Osmifen

Indications

Ospemifene is used to treat moderate to severe pain during sexual intercourse (dyspareunia) and vaginal dryness caused by menopause. These symptoms happen because the lining of the vagina becomes thin and dry when oestrogen levels fall (vulvovaginal atrophy). It is for postmenopausal women.

How It Works

Ospemifene is a selective oestrogen receptor modulator (SERM). It acts like oestrogen in some tissues and blocks it in others. In the vagina it has an oestrogen-like effect, making the lining thicker, moister and less fragile, which reduces pain during intercourse and dryness.

Dosage and Administration

Take as prescribed; the usual dose is one 60 mg tablet by mouth once daily with food, at the same time each day. Your doctor will review whether you still need it at regular intervals and will use it for the shortest time that meets your needs.

Interactions

Do not take with oestrogens, other SERMs (such as Tamoxifen or Raloxifene) or hormone therapy. Fluconazole and other medicines that block both CYP3A4 and CYP2C9 raise Ospemifene levels; Rifampicin and other enzyme inducers lower them. Ketoconazole may also increase levels. Tell your doctor about all medicines, including herbal products.

Contraindications

Do not use if you have or have had breast cancer or another oestrogen-dependent cancer, unexplained vaginal bleeding, blood clots in the veins or lungs, a stroke or heart attack, severe liver disease, or if you are pregnant, could be pregnant, or are allergic to Ospemifene.

Side Effects

Common side effects include hot flushes, vaginal discharge, muscle cramps, sweating and vaginal or genital infections such as thrush. Serious but less common risks include blood clots, stroke, and thickening of the lining of the womb, which can lead to womb cancer.

Get urgent medical help if you have pain or swelling in one leg, chest pain, sudden breathlessness or coughing up blood, sudden weakness, numbness, trouble speaking or seeing, severe headache, or any unusual vaginal bleeding.

Pregnancy and Lactation

Ospemifene is only for women after menopause. It must not be used in pregnancy and should not be used while breastfeeding.

Precautions and Warnings

Report any vaginal bleeding to your doctor promptly, as it needs checking. Women with a womb may need regular checks of the womb lining. Stop it at least 4 to 6 weeks before major surgery or long periods of immobility, as advised by your doctor. Tell your doctor about any history of blood clots, stroke, heart disease, breast lumps or liver problems.

Overdose

Information on overdose is limited. Seek medical advice if a large amount has been taken; treatment is supportive.

Therapeutic Class

Selective oestrogen receptor modulator (SERM).

Storage

Store below 30°C in a dry place, away from light and out of the reach of children.