VASTINOR TABLET 5MG

Страна: Малайзія

мова: англійська

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

Активний інгредієнт:

ROSUVASTATIN CALCIUM

Доступна з:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

ІПН (Міжнародна Ім'я):

ROSUVASTATIN CALCIUM

Одиниць в упаковці:

3 x 10 Tablets

Виробник:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

інформаційний буклет

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
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___________________________________________________________________________________________________________________________
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1
WHAT IS IN THIS LEAFLET
1.
What is Vastinor Tablet used for
2.
How Vastinor Tablet works
3.
Before you use Vastinor Tablet
4.
How to use Vastinor Tablet
5.
While you are using Vastinor Tablet
6.
Side effects
7.
Storage and Disposal of Vastinor
Tablet
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
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WHAT IS VASTINOR TABLET USED FOR
You
have
been
prescribed
Vastinor
because:
-
You have a high cholesterol level. This
means you are at risk from 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
Vastinor, 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.
HOW VASTINOR TABLET WORKS
Rosuvastatin
is
the
drug
classified
as
statins. It works by blocking HMG-CoA
enzyme
that
involves
in
cholesterol
production. Therefore, less cholesterol is
made and reduces cholesterol levels in the
blood.
BEFORE YOU USE VASTINOR TABLET
-
_When you must not use it _
Do not take Vastinor Tablet if you:
•
are
allergic
(hypersensitive)
to
Rosuvastatin or any ingredients in this
medicine.
•
are taking cyclosporine
•
have active liver disease.
•
have severe renal impairment
•
have repeated or unexplained muscle
aches or pains.
•
are
pregnant
or
plan
to
become
pregnant.
•
are
breast-feeding
or
plan
to
start
breast-feeding.
-
_Before you start to use it _
Tell your doctor or pharmacist:
-
If you are pregnant or plan to become
pregnant.
-
If you are breast-feeding or

Характеристики продукта

Important information. Please read carefully.
_VASTINOR TABLET _
_ _
FILM-COATED TABLET 5MG/ 10MG/20MG
COMPOSITION
_Vastinor Tablet 5mg_
:
Each film-coated tablet contains 5mg Rosuvastatin (as Rosuvastatin
Calcium).
_Vastinor Tablet 10mg_
:
Each film-coated tablet contains 10mg Rosuvastatin (as Rosuvastatin
Calcium).
_Vastinor Tablet 20mg_
:
Each film-coated tablet contains 20mg Rosuvastatin (as Rosuvastatin
Calcium).
PHARMACODYNAMICS
Pharmacotherapeutic group: HMG-CoA reductase inhibitors
ATC code: C10A A07
Rosuvastatin is a selective and competitive inhibitor of
Hydroxymethylglutaryl coenzyme A
(HMG-CoA) reductase (or statin) where the rate limiting enzyme that
converts 3-hydroxy-3-
methylglutaryl coenzyme A to mevalonate, a precursor for cholesterol.
The primary site of
action of rosuvastatin is the liver, the target organ for cholesterol
lowering. Rosuvastatin
increases the number of hepatic LDL receptors on the cell surface,
enhancing uptake and
catabolism of LDL and it inhibits the hepatic synthesis of VLDL,
thereby reducing the total
number of VLDL and LDL particles.
PHARMACOKINETICS
Rosuvastatin is incompletely absorbed from the gastrointestinal tract,
with an absolute
bioavailability of about 20%. Peak plasma concentrations are achieved
about 5 hours after an
oral dose.
It is taken up extensively by the liver, its primary site of action,
and undergoes limited
metabolism,
mainly
by
the
cytochrome
P450
isoenzyme
CYP2C9.
Mean
volume
of
distribution at steady state of rosuvastatin is approximately 134 L.
It is about 90% bound to
plasma proteins.
The plasma elimination half-life of rosuvastatin is about 19 hours.
About 90% of an oral dose
of rosuvastatin appears in the faeces, including absorbed and
non-absorbed drug, and the
remainder is excreted in the urine; about 5% of a dose is excreted
unchanged in urine.
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INDICATIONS
Vastinor Tablet (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