AROMASIN

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

EXEMESTANE

Disponible depuis:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

Code ATC:

L02BG06

forme pharmaceutique:

COATED TABLETS

Composition:

EXEMESTANE 25 MG

Mode d'administration:

PER OS

Type d'ordonnance:

Required

Fabriqué par:

PFIZER ITALIA S.R.L, ITALY

Groupe thérapeutique:

EXEMESTANE

Domaine thérapeutique:

EXEMESTANE

indications thérapeutiques:

Aromasin is indicated for the treatment of advanced breast cancer (ABC) in women with natural or induced postmenopausal status whose disease has progressed following anti-oestrogen therapy alone. Aromasin is also indicated for the treatment of postmenopausal women with ABC whose disease has progressed following multiple hormonal therapies. Aromasin is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breas cancer following 2-3 years of initial adjuvant tamoxifen therapy.

Date de l'autorisation:

2020-07-31

Notice patient

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
AROMASIN
® COATED TABLETS 25 MG
The active ingredient and its quantity:
Each coated tablet contains:
exemestane 25 mg
Inactive ingredients and allergens: See section 2 "Important
information about some of this
medicine’s ingredients", section 6 "Additional information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their illness is similar to
yours.
This medicine is not intended for children.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Aromasin
®
is used to treat hormone dependent early breast cancer in
postmenopausal
women after they have completed 2-3 years of treatment with the
medicine tamoxifen.
Additionally, Aromasin
®
is used for the treatment of hormone dependent advanced breast
cancer in women in postmenopausal status (natural or induced) whose
disease has
progressed following a single hormonal (anti-estrogen) therapy or
several hormonal therapies.
THERAPEUTIC GROUP: Steroidal inhibitors of the enzyme aromatase,
anti-neoplastic (anti-
cancer) agents.
Aromasin
®
belongs to a group of medicines known as aromatase inhibitors;
aromatase is an
enzyme required for the production of the female sex hormones,
estrogens, especially in
postmenopausal women. Reduction in estrogen levels in the body is a
way of treating
hormone dependent breast cancer.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
you are or have previously been sensitive (allergic) to the active
ingredient
(exemestane) or to any of the other ingredients of this medicine. For
additional
information, please see section 6.
•
you are pregnant, likely to be pregnant or breastfeeding.
•
you are not po

Résumé des caractéristiques du produit

Aromasin LPD CC 040523
1
2021-0068642
PRESCRIBING INFORMATION
1. NAME OF THE MEDICINAL PRODUCT
AROMASIN
®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 25 mg exemestane.
Excipients with known effect:
Each tablet contains 30.2 mg of sucrose and 0.003 mg of methyl
parahydroxybenzoate.
-For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Coated tablet
Round, biconvex, off-white coated tablet marked 7663 on one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aromasin
is indicated for the adjuvant treatment of postmenopausal women with
oestrogen
receptor positive invasive early breast cancer, following 2 – 3
years of initial adjuvant
tamoxifen therapy.
Aromasin is indicated for the treatment of advanced breast cancer
(ABC) in women with
natural or induced postmenopausal status whose disease has progressed
following anti-
oestrogen therapy alone. Aromasin is also indicated for the treatment
of postmenopausal
women with ABC whose disease has progressed following multiple
hormonal therapies.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adult and elderly patients
The recommended dose of Aromasin is one 25 mg tablet to be taken once
daily, preferably
after a meal.
In patients with early breast cancer, treatment with Aromasin should
continue until
completion of five years of adjuvant endocrine therapy, or until local
or distant recurrence or
new contralateral breast cancer. In patients with advanced breast
cancer, treatment with
Aromasin should continue until tumour progression is evident.
No dose adjustments are required for patients with hepatic or renal
insufficiency (see section
5.2).
Aromasin LPD CC 040523
2
2021-0068642
Paediatric population
Not recommended for use in children.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
In pre-menopausal women and in pregnant or lactating women.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Aromasin should not be administered to women with pre-menopausal
endocri