Ezetimibe/Atorvastatine Rafarm 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:

Rafarm SA 12 Kapodistriou str. Korinthou str. 15451 N. PSYCHIKO - ATHENS (GRIEKENLAND)

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:

2019-10-24

Bijsluiter

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
EZETIMIBE/ATORVASTATINE RAFARM 10 MG/ 10 MG, TABLETTEN
EZETIMIBE/ATORVASTATINE RAFARM 10 MG/ 20 MG, TABLETTEN
EZETIMIBE/ATORVASTATINE RAFARM 10 MG/ 40 MG, TABLETTEN
EZETIMIBE/ATORVASTATINE RAFARM 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 [Invented name] is and what it is used for
2.
What you need to know before you take [Invented name]
3.
How to take [Invented name]
4.
Possible side effects
5.
How to store [Invented name]
6.
Contents of the pack and other information
1.
WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
[Invented name] is a medicine to lower increased levels of
cholesterol. [Invented name] contains
ezetimibe and atorvastatin.
[Invented name] is used in adults to lower levels of total
cholesterol, “bad” cholesterol (LDL
cholesterol), and fatty substances called triglycerides in the blood.
In addition, [Invented name] raises
levels of “good” cholesterol (HDL cholesterol).
[Invented name] 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 arteries
forming plaque. Eventually this plaque build-up can lead to a
narrowi

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ezetimibe/Atorvastatine Rafarm 10 mg/ 10 mg, tabletten
Ezetimibe/Atorvastatine Rafarm 10 mg/ 20 mg, tabletten
Ezetimibe/Atorvastatine Rafarm 10 mg/ 40 mg, tabletten
Ezetimibe/Atorvastatine Rafarm 10 mg/ 80 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
tablet
contains 10
mg
of
ezetimibe
and
10,
20, 40 or
80 m g
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
[Invented name] 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 [Invented name] is 1 tablet per day.
The maximum recommended dose of [Invented name] 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 [Invented name].
[Invented name] is not suitable for initial therapy. Treatment
initiation or dose adjustment if necessary
should only be done with the monocomponents a