FARESTON Tablet Ref.[9651] Active ingredients: Toremifene

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Orion Corporation, Orionintie 1, FI-02200, Espoo, Finland

Therapeutic indications

First line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients.

Fareston is not recommended for patients with estrogen receptor negative tumours.

Posology and method of administration

Posology

The recommended dose is 60 mg daily.

Renal impairment

No dose adjustment is needed in patients with renal insufficiency.

Hepatic impairment

Toremifene should be used cautiously in patients with liver impairment (see section 5.2).

Pediatric population

There is no relevant use of Fareston in the paediatric population.

Method of administration

Toremifene is administered orally. Toremifene can be taken with or without food.

Overdose

Vertigo, headache and dizziness were observed in healthy volunteer studies at daily dose of 680 mg. The dose-related QTc interval prolongation potential of Fareston should also be taken into account in cases of overdose. There is no specific antidote and the treatment is symptomatic.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Green PVC foil and aluminium foil blister in a cardboard box.

Package sizes: 30 and 100 tablets.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

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