AROMASIN 25 Milligram Coated Tablets
Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Preparatomtale
(SPC)
25-04-2024
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Aktiv ingrediens:
EXEMESTANE
Tilgjengelig fra:
Haemato Pharm AG
ATC-kode:
L02BG06
INN (International Name):
EXEMESTANE
Dosering :
25 Milligram
Legemiddelform:
Coated Tablets
Resept typen:
Product subject to prescription which may not be renewed (A)
Terapeutisk område:
Aromatase inhibitors
Autorisasjon status:
Authorised
Autorisasjon dato:
2012-11-30
Preparatomtale
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
_Product imported from Italy:_
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 years of
combined sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin), or earlier if tumour relapse occurs.
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, Pharmacokinetic_
_Properties)._
Children
Not recommended for use in children.
4.3 CONTRAINDICATIONS
Aromasin tablets are contraindicated in patients with a known hypersensitivity to the active su
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