VASCOR TABLET 20MG FC

Ülke: Malezya

Dil: İngilizce

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

Aktif bileşen:

SIMVASTATIN

Mevcut itibaren:

DUOPHARMA (M) SDN. BHD.

INN (International Adı):

SIMVASTATIN

Paketteki üniteler:

3 x 10 Tablets; 10 x 10 Tablets; 12 x 10 Tablets

Tarafından üretildi:

DUOPHARMA (M) SDN. BHD.

Bilgilendirme broşürü

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
VASCOR TABLET 20MG FILM COATED
Simvastatin (20mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What
VASCOR
TABLET
is used for
2.
How
VASCOR
TABLET
works
3.
Before you use VASCOR
TABLET
4.
How
to
use
VASCOR
TABLET
5.
While
you
are
using
VASCOR TABLET
6.
Side effects
7.
Storage
and
disposal
of
VASCOR TABLET
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT VASCOR TABLET IS
USED FOR
VASCOR
TABLET
helps
to
lower cholesterol.
VASCOR TABLET is used in
people
who
have
coronary
heart
disease
(CHD)
[plaque
builds
up
in
the
coronary
arteries] or who are at high risk
of CHD (for example, if they
have
diabetes,
a
history
of
stroke,
or
other
blood
vessel
disease).
VASCOR
TABLET
may
be
used in these people, regardless
of their cholesterol level to:

help
prolong
life
by
reducing the risk of a heart
attack

the reduce risk of stroke

reduce the need for surgery
to
increase
blood
flow
to
the heart
HOW
VASCOR
TABLET
WORKS
VASCOR TABLET belongs to
a group of medicines known as
HMG-CoA
reductase
inhibitors.
It
works
by
reducing
the
amount
of
cholesterol made by the liver.
VASCOR
TABLET
reduces
the
bad
cholesterol
(LDL-C)
and raises the good cholesterol
(HDL-C).
BEFORE
YOU
USE
VASCOR
TABLET
_-_
_ _
_When you must not use it _
Do
not
use
VASCOR
TABLET if you are allergic to
simvastatin or any of the other
ingredients listed at the end of
the leaflet.
Symptoms
of
an
allergic
reaction may include skin rash,
itchiness,
short
of
breath,
swelling of the tongue or face,
or painful joints.
Do
not
used
VASCOR
TABLET
if
you
have
had
muscle
pain,
tenderness
or
weakness from other medicines
used to treat high cholesterol or
triglycerides
_-_
_ _
_Before you start to use it _
Before
taking
VASCOR
TABLET, you must tell your
doctor
or
pharmacist
if
you
have, or have had, any of the
following conditions:

Active liver disease

Kidney disease

Drink alcohol regularly

Allergic
to
any
other
medicines
or
any
other
substances, such as foods,
p

Ürün özellikleri

[DUOPHARMA (M) SDN BHD]
Page 1 of 3
[REVISION DATE: 29.07.2020]
VASCOR TABLET 20MG F/C
DESCRIPTION: VASCOR TABLET 20MG F/C: 11mm, oval, scored and marked
‘20’ on one side, and marked ‘VAS’ on the other side, orange
film-coated tablet.
COMPOSITION: Each tablet contains 20mg of Simvastatin.
PHARMACODYNAMICS: The active form of Simvastatin is a specific
inhibitor of HMG-CoA Reductase, the enzyme which catalyzes the
conversion of HMG-CoA to mevalonate.
However, at therapeutic doses, the enzyme is not completely blocked,
thereby allowing biologically necessary amount of mevalonate to be
available. Because the conversion of HMG-
CoA to mevalonate is an early step in the biosynthetic pathway of
cholesterol, therapy with simvastatin would not be expected to cause
an accumulation of potentially toxic sterols. In
addition, HMG-CoA is metabolized readily back to acetyl-CoA, that
participates in many biosynthetic processes in the body.
Although cholesterol is the precursor of all steroid hormones,
simvastatin has not been shown to have any clinical effect on
steroidogenesis. Simvastatin caused no increase in billiary
lithogenicity and, therefore, would not be expected to increase the
incidence of gallstones.
PHARMACOKINETICS: Simvastatin is an inactive lactone which is readily
hydrolyzed in vivo to the corresponding ß-hydroxyacid, L-654,969, a
potent inhibitor of HMG-CoA reductase.
Inhibition of HMG-CoA reductase is the basis for an assay in
pharmacokinetic studies of the ß-hydroxyacid metabolites (active
inhibitors) and, following base hydrolysis, active plus
latent inhibitors (total inhibitors). Both are measured in plasma
following administration of simvastatin.
In a disposition study with
14
C-labeled simvastatin, 100 mg (20 µCi) of drug was administered as
capsules (5 X 20 mg), and blood, urine, and feces collected. Thirteen
percent of the
radioactivity was recovered in the urine and 60% in feces. The latter
represents absorbed drug equivalents excreted in bile as well as
unabsorbed drug. Less than 0.5% of th