ROSUCOR TABLET 20 MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ROSUVASTATIN CALCIUM

Boleh didapati daripada:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

ROSUVASTATIN CALCIUM

Unit dalam pakej:

10 Tablet Tablets; 30 Tablet Tablets; 100Tablet Tablets

Dikeluarkan oleh:

TORRENT PHARMACEUTICALS LTD.

Risalah maklumat

ROSUCOR TABLET
_ _
Rosuvastatin Calcium (20mg)
_ _
_ _
1
_ _
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is Rosucor used for
2.
How Rosucor works
3.
Before you use Rosucor
4.
How to use Rosucor
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Rosucor
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT ROSUCOR IS USED FOR
Rosucor
is
used
to
lower
high
cholesterol
levels.
As
changing
your
diet and taking more exercise were not
enough
to
correct
your
cholesterol
levels.
HOW ROSUCOR WORKS
Rosucor contains an active ingredient,
rosuvastatin.
Rosuvastatin
belongs
to
a
group
of
medicines called statins.
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.
BEFORE YOU USE ROSUCOR
-
_When you must not use it _
Do not take Rosucor:

If you are allergic (hypersensitive)
to Rosuvastatin, or to any of the
ingredients.

If you have liver disease.

If
you
have
severe
kidney
problems.

If
you
have
repeated
or
unexplained muscle aches or pains.

If
you
take
a
medicine
called
ciclosporin.

Do
not
take
Rosucor
if
you
are
pregnant, trying to get pregnant or
think you may be pregnant. If you
get pregnant while taking Rosucor,
stop
taking
it
immediately
and
contact your doctor.

If you are Breast-feeding; ask your
doctor
or
pharmacist
for
advice
before taking any medicine.
_Pregnancy and lactation _
_ _
_ _
Do
not
take
Rosucor
if
you
are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take Rosucor if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
-
_Before you start use it _
Take special care:

If
you
have
problems
with
your
kidneys.

If
you
have
problems
with
your
liver.

If
you
have
had
repeated
or
unexplained muscle aches or pains,
a
personal
or
family
history
of
muscle
problems,
or
a
previous
history of muscle problems when
t

Ciri produk

PRODUCT NAME
:
ITEM / PACK
:
DESIGN STYLE
:
CODE
:
DIMENSIONS (MM)
:
ART WORK SIZE
:
DATE
:
Reviewed By
NO. OF COLORS: 1
COUNTRY : Malaysia
Front/Back
Rosucor 20
Insert
S/S
180 x 270
xxxxxxxxx-5253
Black
03-07-2018
PANTONE SHADE NOS.:
ACTIVITIES
DEPARTMENT
NAME
SIGNATURE
DATE
Prepared By
PKG.DEV
PKG.DEV
LOCATION :
Chhatral
QUALITY
Approved By
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
ROSUVASTATIN CALCIUM TABLETS 20MG
Each film coated tablet contains
Rosuvastatin Calcium 20.800 equivalent to Rosuvastatin 20 mg
DOSAGE FORM
Film coated Tablets
PRODUCT DESCRIPTION
White to off white colored, round, biconvex, bevelled edged film
coated
tablets with break line on one side and plain surface on other side.
CLINICAL PHAMACOLOGY
PHARMACODYNAMIC:
Rosuvastatin is a 3-hydroxy-3-methyl glutaryl coenzyme A (HMG-CoA)
reductase inhibitor indicated for the treatment of hyperlipidemia.
Rosuvastatin
is a selective and competitive inhibitor of HMG-CoA reductase. HMG-CoA
reductase is a rate-limiting enzyme that converts
3-hydroxy-3-methylglutaryl
coenzyme A to mevalonate, a precursor for cholesterol. The primary
site of
action of Rosuvastatin is the liver, the target organ for cholesterol
lowering. It
differs
structurally
from
other
statins,
containing
a
polar
methane
sulphonamide
group
which
confers
relative
hydrophilicity. The
relative
hydrophilicity of rosuvastatin imparts greater selectivity for uptake
into
hepatic versus nonhepatic cells. Rosuvastatin 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. In preclinical studies, the
potency of
rosuvastatin has been found to be greater than that of other statins
(i.e.
atorvastatin, simvastatin, pravastatin, lovastatin, cerivastatin, and
fluvastatin).
Rosuvastatin
reduces
elevated
LDL-cholesterol,
total
cholesterol
and
triglycerides and increases HDL-cholesterol. It also lowers ApoB,
nonHDL-C,
VLDL-C, VLDL-TG and increases Apo