SENSHIO Film-coated tablet Ref.[7591] Active ingredients: Ospemifene

Posology

The recommended dose is one 60 mg tablet once daily with food taken at the same time each day.

If a dose is missed it should be taken with food as soon as the patient remembers. A double dose should not be taken in the same day.

Special populations

Elderly (>65 years old)

No dose adjustment is necessary in patients above the age of 65 years (see section 5.2).

Renal impairment

No dose adjustment is necessary for patients with mild, moderate or severe renal impairment (see section 5.2).

Hepatic impairment

No dose adjustment is necessary for patients with mild to moderate hepatic impairment. Ospemifene has not been studied in patients with severe hepatic impairment, therefore Senshio is not recommended for use in such patients (see section 5.2).

Paediatric population

There is no relevant use of ospemifene in the paediatric population for the indication of the treatment of moderate to severe symptomatic VVA in post-menopausal women.

Method of administration

Oral use.

One tablet should be swallowed whole once daily with food and should be taken at the same time each day.

Ospemifene has been administered to subjects in single doses for up to 800 mg day and repeat doses up to 240 mg/day for 7 days and up to 200 mg/day for 12 weeks. There is no specific antidote for ospemifene. In the event of overdose, general supportive measures should be initiated based on the patient’s signs and symptoms.

5 years.

This medicinal product does not require any special storage conditions.

PVC/PVdC-Aluminium blister. Pack sizes of 7, 28 or 84 film-coated tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.