Rosuvastatine STADA 10 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ROSUVASTATINE CALCIUM 0-WATER SAMENSTELLING overeenkomend met ; ROSUVASTATINE

Beschikbaar vanaf:

Stada Arzneimittel AG

ATC-code:

C10AA07

INN (Algemene Internationale Benaming):

ROSUVASTATIN CALCIUM 0-WATER COMPOSITION corresponding to ; ROSUVASTATIN

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, GEPOEDERD (E 460) ; COPOVIDON ; CROSPOVIDON (E 1202) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Rosuvastatin

Product samenvatting:

Hulpstoffen: CELLULOSE, GEPOEDERD (E 460); COPOVIDON; CROSPOVIDON (E 1202); LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2015-02-12

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Rosuvastatine STADA 5mg, filmomhulde tabletten
Rosuvastatine STADA 10mg, filmomhulde tabletten
Rosuvastatine STADA 20mg, filmomhulde tabletten
Rosuvastatin
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 PRODUCT NAME is and what it is used for
2. What you need to know before you take PRODUCT NAME
3. How to take PRODUCT NAME
4. Possible side effects
5. How to store PRODUCT NAME
6. Contents of the pack and other information
1. WHAT PRODUCT NAME IS AND WHAT IT IS USED FOR
PRODUCT NAME contains the active ingredient rosuvastatin, which
belongs to a group of
medicines called statins.
YOU HAVE BEEN PRESCRIBED PRODUCT NAME BECAUSE:

You have a high cholesterol level. This means you are at risk from a
heart attack or
stroke. PRODUCT NAME is used in adults, adolescents and children 6
years or older to
treat high cholesterol.
You have been advised to take a statin, because changing your diet and
doing more
exercise were not enough to correct your cholesterol levels. You
should continue with your
cholesterol-lowering diet and exercise while you are taking PRODUCT
NAME.
Or

You have other factors that increase your risk of having a heart
attack, stroke or related
health problems.
Heart attack, stroke and other problems can be caused by a disease
called atherosclerosis.
Atherosclerosis is due to build-up of fatty deposits in your arteries.
WHY IT IS IMPORTANT TO KEEP TAKING PRODUCT NAME
PRODUCT NAME is used to correct the levels of fatty substances in the
bloo

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Rosuvastatine STADA 5mg, filmomhulde tabletten
Rosuvastatine STADA 10mg, filmomhulde tabletten
Rosuvastatine STADA 20mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mg: Each film-coated tablet contains 5 mg rosuvastatin (as
rosuvastatin calcium).
Excipient with known effect: Each tablet contains 41 mg lactose
monohydrate.
10 mg: Each film-coated tablet contains 10 mg rosuvastatin (as
rosuvastatin calcium).
Excipient with known effect: Each tablet contains 83 mg lactose
monohydrate.
20 mg: Each film-coated tablet contains 20 mg rosuvastatin (as
rosuvastatin calcium).
Excipient with known effect: Each tablet contains 165 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
PRODUCT NAME 5 mg are white, round, biconvex film-coated tablets with
a diameter of
5 mm.
PRODUCT NAME 10 mg are white, round, biconvex film-coated tablets with
a diameter of
7 mm.
PRODUCT NAME 20 mg are white, round, biconvex film-coated tablets with
a diameter of
9 mm.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TREATMENT OF HYPERCHOLESTEROLAEMIA
Adults, adolescents and children aged 6 years or older with primary
hypercholesterolaemia
(type IIa including heterozygous familial hypercholesterolaemia) or
mixed dyslipidaemia (type
IIb) as an adjunct to diet when response to diet and other
non-pharmacological treatments
(e.g. exercise, weight reduction) is inadequate.
Adults,
adolescents
and
children
aged
6 years
or
older
with
homozygous
familial
hypercholesterolaemia as an adjunct to diet and other lipid lowering
treatments (e.g. LDL
apheresis) or if such treatments are not appropriate.
PREVENTION OF CARDIOVASCULAR EVENTS
Prevention of major cardiovascular events in patients who are
estimated to have a high risk
for a first cardiovascular event (see section 5.1), as an adjunct to
correction of other risk
factors.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Before treatment initiation the p