SIMTORSI 10/10 ezetimibe 10 mg and simvastatin 10 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Torrent Australasia Pty Ltd

Pharmaceutical form:

Tablet

Composition:

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

Administration route:

Oral

Units in package:

30, 10, 5

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adults (greater than or equal to 18 years),Prevention of Cardiovascular Disease,SIMTORSI 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,SIMTORSI 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),SIMTORSI 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),SIMTORSI 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),SIMTORSI 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 335 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; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2019-10-15

Patient Information leaflet

1
SIMTORSI 10/10, SIMTORSI 10/20, SIMTORSI 10/40 AND SIMTORSI
10/80
_Ezetimibe/Simvastatin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SIMTORSI.
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
SIMTORSI 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 SIMTORSI
IS USED FOR
SIMTORSI 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 SIMTORSI WORKS_
_ _
SIMTORSI reduces elevated total-
cholesterol, LDL (bad) cholesterol
and triglycerides and increases HDL
(good) cholesterol.
SIMTORSI works by decreasing the
absorption of cholesterol in the small
intestine and by reducing the amount
of cholesterol made in the liver.
SIMTORSI does not help you
lose weight.
If you have heart disease and a
history of heart attack or
hospitalisation for unstable angina
(chest

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – SIMTORSI 10/10, SIMTORSI
10/20, SIMTORSI 10/40, SIMTORSI 10/80
(
Ezetimibe and Simvastatin
)
1
NAME OF THE MEDICINE
Ezetimibe
Simvastatin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SIMTORSI is available for oral use as tablets containing:
•
10 mg of ezetimibe and 10 mg of simvastatin (SIMTORSI 10/10);
•
10 mg of ezetimibe and 20 mg of simvastatin (SIMTORSI 10/20);
•
10 mg of ezetimibe and 40 mg of simvastatin (SIMTORSI 10/40); or
•
10 mg of ezetimibe and 80 mg of simvastatin (SIMTORSI 10/80).
List of excipients with known effect:
•
lactose (as monohydrate)
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Tablets
SIMTORSI
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.
SIMTORSI
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.
SIMTORSI
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.
SIMTORSI
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
SIMTORSI 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
Page 2 of 43
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
SIMTORSI is indicated as adju