EZETROL 10MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

EZETIMIBE

Boleh didapati daripada:

ORGANON MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

EZETIMIBE

Unit dalam pakej:

5Tablet Tablets; 10Tablet Tablets; 30Tablet Tablets

Dikeluarkan oleh:

MSD International GmbH (Puerto Rico Branch) LLC...

Risalah maklumat

EZETROL
®
Ezetimibe (10mg)
_Consumer Medication Information Leaflet (RiMUP) _
1
Copyright 2021 Organon group of companies. All rights reserved.
WHAT IS IN THIS LEAFLET
1.
What EZETROL is used for
2.
How EZETROL works
3.
Before you take EZETROL
4.
How to take EZETROL
5.
While you are taking
EZETROL
6.
Side effects
7.
Storage and disposal of
EZETROL
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT EZETROL IS USED FOR
EZETROL (
_ezetimibe) _
is a
tablet that contains 10 mg of
ezetimibe as the active
ingredient.
•
EZETROL is a
cholesterol-lowering
medicine.
•
EZETROL is for patients
whose cholesterol levels are
too high and when diet
alone cannot lower these
levels adequately.
•
EZETROL reduces elevated
total-cholesterol, LDL (bad)
cholesterol and triglycerides
and increases HDL (good)
cholesterol.
•
EZETROL may be taken
with other
cholesterol-lowering
medicines known as statins
or alone, in addition to diet.
•
EZETROL may be taken
with fenofibrate, another
cholesterol-lowering
medicine, in addition to
diet.
•
For patients with heart
disease, EZETROL
combined with cholesterol-
lowering medicines called
statins reduces the risk of
heart attack, stroke, surgery
to increase heart blood
flow, or hospitalization for
chest pain.
If you have sitosterolemia, your
doctor has prescribed
EZETROL to lower the level of
plant sterols in your blood.
Sitosterolemia is a hereditary
illness that increases the levels
of plant sterols in your blood.
HOW EZETROL WORKS
•
EZETROL 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.
•
EZETROL adds to the
cholesterol-lowering effect
of statins and fenofibrate.
WHY HAS MY DOCTOR PRESCRIBED
EZETROL?
Your doctor has prescribed
EZETROL 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

Ciri produk

EZETROL
(ezetimibe)
LPC-OG0653-T-102015-Malaysia
1
Copyright 2021 Organon group of companies. All rights reserved.
LOCAL PRODUCT CIRCULAR
TABLETS
EZETROL®
(EZETIMIBE)
EZETROL
®
(ezetimibe) is in a new class of lipid-lowering compounds that
selectively inhibit the
intestinal absorption of cholesterol and related plant sterols.
Each tablet of EZETROL for oral administration contains 10 mg
ezetimibe.
_PRIMARY_
_ _
_HYPERCHOLESTEROLAEMIA_
_ _
EZETROL administered alone, or with an HMG-CoA reductase inhibitor
(statin), is indicated as
adjunctive therapy to diet in patients with primary (heterozygous
familial and non-familial)
hypercholesterolaemia.
EZETROL, administered in combination with fenofibrate, is indicated as
adjunctive therapy to
diet for the reduction of elevated total-C, LDL-C, Apo B, and
non-HDL-C in patients with mixed
hyperlipidemia.
_PREVENTION OF CARDIOVASCULAR_
_ _
_EVENTS_
_ _
EZETROL, administered with a statin, is indicated to reduce the risk
of cardiovascular events
(cardiovascular
death,
nonfatal
myocardial
infarction,
nonfatal
stroke,
hospitalization
for
unstable angina, or need for revascularization), in patients with
coronary heart disease (CHD)
and a history of acute coronary syndrome (ACS).
I. THERAPEUTIC CLASS
II. COMPOSITION
III. INDICATIONS
EZETROL
(ezetimibe)
LPC-OG0653-T-102015-Malaysia
2
Copyright 2021 Organon group of companies. All rights reserved.
_ _
_HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH)_
_ _
EZETROL, administered with a statin, is indicated for patients with
HoFH. Patients may also
receive adjunctive treatments (e.g., LDL apheresis).
_HOMOZYGOUS_
_ _
_SITOSTEROLAEMIA_
_ _
_(PHYTOSTEROLAEMIA)_
_ _
EZETROL is indicated for the reduction of elevated sitosterol and
campesterol levels in
patients with homozygous familial sitosterolaemia.
The patient should be on an appropriate lipid-lowering diet and should
continue on this diet
during treatment with EZETROL.
_USE IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA_
_ _
The recommended dose of EZETROL is 10 mg once daily, used