EXEMESTANE SANDOZ

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

exemestane, Quantity: 25 mg

Disponibil de la:

Sandoz Pty Ltd

INN (nume internaţional):

Exemestane

Forma farmaceutică:

Tablet, film coated

Compoziție:

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

Calea de administrare:

Oral

Unități în pachet:

15, 90, 30

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

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

Rezumat produs:

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

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2011-09-12

Prospect

EXEMESTANE SANDOZ
®
1
EXEMESTANE SANDOZ
®
_exemestane film-coated tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Exemestane Sandoz.
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 this medicine
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 EXEMESTANE
SANDOZ IS USED
FOR
This medicine 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
•
to reduce the risk of recurrence or
spreading of the breast cancer
•
when the cancer has not
responded or has returned after
treatment with another medicine
or medicines.
It contains the active ingredient
exemestane.
Exemestane 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 THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
EXEMESTANE
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
exemestane, the active ingredient,
or to any of the other ingredients
listed at the end of this leaflet
under Product Description.
Some of the 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 TA

Caracteristicilor produsului

220214-Exemestane Sandoz-pi
Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
EXEMESTANE SANDOZ
® (EXEMESTANE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Exemestane
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Exemestane Sandoz 25 mg tablet contains 25 mg exemestane.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Exemestane Sandoz 25 mg film-coated tablets – White to off-white
round, biconvex film-
coated tablet, debossed with ‘E25’ on one side and plane on the
other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Exemestane Sandoz is indicated for the sequential adjuvant treatment
of oestrogen receptor-
positive early breast cancer in post-menopausal women who have
received prior adjuvant
tamoxifen therapy.
Exemestane Sandoz is indicated for the treatment of oestrogen
receptor-positive advanced
breast cancer in women with natural or induced postmenopausal status
whose disease has
progressed following anti-oestrogen therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_Adults _
The recommended dose of Exemestane Sandoz in adults is one 25 mg
tablet.
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
Sandoz should continue
until tumour progression is evident.
No dose adjustments are required for patients with hepatic or renal
insufficiency.
Not recommended for use in children.
METHOD OF ADMINISTRATION
Taken once daily, preferably after a meal.
4.3
C
ONTRAINDICATIONS
Exemestane Sandoz tablets are contraindicated in pregnant or lactating
women and in patients
with a known hypersensitivity to the active ingredient or to any of
the excipients.
220214-Exemestane Sandoz-pi
Page 2 of 16
4.4
S
PECIAL 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
app