Ridutrin 40 mg/10 mg capsule, hard

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

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

Beschikbaar vanaf:

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

ATC-code:

C10BA06

INN (Algemene Internationale Benaming):

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

farmaceutische vorm:

Capsule, hard

Samenstelling:

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),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Rosuvastatin and ezetimibe

Product samenvatting:

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);

Autorisatie datum:

2014-08-11

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RIDUTRIN 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 Ridutrin is and what it is used for
2.
What you need to know before you take Ridutrin
3.
How to take Ridutrin
4.
Possible side effects
5.
How to store Ridutrin
6.
Contents of the pack and other information
1.
WHAT RIDUTRIN IS AND WHAT IT IS USED FOR
Ridutrin 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.
Ridutrin 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 the heart
or brain leading to a heart attack or a stroke. By lowering your
cholesterol levels, you can reduce your risk
of having a heart attack, a stroke or re

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ridutrin 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
c
oloured 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.
CL
INICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Primary hypercholesterolemia: _
Ridutrin 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:_
Ridutrin 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
Ridutrin 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 Ridutrin.
The recommended daily dose is one capsule
_ _
of the given strength
_ _
with or without food.
2
Ridutrin are not suitable f