VASTINOR TABLET 20MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ROSUVASTATIN CALCIUM

Boleh didapati daripada:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

INN (Nama Antarabangsa):

ROSUVASTATIN CALCIUM

Unit dalam pakej:

100 Tablets; 3 x 10 Tablets

Dikeluarkan oleh:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

Risalah maklumat

_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
_ _
_ _
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-f

Ciri produk

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IMPORTANT INFORMATION. PLEASE READ CAREFULLY.
_VAST/NOR_
_™ _
Film-Coated Tablet 5mg/ 10mg/20mg
COMPOSITION
VostinorTab/etSmg:Eachfilm-coatedtabletcontainsSmgRosumtatin(asRosuvastatinCalcium).
_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-CoAreductaseinhibitors
ATC code:ClOA A07
Rosuvastatin Isa selective and competitive inhibitor
ofHydroxymethylglutaryl coenzyme A
(HMG-CoA) reductase
(or
statin) where the rate limiting enzyme that converts
3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a
precursorfor cho!esterol.The primary site ofaction ofrosuvastatin is
the liver,the target organfor cholesterol
lowering.Rosuvastatin increases the number ofhepaticlDLreceptors on
the cell surface,enhancing uptake and
catabolismofLOland itinhibitsthe hepaticsynthesisofVLOLthereby
reduciog thetotal number ofVLDlandlDL
particles.
PHARMACOKJNrncs
Rosuvastatin is incompletely absorbed from the gastrointestinal tract,
with an absolute bioavaUability
of
abollt 20%.
Peakplasma concentrations areachieved aboutShoursafteranoral 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.ltlsabout90%boundto plasma proteins.
The plasma elimination half-lifeofrosuvastatin is about 19 hours.
About 90%of
an oral dose of
rosuvastatin appears
in thefaeces,includingabsorbedand non-absorbed drug.andthe remainder
isexaetedinthe urine;about5%ofa
doseis excretedunchanged inurine.
INDICATIONS
VastinorTablet(rosuvastatin calcium)is indicated as an adjunct to
diet,atleast equivalent to the AdultTreatment
Panelt!l(ATPIIITl(diet),for thereductionofelevatedtotal
cholesterol,LDL-dwlesterol,ApoB,thetotal cholesterol:
HDL-cholesterol
ratio and triglyceride