AKM-EZETIMIBE SIMVASTATIN 10/10 ezetimibe & simvastatin 10/10 mg tablet bottle pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet

Composition:

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

Administration route:

Oral

Units in package:

30 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 "A029" on one side and plain on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2019-02-18

Patient Information leaflet

AKM-EZETIMIBE SIMVASTATIN
Ver 02
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
SIM

Summary of Product characteristics

AKM EZETIMIBE SIMVASTATIN
Ver 02
1
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
Excipients with known effect: contains sugars (as lactose).
For the full list of excipients, see Section 6.1 List of excipients.
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
Ver 02
2
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
4.1
THERAPEUTIC INDICATIONS
_ _
_ADULTS (≥18 YEARS)_
_PREVENTION OF CARDIOVASCULAR DISEASE_
AKM EZETIMIBE SIMVASTATIN is indicated in