Ezemibe

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ezetimibe 10mg;  

Available from:

Viatris Limited

INN (International Name):

Ezetimibe 10 mg

Dosage:

10 mg

Pharmaceutical form:

Tablet

Composition:

Active: Ezetimibe 10mg   Excipient: Croscarmellose sodium Crospovidone Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Purified water Sodium laurilsulfate

Units in package:

Blister pack, PVC-ACLAR/aluminium-VMCH heat seal lacquer, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Mylan Laboratories Limited

Therapeutic indications:

Administered with an HMG-CoA reductase inhibitor (statin) or alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG) and to increase high-density lipoprotein cholesterol (HDL-C) in adult and adolescent (10 to 17 years of age) patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Aluminium -VMCH heat seal lacquer - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC-ACLAR/aluminium-VMCH heat seal lacquer - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVdC/Aluminium -VMCH heat seal lacquer - 90 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC-ACLAR/aluminium-VMCH heat seal lacquer - 90 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with PP cap, induction seal liner and absorbent cotton - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with PP cap, induction seal liner and absorbent cotton - 500 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2010-05-20

Patient Information leaflet

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
EZEMIBE
_EZETIMIBE TABLET 10 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Ezemibe.
This leaflet answers some common
questions about Ezemibe.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Ezemibe
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT EZEMIBE IS
USED FOR
Ezemibe helps to lower cholesterol
levels in people whose cholesterol
levels are too high and when diet
alone cannot lower these levels
adequately.
Ezemibe is used to treat:
•
Primary
hypercholesterolemia
•
Homozygous familial
hypercholesterolemia
(HoFH)
Cholesterol is one of several fatty
substances found in the
bloodstream. Your total cholesterol
is made up mainly of low-density
lipoprotein (LDL) and high-density
lipoprotein (HDL) cholesterol.
LDL cholesterol is often called 'bad'
cholesterol because it can build up
in the walls of your arteries forming
plaque. Eventually this plaque build-
up can lead to narrowing of the
arteries.
This narrowing can slow or block
blood flow to vital organs such as
the heart and brain. This blocking of
blood flow can result in a heart
attack or stroke.
HDL cholesterol is often called
'good' cholesterol because it helps
keep the bad cholesterol from
building up in the arteries and
protects against heart disease.
This medicine belongs to a group of
medicines called selective
cholesterol-absorption inhibitors.
_HOW EZEMIBE WORKS_
Ezemibe contains the active
ingredient ezetimibe.
It may be taken alone, or with other
cholesterol-lowering medicines
known as statins.
Ezemibe works by decreasing the
absorption of cholesterol in the
small intestine. Statins lower
cholesterol in a different way – they
work in th

Summary of Product characteristics

Page 1 of 27
NEW ZEALAND DATA SHEET
EZEMIBE
1. PRODUCT NAME
Ezemibe, 10 mg, tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of ezetimibe.
Excipient(s) with known effect: lactose monohydrate.
Allergen Declaration:
Contains lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White to off-white, capsule shaped bevelled edge tablet debossed with
“M” on one side and “EE 1”
on other side.
The tablet cannot be halved.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
PRIMARY HYPERCHOLESTEROLEMIA
Ezemibe, administered with an HMG-CoA reductase inhibitor (statin) or
alone, is indicated as
adjunctive therapy to diet for the reduction of elevated total
cholesterol (total-C), low-density
lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and
triglycerides (TG) and to increase
high-density lipoprotein cholesterol (HDL-C) in adult and adolescent
(10 to 17 years of age) patients
with primary (heterozygous familial and non-familial)
hypercholesterolemia.
HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HOFH)
Ezemibe, administered with a statin, is indicated for the reduction of
elevated total-C and
LDL-C levels in adult and adolescent (10 to 17 years of age) patients
with HoFH. Patients may also
receive adjunctive treatments (e.g., LDL apheresis).
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
The patient should be on an appropriate lipid-lowering diet and should
continue on this diet during
treatment with Ezemibe.
The recommended dose of Ezemibe is 10 mg once daily, used alone or
with a statin. Ezemibe can
be administered at any time of the day, with or without food. Do not
halve the tablet.
Page 2 of 27
SPECIAL POPULATIONS
_USE IN RENAL IMPAIRMENT/CHRONIC KIDNEY DISEASE_
MONOTHERAPY
In patients with renal impairment, no dosage adjustment of Ezemibe is
necessary (see section 5.2).
COMBINATION THERAPY WITH SIMVASTATIN
In patients with mild renal impairment (estimated GFR ≥ 60
mL/min/1.73 m
2
), no dosage adjustment
of Ezemibe or simvastatin is necessary. I