Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus, EU
Novofen is indicated for:
The recommended daily dose of tamoxifen is 20 mg. No additional benefit, in terms of delayed recurrence or improved survival in patients, has been demonstrated with higher doses. Substantive evidence supporting the use of treatment with 30-40 mg per day is not available, although these doses have been used in some patients with advanced disease.
Similar dosing regimens of Novofen have been used in older people with breast cancer and in some of these patients it has been used as sole therapy.
Before commencing any course of treatment, whether initial or subsequent, the possibility of pregnancy must be excluded. In women who are menstruating regularly, but with anovular cycles, the initial course of treatment consists of 20 mg given daily on the second, third, fourth and fifth days of the menstrual cycle. If unsatisfactory basal temperature records or poor pre-ovulatory cervical mucus indicate that this initial course of treatment has been unsuccessful, further courses may be given during subsequent menstrual periods, increasing the dosage to 40 mg and then to 80 mg daily.
In women who are not menstruating regularly, the initial course may begin on any day. If no signs of ovulation are demonstrable, then a subsequent course of treatment may start 45 days later, with dosage increased as above. If a patient responds with menstruation, then the next course of treatment is commenced on the second day of the cycle.
The use of Novofen is not recommended in children. The safety and efficacy of Novofen in children has not yet been established (see sections 5.1 and 5.2).
Oral administration.
On theoretical grounds, an overdosage would be expected to cause enhancement of the pharmacological side effects mentioned above. Observation in animals show that extreme overdosage (100-200 times recommended daily dose) may produce oestrogenic effects.
There have been reported in the literature that Novofen 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.
Stored below 25°C. Protect from light and moisture.
Aluminium strips. Pack sizes of 30 and 1000 tablets.
Not all pack sizes may be marketed.
Not applicable.
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