Rosuvastatin Stella Film-Coated Tablet 10mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

ROSUVASTATIN CALCIUM

Boleh didapati daripada:

STADPHARM SDN. BHD.

INN (Nama Antarabangsa):

ROSUVASTATIN CALCIUM

Unit dalam pakej:

3 x 10'stablet Tablets

Dikeluarkan oleh:

STELLAPHARM J.V. Co., LTD. - BRANCH 1

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ROSUVASTATIN STELLA FILM-COATED
TABLET 10MG
Rosuvastatin (as rosuvastatin calcium) 10 mg
Page no. 1
WHAT IS IN THIS LEAFLET
1.
What Rosuvastatin STELLA
Film-Coated Tablet 10mg is used for
2.
How Rosuvastatin STELLA
Film-Coated Tablet 10mg works
3.
Before you use Rosuvastatin
STELLA Film-Coated Tablet 10mg
4.
How to use Rosuvastatin STELLA
Film-Coated Tablet 10mg
5.
While you are using Rosuvastatin
STELLA Film-Coated Tablet 10mg
6.
Side effects
7.
Storage and Disposal of
Rosuvastatin STELLA Film-
Coated Tablet 10mg
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of Revision
WHAT ROSUVASTATIN STELLA FILM-
COATED TABLET 10MG IS USED FOR
You have been prescribed
Rosuvastatin STELLA Film-Coated
Tablet 10mg because:
a)
You have a high cholesterol level.
This means you are at risk of
getting a heart attack or stroke.
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 STELLA Film-
Coated Tablet 10mg. Or
b)
You have other factors that
increase your risk of getting 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.
HOW ROSUVASTATIN STELLA FILM-
COATED TABLET 10MG WORKS
This medicine is used to correct the
levels of fatty substances in the blood
called lipids, the most common of
which is cholesterol.
There are different types of cholesterol
found in the blood – ‘bad’ cholesterol
(LDL-C) and ‘good’ cholesterol
(HDL-C).

This medicine can reduce the ‘bad’
cholesterol and increase the ‘good’
cholesterol.

It works by helping to block your
body’s production of ‘bad’
cholesterol. It also improves your
body’s ability to remove it from your
blood.
For most people, hi

Ciri produk

32.5 mm
_RX PRESCRIPTION ONLY _
1.
NAME OF THE MEDICINAL PRODUCT
ROSUVASTATIN STELLA FILM-COATED TABLET 10MG
2.
SPECIAL NOTICE AND RECOMMENDATION
Keep out of reach of children
Read the package insert carefully before use
3.
COMPOSITION
Each film-coated tablet contains:
Rosuvastatin
...........................................................................
10 mg
_(as rosuvastatin calcium 10.4 mg)_
4.
PHARMACEUTICAL FORM
Film-coated tablet.
Light red, round-shaped, film-coated tablet, biconvex, breakable line
on one side and plain on the other side.
5.
INDICATIONS
Rosuvastatin is indicated as an adjunct to diet, at least equivalent
to the
Adult Treatment Panel III (ATP III TLC diet), for the reduction of
elevated
total cholesterol, LDL-cholesterol, ApoB, the total cholesterol: HDL-
cholesterol ratio and triglycerides and for increasing HDL-C, in
hyperlipidemic and dyslipidemic conditions, when response to diet
and exercise alone has been inadequate including:
Prevention of Cardiovascular Events. In adult patients with an
increased risk of atherosclerotic cardiovascular disease based on
the presence of cardiovascular disease risk markers such as an
elevated hsCRP level, age, hypertension, low HDL-C, smoking or a
family history of premature coronary heart disease, Rosuvastatin is
indicated to reduce total mortality and the risk of major
cardiovascular
events (cardiovascular death, stroke, MI, unstable angina, or arterial
revascularization).
Rosuvastatin is indicated as an adjunct to diet for the treatment of
patients
with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
Primary hypercholesterolaemia (Type IIa including heterozygous
familial
hypercholesterolaemia and severe non-familial hypercholesterolaemia).
Combined (mixed) dyslipidemia (Type IIb).
Homozygous familial hypercholesterolaemia where Rosuvastatin is
used either alone or as an adjunct to diet and other lipid lowering
treatment such as apheresis.
Rosuvastatin is indicated as adjunctive therapy to diet to slow the
progression of atheroscler