ZETEZE-SM TABLETS 10+20 MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

EZETIMIBE; SIMVASTATIN

Boleh didapati daripada:

RANBAXY (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

EZETIMIBE; SIMVASTATIN

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

Sun Pharmaceutical Industries Limited

Risalah maklumat

ZETEZE-SM
Page 1
ZETEZE-SM
(Ezetimibe/Simvastatin Tablets
_Consumer Medication Information Leaflet (RiMUP) _
10+10 mg, 10+20 mg,10+40 mg, 10+80 mg)
_ _
WHAT IS IN THIS LEAFLET
1. What
ZETEZE-SM
is used for
2. How
ZETEZE-SM
works
3. Before you use
ZETEZE-SM
4. How to use
ZETEZE-SM
5. While you are using it
6. Side effects
7. Storage and Disposal of
ZETEZE-
SM
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
This leaflet answers some common
questions about
ZETEZE-SM
.
It does not contain all of the available
information. It does not take the place
of talking to your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking
ZETEZE-SM
against the
benefits it is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ZETEZE-SM IS USED FOR
ZETEZE-SM
contains
the
active
ingredients ezetimibe and simvastatin.
ZETEZE-SM
is used to lower levels
of
total
cholesterol,
LDL
(bad)
cholesterol, and fatty substances called
triglycerides in the blood. In addition,
it
raises
levels
of
HDL
(good)
cholesterol.
ZETEZE-SM
is
for
patients
who
cannot
control
their
cholesterol levels by diet alone. You
should stay on a cholesterol-lowering
diet while taking this medicine.
HOW ZETEZE-SM WORKS
ZETEZE-SM
works to
reduce
your
cholesterol
in
two
ways.
The
active
ingredient
ezetimibe
reduces
the
cholesterol absorbed in your digestive
tract. The active ingredient simvastatin
belonging
to
the
class
of
"statins"
inhibits
the
production
of
the
cholesterol your body makes by itself.
Cholesterol
is
one
of
several
fatty
substances found in the bloodstream.
Your
total
cholesterol
is
made
up
mainly of LDL and HDL cholesterol.
LDL cholesterol is often called “bad”
cholesterol because it can build up in
the
walls
of
your
arteries
forming
plaque. Eventually this plaque build-up
can lead to a narrowing of the arteries.
This
narrowing
ca

Ciri produk

_For the use of a Registered Medical Practitioner only _
PRESCRIBING INFORMATION
ZETEZE-SM 10+10, 10+20, 10+40, 10+80 MG
(Ezetimibe and Simvastatin Tablets)
COMPOSITION
ZETEZE-SM 10+10 MG TABLETS
Each uncoated tablet contains
Ezetimibe USP ……………….10 mg
Simvastatin Ph. Eur…………..10 mg
ZETEZE-SM 10+20 MG TABLETS
Each uncoated tablet contains
Ezetimibe USP ……………….10 mg
Simvastatin Ph. Eur.……….....20 mg
ZETEZE-SM 10+40 MG TABLETS
Each uncoated tablet contains
Ezetimibe USP ……………….10 mg
Simvastatin Ph. Eur.……….....40 mg
ZETEZE-SM 10+80 MG TABLETS
Each uncoated tablet contains
Ezetimibe USP ……………….10 mg
Simvastatin Ph. Eur.……….....80 mg
Excipients: Lactose Monohydrate, Croscarmellose Sodium, Hypromellose,
Cellulose Microcrystalline,
Citric Acid Monohydrate, Propyl Gallate, Butylated Hydroxy Anisole,
Magnesium Stearate, Purified
Water and Isopropyl Alcohol.
PRODUCT DESCRIPTION
ZETEZE-SM 10+10 MG are white to off white, capsule shaped uncoated
tablets, debossed with ‘L’
on one side and plain on other side.
ZETEZE-SM 10+20 MG are white to off white, capsule shaped uncoated
tablets, debossed with ‘I’ on
one side and plain on other side.
ZETEZE-SM 10+40 MG are white to off white, capsule shaped uncoated
tablets, debossed with ‘F’
on one side and plain on other side.
ZETEZE-SM 10+80 MG are white to off white, capsule shaped uncoated
tablets, debossed with ‘T’
on one side and plain on other side.
DESCRIPTION
ZETEZE-SM (ezetimibe/simvastatin) is a lipid lowering product that
selectively inhibits the intestinal
absorption
of
cholesterol
and
related
plant
sterols
and
inhibits
the
endogenous
synthesis
of
cholesterol.
PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES

PHARMACODYNAMICS
Mechanism of action:
_Ezetimibe and Simvastatin _
Plasma cholesterol is derived from intestinal absorption and
endogenous synthesis. Ezetimibe and
simvastatin are two lipid-lowering compounds with complementary
mechanisms of action. Ezetimibe
and simvastatin redu