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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.

2). 2). Hepatic impairment No dose adjustment is necessary for patients with mild to moderate hepatic impairment. 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.

3 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.

5%). Tabulated list of adverse reactions Adverse reactions are listed below by MedDRA preferred term system organ class and by frequency. Frequencies are defined as very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from available data).

Table 1 Adverse reactions MedDRA system organ class Common Uncommon Infections and infestations Vulvovaginal candidiasis / mycotic infections - Immune system disorders - Drug hypersensitivityb, Hypersensitivityb, Swollen tongue Nervous system disorders Headachec Vascular disorders Hot flushd - Skin and subcutaneous tissue disorders Rash (includes rash erythematous, rash generalised) Pruritus Urticaria Musculoskeletal and connective tissue disorders Muscle spasms - Reproductive system and breast disorders Vaginal discharge, Genital discharge, Vaginal haemorrhage Endometrial hypertrophya (sonographic endometrial thickness) a Endometrial hypertrophy is a MedDRA dictionary term that represents sonographic endometrial thickness findings.

b Hypersensitivity reactions including adverse reactions listed under skin and subcutaneous tissue disorders, swollen tongue, pharyngeal oedema and throat tightening were reported. 9%) groups. d Hot flushes including hyperhidrosis. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 7

g. dyspareunia and vaginal dryness. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually taking into consideration other menopausal symptoms, effects on uterine and breast tissues, thromboembolic and cerebrovascular risks.

Ospemifene should only be continued as long as the benefit outweighs the risk. 8 mm in endometrial thickness after 12 months (as assessed by protocol-specified ultrasonography) was observed and there was no increase in vaginal bleeding or spotting in the ospemifene-treated group compared to the placebo-treated group.

If bleeding or spotting occurs on therapy, or continues after treatment has been discontinued, this should always be investigated, which may include an endometrial biopsy to exclude endometrial malignancy. 1). 2% in women who received placebo treatment.

Venous thromboembolic events (VTEs) The risk of VTE (deep vein thrombosis and pulmonary embolism) is increased with other selective oestrogen receptor modulators (SERMs). The risk of VTE associated with ospemifene cannot be excluded.

Generally recognised risk factors for VTE include advanced age, a family history, severe obesity (BMI> 30 kg/m2) and systemic lupus erythematosus (SLE). The risk of VTE is temporarily increased with prolonged immobilisation, major trauma or major surgery.

, post-surgical recovery, prolonged bed rest). Treatment should be resumed only after the patient is mobilised. If VTE develops after initiating therapy, the treatment should be discontinued. g. painful swelling of a leg, sudden pain in the chest, dyspnoea).

4 Cerebro-vascular events The risk of cerebrovascular events is possibly increased with other SERMs. The risk of cerebrovascular events associated with ospemifene cannot be excluded. This should be considered when prescribing ospemifene for post-menopausal women with a history of stroke or other significant stroke risk factors.

1. - Active or past history of venous thromboembolic events (VTEs), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis. - Unexplained vaginal bleeding. 4). g. endometrial cancer). - Patients with signs or symptoms of endometrial hyperplasia; safety in this patient group has not been studied.