Kardak Tablet 40 mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Simvastatin Ph.Eur.

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

Simvastatin Ph.Eur.

Unit dalam pakej:

10Tablet Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited (Unit III),

Risalah maklumat

KARDAK TABLET
Simvastatin (10 mg, 20mg,40 mg, 80 mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Kardak is used for
2.
How Kardak works
3.
Before you use Kardak
4.
How to use Kardak
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Kardak
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT KARDAK
IS USED FOR
Kardak is used to treat:
•Coronary heart disease (CHD)
•Higher than normal levels of fats in the
blood (hyperlipidaemia)
•An
inherited
condition
causing
high
levels of cholesterol in the blood
HOW KARDAK WORKS
Kardak
is
a
medicine
used
to
lower
levels
of
total
cholesterol,
“bad”
cholesterol
(LDL
cholesterol)
and
any
fatty
substances
called
triglycerides
in
the
blood.
In
addition,
Kardak
raises
levels
of
“good”
cholesterol
(HDL
cholesterol).
You
should
stay
on
a
cholesterol-lowering
diet
while
taking
this medicine.
Kardak is a member of the class of drug
called statins.
BEFORE YOU USE KARDAK
-
_When you must not use it _
_ _
•
If you are allergic (hypersensitive)to
Kardak or any other Ingredients of
Kardak Tablets.
•
If you currently have a liver problem
•
If you are pregnant or breast-feeding
- Before you start use it
•
Tell your doctor about your medical
conditions including allergies
•
Tell your doctor if you drink large
amount of alcohol
•
Tell
your
doctor
if
you
ever
had
liver
disease.
Kardak
may
not
be
right for you.
•
Tell your doctor if you are due to
have an operation. You may need to
stop taking Kardak tablets for a short
time.
•
Your doctor should do a blood test
before you start taking Kardak. This
is to check how well your liver is
working.
Talk
to
your
doctor
if
any
other
following applies:
•
you have kidney problems
•
you have thyroid problems
•
you are more than 70 years old
•
you have ever had muscle problems
during
treatment
with
cholesterol-
lowering medicines called “statins”
or fibrates
•
you or a close family member have a
hereditary muscle di

Ciri produk

KARDAK 10 (SIMVASTATIN TABLETS 10MG)
KARDAK 20 (SIMVASTATIN TABLETS 20MG)
KARDAK 40 (SIMVASTATIN TABLETS 40MG)
KARDAK 80 (SIMVASTATIN TABLETS 80MG)
DESCRIPTION AND COMPOSITION:
KARDAK 10 (SIMVASTATIN TABLETS 10 MG)
Light pink coloured, round shaped, biconvex, film coated tablets,
debossed with' A' on one side and
'01'on the other side. Each film coated tablet contains: Simvastatin
Ph.Eur. 10mg
KARDAK 20 (SIMVASTATIN TABLETS 20 MG)
Light pink coloured, round shaped, biconvex, film coated tablets,
debossed with 'A' on one side and
'02' on the other side. Each film coated tablet contains: Simvastatin
Ph Eur. 20mg
KARDAK 40 (SIMVASTATIN TABLETS 40 MG)
Pink coloured, round shaped, biconvex, film coated tablets, debossed
with 'A' on one side and '03'on
the other side. Each film coated tablet contains: Simvastatin Ph.Eur.
40mg
KARDAK 80 (SIMVASTATIN TABLETS 80 MG)
Pink coloured, capsule shaped, biconvex, film coated tablets, debossed
with 'A' on one side and '04'
on the other side. Each film coated tablet contains: Simvastatin
Ph.Eur. 80mg
PHARMACODYNAMICS
Simvastatin is a synthetic blood lipid-lowering agent deriving from
fermentation product of
Aspergillus terreus.
After oral ingestion, simvastatin, which is an inactive lactone, is
hydrolysed to the corresponding
betahydroxyacid. This main metabolite of simvastatin inhibits
3-hydroxy-3-methyl-glutaryl-coenzyme
A (HMG-CoA) reductase which catalyses an early step in the
biosynthesis of cholesterol limiting the
rate of the total reaction. At daily doses of 10 to 80 mg, simvastatin
reduced total plasma cholesterol,
LDL and VLDL cholesterol. Simvastatin also slightly increased HDL
cholesterol thus reducing the
LDL/HDL ratio and total cholesterol/HDL ratio.
Patients with hypertriglyceridaemia (TG concentration exceeding 2.25
mmol/l), simvastatin reduces
the plasma triglyceride concentration by up to 30%. Treatment with
simvastatin also results in a
substantial reduction of Apo-B. The active form of simvastatin
specifically inhibits HMG-CoA
reductase which catalyses the conv