EZETIMIBE/SIMVASTATIN SANDOZ 10/10 ezetimibe/simvastatin 10/10 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Tablet

Composition:

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

Administration route:

Oral

Units in package:

10, 5, 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, round about 6 mm biconvex tablets. Marking 511 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 10/10 mg, 10/20 mg, 10/40 mg, 10/80 mg tablets
CONSUMER MEDICINE INFORMATION
Medis Pharma Pty Ltd
EZETIMIBE/SIMVASTATIN SANDOZ

v02 0817
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.
Ezetimibe/simvastatin 10/10 mg, 10/20 mg, 10/40 mg, 10/80 mg tablets
CONSUMER MEDICINE INFORMATION
Medis Pharma Pty Ltd
EZETIMIBE/SIMVASTATIN SANDOZ

v02 0817
2
_TRIGLYCERIDES _
Triglycerides are another form of fat in your blood that may increase
your risk for heart
disease.
_HOW EZETIMIBE/SIMVASTATIN SANDOZ WORKS _
EZETIMIBE/SIMV

Summary of Product characteristics

yymmdd-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