AROMASIN Tablets 25mg Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
02-04-2023
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Active ingredient:
EXEMESTANE
Available from:
Pharmacia Ireland
Dosage:
25mg Milligram
Pharmaceutical form:
Tablets
Authorization date:
2005-02-04
Summary of Product characteristics
License
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Aromasin
®
25 mg coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance: exemestane
Each coated tablet contains 25 mg exemestane.
Each tablet contains 30.2mg of sucrose and 0.003mg of methyl parahydroxybenzoate
(E218).
For a 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 in women with natural or induced postmenopausal
status whose disease has progressed following anti-oestrogen therapy. Efficacy has not been demonstrated in patients
with oestrogen receptor negative status.
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 year
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