AKM-EZETIMIBE SIMVASTATIN 10/80 ezetimibe & simvastatin 10/80 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:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: propyl gallate; croscarmellose sodium; lactose monohydrate; citric acid monohydrate; magnesium stearate; microcrystalline cellulose; hypromellose; sodium lauryl sulfate; butylated hydroxyanisole

Administration route:

Oral

Units in package:

30 Tablets, 10 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adults (?18 years),Prevention of Cardiovascular Disease,Ezetimibe and Simvastatin Tablets 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.,Primary Hypercholesterolaemia,Ezetimibe and Simvastatin Tablets 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 and Simvastatin Tablets 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 and Simvastatin Tablets 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 and Simvastatin Tablets 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: White to off white, capsule shaped tablets debossed with "A026" on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-02-18

Patient Information leaflet

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

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
AKM EZETIMIBE SIMVASTATIN 10/10
AKM EZETIMIBE SIMVASTATIN 10/20
AKM EZETIMIBE SIMVASTATIN 10/40
AKM EZETIMIBE SIMVASTATIN 10/80
(ezetimibe and simvastatin)
1.
NAME OF THE MEDICINE
The active ingredients of AKM EZETIMIBE SIMVASTATIN are Ezetimibe and
Simvastatin.
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AKM
EZETIMIBE
SIMVASTATIN
10/10
(Ezetimibe
10
mg
and
Simvastatin
10
mg
Tablets)
Each tablet contains 10 mg ezetimibe and 10 mg of simvastatin
AKM
EZETIMIBE
SIMVASTATIN
10/20
(Ezetimibe
10
mg
and
Simvastatin
20
mg
Tablets)
Each tablet contains 10 mg ezetimibe and 20 mg of simvastatin
AKM
EZETIMIBE
SIMVASTATIN
10/40
(Ezetimibe
10
mg
and
Simvastatin
40
mg
Tablets)
Each tablet contains 10 mg ezetimibe and 40 mg of simvastatin
AKM
EZETIMIBE
SIMVASTATIN
10/80
(Ezetimibe
10
mg
and
Simvastatin
80
mg
Tablets)
Each tablet contains 10 mg ezetimibe and 80 mg of simvastatin
Excipient(s) with known effect: lactose monohydrate 57.392 mg (10
mg/10 mg)
Excipient(s) with known effect: lactose monohydrate 124.785 mg (10
mg/20 mg)
Excipient(s) with known effect: lactose monohydrate 259.570 mg (10
mg/40 mg)
Excipient(s) with known effect: lactose monohydrate 529.140 mg (10
mg/80 mg)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
AKM
EZETIMIBE
SIMVASTATIN
10/10
(Ezetimibe
10
mg
and
Simvastatin
10
mg
Tablets)
White to off white, capsule shaped tablets debossed with "A029" on one
side and plain on
other side.
AKM
EZETIMIBE
SIMVASTATIN
10/20
(Ezetimibe
10
mg
and
Simvastatin
20
mg
Tablets)
White to off white, capsule shaped tablets debossed with "A028" on one
side and plain on
other side.
AKM
EZETIMIBE
SIMVASTATIN
10/40
(Ezetimibe
10
mg
and
Simvastatin
40
mg
Tablets)
White to off white, capsule shaped tablets debossed with "A027" on one
side and plain on
other side.
AKM
EZETIMIBE
SIMVASTATIN
10/80
(Ezetimibe
10
mg
and
Simvastatin
80
mg
Tablets)
White to off white, capsule shaped tablets debossed with "A026" on one
side and plain on
other side.
4.
CLINICAL PARTICULARS
4