/stuk ; SIMVASTATINE 10 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:

2019-06-19

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SIMVEZOR 10 MG/10 MG TABLETTEN
SIMVEZOR 10 MG/20 MG TABLETTEN
SIMVEZOR 10 MG/40 MG TABLETTEN
SIMVEZOR 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 Simvezor is and what it is used for
2.
What you need to know before you take Simvezor
3.
How to take Simvezor
4.
Possible side effects
5.
How to store Simvezor
6.
Contents of the pack and other information
1.
WHAT SIMVEZOR IS AND WHAT IT IS USED FOR
Simvezor contains the active substances ezetimibe and simvastatin.
Simvezor is a medicine used
to lower
levels of total cholesterol, “bad” cholesterol (LDL cholesterol),
and fatty substances
called triglycerides
in the blood. In addition, Simvezor raises levels of “good”
cholesterol
(HDL cholesterol).
Simvezor 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
plaque
build-up
can
lead
to
a
narrowing
of
the
arteries. This
narrowing can slow or block blood flow to vital organs such as the
heart and
brai

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Simvezor 10 mg/10 mg tabletten
Simvezor 10 mg/20 mg tabletten
Simvezor 10 mg/40 mg tabletten
Simvezor 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 οff 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 οff 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 οff 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 οff 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
Simvezor 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
Simvezor 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 appropriately controlled with a statin alone
•
patients already treated with a statin and ezetimibe
Homozyg