ZETIVASIM 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

INN (Algemene Internationale Benaming):

EZETIMIB 10 mg/stuk ; SIMVASTATINE 20 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

BUTYLHYDROXYANISOL (E 320) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; 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 ; PROPYLGALLAAT (E 310), 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

Autorisatie datum:

1900-01-01

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZETIVASIM 10 MG/10 MG, TABLETTEN
ZETIVASIM 10 MG/20 MG, TABLETTEN
ZETIVASIM 10 MG/40 MG, TABLETTEN
ZETIVASIM 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 ZETIVASIM is and what it is used for
2.
What you need to know before you take ZETIVASIM
3.
How to take ZETIVASIM
4.
Possible side effects
5.
How to store ZETIVASIM
6.
Contents of the pack and other information
1.
WHAT ZETIVASIM IS AND WHAT IT IS USED FOR
ZETIVASIM contains the active substances ezetimibe and simvastatin.
ZETIVASIM is a medicine
used to lower levels of total cholesterol, “bad” cholesterol (LDL
cholesterol), and fatty substances
called triglycerides in the blood. In addition, ZETIVASIM raises
levels of “good” cholesterol (HDL
cholesterol).
ZETIVASIM 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

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ZETIVASIM 10 mg/10 mg, tabletten
ZETIVASIM 10 mg/20 mg, tabletten
ZETIVASIM 10 mg/40 mg, tabletten
ZETIVASIM 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.
10 mg/10 mg:
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.
10 mg/20 mg:
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.
10 mg/40 mg:
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.
10 mg/80 mg:
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
ZETIVASIM 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
ZETIVASIM 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 ezetimib