NNA-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:

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

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet

Composition:

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

Administration route:

Oral

Units in package:

5, 10, 30

Prescription type:

(S4) Prescription Only Medicine

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 events following at least one year of therapy (see Clinical Trials).,Primary Hypercholesterolaemia APO-EZETIMIBE/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-EZETIMIBE/SIMVASTATIN is indicated in patients with HoFH. Patients may also receive adjunctive treatments (e.g., 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-EZETIMIBE/SIMVASTATIN is indicated as 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) APO-EZETIMIBE/SIMVASTATIN is indicated in adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).

Product summary:

Visual Identification: Light tan, mottled, capsule shaped about 17.5 x 7.55 mm, biconvex tablets. marking 515 on one side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-11-06

Patient Information leaflet

APO-EZITIMIBE/SIMVASTATIN
1
APO-EZETIMIBE/
SIMVASTATIN
_Ezetimibe/Simvastatin _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. 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 this medicine
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 THIS MEDICINE IS
USED FOR
APO-Ezetimibe/Simvastatin contains
two ingredients, ezetimibe and
simvastatin, which help 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 is used to treat high
cholesterol.
_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 APO-_
_EZETIMIBE/SIMVASTATIN WORKS _
Ezetimibe/Simvastatin reduces
elevated total-cholesterol, LDL (bad)
cholesterol and triglycerides, and
increases HDL (good) cholesterol.
It works by decreasing the absorption
of cholesterol in the small intestine
and by

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
APO-EZETIMIBE/SIMVASTATIN 10/10 (EZETIMIBE/SIMVASTATIN)
APO-EZETIMIBE/SIMVASTATIN 10/20 (EZETIMIBE/SIMVASTATIN)
APO-EZETIMIBE/SIMVASTATIN 10/40 (EZETIMIBE/SIMVASTATIN)
APO-EZETIMIBE/SIMVASTATIN 10/80 (EZETIMIBE/SIMVASTATIN)
1
NAME OF THE MEDICINE
Ezetimibe and 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), or 10 mg of ezetimibe,
and 80 mg of
simvastatin (APO-EZETIMIBE/SIMVASTATIN 10/80).
Excipient with known effect: sugars (as lactose).
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
10/10 MG TABLETS:
Light tan, mottled, round, biconvex, 6mm tablets with markings
“511” on one side.
10/20 MG TABLETS:
Light tan, mottled, round, biconvex, 8mm tablets with markings
“512” on one side.
10/40 MG TABLETS:
Light tan, mottled, round, biconvex, 10mm tablets with markings
“513” on one side.
10/80 MG TABLETS:
Light tan, mottled, capsule shaped, biconvex, 17.5 x 7.55 mm tablets
with markings “515” on one
side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS (≥18 YEARS)
_PREVENTION OF CARDIOVASCULAR DISEASE _
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 events following at least one year of therapy (SEE
SECTION 5.1 PHARMACODYNAMIC
PROPERTIES, CLINICAL TRIALS).
2
_PRIMARY HYPERCHOLESTEROLAEMIA_
Ezetimibe/Simvastatin
is
indicated
as
adjunctive
therapy
to
diet
in
patients
with
primary
(heterozygous familial and non-familial) hypercholesterolaemia or
mixed hyp