Ezetrol

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ezetimibe 10mg

Available from:

Merck Sharp & Dohme (New Zealand) Limited

INN (International Name):

Ezetimibe 10 mg

Dosage:

10 mg

Pharmaceutical form:

Tablet

Composition:

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

Units in package:

Blister pack, Aclar/PVC/Al 7-tablets, sample, 7 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

MSD International GmbH (Singapore Branch)

Product summary:

Package - Contents - Shelf Life: Blister pack, Aclar/PVC/Al , sample - 7 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Aclar/PVC/Al , sample - 10 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Aclar/PVC/Al - 28 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Aclar/PVC/Al - 30 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2002-04-11

Patient Information leaflet

EZETROL
®
_ezetimibe_
10 mg tablet
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about EZETROL. 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
EZETROL 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.
You should also read any information provided with other medicines you
are currently
taking.
WHAT EZETROL IS USED FOR

EZETROL is a cholesterol-lowering medicine.

EZETROL is for adults and adolescents (10 to 17 years of age) whose
cholesterol
levels are too high and when diet alone can not 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.
CHOLESTEROL
Some of the reasons cholesterol is needed by the body include;
building cell walls, making
bile acids (which help to digest food) and certain hormones. However,
too much
cholesterol can be a problem.
Your body makes cholesterol, but it also comes from food.
Normally the body balances the cholesterol it makes with the
cholesterol it gets from food.
This means if more cholesterol comes from food, less is made by the
body. However, if
you eat a diet high in fat, your body may not keep this balance and
your cholesterol levels
rise.
High cholesterol is more likely to occur with certain diseases or if
you have a family history
of high cholesterol.
When you have high levels of cholesterol, it may 'stick' to the inside
of your blood vessels
instead of being carried to the parts of the body where it is needed.
Over time, this can
form hard areas, called plaque, on the walls of blood vessels, making
it more difficult for
th

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 16
1 EZETROL (EZETIMIBE) 10 MG TABLET
EZETROL (ezetimibe) 10 mg tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of EZETROL for oral administration contains 10 mg
ezetimibe.
Excipients with known effect
Each 10 mg tablet contains 55 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
EZETROL 10 mg is a white to off white capsule shaped tablet debossed
with 414 on one side and
plain on the other. Dimensions are 8.13 mm x 4.06 mm.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Primary Hypercholesterolaemia
EZETROL, 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.
Homozygous Familial Hypercholesterolaemia (HoFH)
EZETROL, 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).
Homozygous Sitosterolaemia (Phytosterolaemia)
EZETROL is indicated for the reduction of elevated sitosterol and
campesterol levels in patients with
homozygous familial sitosterolaemia.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
The patient should be on an appropriate lipid-lowering diet and should
continue on this diet during
treatment with EZETROL.
The recommended dose of EZETROL is 10 mg once daily, used alone or
with a statin. EZETROL
can be administered at any time of the day, with or without food.
_Elderly population_
No dosage adjustment is required for elderly patients (see section
5.2).
_ _
_Renal impairment/Chronic Kidney Disease _
Monotherapy
In patients with renal