Rosuvastatine/Omega-3 vetzuren ethylesters 90 Kuhnil 5 mg/1000 mg, zachte capsules

Country: Belanda

Bahasa: Belanda

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

Bahan aktif:

OMEGA-3-ZUREN ETHYLESTERS 90 1000 mg/stuk ; ROSUVASTATINE CALCIUM 0-WATER 5,2 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 5 mg/stuk

Boleh didapati daripada:

Oy Medfiles Ltd Volttikatu 5 70700 KUOPIO (FINLAND)

INN (Nama Antarabangsa):

OMEGA-3-ZUREN ETHYLESTERS 90 1000 mg/stuk ; ROSUVASTATINE CALCIUM 0-WATER 5,2 mg/stuk SAMENSTELLING overeenkomend met ; ROSUVASTATINE 5 mg/stuk

Borang farmaseutikal:

Capsule, zacht

Komposisi:

BASISCH GEBUTYLEERD METHACRYLAAT COPOLYMEER (E 1205) ; GELATINE (E 441) ; GLYCEROL (E 422) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MAGNESIUMOXIDE (E 530) ; SOJABOONOLIE (E 479b) ; TOCOFEROL, D-ALFA (E 307) ; TRIETHYLCITRAAT (E 1505) ; WATER, GEZUIVERD, BASISCH GEBUTYLEERD METHACRYLAAT COPOLYMEER ; GELATINE (E 441) ; GLYCEROL (E 422) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MAGNESIUMOXIDE (E 530) ; SOJABOONOLIE ; TOCOFEROL, D-ALFA (E 307) ; TRIETHYLCITRAAT (E 1505) ; WATER, GEZUIVERD

Laluan pentadbiran:

Oraal gebruik

Tarikh kebenaran:

1900-01-01

Risalah maklumat

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROSUVASTATINE/OMEGA-3 VETZUREN ETHYLESTERS 90 KUHNIL 5 MG/1000 MG,
ZACHTE CAPSULES
rosuvastatin/omega-3-acid ethyl esters 90
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Rosuvastatine/Omega-3 vetzuren ethylesters 90 Kuhnil is and what
it is used for
2.
What you need to know before you take Rosuvastatine/Omega-3 vetzuren
ethylesters 90 Kuhnil
3.
How to take Rosuvastatine/Omega-3 vetzuren ethylesters 90 Kuhnil
4.
Possible side effects
5.
How to store Rosuvastatine/Omega-3 vetzuren ethylesters 90 Kuhnil
6.
Contents of the pack and other information
1.
WHAT ROSUVASTATINE/OMEGA-3 VETZUREN ETHYLESTERS 90 KUHNIL IS AND WHAT
IT IS USED FOR
Rosuvastatine/Omega-3 vetzuren ethylesters 90 Kuhnil contains the
active ingredients rosuvastatin
and omega-3-acid ethyl esters 90. Rosuvastatin belongs to a group of
medicines called statins. Omega-
3-acid ethyl esters 90 belong to a group of so called reducers of
cholesterol and triglycerides.
You have been prescribed Rosuvastatine/Omega-3 vetzuren ethylesters 90
Kuhnil for the treatment of
high cholesterol and triglyceride levels in your blood.
If you have high cholesterol and triglyceride levels, it means you are
at risk from a heart attack or
stroke. You have been advised to take Rosuvastatine/Omega-3 vetzuren
ethylesters 90 Kuhnil, because
changing your diet and taking more exercise were not enough to correct
your cholesterol and
triglyceride levels. You should continue with your
cholesterol-lowering d

Ciri produk

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rosuvastatine/Omega-3 vetzuren ethylesters 90 Kuhnil 5 mg/1000 mg,
zachte capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 5 mg rosuvastatin (as rosuvastatin calcium)
and 1000 mg omega-3-acid
ethyl esters 90 (comprising 460 mg eicosapentaenoic acid (EPA), 380 mg
docosahexaenoic acid
(DHA) and 4 mg alpha tocopherol).
Excipient with known effect:
The anti-oxidant alpha tocopherol is derived from soy beans. The soft
capsule may therefore contain
traces of soybean oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, soft (capsule)
White, film-coated, oblong-shaped soft capsules, 23.5±2.0 mm x
9,5±1.0 mm in size, filled with light
yellow oil.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rosuvastatine/Omega-3 vetzuren ethylesters 90 Kuhnil is indicated as
substitution therapy for the
treatment of mixed hyperlipidaemia (type IIb) in adult patients
adequately controlled with rosuvastatin
and omega-3-acid ethyl esters 90 given concurrently at the same dose
level.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
The recommended dose is 4 capsules daily.
Rosuvastatine/Omega-3 vetzuren ethylesters 90 Kuhnil should not be
used for initiating treatment of
mixed hyperlipidaemia (type IIb). Patients should be adequately
controlled with each component
given concurrently before initiating treatment with
Rosuvastatine/Omega-3 vetzuren ethylesters 90
Kuhnil.
In order to avoid gastrointestinal disturbances, administer capsules
with food.
_ _
_Elderly population_
There is limited clinical data regarding the use of omega-3-acid ethyl
esters 90 in elderly patients over
70 years of age (see section 4.4).
2
_Patients with renal insufficiency _
No dose adjustment is necessary for rosuvastatin in patients with mild
to moderate renal impairment.
The use of rosuvastatin in patients with severe renal impairment is
contraindicated for all doses (see
sections 4.3 and 5.2).
There is limited clinical