Senshio® (ospemifene) 60 mg tablets. Please refer to full Summary of Product Characteristics (SmPC) before prescribing.
Presentation: Each film-coated tablet contains 60 mg ospemifene.
Indication: Treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women.
Posology and method of administration: The recommended dose is one 60 mg tablet once daily with food taken at the same time each day.
Contraindications: Hypersensitivity to the active substance or any of the excipients. Active or previous venous thromboembolic events (VTEs), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis. Unexplained vaginal bleeding. Suspected or actively treated breast cancer, active or suspected sex-hormone dependent malignancy. Signs or symptoms of endometrial hyperplasia.
Warnings and precautions: For the treatment of vulvar and vaginal atrophy, Senshio should only be initiated for symptoms that adversely affect quality of life e.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. Senshio should only be continued as long as the benefit outweighs the risk. Endometrial thickening has been observed; Risk of VTE is increased with other selective oestrogen receptor modulators (SERMs) and cannot be excluded with Senshio, discontinue 4 to 6 weeks prior to and during prolonged immobilisation, major trauma or major surgery. Advise patients to seek immediate help if they experience potential thromboembolic symptoms. Risk of cerebrovascular events is possibly increased with other SERMs and cannot be excluded with Senshio; take into consideration in postmenopausal women with history of stroke or other significant risk factors. It is recommended that pre—existing gynaecological pathology other than VVA be investigated and treated appropriately before starting Senshio. Use only after treatment of breast cancer, including adjuvant therapy, has been completed. May increase incidence of hot flushes. Caution when co-administering with fluconazole, rifampicin, carbamazepine, phenytoin, St John’s wort, rifabutin, metformin, acyclovir, ganciclovir, oxaliplatin or orlistat. Concurrent use with oestrogens or other SERMs not recommended. Contains lactose.
Pregnancy & lactation: Not to be used in women of child-bearing potential. If pregnancy occurs during treatment with ospemifene, ospemifene should be withdrawn immediately. Senshio is not indicated during breast-feeding.
Undesirable effects: Common; Vulvovaginal candidiasis / mycotic infections, hot flush, muscle spasms, vaginal discharge, genital discharge, vaginal haemorrhage, headache, rash. Uncommon; Endometrial hypertrophy, drug hypersensitivity, hypersensitivity, swollen tongue, pruritus, urticaria. Healthcare professionals are asked to report any suspected adverse reactions in line with local regulatory requirements and to contact@shionogi.eu
Legal classification: Prescription only medicine.
MA number: EU/1/14/978/002.
Pack sizes and Cost: 28 tablets £39.50.
MA Holder: Shionogi B.V., Kingsfordweg 151, 1043GR, Amsterdam, Netherlands.
Date of preparation: February 2023