ETIMICOL 10 (Ezetimibe Tablets 10mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

EZETIMIBE

Boleh didapati daripada:

SYNERRV SDN BHD

INN (Nama Antarabangsa):

EZETIMIBE

Unit dalam pakej:

3 x 10 Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited (Unit VII)

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ETIMICOL 10 (EZETIMIBE TABLETS 10MG)
Ezetimibe (10mg)
1
WHAT IS IN THIS LEAFLET
1.
What ETIMICOL 10 is used for
2.
How ETIMICOL 10 works
3.
Before you use ETIMICOL 10
4.
How to use ETIMICOL 10
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
ETIMICOL 10
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
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 IS ETIMICOL 10 USED FOR
ETIMICOL 10 is a tablet that
contains 10mg of ezetimibe as the
active ingredient.
-ETIMICOL 10 is a cholesterol
lowering medicine.
-ETIMICOL 10 is for patients whose
cholesterol levels are too high and
when diet alone cannot lower these
levels adequately.
-ETIMICOL 10 reduces elevated
total-cholesterol, LDL (bad)
cholesterol and triglycerides and
increases HDL (good) cholesterol.
-ETIMICOL 10 may be taken with
other cholesterol-lowering medicines
known as statins or alone, in addition
to diet.
-ETIMICOL 10 may be taken with
fenofibrate, another cholesterol-
lowering medicine, in addition to
diet.
-For patients with heart disease,
ETIMICOL 10 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 ETIMICOL 10
to lower the level of plant sterols in
your blood.
Sitosterolemia is a hereditary illness
that increases levels of plant sterols
in your blood.
HOW ETIMICOL 10 WORKS
ETIMICOL 10 works by decreasing
the absorption of cholesterol in the
small intestine. Statins and
fenofibrate lower cholesterol in a
different way, they work in th

Ciri produk

P1523456
Black
A/s : 140 x 360 mm
Date & Time
Component
Item Code
Reason Of Issue
Version No.
Customer / Country
Reviewed / Approved
by
Product
Name
Etimicol 10 mg
Leaflet
P1523456
Malaysia_Unit-7
Submission
05
28.04.2021 & 10.00 am
Dimensions
Pharmacode
Team Leader
Initiator
Additional Information :
Word Replacement :28.04.2021
Artist:
SCDesigners
No. of Colours : 01
140 x 360 mm
Kiran Kumar
Shirisha N
23456
Packaging Development
SUMMARY OF PRODUCT
CHARACTERISTICS
ETIMICOL 10
EZETIMIBE TABLETS 10 MG
_Rx Only_
NAME OF THE PRODUCT:
Ezetimibe Tablets 10 mg
(TRADE) NAME OF PRODUCT:
ETIMICOL 10
STRENGTH
:
10 mg
PHAPMACEUTICAL DOSAGE FORM: Tablet
QUALITATIVE AND QUANTITATIVE COMPOSITIONS:
_Ezetimibe Tablets 10 mg _
Each tablet contains 10 mg of Ezetimibe
PHARMACEUTICAL FORM
_Ezetimibe Tablets 10 mg: _ White to off-white uncoated, capsule
shaped bevelled edge tablets debossed with ‘E Z’ on one side and
‘10’ on other side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Primary Hypercholesterolaemia
Ezetimibe
tablets
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.
Ezetimibe tablets, 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 _
Ezetimibe tablets, 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).
Homozygous Familial Hypercholesterolaemia (HoFH)
Ezetimibe tablets, administered with a statin, is indicated for
patients
with HoFH. Patients may also receive adjunctive treatments (e.g.,
LDL apheresis).
Homozygous Sitostero