ROSUCOR TABLET 10 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 (10mg)
_ _
_ _
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 10 mg
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 10MG
Each film coated tablet contains
Rosuvastatin Calcium 10.400 equivalent to Rosuvastatin 10 mg
DOSAGE FORM
Film coated Tablets
PRODUCT DESCRIPTION
ROSUCOR TABLETS 10 MG: White to off white colored, round, biconvex,
film coated tablets with break line on one side and plain on other
side
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS:
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
increase