EZEMICHOL ezetimibe 10mg tablet blister pack

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

ezetimibe, Quantity: 10 mg

Disponibbli minn:

Arrotex Pharmaceuticals Pty Ltd

INN (Isem Internazzjonali):

Ezetimibe

Għamla farmaċewtika:

Tablet, uncoated

Kompożizzjoni:

Excipient Ingredients: lactose monohydrate; carmellose sodium; povidone; sodium lauryl sulfate; polysorbate 80; magnesium stearate

Rotta amministrattiva:

Oral

Unitajiet fil-pakkett:

30 tablets in blister pack, 10 tablets in blister pack, 7 tablets in blister pack

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

Adults (greater than or equal to 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).,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 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),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)

Sommarju tal-prodott:

Visual Identification: White to off white, capsule shaped, flat faced with beveled edge, uncoated tablets, debossed with 10 on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Licence status A

Data ta 'l-awtorizzazzjoni:

2016-10-05

Fuljett ta 'informazzjoni

-2018- Page 1 of 5
EZEMICHOL
_Ezetimibe _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This
leaflet
answers
some
common
questions
about
EZEMICHOL.
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
EZEMICHOL
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 EZEMICHOL IS
USED FOR
EZEMICHOL
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.
_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 EZEMICHOL _
_WORKS _
EZEMICHOL
reduces
elevated
total-cholesterol,
LDL
(bad)
cholesterol
and
triglycerides
and
increases
HDL (good) cholesterol.
EZEMICHOL
works
by
decreasing the absorption of
cholesterol
in
the
small
intestine.
Statins
lower
cholesterol in a different way,
by
reducing
the
amount
of
cholesterol made in the liver.
EZEMICHOL
adds
to
the
cholesterol-lowering effect of
statins.
Your
doctor
may
have
prescribed
EZEMICHOL
for
another reason.
ASK YOUR DOCTOR IF YOU HAVE
ANY

Karatteristiċi tal-prodott

1
AUSTRALIAN PI – EZEMICHOL (EZETIMIBE) TABLETS
1
NAME OF THE MEDICINE
Ezetimibe
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of EZEMICHOL for oral administration contains 10mg
ezetimibe.
EXCIPIENTS:
EZEMICHOL tablets contain lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
EZEMICHOL tablets are white to off white, capsule shaped, flat faced
with beveled edge, uncoated
tablets, debossed with “10” on one side and plain on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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).
_CHILDREN AND ADOLESCENTS 10-17 YEARS_
_(PUBERTAL STATUS: BOYS TANNER STAGE II AND ABOVE AND GIRLS WHO ARE AT
LEAST ONE YEAR POST-_
_MENARCHE) _
_ _
2
_HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HEFH)_
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)_
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)
4.2
D
OSE AND METHOD OF ADMINISTRATION
The patient should be on an appropriate lipid-lowering diet and should
continue on this diet during
treatment with ezetimibe.
The recommended