EZETIMIBE GH ezetimibe 10 mg tablet blister pack (PVC-Aclar blister)

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ezetimibe, Quantity: 10 mg

Available from:

Lupin Australia Pty Limited

INN (International Name):

Ezetimibe

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: crospovidone; colloidal anhydrous silica; lactose monohydrate; stearic acid; sodium lauryl sulfate; povidone

Administration route:

Oral

Units in package:

PVC-Aclar blister pack of 10,14,15 and 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adults (greater than or equal to 18 Years),Primary Hypercholesterolaemia,Ezetimibe GH 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.,Homozygous Familial Hypercholesterolaemia (HoFH),Ezetimibe GH, administered with a statin, is indicated for patients with HoFH. Patients may also receive adjunctive treatments (eg. LDL apheresis).,Homozygous Sitosterolaemia (Phytosterolaemia) Ezetimibe GH is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia. Prevention of Cardiovascular Disease,Ezetimibe GH is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) in need of additional lowering of LDL-C in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see Section 5.1 Pharmacodynamic Properties ? Clinical Trials).,Children and Adolescents 10-17 Years (Pubertal status: boys Tanner Stage II and above and girls who are at least one year post-menarche),Heterozygous Familial Hypercholesterolaemia (HeFH),Ezetimibe GH co-administered with simvastatin (doses up to 40 mg) is indicated as an adjunctive therapy to diet in adolescent patients (10-17 years old) with Heterozygous Familial Hypercholesterolaemia where use of a combination product is appropriate:,Patients not appropriately controlled with a statin or ezetimibe alone.;,Patients already treated with a statin and ezetimibe.,Homozygous Familial Hypercholesterolaemia (HoFH),Ezetimibe GH co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (eg. LDL apheresis).

Product summary:

Visual Identification: White to off white, capsule shaped, flat faced, beveled edge tablet, debossed with E on one side and 10 on the other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-07-04

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
EZETIMIBE GH
(EZETIMIBE) UNCOATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Ezetimibe GH. 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
Ezetimibe GH 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 EZETIMIBE GH IS
USED FOR
Ezetimibe GH helps to lower
cholesterol levels. It is used in
people whose cholesterol levels
are too high and when diet alone
cannot lower these levels
adequately.
Ezetimibe GH may be taken
alone or with other cholesterol-
lowering medicines known as
HMG-CoA reductase inhibitors
(or statins), in addition to diet.
In people who have high levels
of plant sterols in their blood
(which doctors call
sitosterolaemia), Ezetimibe GH
helps to lower these levels.
_CHOLESTEROL _
Cholesterol is one of several
fatty substances found in the
bloodstream. Your total
cholesterol is made up mainly of
LDL and 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 a 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.
_TRIGLYCERIDES_
_ _
Triglycerides are another form of
fat in your blood that may
increase your risk for heart
disease.
HOW EZETIMIBE GH WORKS
Ezetimibe GH reduces elevated
total-cholesterol, LDL (bad)
cholesterol and triglycerides and
increases HDL (good)
cholesterol.
Ezetimibe GH works by
decreasing the

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – EZETIMIBE GH
(EZETIMIBE) UNCOATED TABLET
1
NAME OF THE MEDICINE
Ezetimibe.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Ezetimibe GH contains 10 mg ezetimibe.
List of excipients with known effect: Lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Ezetimibe GH 10 mg: White to off-white, capsule shaped, flat faced,
bevelled edge tablet, debossed with
“
E
”
on one side and
“
10
”
on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS (
≥
18 YEARS)
Primary Hypercholesterolaemia
Ezetimibe GH 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.
Homozygous Familial Hypercholesterolaemia (HoFH)
Ezetimibe GH, administered with a statin, is indicated for patients
with HoFH. Patients may also receive
adjunctive treatments (eg. LDL apheresis).
Homozygous Sitosterolaemia (Phytosterolaemia)
Ezetimibe GH is indicated for the reduction of elevated sitosterol and
campesterol levels in patients with
homozygous familial sitosterolaemia.
Prevention of Cardiovascular Disease
Ezetimibe GH is indicated for administration in combination with the
maximum tolerated dose of a statin
with proven cardiovascular benefit in patients with coronary heart
disease (CHD) and a history of acute
coronary syndrome (ACS) in need of additional lowering of LDL-C in the
expectation of a modest further
Ezetimibe GH v4.0
Page 2 of 28
(ezetimibe) uncoated tablet
reduction in the risk of cardiovascular events following at least one
year of therapy (see SECTION 5.1
PHARMACODYNAMIC PROPERTIES – CLINICAL TRIALS).
CHILDREN AND ADOLESCENTS 10-17 YEARS (PUBERTAL STATUS: BOYS TANNER
STAGE II AND ABOVE AND
GIRLS WHO ARE AT LEAST ONE YEAR POST-MENARCHE)
Heterozygous Familial Hypercholesterolaemia (HeFH)
Ezetimibe GH co-administered with simvastatin (doses up to 40 mg) is
indicated