SimvaHEXAL 10mg Film-coated Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

SIMVASTATIN

Boleh didapati daripada:

IMEKS PHARMA SDN. BHD.

INN (Nama Antarabangsa):

SIMVASTATIN

Unit dalam pakej:

40Tablet Tablets; 49Tablet Tablets; 30Tablet Tablets; 28Tablet Tablets; 98Tablet Tablets; 20Tablet Tablets; 100Tablet Tablets; 10Tablet Tablets; 50Tablet Tablets

Dikeluarkan oleh:

Sandoz Grup Saglik Urunleri Ilaclari San. Ve Tic. A.S.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
SIMVAHEXAL
® FILM-COATED TABLET
Simvastatin (10mg, 20mg)
_ _
1
WHAT IS IN THE LEAFLET
1.
What SimvaHEXAL is used for
2.
How SimvaHEXAL works
3.
Before you use SimvaHEXAL
4.
How to use SimvaHEXAL
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of SimvaHEXAL
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT SIMVAHEXAL IS USED FOR
SimvaHEXAL helps to lower cholesterol and
triglyceride levels in your blood.
SimvaHEXAL is used in addition to your
cholesterol-lowering diet if you have:
• a raised cholesterol level in your blood
(primary hypercholesterolaemia) or elevated
fat
levels
in
your
blood
(mixed
hyperlipidaemia).
• a hereditary illness (homozygous familial
hypercholesterolaemia)
that
increases
the
cholesterol level in your blood. You may
also receive other treatments.
• coronary heart disease (CHD) or are at high
risk of
CHD (because
you
have diabetes,
history
of
stroke,
or
other
blood
vessel
disease). SimvaHEXAL may prolong your
life by reducing the risk of heart disease
problems,
regardless
of
the
amount
of
cholesterol in your blood.
HOW SIMVAHEXAL WORKS
SimvaHEXAL contains the active ingredient
Simvastatin, which belongs to a group of
medicines
known
as
HMG-CoA
reductase
inhibitors. It works by reducing the amount
of cholesterol made by the liver. It reduces
‘bad’
(LDL)
cholesterol
and
plasma
triglyceride while raises the ‘good’ (HDL)
cholesterol.
SimvaHEXAL affects only
the cholesterol
and triglycerides made by the liver in your
body. It has
no effect on
cholesterol and
triglycerides that come from fats in food.
Therefore,
when
you
are
taking
SimvaHEXAL, you also need to follow a
low
fat
diet
and
other
measures,
such
as
exercise and weight control.
In most people, there are no symptoms of
high cholesterol or triglycerides. Your doctor
can
measure
your
cholesterol
and
triglycerides with a simple blood test.
BEFORE YOU USE SIMVAHEXAL_ _
-
_When you must not use it_
Do not use SimvaH

Ciri produk

CONTENT
Each SIMVAHEXAL
® 10 MG and SIMVAHEXAL
® 20 MG film-coated tablets contains 10
mg and 20 mg Simvastatin respectively.
DESCRIPTION
SIMVAHEXAL
® 10 MG film-coated tablet: Pale pink coated, oval, scored, convex
tablet
coded SIM 10 on one side.
SIMVAHEXAL
® 20 MG film-coated tablet: Orange coated, oval, scored, convex tablet
coded SIM 20 on one side.
Each tablet can be divided into equal halves.
PHARMACODYNAMICS
After oral ingestion, simvastatin, which is an inactive lactone, is
hydrolysed in the
liver to the corresponding active beta-hydroxyacid form which has a
potent activity
in inhibiting HMG-CoA reductase (3-hydroxy-3-methylglutaryl-CoA
reductase). This
enzyme catalyses the conversion of HMG-CoA to mevalonate, an early and
rate-
limiting step in the biosynthesis of cholesterol.
Simvastatin has been shown to reduce both normal and elevated
low-density
lipoprotein cholesterol (LDL-C) concentrations. LDL is formed from
very-low-density
lipoprotein
(VLDL)
and
is
catabolised
predominantly
by
the
high
affinity
LDL
receptor. The mechanism of the LDL-lowering effect of simvastatin may
involve
both reduction of VLDL-cholesterol (VLDL-C) concentration and
induction of the LDL
receptor, leading to reduced production and increased catabolism of
LDL-C.
Apolipoprotein B also falls substantially during treatment with
simvastatin. In
addition, simvastatin moderately increases high-density lipoprotein
cholesterol
(HDL-C) and reduces plasma triglyceride (TG). As a result of these
changes the ratios
of total- to HDL-C and LDL- to HDL-C are reduced.
PHARMACOKINETICS
Simvastatin
is
an
inactive
lactone
which
is
readily
hydrolysed
_in _
_vivo_
to
the
corresponding
beta-hydroxyacid,
a
potent
inhibitor
of
HMG-CoA
reductase.
Hydrolysis takes place mainly in the liver; the rate of hydrolysis in
human plasma is
very
slow.
The
pharmacokinetic
properties
have
been
evaluated
in
adults.
Pharmacokinetic data in children and adolescents are not available.
Absorption: In man, simvastatin is well absorbed and undergoes
extensive hepati