CRESTOR 10MG TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ROSUVASTATIN CALCIUM

Boleh didapati daripada:

ASTRAZENECA SDN. BHD.

INN (Nama Antarabangsa):

ROSUVASTATIN CALCIUM

Unit dalam pakej:

28Tablet Tablets

Dikeluarkan oleh:

IPR PHARMACEUTICALS INC

Risalah maklumat

CRESTOR
® TABLET
ROSUVASTATIN 5 MG, 10 MG & 20 MG
_CONSUMER MEDICATION INFORMATION LEAFLET _
_(RIMUP)_
1
WHAT IS IN THIS LEAFLET
1.
What Crestor is used for
2.
How Crestor works
3.
Before you use Crestor
4.
How to use Crestor
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Crestor
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
12.
Serial number
WHAT CRESTOR IS USED FOR
You have been prescribed Crestor
because you have a high
cholesterol level. This means you
are at risk from a heart attack or
stroke.
HOW CRESTOR WORKS
Crestor 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).
•
Crestor 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, 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 the
heart or brain leading to a heart
attack or a stroke. By lowering
your cholesterol levels, you can
reduce your risk of having a heart
attack, a stroke or related health
problems.
You need to keep taking Crestor,
even if it has got your cholesterol
to the right level, because it
prevents your cholesterol levels
from creeping up again and
causing build up of fatty deposits.
BEFORE YOU USE CRESTOR
-
_When you must not use it _
Do not take Crestor:
•
If you have ever had an allergic
reaction to Crestor or similar
medicines, or to any of its
ingredients. Crestor contains
lactose, which may cause a
problem in a small number

Ciri produk

CRESTOR
®
5 mg, 10 mg, 20 mg
Film-coated Tablets
COMPOSITION
Each tablet contains 5 mg, 10 mg or 20 mg of rosuvastatin as
rosuvastatin calcium.
PHARMACEUTICAL FORM
Film-coated tablet.
Round, yellow coloured (5 mg); Round, pink coloured (10 mg and 20 mg).
THERAPEUTIC INDICATIONS
Crestor (rosuvastatin calcium) 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, Crestor is
indicated to reduce total
mortality and the risk of major cardiovascular events (cardiovascular
death, stroke, MI,
unstable angina, or arterial revascularization)
Crestor 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 Crestor is used either
alone or as an
adjunct to diet and other lipid lowering treatment such as apheresis.
Crestor is indicated as adjunctive therapy to diet to slow the
progression of atherosclerosis in
adult patients as part of a treatment strategy to lower Total-C and
LDL-C to target levels.
Pediatric Patients 10 to 17 years of age with Heterozygous Familial
Hypercholesterolemia
(HeFH): Adjunct to diet to reduce Total-C, LDL-C and ApoB levels in
adolescent boys and
girls, who are at l