ROSUVASTATIN DSM SINOCHEM

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

ROSUVASTATIN CALCIUM

Beschikbaar vanaf:

DSM Sinochem Pharmaceuticals Netherlands B.V.

ATC-code:

C10AA07

INN (Algemene Internationale Benaming):

ROSUVASTATIN CALCIUM

Dosering:

40 Milligram

farmaceutische vorm:

Film Coated Tablet

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

rosuvastatin

Autorisatie-status:

Not Marketed

Autorisatie datum:

2016-10-14

Bijsluiter

ROSUVASTATIN
5 MG, 10 MG, 20 MG, 40 MG
FILM-COATED TABLET
1.3.1 SMPC, LABELLING
AND PACKAGE LEAFLET
DSM SINOCHEM PHARMACEUTICALS NETHERLANDS B.V
Version no. 1.4
Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROSUVASTATIN 5 MG FILM-COATED TABLETS
ROSUVASTATIN 10 MG FILM-COATED TABLETS
ROSUVASTATIN 20 MG FILM-COATED TABLETS
ROSUVASTATIN 40 MG FILM-COATED TABLETS
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 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, or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Rosuvastatin

is and what it is used for
2.
What you need to know before you take Rosuvastatin

3.
How to take Rosuvastatin

4.
Possible side effects
5.
How to store Rosuvastatin

6.
Contents of the pack and other information.
1.
WHAT ROSUVASTATIN

IS AND WHAT IT IS USED FOR
Rosuvastatin

belongs to a group of medicines called statins.
YOU HAVE BEEN PRESCRIBED ROSUVASTATIN
BECAUSE:
-
You have a high cholesterol level. This means you are at risk from a
heart attack
or stroke. Rosuvastatin

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
taking more exercise were not
enough to correct your cholesterol levels. You should continue with
your cholesterol-lowering diet and
exercise while you are taking Rosuvastatin

.
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

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rosuvastatin DSM Sinochem 40 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg of rosuvastatin (as
Rosuvastatin Calcium).
Excipients with known effect: Each film-coated tablet contains 160.00
mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
White, round, biconvex, film-coated tablets, and 9.0 mm±0.5 mm in
diameter.
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.
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
Posology
Before treatment initiation the patient should be placed on a standard
cholesterol-lowering diet that should continue
during treatment. The dose should be individualised according to the
goal of therapy and patient response, using current
consensus guidelines.
_Treatment of hypercholesterolaemia_
The recommended start dose is 5 mg or 10 mg orally once daily in both
statin naïve or patients switched from another
HMG CoA reductase inhibitor. The choice of start dose should take into
account the individual patient's cholesterol
level and future cardiovascular risk as well as the potential risk for
adverse reactions (see below). A dose adjustment to
the next dose level can