Rosuvastatine/ezetimibe EGIS 40 mg/10 mg capsule, hard

Țară: Țările de Jos

Limbă: olandeză

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

Ingredient activ:

EZETIMIB 10 mg/stuk ; ROSUVASTATINE ZINK 42,72 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 40 mg/stuk

Disponibil de la:

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

Codul ATC:

C10BA06

INN (nume internaţional):

EZETIMIB 10 mg/stuk ; ROSUVASTATINE ZINK 42,72 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 40 mg/stuk

Forma farmaceutică:

Capsule, hard

Compoziție:

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),

Calea de administrare:

Oraal gebruik

Zonă Terapeutică:

Rosuvastatin and ezetimibe

Rezumat produs:

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 de autorizare:

2014-09-12

Prospect

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROSUVASTATINE/EZETIMIBE EGIS 40 MG/10 MG CAPSULE, HARD
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
causing them to narrow.
Sometimes, these narrowed blood vessels can get blocked which can cut
off the blood supply to

Caracteristicilor produsului

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rosuvastatine/ezetimibe EGIS 40 mg/10 mg capsule, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 40 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.
Unmarked self-closing Coni Snap type, size 0, hard gelatin capsule
with red coloured cap and yellow
coloured body filled with three 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; two
pieces of white or almost white round _Rosuvastatin 20 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).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Primary hypercholesterolemia: _
Rosuvastatine/ezetimibe EGIS is indicated as adjunct to diet for
treatment of primary
hypercholesterolemia as substitution therapy in adult patients
adequately controlled with the individual
substances given concurrently at the same dose level as in the fixed
dose combination, but as separate
products.
_ _
_Prevention of cardiovascular events:_
Rosuvastatine/ezetimibe EGIS is indicated as substitution treatment in
adult patients with coronary heart
disease (CHD) and a history of acute coronary syndrome (ACS), who are
adequately controlled with the
individual substances administered simultaneously at the same dose
level as in the fixed combination
medicinal products, but as separate products.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Rosuvastatine/ezetimibe EGIS is indicated in adult patients adequately
controlled with separately
administered monocomponent preparations of the same doses as the
recommended combination.
The patient should be on an appropriate lipid-lowering diet and should
continue on this diet during
treatment with Rosuvastatine/ezetimibe EGIS.
2
The recommended daily dos