Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Aremed is indicated for the treatment of hormone receptor-positive advanced breast cancer in postmenopausal women.
The recommended dose of Aremed for adults including the elderly in one 1 mg tablet once a day.
Aremed is not recommended for use in children and adolescents due to insufficient data on safety and efficacy (see sections 4.4 and 5.1).
No dose change is recommended in patients with mild or moderate renal impairment. In patients with severe renal impairment, administration of Aremed should be performed with caution (see section 4.4 and 5.2).
No dose change is recommended in patients with mild hepatic disease. Caution is advised in patients with moderate to severe hepatic impairment (see section 4.4).
Oral administration.
There is limited clinical experience of accidental overdose. In animal studies, anastrozole demonstrated low acute toxicity. Clinical trials have been conducted with various dosages of anastrozole, up to 60 mg in a single dose given to healthy male volunteers and up to 10 mg daily given to postmenopausal women with advanced breast cancer; these dosages were well tolerated. A single dose of anastrozole that results in life-threatening symptoms has not been established. There is no specific antidote to overdose and treatment must be symptomatic.
In the management of an overdose, consideration should be given to the possibility that multiple agents may have been taken. Vomiting may be induced if the patient is alert. Dialysis may be helpful because anastrozole is not highly protein bound. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.
5 years.
Store below 25°C. Protect from light and moisture.
PVC/Aluminium blisters. Pack-sizes of 20, 28, 30, 84, 98, 100 and 300 film-coated tablets.
Not all pack-sizes may be marketed.
None.
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