Rosuvastatine calcium/ezetimibe Egis 10 mg/10 mg harde capsules

Country: Netherlands

Language: Dutch

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

Active ingredient:

EZETIMIB 10 mg/stuk ; ROSUVASTATINE CALCIUM 0-WATER 10,4 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 10 mg/stuk

Available from:

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

ATC code:

C10BA06

INN (International Name):

EZETIMIB 10 mg/stuk ; ROSUVASTATINE CALCIUM 0-WATER 10,4 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 10 mg/stuk

Pharmaceutical form:

Capsule, hard

Composition:

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

Administration route:

Oraal gebruik

Therapeutic area:

Rosuvastatin and ezetimibe

Product summary:

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

Authorization date:

2018-04-25

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROSUVASTATINE CALCIUM/EZETIMIBE EGIS 10 MG/10 MG HARDE CAPSULES
ROSUVASTATINE CALCIUM/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 calcium/ezetimibe Egis is and what it is used for
2.
What you need to know before you take Rosuvastatine calcium/ezetimibe
Egis
3.
How to take Rosuvastatine calcium/ezetimibe Egis
4.
Possible side effects
5.
How to store Rosuvastatine calcium/ezetimibe Egis
6.
Contents of the pack and other information
1.
WHAT ROSUVASTATINE CALCIUM/EZETIMIBE EGIS IS AND WHAT IT IS USED FOR
Rosuvastatine calcium/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 calcium/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 blo

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rosuvastatine calcium/ezetimibe Egis 10 mg/10 mg harde capsules
Rosuvastatine calcium/ezetimibe Egis 20 mg/10 mg harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rosuvastatine calcium/ezetimibe Egis 10 mg/10 mg hard capsules
Each capsule contains 10 mg of rosuvastatin (as rosuvastatin calcium)
and 10 mg of ezetimibe.
Rosuvastatine calcium/ezetimibe Egis 20 mg/10 mg hard capsules
Each capsule contains 20 mg of rosuvastatin (as rosuvastatin calcium)
and 10 mg of ezetimibe.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Rosuvastatine calcium/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. The length of the capsule is about 21.7
mm (±
0.3
mm).
Rosuvastatine calcium/ezetimibe Egis 20 mg/10 mg hard capsules:
Unmarked self-closing Coni Snap
type, size 0, hard gelatin capsule with caramel coloured cap and
yellow coloured body filled with two
tablets. The length of the capsule is about 21.7
mm (±
0.3
mm).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rosuvastatine calcium/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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Rosuvastatine calcium/ezetimibe Egis is indicated in adult patients
whose hypercholesterolemia is
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 calcium/ezetimibe Egis.
The recommended daily dose is one capsule of the given strength with
or without food.