Exemestane Pfizer

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Exemestane 25mg

Disponible des:

Pfizer New Zealand Limited

Designació comuna internacional (DCI):

Exemestane 25 mg

Dosis:

25 mg

formulario farmacéutico:

Coated tablet

Composición:

Active: Exemestane 25mg Excipient: Crospovidone Hydrated silica Hypromellose   Macrogol 6000 Magnesium carbonate Magnesium stearate Mannitol Methyl hydroxybenzoate Polysorbate 80 Polyvinyl alcohol Powdered cellulose Simeticone Sodium starch glycolate Sucrose   Titanium dioxide

Unidades en paquete:

Blister pack, PVC/PVdC-Al, 30 tablets

clase:

Prescription

tipo de receta:

Prescription

Fabricat per:

Olon SpA

indicaciones terapéuticas:

· The adjuvant treatment of postmenopausal women with oestrogen receptor positive or receptor unknown early breast cancer after initial adjuvant tamoxifen to reduce the risk of recurrence (distant and loco-regional) and contralateral breast cancer · The treatment of advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following anti-oestrogen therapy · the third-line hormonal treatment of advanced breast cancer in women with natural or induced postmenopausal status whose disease progressed following treatment with anti-oestrogens and either non-steroidal aromatase inhibitors or progestins.

Resumen del producto:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC-Al - 30 tablets - 36 months from date of manufacture stored at or below 30°C

Data d'autorització:

1999-11-01

Informació per a l'usuari

AROMASIN®
1
EXEMESTANE PFIZER®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING EXEMESTANE PFIZER?
EXEMESTANE PFIZER contains the active ingredient exemestane.
EXEMESTANE PFIZER 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 PFIZER is also 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.
For more information, see Section 1. Why am I using EXEMESTANE PFIZER?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE EXEMESTANE PFIZER?
Do not use if you have ever had an allergic reaction to exemestane or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
EXEMESTANE PFIZER? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with EXEMESTANE PFIZER and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE EXEMESTANE PFIZER?
•
The recommended dose is one 25 mg tablet taken once daily after meals,
however, follow all directions given to you by your
doctor or pharmacist carefully as they may differ from the information
contained in this leaflet.
•
Your doctor or pharmacist will tell you how long to take EXEMESTANE
PFIZER.
More instructions can be found in Section 4. How do I use EXEMESTANE
PFIZER? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING EXEMESTANE PFIZER?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are

Fitxa tècnica

Version: pfdexemt10921
Supersedes: pfdexemt10418
Page 1 of 18
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
EXEMESTANE PFIZER
®
25 mg coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: exemestane.
Each coated tablet contains 25 mg exemestane.
EXCIPIENT(S) WITH KNOWN EFFECT
Each tablet contains 30.2 mg of sucrose and 0.003 mg of methyl
parahydroxybenzoate
(E218).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Sugar-coated tablets for oral administration.
The tablets are imprinted “7663” on one side with black printing
ink.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
EXEMESTANE PFIZER is indicated for:
•
the adjuvant treatment of postmenopausal women with estrogen receptor
positive
or receptor unknown early breast cancer after initial adjuvant
tamoxifen to reduce
the risk of recurrence (distant and loco-regional) and contralateral
breast cancer
•
the treatment of advanced breast cancer in women with natural or
induced
postmenopausal
status
whose
disease
has
progressed
following
anti-estrogen
therapy
•
the third-line hormonal treatment of advanced breast cancer in women
with natural
or induced postmenopausal status whose disease progressed following
treatment
with anti-estrogens and either non-steroidal aromatase inhibitors or
progestins.
Version: pfdexemt10921
Supersedes: pfdexemt10418
Page 2 of 18
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
Adult and elderly patients
The recommended dose of EXEMESTANE PFIZER is one 25 mg tablet to be
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
PFIZER
should continue until tumour progression is evident.
No dose adjustments are required for patients with hepatic or renal
insufficiency.
Paediatric population
Not recommended for use in children.
4.3 CONTRAINDICATIONS
EXEMESTANE PFIZER tablets are contraind