APO-EZETIMIBE/SIMVASTATIN 10/80 ezetimibe 10 mg and simvastatin 80 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

simvastatin, Quantity: 80 mg; ezetimibe, Quantity: 10 mg

Available from:

Torrent Australasia Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: lactose monohydrate; propyl gallate; croscarmellose sodium; butylated hydroxyanisole; ascorbic acid; citric acid monohydrate; microcrystalline cellulose; hypromellose; magnesium stearate; ferric oxide

Administration route:

Oral

Units in package:

5, 10, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adults (greater than or equal to 18 years),Prevention of Cardiovascular Disease,APO-EZETIMINE/SIMVASTATIN is indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of simvastatin and 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),Primary Hypercholesterolaemia,APO-EZETIMINE/SIMVASTATIN is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia 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),APO-EZETIMINE/SIMVASTATIN is indicated in patients with HoFH. Patients may also receive adjunctive treatments (eg. LDL apheresis).,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),APO-EZETIMINE/SIMVASTATIN is indicated as adjunctive therapy to diet in adolescent patients (10-17 years old) with HeFH 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),APO-EZETIMINE/SIMVASTATIN is indicated in adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (eg. LDL apheresis).

Product summary:

Visual Identification: Light pink to pink colored with mosaic appearance, capsule shaped biconvex uncoated tablets 338 on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-10-15

Patient Information leaflet

1
EZETREE 10/10, EZETREE 10/20, EZETREE 10/40 AND EZETREE
10/80
_Ezetimibe/Simvastatin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about EZETREE.
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 EZETREE
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 EZETREE
IS USED FOR
EZETREE helps to lower
cholesterol and triglyceride levels. It
is used in people whose cholesterol
levels are too high and when diet
alone cannot lower these levels
adequately.
_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 EZETREE WORKS_
_ _
EZETREE reduces elevated total-
cholesterol, LDL (bad) cholesterol
and triglycerides and increases HDL
(good) cholesterol.
EZETREE works by decreasing the
absorption of cholesterol in the small
intestine and by reducing the amount
of cholesterol made in the liver.
EZETREE does not help you
lose weight.
If you have heart disease and a
history of heart attack or
hospitalisation for unstable angina
(chest pain), EZET

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – APO-EZETIMIBE/SIMVASTATIN
(
EZETIMIBE AND SIMVASTATIN
) TABLETS
1
NAME OF THE MEDICINE
Ezetimibe
Simvastatin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APO-EZETIMIBE/SIMVASTATIN is available for oral use as tablets
containing:

10 mg of ezetimibe and 10 mg of simvastatin (APO-EZETIMIBE/SIMVASTATIN
10/10);

10 mg of ezetimibe and 20 mg of simvastatin (APO-EZETIMIBE/SIMVASTATIN
10/20);

10 mg of ezetimibe and 40 mg of simvastatin (APO-EZETIMIBE/SIMVASTATIN
10/40);

10 mg of ezetimibe and 80 mg of simvastatin (APO-EZETIMIBE/SIMVASTATIN
10/80).
Excipients with known effect:
contains sugars (as lactose).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APO-EZETIMIBE/SIMVASTATIN 10/10: [10mg Ezetimibe/ 10mg Simvastatin]:
Light pink to pink colored
with mosaic appearance, capsule shaped biconvex uncoated tablets
‘335’ on one side and plain on other
side.
APO-EZETIMIBE/SIMVASTATIN 10/20 [10mg Ezetimibe/ 20mg Simvastatin]:
Light pink to pink colored
with mosaic appearance, capsule shaped biconvex uncoated tablets
‘336’ on one side and plain on other
side.
APO-EZETIMIBE/SIMVASTATIN 10/40 [10mg Ezetimibe/ 40mg Simvastatin]:
Light pink to pink colored
with mosaic appearance, capsule shaped biconvex uncoated tablets
‘337’ on one side and plain on other
side.
APO-EZETIMIBE/SIMVASTATIN 10/80 [10mg Ezetimibe/ 80mg Simvastatin]:
Light pink to pink colored
with mosaic appearance, capsule shaped biconvex uncoated tablets
‘338’ on one side and plain on other
side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS (≥18 YEARS)
PREVENTION OF CARDIOVASCULAR DISEASE
APO-EZETIMIBE/SIMVASTATIN is indicated in patients with coronary heart
disease (CHD) and a history
of acute coronary syndrome (ACS) taking their maximum tolerated dose
of simvastatin and in need of
additional lowering of LDL-C in the expectation of a modest further
reduction in the risk of cardiovascular
APO-EZETIMIBE/SIMVASTATIN
Page 2 of 44
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