ESTAMANE exemestane 25mg tablet blister pack

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

exemestane

Доступна з:

Juno Pharmaceuticals Pty Ltd

ІПН (Міжнародна Ім'я):

Exemestane

Статус Авторизація:

Registered

інформаційний буклет

ESTAMANE TABLETS
CONSUMER MEDICINE INFORMATION VERSION 1.1
2016 Page: 1 of 4
ESTAMANE
Exemestane tablets 25 mg
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Estamane
tablets.
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
Estamane
tablets
against
the
benefits it is expected to have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ESTAMANE IS USED
FOR
Estamane
tablets
are
used
to
treat
breast
cancer
in
women
who
no
longer
have
their
menstrual
periods,
either
naturally due to their age (after
menopause)
or
because
they
have had their ovaries surgically
removed.
Estamane
tablets
are
used
to
reduce the risk of recurrence or
spreading of the breast cancer. It
is also used when the cancer has
not responded or has returned
after
treatment
with
another
medicine or medicines.
_HOW ESTAMANE WORKS _
_ _
Estamane tablets is an
aromatase inactivator. It works
by significantly reducing the
supply of oestrogen to cancer
cells.
This stops the growth of those
cancer
cells
which
need
oestrogen, a natural female sex
hormone, to grow.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ESTAMANE
TABLETS
HAVE
BEEN
PRESCRIBED
FOR YOU.
Your
doctor
may
have
prescribed
it
for
another
purpose.
Estamane
tablets
are
only
available
with
a
doctor's
prescription. It is not addictive.
BEFORE YOU TAKE
ESTAMANE TABLETS
WHEN YOU MUST NOT TAKE
IT
DO NOT TAKE ESTAMANE TABLETS
AND TALK TO YOUR DOCTOR IF YOU
THINK YOU MAY HAVE AN ALLERGY
TO:
*exemestane,
the
active
ingredient in Estamane tablets
* any of the other ingredients in
Estamane tablets listed at the
end of this leaflet.
Symptoms
of
an
allergic
reaction may include shortness
of breath, wheezing or difficulty
breathing; swelling of the face,
lips,
tongue
or
other
parts
of
the body; rash, itch

Характеристики продукта

Estamane PI
Juno Pharmaceuticals Pty Ltd
Doc ID:xxxxx
Page
1
of
1
4
PRODUCT INFORMATION
ESTAMANE
(EXEMESTANE FILM-COATED TABLETS 25 MG)
NAME OF THE MEDICINE
AUSTRALIAN APPROVED NAME
Exemestane
STRUCTURAL FORMULA
:
Chemical name: 6-methylenandrosta-1,4-diene-3,17-dione.
CAS NUMBER
: CAS-107868-30-4
Exemestane has a molecular formula of C
20
H
24
O
2
and a molecular weight of 296.4.
DESCRIPTION
Exemestane is a white or yellowish-white powder, which is freely
soluble in N,N-
dimethylformamide, soluble in methanol and practically insoluble in
water. Due to the
very low solubility in water, the medicine is micronised.
Estamane are white to off-white, round, biconvex film-coated tablets
debossed with
‘E25’ on one side and plain on the other.
Estamane tablets contain the following excipients: Mannitol,
Microcrystalline cellulose,
Crospovidone,
Sodium
starch
glycollate
(Type
A),
Hypromellose,
Polysorbate
80,
Colloidal anhydrous silica, Magnesium stearate and Opadry Complete
Film Coating
System 03B58900 White (Ingredient ID: 106176).
PHARMACOLOGY
PHARMACODYNAMICS
Estamane PI
Juno Pharmaceuticals Pty Ltd
Doc ID:xxxxx
Page
2
of
1
4
Exemestane is an irreversible, steroidal aromatase inactivator,
structurally related to the
natural substrate androstenedione. In post-menopausal women,
oestrogens are produced
primarily from the conversion of androgens into oestrogens through the
aromatase
enzyme in peripheral tissues. Oestrogen deprivation through aromatase
inhibition is an
effective and selective treatment for hormone dependent breast cancer
in postmenopausal
women. Exemestane acts by binding irreversibly to the active site of
the enzyme causing
its inactivation. Such type of inactivation is also known as
“suicidal inhibition”. In
postmenopausal
women,
exemestane
significantly
lowered
serum
oestrogen
concentrations starting from a 5 mg dose, reaching maximal suppression
(80-90%) with a
dose of 10-25 mg.
In postmenopausal breast cancer patients treated with the 25 mg daily
dose, whole body
aromatisation was reduced by 9