TAMIFEN Tablet Ref.[28261] Active ingredients: Tamoxifen

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

4.1. Therapeutic indications

Tamifen is indicated for:

  • the treatment of breast cancer.
  • the treatment of anovulatory infertility.

4.2. Posology and method of administration

Posology

1. Breast cancer

Adults

The recommended daily dose of tamoxifen is normally 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.

Elderly

Similar dosing regimens of tamoxifen have been used in elderly patients with breast cancer and in some of these patients it has been used as sole therapy.

2. Anovulatory infertility

Adults

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 consist of 20mg 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 40mg and then to 80mg 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.

Paediatric population

The use of tamoxifen is not recommended in children, as safety and efficacy have not been established (see sections 5.1 and 5.2).

Method of administration

Oral administration.

4.9. Overdose

Symptoms

On theoretical grounds, an overdosage would be expected to cause enhancement of the pharmacological 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 tamoxifen given at several times the standard dose may be associated with prolongation of the QT interval of the ECG.

Management

There is no specific antidote to overdosage, and treatment must be symptomatic.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C, in the original package.

6.5. Nature and contents of container

Tamifen 10mg: PVC/PVDC-Al blisters of 10 tablets are available. Packs of 30 and 100 tablets are available.

Tamifen DS 20mg: PVC-Al blisters of 10 tablets are available. Packs of 30 and 100 tablets are available.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

None.

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