Rosuvastatine/ezetimibe EGIS 20 mg/10 mg harde capsules

Nazione: Paesi Bassi

Lingua: olandese

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

Principio attivo:

EZETIMIB 10 mg/stuk ; ROSUVASTATINE ZINK 21,36 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 20 mg/stuk

Commercializzato da:

Egis Pharmaceuticals Plc Kereszturi ut 30-38 1106 BOEDAPEST (HONGARIJE)

Codice ATC:

C10BA06

INN (Nome Internazionale):

EZETIMIB 10 mg/stuk ; ROSUVASTATINE ZINK 21,36 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 20 mg/stuk

Forma farmaceutica:

Capsule, hard

Composizione:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463a) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT (E 487) ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Via di somministrazione:

Oraal gebruik

Area terapeutica:

Rosuvastatin and ezetimibe

Dettagli prodotto:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); GELATINE (E 441); HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); NATRIUMLAURILSULFAAT (E 487); POVIDON K 25 (E 1201); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Data dell'autorizzazione:

2014-09-12

Foglio illustrativo

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROSUVASTATINE/EZETIMIBE EGIS 5 MG/10 MG HARDE CAPSULES
ROSUVASTATINE/EZETIMIBE EGIS 10 MG/10 MG HARDE CAPSULES
ROSUVASTATINE/EZETIMIBE EGIS 20 MG/10 MG HARDE CAPSULES
rosuvastatin and ezetimibe
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 Rosuvastatine/ezetimibe EGIS is and what it is used for
2.
What you need to know before you take Rosuvastatine/ezetimibe EGIS
3.
How to take Rosuvastatine/ezetimibe EGIS
4.
Possible side effects
5.
How to store Rosuvastatine/ezetimibe EGIS
6.
Contents of the pack and other information
1.
WHAT ROSUVASTATINE/EZETIMIBE EGIS IS AND WHAT IT IS USED FOR
Rosuvastatine/ezetimibe EGIS contains two different active substances
in one capsule. One of the active
substances is rosuvastatin, belonging to the group of so-called
statins, the other active substance is
ezetimibe.
Rosuvastatine/ezetimibe EGIS is a medicine used 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 vessels
causin

Scheda tecnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rosuvastatine/ezetimibe EGIS 5 mg/10 mg harde capsules
Rosuvastatine/ezetimibe EGIS 10 mg/10 mg harde capsules
Rosuvastatine/ezetimibe EGIS 20 mg/10 mg harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rosuvastatine/ezetimibe EGIS 5 mg/10 mg hard capsules
Each capsule contains 5 mg of rosuvastatin (as rosuvastatin zinc) and
10 mg of ezetimibe.
Rosuvastatine/ezetimibe EGIS 10 mg/10 mg hard capsules
Each capsule contains 10 mg of rosuvastatin (as rosuvastatin zinc) and
10 mg of ezetimibe.
_ _
Rosuvastatine/ezetimibe EGIS 20 mg/10 mg hard capsules
Each capsule contains 20 mg of rosuvastatin (as rosuvastatin zinc) and
10 mg of ezetimibe.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Rosuvastatine/ezetimibe EGIS 5 mg/10 mg hard capsules: Unmarked
self-closing Coni Snap type, size 0,
hard gelatin capsule with yellow coloured cap and white coloured body
filled with two tablets: one piece
of white or almost white round, flat and bevel-edged _Ezetimibe 10 mg
tablet _with a stylized E sign on one
side of the tablet and 612 code on the other side; one piece of white
or almost white, round _Rosuvastatin _
_5 mg tablet_ with
mark on one side of the tablet and no mark on the other side. The
length of the capsule
is about 21.7 mm (± 0.5 mm).
Rosuvastatine/ezetimibe EGIS 10 mg/10 mg hard capsules: Unmarked
self-closing Coni Snap type, size 0,
hard gelatin capsule with yellow coloured cap and yellow coloured body
filled with two tablets:
one piece
of white or almost white round, flat and bevel-edged _Ezetimibe 10 mg
tablet_ with a stylized E sign on one
side of the tablet and 612 code on the other side; one piece of white
or almost white round _Rosuvastatin _
_10 mg tablet_ with
mark on one side of the tablet and no mark on the other side. The
length of the
capsule is about 21.7 mm (± 0.5 mm).
Rosuvastatine/ezetimibe EGIS 20 mg/10 mg hard capsules: Unmarked
self-closing Coni Snap type, size 0,
hard gelatin ca