SUROTIN 20 MG FC TABLET

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
28-06-2023
Ciri produk Ciri produk (SPC)
20-05-2023

Bahan aktif:

ROSUVASTATIN CALCIUM

Boleh didapati daripada:

SPG PHARMA (MALAYSIA) SDN BHD

INN (Nama Antarabangsa):

ROSUVASTATIN CALCIUM

Unit dalam pakej:

3 x 10's Tablets

Dikeluarkan oleh:

SIAM BHEASACH CO LTD

Risalah maklumat

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
SUROTIN FC TABLET
Rosuvastatin (10mg / 20mg)
WHAT IS IN THIS LEAFLET
1.
What SUROTIN Tablet is used
for
2.
How SUROTIN Tablet works
3.
Before you use SUROTIN Tablet
4.
How to use SUROTIN Tablet
5.
While
you
are
using SUROTIN Tablet
6.
Side effects
7.
Storage
and
disposal
of SUROTIN Tablet
8.
Product description
9.
Manufacturer
and
Product Registration Holder
10.
Date of Revision
1.
WHAT
SUROTIN
TABLET
IS
USED FOR
You have been prescribed
SUROTIN because:
a)
You
have
a
high
cholesterol
level. This means you are at risk
of
getting
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 SUROTIN. Or
b)
You
have
other
factors
that
increase your risk of getting 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.
2.
HOW SUROTIN TABLET WORKS
SUROTIN
is
used
to
correct
the
levels of fatty substances in the blood
called lipids, the most common of
which is cholesterol.
There
are
different
types
of
cholesterol
found
in
the
blood,
including ‘bad’ cholesterol (LDL-
C) and ‘good’ cholesterol (HDL- C).
•
SUROTIN can reduce the ‘bad’
cholesterol
and
increase
the
‘good’ cholesterol.
•
It works by helping to block
your body’s production of ‘bad’
cholesterol in the liver. It also
improves your body’s ability to
remove it from your blood.
For most people, high cholesterol
does not affect the way they feel
because
it
does
not
produce
any
symptoms.
However,
if
it
is
left
untreated, fatty deposits can build up
in the walls of your blood vessels
causing them to narrow.
Sometimes,
these
narrowed blood
vessels can get blocked which can
cut off the blood supply to the heart
or brain leading to a heart
                                
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Ciri produk

                                Sent date 25/04/2023
Drawing No. SUR-10-20-02-L-ENG-MY-BN-A0001
PRODUCT NAME
SUROTIN 10 MG FC TABLET
SUROTIN 20 MG FC TABLET
NAME AND STRENGTH OF ACTIVE SUBSTANCE
10 mg: Each tablet contains 10 mg rosuvastatin (as rosuvastatin
calcium)
20 mg: Each tablet contains 20 mg rosuvastatin (as rosuvastatin
calcium)
PRODUCT DESCRIPTION
10 mg: A pink round (diameter: 7 mm), biconvex film-coated tablet
engraved with “
”
logo on one side and a score with “R” and “10” on the other
side
20 mg: A pink round (diameter: 9 mm), biconvex film-coated tablet
engraved with “
”
logo on one side and on the other side having a score with “R” on
the top and “20”
on the bottom
The tablet is not meant to be split
PHARMACODYNAMICS
Pharmacotherapeutic group: HMG-CoA reductase inhibitors
Mechanism of action
Rosuvastatin is a selective and competitive inhibitor of HMG-CoA
reductase, the rate-limiting
enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to
mevalonate (a precursor
for cholesterol). Triglycerides (TG) and cholesterol in the liver are
incorporated, with
apolipoprotein B (ApoB), into very low density lipoprotein (VLDL) and
released into the
plasma for delivery to peripheral tissues. VLDL particles are TG-rich.
Cholesterol-rich low
density lipoprotein (LDL) is formed from VLDL and is cleared primarily
through the high
affinity LDL receptor in the liver.
Rosuvastatin produces its lipid-modifying effects in two ways; it
increases the number of
hepatic LDL receptors on the cell-surface, enhancing uptake and
catabolism of LDL and
it inhibits the hepatic synthesis of VLDL, thereby reducing the total
number of VLDL and
LDL particles.
High density lipoprotein (HDL), which contains ApoA-I is involved,
amongst other things,
in transport of cholesterol from tissues back to the liver (reverse
cholesterol transport).
The involvement of LDL-C in atherogenesis has been well documented.
Epidemiological
studies have established that high LDL-C, TG, low HDL-C and ApoA-I
have been linked
to a higher risk of cardiovascular
                                
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