AKM EZETIMIBE ezetimibe 10 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ezetimibe, Quantity: 10 mg

Available from:

Pharmacor Pty Ltd

INN (International Name):

Ezetimibe

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: microcrystalline cellulose; hypromellose; crospovidone; lactose monohydrate; magnesium stearate; croscarmellose sodium; sodium lauryl sulfate

Administration route:

Oral

Units in package:

30, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adults (? 18 Years) Primary Hypercholesterolaemia,AKM EZETIMIBE administered alone, or with an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,Homozygous Familial Hypercholesterolaemia (HoFH),AKM EZETIMIBE, administered with a statin, is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).,Homozygous Sitosterolaemia (Phytosterolaemia),AKM EZETIMIBE is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,Prevention of Cardiovascular Disease,AKM EZETIMIBE, is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) 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).,Children and Adolescents 10-17 Years (pubertal status: boys Tanner Stage II and above and girls who are at least one year postmenarche),Heterozygous Familial Hypercholesterolaemia (HeFH),AKM EZETIMIBE co-administered with simvastatin (doses up to 40 mg) is indicated as an 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),AKM EZETIMIBE co-administered with simvastatin (doses up to 40 mg) 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, flat faced, beveled edge tablets, debossed with A25 on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-06-07

Patient Information leaflet

AKM EZETIMIBE
_Ezetimibe _ Consumer Medicine Information
AKM EZETIMIBE VER: 03 1
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions about AKM EZETIMIBE. 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 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
IS USED FOR
AKM
EZETIMIBE
helps
to
lower
cholesterol levels. It is used in people
whose cholesterol levels are too high
and
when
diet
alone
cannot
lower
these levels adequately.
AKM
EZETIMIBE
may
be
taken
alone
or
with
other
cholesterol-
lowering medicines known as HMG-
CoA reductase inhibitors (or statins),
in addition to diet.
In
people
who
have
high
levels
of
plant
sterols
in
their
blood
(which
doctors
call
sitosterolaemia),
AKM
EZETIMIBE
helps
to
lower
these
levels.
_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 on
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 _
_TABLET WORKS _
AKM
EZETIMIBE
reduces
elevated
total-cholesterol,
LDL
(bad)
cholesterol
and
triglycerides
and
increases HDL (good) cholesterol.
AKM
EZETIM

Summary of Product characteristics

AKM Ezetimibe
Ver: 03
1
AUSTRALIAN PRODUCT INFORMATION
AKM EZETIMIBE TABLETS
(ezetimibe)
1. NAME OF THE MEDICINE
Ezetimibe.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AKM Ezetimibe 10 mg tablets:
Each tablet of AKM Ezetimibe for oral administration contains 10 mg
ezetimibe..
List of excipients with known effect
Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Tablets
AKM Ezetimibe 10 mg tablets:
white to off white capsule shaped, flat faced, beveled edge tablets,
debossed with 'A25' on one side
and
plain on other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_ADULTS (≥ 18 YEARS)_
_PRIMARY HYPERCHOLESTEROLAEMIA_
EZETIMIBE administered alone, or with an HMG-CoA reductase inhibitor
(statin), is indicated as
adjunctive therapy to diet in patients with
primary (heterozygous familial and non-familial)
hypercholesterolaemia.
_HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH)_
EZETIMIBE, administered with a statin, is indicated for patients with
HoFH. Patients may
also receive adjunctive treatments (e.g., LDL apheresis).
AKM Ezetimibe
Ver: 03
2
_HOMOZYGOUS SITOSTEROLAEMIA (PHYTOSTEROLAEMIA)_
EZETIMIBE is indicated for the reduction of elevated sitosterol and
campesterol levels in
patients with homozygous familial sitosterolaemia.
_PREVENTION OF CARDIOVASCULAR DISEASE _
Ezetimibe, is indicated for administration in combination with the
maximum tolerated dose of
a statin with proven cardiovascular benefit in patients with coronary
heart disease (CHD) and
a history of acute coronary syndrome (ACS) 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).
_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 co-administered with sim