SIMVOR TABLETS 10MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

SIMVASTATIN

Boleh didapati daripada:

RANBAXY (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

SIMVASTATIN

Unit dalam pakej:

50 Tablets; 100 Tablets; 30 Tablets

Dikeluarkan oleh:

RANBAXY (MALAYSIA) SDN. BHD.

Risalah maklumat

SIMVOR TABLETS
Page 1
SIMVOR TABLETS
(Simvastatin 10/ 20/ 40 mg)
Consumer Medication Information Leaflet (RiMUP)
WHAT IS IN THIS LEAFLET
1.
What
SIMVOR
TABLETS
are
used for
2.
How
SIMVOR
TABLETS
work
3.
Before
you
use
SIMVOR
TABLETS
4.
How to use
SIMVOR TABLETS
5.
While
you
are
using
SIMVOR
TABLETS
6.
Side Effects
7.
Storage and Disposal of
SIMVOR
TABLETS
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
11.
Serial No.
This
leaflet
answers
some
common
questions about
SIMVOR TABLETS
.
It
does
not
contain
all
the
available
information.
SIMVOR
TABLETS
contains
simvastatin.
IF YOU HAVE ANY CONCERNS ABOUT TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR
OR
PHARMACIST.
KEEP THIS LEAFLET WITH
THE MEDICINE.
You may need to read it again.
WHAT SIMVOR TABLETS ARE USED
FOR
SIMVOR TABLETS
are used in people
who have coronary heart disease (CHD)
or who are at high risk of CHD (for
example, if they have diabetes, a history
of stroke, or other blood vessel disease)
to:

help prolong life by reducing the risk
of a heart attack

reduce the risk of stroke

reduce the need for surgery to increase
blood flow to the heart

reduce the need for hospitalisation due
to angina.
SIMVOR
TABLETS
are
used
along
with 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.
Your doctor should exclude other causes
of
high
cholesterol
level
before
start
therapy with
SIMVOR TABLETS
.
HOW SIMVOR TABLETS WORK
Simvastatin
belongs
to
a
group
of
medicines known as statins. Simvastatin
is a medicine used to lower levels of
total cholesterol, “bad” cholesterol (LDL
cholesterol), and fatty substances called
triglycerides in the blood. In addition,
simvastatin
raises
levels
of
“good”
cholesterol (HDL cholesterol).
Ask
your
doctor
if
you
have
any
questi

Ciri produk

_For the use only of a Registered Medical Practitioner _
PRESCRIBING INFORMATION
SIMVOR TABLETS
(Simvastatin 10 / 20/ 40 mg)
COMPOSITION
SIMVOR TABLETS 10 MG
Each film-coated tablet contains
Simvastatin USP………….10mg
_Inactive _
_components_:
Microcrystalline
Cellulose,
Pregelatinised
Starch,
Magnesium
Stearate,
Purified
Water,
Butylated
Hydroxyanisole,
Isopropyl
Alcohol,
Low
Subtituted
Hydroxypropyl
Cellulose, Opadry Pink OY-LS-54901, Lactose DC Grade and Lactose
Monohydrate.
SIMVOR TABLETS 20 MG
Each film-coated tablet contains
Simvastatin USP………….20mg
_Inactive _
_components_:
Microcrystalline
Cellulose,
Pregelatinised
Starch,
Magnesium
Stearate,
Purified
Water,
Butylated
Hydroxyanisole,
Isopropyl
Alcohol,
Low
Subtituted
Hydroxypropyl
Cellulose, Opadry Brown OY-LS-56504, Lactose DC Grade and Lactose
Monohydrate
SIMVOR TABLETS 40 MG
Each film-coated tablet contains
Simvastatin USP …………40mg
_Inactive _
_components_:
Microcrystalline
Cellulose,
Pregelatinised
Starch,
Magnesium
Stearate,
Purified
Water,
Butylated
Hydroxyanisole,
Isopropyl
Alcohol,
Low
Subtituted
Hydroxypropyl
Cellulose, Opadry Pink OY-LS-54902, PEG 400, Lactose DC Grade and
Lactose Monohydrate
PRODUCT DESCRIPTION
SIMVOR TABLETS 10 MG
Light pink coloured film coated oval shaped tablets, debossed with
‘10’ on one side and score line
on the other side.
SIMVOR TABLETS 20 MG
Peach coloured film coated oval shaped tablets, debossed with ‘20’
on one side and score line on
the other side.
SIMVOR TABLETS 40 MG
Pink coloured film coated oval shaped tablets, debossed with ‘40’
on one side and score line on the
other side.
DESCRIPTION
Simvastatin is a lipid-lowering agent that is derived synthetically
from a fermentation product of
_Aspergillus terreus_. After oral ingestion, simvastatin, which is an
inactive lactone, is hydrolyzed to
the corresponding β-hydroxyacid form. Simvastatin is butanoic acid,
2, 2-dimethyl-,1,2,3,7,8,8a-
hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2_H_-pyran-2-yl)-ethyl]-1-naphthalenyl
e