Ezzicad 10mg Tablets

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

EZETIMIBE

Verfügbar ab:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

INN (Internationale Bezeichnung):

EZETIMIBE

Einheiten im Paket:

3 x 10s Tablets

Hergestellt von:

Glenmark Pharmaceuticals Limited

Gebrauchsinformation

_Consumer Medication Information Leaflet (RiMUP) _
EZZICAD 10MG TABLETS
Ezetimibe Tablets 10mg
1
WHAT IS IN THIS LEAFLET
1.
What EZZICAD is used
for
2.
How EZZICAD works
3.
Before you use EZZICAD
4.
How to use EZZICAD
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
EZZICAD
8.
Product Description
9.
Manufacturer
10.
Product Registration
Holder
11.
Date of Revision
12.
Serial Number
WHAT EZZICAD IS USED FOR
EZZICAD is a tablet that
contains 10mg of ezetimibe as
the active ingredient.

EZZICAD is a cholesterol-
lowering medicine.

EZZICAD is for patients
whose cholesterol levels
are too high and when diet
alone cannot lower these
levels adequately.

EZZICAD reduces
elevated total-cholesterol,
LDL (bad) cholesterol and
triglycerides and increases
HDL (good) cholesterol.

EZZICAD may be taken
with other cholesterol-
lowering medicines known
as statins or alone, in
addition to diet.

EZZICAD may be taken
with fenofibrate, another
cholesterol-lowering
medicine, in addition to
diet.
HOW EZZICAD WORKS
EZZICAD works by
decreasing the absorption of
cholesterol in the small
intestine. Statins and
fenofibrate lower cholesterol in
a different way, they works in
the liver.
EZZICAD adds to the
cholesterol-lowering effect of
statins and fenofibrate.
BEFORE YOU USE EZZICAD
_- When you must not use it _
Patients who are hypersensitive
(allergic) to Ezetimibe or any
of its ingredients should not
take EZZICAD.
_Pregnancy and lactation _
If you are pregnant or plan to
become pregnant, EZZICAD
may not be right for you.
If you are breast-feeding,
EZZICAD may be passed in
your milk to your baby.
Ask your doctor or pharmacist
for advice before taking any
medicine.
_- Before you start to use it _
Ell your doctor about any
medical problems (including
liver disease or liver problems)
or allergies you have now or
have had in the past before you
start EZZICAD.
_- Taking other medicines _
Tell your doctor or pharmacist
if you are taking any other
medicines, if you have taken
any recently, or if you start
taki

Fachinformation

_For the use only of a Registered Medical Practitioners _
_or a Hospital or a Laboratory_
SAME SIZE ARTWORK
LEAFLET SIZE : 115 mm x 280 mm
50 mm
35 mm
SPACE FOR
PHARMACODE
PE00000 MY
PANTONE
BLACK PROCESS C
SUPERSEDES
ARTWORK CODE
PANTONE SHADE
ICONGRAPHICS CODE:
PHARMACODE:
LABEL CLAIM
Each uncoated tablet contains:
Ezetimibe............10 mg.
PHARMACEUTICAL FORM
Tablets
White to off-white, capsule shaped, flat, beveled edged uncoated
tablets
engraved with glenmark logo 'G' on one side and'44'on the other side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
_PRIMARY HYPERCHOLESTEROLAEMIA_
Ezetimibe, administered alone, or with an HMG-CoA reductase inhibitor
(statin), is indicated as adjunctive therapy to diet for use 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.
POSOLOGY AND METHOD OF ADMINISTRATION
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 HYPERCHOLESTEROLEMIA _
The recommended dose of ezetimibe is 10 mg once daily,