Ezetimibe/Atorvastatine Zentiva 10 mg/10 mg, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ATORVASTATINE CALCIUM 3-WATER SAMENSTELLING overeenkomend met ; ATORVASTATINE ; EZETIMIB

Beschikbaar vanaf:

Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)

ATC-code:

C10BA05

INN (Algemene Internationale Benaming):

ATORVASTATIN CALCIUM 3-WATER COMPOSITION equivalent to ; ATORVASTATIN ; EZETIMIB

farmaceutische vorm:

Tablet

Samenstelling:

CALCIUMCARBONAAT (E 170) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Atorvastatin and ezetimibe

Autorisatie datum:

2019-10-22

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EZETIMIBE/ATORVASTATINE ZENTIVA 10 MG/10 MG, TABLETTEN
EZETIMIBE/ATORVASTATINE ZENTIVA 10 MG/20 MG, TABLETTEN
EZETIMIBE/ATORVASTATINE ZENTIVA 10 MG/40 MG, TABLETTEN
EZETIMIBE/ATORVASTATINE ZENTIVA 10 MG/80 MG, 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 Zentiva is and what it is used for
2.
What you need to know before you take Ezetimibe/Atorvastatine Zentiva
3.
How to take Ezetimibe/Atorvastatine Zentiva
4.
Possible side effects
5.
How to store Ezetimibe/Atorvastatine Zentiva
6.
Contents of the pack and other information
1.
WHAT EZETIMIBE/ATORVASTATINE ZENTIVA IS AND WHAT IT IS USED FOR
Ezetimibe/Atorvastatine Zentiva is a medicine to lower increased
levels of cholesterol.
Ezetimibe/Atorvastatine Zentiva contains ezetimibe and atorvastatin.
Ezetimibe/Atorvastatine Zentiva 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 Zentiva raises levels of “good”
cholesterol (HDL cholesterol).
Ezetimibe/Atorvastatine Zentiva 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 cholesterol.
LDL cholesterol is often called “

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ezetimibe/Atorvastatine Zentiva 10 mg/10 mg, tabletten
Ezetimibe/Atorvastatine Zentiva 10 mg/20 mg, tabletten
Ezetimibe/Atorvastatine Zentiva 10 mg/40 mg, tabletten
Ezetimibe/Atorvastatine Zentiva 10 mg/80 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg ezetimibe and 10, 20, 40 or 80 mg of
atorvastatin (as atorvastatin calcium
trihydrate).
Excipients with known effect
Each 10 mg/ 10 mg tablet contains 145 mg lactose.
Each 10 mg/ 20 mg tablet contains 170 mg lactose.
Each 10 mg/ 40 mg tablet contains 219 mg lactose.
Each 10 mg/ 80 mg tablet contains 317 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
10 mg/ 10 mg tablet: White to off white, capsule shaped tablets
(12.7mm x 5.1mm) on one side
debossed with“1”
10 mg/ 20 mg tablet: White to off white, capsule shaped tablets
(14.5mm x 6.8 mm) on one side
debossed with“2”
10 mg/ 40 mg tablet: White to off white, capsule shaped tablets
(16.4mm x 6.3 mm) on one side
debossed with“3”
10 mg/ 80 mg tablet: White to off white, capsule shaped tablets
(17.0mm x 8.0mm) on one side
debossed with“4”
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ezetimibe/Atorvastatine Zentiva as an adjunct to diet is indicated as
substitution therapy for treatment
of adults with primary (heterozygous and homozygous familial and
non-familal)
hypercholesterolaemia or mixed hyperlipidaemia already controlled with
atorvastatin and ezetimibe
given concurrently at the same dose level.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Ezetimibe/Atorvastatine Zentiva is 1 tablet
per day.
The maximum recommended dose of Ezetimibe/Atorvastatine Zentiva is 10
mg/80 mg per day.
The patient should be on an appropriate lipid lowering diet and should
continue on this diet during
treatment with Ezetimibe/Atorvastatine Zentiva.
Ezetimibe/Atorvastatine Zentiva is not suitable for initial therapy.
Treatment initiation o