Rosuvastatin Sandoz 20mg Film Coated Tablet

Country: Малезија

Језик: Енглески

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

Активни састојак:

ROSUVASTATIN CALCIUM

Доступно од:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Међународно име):

ROSUVASTATIN CALCIUM

Јединице у пакету:

28 Tablets; 30 Tablets

Произведен од:

LEK PHARMACEUTICALS D.D.

Информативни летак

ROSUVASTATIN SANDOZ FILM-COATED TABLETS
Rosuvastatin calcium (10 mg and 20 mg)
1
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET
1.
What is Rosuvastatin Sandoz used
for
2.
How Rosuvastatin Sandoz works
3.
Before you use Rosuvastatin
Sandoz
4.
How to use Rosuvastatin Sandoz
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
Rosuvastatin Sandoz
8.
Product description
9.
Manufacturer & Product
Registration Holder
10.
Date of revision
WHAT IS ROSUVASTATIN
SANDOZ USED FOR
You have been prescribed
Rosuvastatin Sandoz because either:
(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
Sandoz.
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 SANDOZ
WORKS
Rosuvastatin Sandoz belongs to a
group of medicines called statins.
There are different types of
cholesterol found in the blood,
including – ‘bad’ cholesterol (LDL-
C) and ‘good’ cholesterol (HDL-C).
•
Rosuvastatin Sandoz can reduce
the ‘bad’ cholesterol and increase
the ‘good’ cholesterol.
•
It works by helping to block
your body’s production of ‘bad’
cholesterol in the liver. It also
improves your body’s ability to
remove it from your blood.
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 t

Карактеристике производа

PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Rosuvastatin Sandoz 10 mg film-coated tablets
Rosuvastatin Sandoz 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rosuvastatin Sandoz 10 mg film-coated tablets
Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin
calcium).
Each film-coated tablet contains 52.92 mg lactose anhydrous.
Rosuvastatin Sandoz 20 mg film-coated tablets
Each film-coated tablet contains 20 mg rosuvastatin (as rosuvastatin
calcium).
Each film-coated tablet contains 105.84 mg lactose anhydrous.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Rosuvastatin Sandoz 10 mg film-coated tablets
Brown, round, film-coated tablets with “RSV 10” debossed on one
side.
Rosuvastatin Sandoz 20 mg film-coated tablets
Brown, round, film-coated tablets with “RSV 20” debossed on one
side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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 e.g., an elevated hsCRP level,
age, hypertension, low HDL-C,
smoking or a family history of premature coronary heart disease.
Rosuvastatin Sandoz is indicated to
reduce total mortality and the risk of major cardiovascular events
(cardiovascular death, stroke, myocardial
infarction (MI), unstable angina, or arterial revascularization).
As an adjunct to diet for the treatment of patients with primary
dysbetalipoproteinemia (type III
hyperlipoproteinemia).
Primary hypercholesterolaemia.
Combined (mixed) dyslipidemia (type IIb).
Homozygous familial hypercholesterolaemia where Rosuvastatin Sandoz