Letimble 10mg Tablets

Country: Մալայզիա

language: անգլերեն

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

active_ingredient:

EZETIMIBE

MAH:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN:

EZETIMIBE

units_in_package:

30 Tablets; 60 Tablets; 100 Tablets

manufactured_by:

LEK PHARMACEUTICALS D.D.

PIL

LETIMBLE TABLETS
Ezetimibe (10 mg)
1
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET
1.
What LETIMBLE is used for
2.
How LETIMBLE works
3.
Before you take LETIMBLE
4.
How to take LETIMBLE
5.
While you are taking
LETIMBLE
6.
Side effects
7.
Storage and disposal of
LETIMBLE
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 LETIMBLE IS USED FOR
LETIMBLE (ezetimibe) is a tablet
that contains 10 mg of ezetimibe as
the active ingredient.
•
LETIMBLE is a cholesterol-
lowering medicine.
•
LETIMBLE is for patients
whose cholesterol levels are too
high and when diet alone
cannot lower these levels
adequately.
•
LETIMBLE reduces elevated
total-cholesterol, LDL (bad)
cholesterol and triglycerides
and increases HDL (good)
cholesterol.
•
LETIMBLE may be taken with
other cholesterol-lowering
medicines known as statins or
alone, in addition to diet.
•
LETIMBLE may be taken with
fenofibrate, another
cholesterol-lowering medicine,
in addition to diet.
•
For patients with heart disease,
LETIMBLE combined with
cholesterol-lowering medicines
called statins reduces the risk of
heart attack, stroke, surgery to
increase blood flow or
hospitalization for chest pain.
If you have sitosterolemia, your
doctor has prescribed LETIMBLE
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 LETIMBLE WORKS
•
LETIMBLE 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.
•
LETIMBLE adds to the
cholestero

SPC

1
PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Letimble 10 mg Tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of ezetimibe.
Excipient(s) with known effect: 67.50 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to almost white, oval tablets with debossing “10” on one
side and “EZT” on the other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Primary hypercholesterolaemia _
Ezetimibe, 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, 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, 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, administered with a statin, is indicated for patients with
HoFH. Patients may also receive adjunctive
treatments (e.g. LDL apheresis)._ _
_Homozygous Sitosterolaemia (Phytosterolaemia) _
Ezetimibe is indicated for the reduction of elevated sitosterol and
campesterol levels in patients with homozygous
familial sitosterolaemia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The patient should be on an appropriate lipid-lowering diet and should
continue on this diet during treatment with
ezetimibe.
_Use in Patients with Primary Hypercholesterolaemia _
The recommended dose of ezetimibe is 10 mg once daily, used alone,
with a statin or with fenofibrate. Ezetimibe
can be administered at any time of t