Ezetimibe/Atorvastatine Egis 10 mg/10 mg harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ATORVASTATINE CALCIUM 3-WATER 10,8 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 10 mg/stuk ; EZETIMIB 10 mg/stuk

Beschikbaar vanaf:

Egis Pharmaceuticals Kereszturi ut 30-38 H-1106 BUDAPEST (HONGARIJE)

INN (Algemene Internationale Benaming):

ATORVASTATINE CALCIUM 3-WATER 10,8 mg/stuk SAMENSTELLING overeenkomend met ; ATORVASTATINE 10 mg/stuk ; EZETIMIB 10 mg/stuk

farmaceutische vorm:

Capsule, hard

Samenstelling:

CALCIUMCARBONAAT (E 170) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463a) ; HYPROLOSE (E 463) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT ; POLYSORBAAT 80 (E 433) ; POVIDON K 25 (E 1201) ; SACCHAROSE ; SUIKERMAÏSBOLLETJES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CALCIUMCARBONAAT (E 170) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROLOSE (E 463) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; POVIDON K 25 (E 1201) ; SACCHAROSE ; SUIKERMAÏSBOLLETJES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CALCIUMCARBONAAT (E 170) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROLOSE (E 463) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; POVIDON K 25 (E 1201) ; SACCHAROSE ; SUGAR SPHERES ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EZETIMIBE/ATORVASTATINE EGIS 10 MG/10 MG HARDE CAPSULES
EZETIMIBE/ATORVASTATINE EGIS 10 MG/20 MG HARDE CAPSULES
EZETIMIBE/ATORVASTATINE EGIS 10 MG/40 MG HARDE CAPSULES
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 Egis is and what it is used for
2.
What you need to know before you take Ezetimibe/Atorvastatine Egis
3.
How to take Ezetimibe/Atorvastatine Egis
4.
Possible side effects
5.
How to store Ezetimibe/Atorvastatine Egis
6.
Contents of the pack and other information
1.
WHAT EZETIMIBE/ATORVASTATINE EGIS IS AND WHAT IT IS USED FOR
Ezetimibe/Atorvastatine Egis contains two different active substances
in one capsule. One of the active
substances is ezetimibe, the other active substance is atorvastatin,
belonging to the group of so called
statins.
Ezetimibe/Atorvastatine Egis is a medicine used in adults to lower
levels of total cholesterol, “bad”
cholesterol (LDL cholesterol) and fatty substances called
triglycerides in your blood. In addition, it also
raises levels of “good” cholesterol (HDL cholesterol).
This medicine 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.
_ _
For most people, high cholesterol does not affect the way they feel
because it does not produce any
symptoms. However, if it is left untreated, fatty deposits can build
up in the walls of your blood ve

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ezetimibe/Atorvastatine Egis 10 mg/10 mg harde capsules
Ezetimibe/Atorvastatine Egis 10 mg/20 mg harde capsules
Ezetimibe/Atorvastatine Egis 10 mg/40 mg harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ezetimibe/Atorvastatine Egis 10 mg/10 mg harde capsules
Each hard capsule contains 10 mg ezetimibe and 10 mg of atorvastatin
(as atorvastatin calcium trihydrate).
Ezetimibe/Atorvastatine Egis 10 mg/20 mg harde capsules
Each hard capsule contains 10 mg ezetimibe and 20 mg of atorvastatin
(as atorvastatin calcium trihydrate).
Ezetimibe/Atorvastatine Egis 10 mg/40 mg harde capsules
Each hard capsule contains 10 mg ezetimibe and 40 mg of atorvastatin
(as atorvastatin calcium trihydrate).
Excipient with known effect
Each Ezetimibe/Atorvastatine Egis 10 mg/10 mg capsule contains 13 mg
sucrose.
Each Ezetimibe/Atorvastatine Egis 10 mg/20 mg capsule contains 26 mg
sucrose.
Each Ezetimibe/Atorvastatine Egis 10 mg/40 mg capsule contains 51.5 mg
sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules, hard
Ezetimibe/Atorvastatine Egis 10 mg/10 mg hard capsules:
Unmarked self-closing size 0, hard gelatin capsule with caramel
coloured cap and yellow coloured body,
filled with pellets and a tablet. The length of the capsule is about
21.7 mm.
Ezetimibe/Atorvastatine Egis 10 mg/20 mg hard capsules:
Unmarked self-closing size 0, hard gelatin capsule with reddish brown
coloured cap and yellow coloured
body, filled with pellets and a tablet. The length of the capsule is
about 21.7 mm.
Ezetimibe/Atorvastatine Egis 10 mg/40 mg
hard capsules:
Unmarked self-closing size 0, hard gelatin capsule with dark brown
coloured cap and yellow coloured
body, filled with pellets and a tablet. The length of the capsule is
about 21.7 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ezetimibe/Atorvastatine Egis hard capsules are indicated as adjunct to
diet as substitution therapy for
treatment of adults with primary hypercholesterol