Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: AstraZeneca AB, SE-151 85 Sodertalje, Sweden
‘Nolvadex’ is indicated in the treatment of breast cancer.
The dosage range is 20 to 40 mg daily, given either in divided doses twice daily or as a single dose once daily. In early disease, it is currently recommended that treatment is given for not less than 5 years. The optimal duration of Nolvadex therapy remains to be determined.
The use of Nolvadex is not recommended in children, as safety and efficacy have not been established (see sections 5.1 and 5.2).
For administration by the oral route.
On theoretical grounds, overdosage would be expected to cause enhancement of the anti-oestrogenic side effects mentioned above. Observations in animals show that extreme overdosage (100 – 200 times recommended daily dose) may produce oestrogenic effects.
There have been reports in the literature that ‘Nolvadex’ given at several times the standard dose may be associated with prolongation of the QT interval of the ECG.
There is no specific antidote to overdosage and treatment must be symptomatic.
5 years.
Store in the original container in order to protect from light.
Do not store above 30°C.
Aluminium blister pack (30).
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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