EZETIMIBE/SIMVASTATIN SANDOZ 10/80 ezetimibe/simvastatin 10/80 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:

Sandoz Pty Ltd

Pharmaceutical form:

Tablet

Composition:

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

Administration route:

Oral

Units in package:

5, 10, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adults (?18 years),Prevention of Cardiovascular Disease EZETIMIBE/SIMVASTATIN-SANDOZ 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 EZETIMIBE/SIMVASTATIN-SANDOZ 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) EZETIMIBE/SIMVASTATIN-SANDOZ 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) EZETIMIBE/SIMVASTATIN-SANDOZ 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) EZETIMIBE/SIMVASTATIN-SANDOZ 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

EZETIMIBE/SIMVASTATIN SANDOZ
®
1
EZETIMIBE/SIMVASTATIN
SANDOZ
®
_Ezetimibe/Simvastatin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about
Ezetimibe/Simvastatin Sandoz. 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/Simvastatin Sandoz
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/SIMVASTATIN
SANDOZ IS USED FOR
Ezetimibe/Simvastatin Sandoz
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 _
_EZETIMIBE/SIMVASTATIN _
_SANDOZ WORKS _
Ezetimibe/Simvastatin Sandoz
reduces elevated total-cholesterol,
LDL (bad) cholesterol and
triglycerides and increases HDL
(good) cholesterol.
Ezetimibe/Simvastatin Sandoz works
by decreasing the absorption of
cholesterol in the small intestine and
by reducing the amount of
cholesterol made in the liv

Summary of Product characteristics

220513-Ezetimibe/Simvastatin Sandoz-pi
Page 1 of 46
AUSTRALIAN PRODUCT INFORMATION
EZETIMIBE/SIMVASTATIN SANDOZ (EZETIMIBE AND SIMVASTATIN)
1.
NAME OF THE MEDICINE
Ezetimibe and simvastatin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ezetimibe/Simvastatin Sandoz is available for oral use as tablets
containing 10 mg of
ezetimibe, and 10 mg of simvastatin (Ezetimibe/Simvastatin Sandoz
10/10), 20 mg of
simvastatin
(Ezetimibe/Simvastatin
Sandoz
10/20),
40
mg
of
simvastatin
(Ezetimibe/Simvastatin Sandoz 10/40), or 80 mg of simvastatin
(Ezetimibe/Simvastatin
Sandoz 10/80).
_Excipients with known effect:_
Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Ezetimibe/Simvastatin Sandoz 10/10: [10 mg Ezetimibe/ 10 mg
Simvastatin]: Light tan,
mottled, round, biconvex, 6mm tablets with markings “511” on one
side.
Ezetimibe/Simvastatin Sandoz 10/20 [10 mg Ezetimibe/ 20 mg
Simvastatin]: Light tan,
mottled, round, biconvex, 8mm tablets with markings “512” on one
side.
Ezetimibe/Simvastatin Sandoz 10/40 [10 mg Ezetimibe/ 40 mg
Simvastatin]: Light tan,
mottled, round, biconvex, 10mm tablets with markings “513” on one
side.
Ezetimibe/Simvastatin Sandoz 10/80 [10 mg Ezetimibe/ 80 mg
Simvastatin]: Light tan,
mottled, capsule shaped, biconvex, 17.5 x 7.55 mm tablets with
markings “515” on one side.
_Not all strengths may be available in Australia. _
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
_ADULTS (≥ 18 YEARS) _
_PREVENTION OF CARDIOVASCULAR DISEASE _
Ezetimibe/Simvastatin Sandoz 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 _
Ezetimibe/Simvastatin Sandoz is indicated as adju