Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, CT13 9NJ, UK
Aromasin is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer (EBC), 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.
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).
Not recommended for use in children.
Clinical trials have been conducted with Aromasin given up to 800 mg in a single dose to healthy female volunteers and up to 600 mg daily to postmenopausal women with advanced breast cancer; these dosages were well tolerated. The single dose of Aromasin that could result in life-threatening symptoms is not known. In rats and dogs, lethality was observed after single oral doses equivalent respectively to 2000 and 4000 times the recommended human dose on a mg/m² basis. There is no specific antidote to overdosage and treatment must be symptomatic. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.
Shelf life: 3 years.
This medicinal product does not require any special storage conditions.
15, 20, 30, 90, 100 and 120 tablets in blister packs (Aluminium-PVDC/PVC-PVDC)
Not all pack sizes may be marketed.
No special requirements for disposal.
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