Ezetimibe/Atorvastatine GL 10 mg/ 10 mg, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ATORVASTATINE CALCIUM 3-WATER 10,9 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 10 mg/stuk ; EZETIMIB 10 mg/stuk

Beschikbaar vanaf:

G.L. Pharma GmbH Schlossplatz 1 A-8502 LANNACH (OOSTENRIJK)

INN (Algemene Internationale Benaming):

ATORVASTATINE CALCIUM 3-WATER 10,9 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 10 mg/stuk ; EZETIMIB 10 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

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

Autorisatie datum:

1900-01-01

Bijsluiter

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

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Ezetimibe/Atorvastatine GL 10 mg/ 10 mg, tabletten
Ezetimibe/Atorvastatine GL 10 mg/ 20 mg, tabletten
Ezetimibe/Atorvastatine GL 10 mg/ 40 mg, tabletten
Ezetimibe/Atorvastatine GL 10 mg/ 80 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of ezetimibe and 10 mg, 20 mg, 40 mg 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 (12.7
mm x 5.1 mm) on one side
debossed with “1”
10 mg/20 mg tablet: White to off white, capsule shaped tablets (14.5
mm x 6.8 mm) on one side
debossed with “2”
10 mg/40 mg tablet: White to off white, capsule shaped tablets (16.4
mm x 6.3 mm) on one side
debossed with “3”
10 mg/80 mg tablet: White to off white, capsule shaped tablets (17.0
mm x 8.0 mm) on one side
debossed with “4”
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ezetimibe/Atorvastatine GL 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 GL is 1 tablet per
day.
2
The maximum recommended dose of Ezetimibe/Atorvastatine GL 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 GL.
Ezetimibe/Atorvastatine GL is not suitable for initial therapy.
Treatment initiation or dose adjustment
if necessar