Rovastin 5mg Film Coated Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ROSUVASTATIN CALCIUM

Boleh didapati daripada:

Abio Marketing Sdn Bhd

INN (Nama Antarabangsa):

ROSUVASTATIN CALCIUM

Unit dalam pakej:

28tablet Tablets

Dikeluarkan oleh:

CHINA CHEMICAL & PHARMACEUTICAL CO., LTD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ROVASTIN FILM COATED TABLET
ROSUVASTATIN 5MG AND 10MG
1
WHAT IS IN THIS LEAFLET
1.
What
Rovastin
is
used
for
2.
How it works
3.
Before you use Rovastin
4.
How to use Rovastin
5.
While
you
are
using
Rovastin
6.
Side effects
7.
Storage and Disposal of
Rovastin
8.
Product Description
9.
Manufacturer
10.Product
Registration
Holder
11.Date of Revision
WHAT ROVASTIN IS USED FOR
Rovastin belongs to a group
of medicines called statins.
You
have
been
prescribed
Rovastin because:
-
You
have
a
high
cholesterol
level.
This
means you are at risk from
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 Rovastin.
Or
-
You
have
other
factors
that increase your risk of
having
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.
HOW IT WORKS
Most of the cholesterol in
your blood is made in the
liver.
Rovastin
works
by
reducing
cholesterol
in
2
ways:
-
Rovastin
blocks
an
enzyme
in
the
liver
causing the liver to make
less cholesterol
-
Rovastin
increases
the
uptake and breakdown by
the
liver
of
cholesterol
already in the blood
Along
with
diet,
Rovastin
lowers
bad
(LDL)
cholesterol
and
slows
plaque buildup in arteries as
part of a treatment plan to
lower cholesterol to goal.
You
may
see
results
for
lowering
your
bad
cholesterol as soon as 2-4
weeks
after
starting
Rovastin. People can have
different
responses
to
the
same
medicine,
so
your
results may vary.
BEFORE YOU USE ROVASTIN
When you must not use it
Do not take Rovastin:
-
If you have ever had an
allergic
reaction
to
Rovastin
or
similar
medicines,, or to any of its
ingredients.
Rovastin
contains
lactose,
which
may cause a problem in a
small number of patients
who are a

Ciri produk

COMPOSITION
Rovastin
5mg
Film
Coated
Tablet:
Each
tablet
contains
Rosuvastatin
calcium
equivalent to Rosuvastatin 5 mg
Rovastin
10mg
Film
Coated
Tablet:
Each
tablet
contains
Rosuvastatin
calcium
equivalent to Rosuvastatin 10 mg
PRODUCT DESCRIPTION
Rovastin 5mg Film Coated Tablet: Round, yellow film coated tablets,
engraved with
CCP
231
on one side and plain on the reverse.
Rovastin 10mg Film Coated Tablet: Round, pink film-coated tablets,
engraved with
CCP
173
on one side and plain on the reverse.
PHARMACOLOGY
Mechanism of Action:
Rosuvastatin is a selective, potent and competitive inhibitor of
HMG-CoA reductase,
the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl
coenzyme A to
mevalonate, a precursor of 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 2 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-Cholesterol
(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
(CV) disease.
Intervention studies have shown the benefits on mortality and CV event
rates of
lowering
LDL-C
and
TG
or
raising
HDL-C.
More
recent
data
has
linked
the
beneficial effects of HMG-CoA reductase inhibitors to lowering of
non-HDL (ie, all
circ