ZETEZE TABLETS 10 MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

EZETIMIBE

Boleh didapati daripada:

RANBAXY (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

EZETIMIBE

Unit dalam pakej:

28tablet Tablets; 28tablet Tablets

Dikeluarkan oleh:

Sun Pharmaceutical Industries Limited

Risalah maklumat

_CONSUMER MEDICINE INFORMATION LEAFLET (RIMUP)_
1
ZETEZE TABLET
_ _
Ezetimibe (10 mg)
WHAT IS IN THIS LEAFLET
1.
What
ZETEZE TABLET
is used
for
2.
How
ZETEZE TABLET
works
3.
Before you take
ZETEZE
TABLET
4.
How to take
ZETEZE TABLET
5.
While you are taking
ZETEZE
TABLET
6.
Side effects
7.
Storage and disposal of
ZETEZE
TABLET
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
Please read this information carefully
before you start to take your
medicine, even if you have just
refilled your prescription. Some of
the information may have changed.
You should also read any information
provided with other medicines you
are currently taking.
Remember that your doctor has
prescribed this medicine only for
you. Never give it to anyone else.
WHAT ZETEZE TABLET IS USED FOR
ZETEZE TABLET
contains 10 mg of
ezetimibe as the active ingredient.

ZETEZE TABLET
is a
cholesterol-lowering medicine.

ZETEZE TABLET
is for patients
whose cholesterol levels are too
high and when diet alone cannot
lower these levels adequately.

ZETEZE TABLET
reduces
elevated total-cholesterol, LDL
(bad) cholesterol and triglycerides
and increases HDL (good)
cholesterol.

ZETEZE TABLET
may be taken
with other cholesterol-lowering
medicines known as statins or
alone, in addition to diet.

ZETEZE TABLET
may be taken
with fenofibrate, another
cholesterol-lowering medicine, in
addition to diet.
HOW ZETEZE TABLET WORKS
•
ZETEZE TABLET
works by
decreasing the absorption of
cholesterol in the small intestine.
Statins and fenofibrate lower
cholesterol in a different way; they
work in the liver.
•
ZETEZE TABLET
adds to the
cholesterol-lowering effect of
statins and fenofibrate.
WHY HAS MY DOCTOR PRESCRIBED
ZETEZE TABLET?
Your doctor has prescribed
ZETEZE
TABLET
to reduce the amount of
cholesterol and triglycerides in your
blood. 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 “b

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creatine phosphokinase (CPK) level >10 times the ULN, ezetimibe, any
statin, and any of
these other agents that the patient is taking concomitantly should be
immediately
discontinued. All patients starting therapy with ezetimibe should be
advised of the risk of
myopathy and told to report promptly any unexplained muscle pain,
tenderness or
weakness.
_Hepatic insufficiency_
Due to the unknown effects of the increased exposure to ezetimibe in
patients with
moderate or severe hepatic insufficiency, ezetimibe is not
recommended.
_Paediatric (10 to 17 Years of Age) Patients_
Efficacy and safety of ezetimibe co-administered with simvastatin in
patients 10 to 17 years
of age with heterozygous familial hypercholesterolemia have been
evaluated in adolescent
boys (Tanner stage II or above) and in girls who were at least one
year post-menarche.
There was generally no detectable effect on growth or sexual
maturation in the adolescent
boys or girls, or any effect on menstrual cycle length in girls.
However, the effects of
ezetimibe for a treatment period > 33 weeks on growth and sexual
maturation have not been
studied.
The safety and efficacy of ezetimibe co-administered with doses
simvastatin above 40 mg
daily have not been studied in paediatric patients 10 to 17 years of
age.
Ezetimibe has not been studied in patients younger than 10 years of
age or in pre-
menarchal girls.
The long-term efficacy of therapy with ezetimibe in patients below 17
years of age to reduce
morbidity and mortality in adulthood has not been studied.
_Fibrates_
The co-administration of ezetimibe with fibrates other than
fenofibrate has not been studied.
Therefore co-administration of ezetimibe and fibrate (other than
fenofibrate) is not
recommended.
If cholelithiasis is suspected in a patient receiving ezetimibe and
fenofibrate, gallbladder
studies are indicated and alternative lipid lowering therapy should be
considered.
_Cyclosporin_
Caution should be exercised when initiating ezetimibe in the setting
of cyclosporin.
Cyclospori