EXEMESTANE GH exemestane 25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

exemestane, Quantity: 25 mg

Available from:

Generic Health Pty Ltd

INN (International Name):

Exemestane

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: crospovidone; sodium starch glycollate type A; hypromellose; magnesium stearate; mannitol; microcrystalline cellulose; colloidal anhydrous silica; polysorbate 80; titanium dioxide; macrogol 400

Administration route:

Oral

Units in package:

30 Tablets, 15 Tablets, 90 Tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Exemestane is indicated for the sequential adjuvant treatment of estrogen receptor-positive early breast cancer in post-menopausal women who have received prior adjuvant tamoxifen therapy. . Exemestane is indicated for the treatment of estrogen receptor-positive advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following anti-estrogen therapy.

Product summary:

Visual Identification: White to off-white, round, biconvex film-coated tablets debossed with 'E25' on one side and plain on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-04-04

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
EXEMESTANE GH
(EXEMESTANE) FILM COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Exemestane GH. 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
Exemestane GH 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 EXEMESTANE GH IS
USED FOR
Exemestane GH is 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.
Exemestane GH is 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 EXEMESTANE GH WORKS _
Exemestane GH 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
EXEMESTANE GH HAS BEEN
PRESCRIBED FOR YOU. Your doctor
may have prescribed it for
another purpose.
Exemestane GH is only
available with a doctor's
prescription. It is not addictive.
BEFORE YOU TAKE
EXEMESTANE GH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE EXEMESTANE GH
AND TALK TO YOUR DOCTOR IF YOU
THINK YOU MAY HAVE AN ALLERGY
TO:
•
exemestane, the active
ingredient in Exemestane
GH;
•
any of the other ingredients
in Exemestane GH 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,
itching or hives on the skin.
DO NOT TAKE EXEMESTANE GH IF
YOU ARE PREGNANT OR INTEND TO
BE

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – EXEMESTANE GH
(EXEMESTANE) FILM COATED TABLET
1
NAME OF THE MEDICINE
Exemestane.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg exemestane.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Exemestane GH is white to off-white, round, biconvex film-coated
tablets debossed with ‘E25’ on one
side and plain on the other.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Exemestane is indicated for the sequential adjuvant treatment of
estrogen receptor-positive early breast
cancer in postmenopausal women who have received prior adjuvant
tamoxifen therapy.
Exemestane is indicated for the treatment of estrogen
receptor-positive advanced breast cancer in
women with natural or induced postmenopausal status whose disease has
progressed following anti-
estrogen therapy.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULTS
The recommended dose of exemestane in adults is one 25 mg tablet taken
once daily, preferably after
a meal.
In patients with early breast cancer, treatment should continue until
completion of five years adjuvant
hormonal therapy, or until tumour relapse occurs.
In patients with advanced breast cancer, treatment with exemestane
should continue until tumour
progression is evident.
No dose adjustments are required for patients with hepatic or renal
insufficiency.
Exemestane GH v7.0
Page 2 of 17
(exemestane) film coated tablet
PAEDIATRIC USE
Not recommended for use in children.
4.3 CONTRAINDICATIONS
Exemestane
is
contraindicated
in
pregnant
or
lactating
women
and
in
patients
with
a
known
hypersensitivity to the medicine or to any of the excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
CHECK THE FOLLOWING BEFORE USE
Because of its mode of action, exemestane should not be administered
to women with pre-menopausal
endocrine status. Whenever clinically appropriate, confirmation of
postmenopausal status may be
assisted by laboratory tests, such as assessment of luteinising
hormone (LH), follicle stimulating
hormo