Why is this drug prescribed?

Livial tablets contain the active ingredient tibolone, which is a synthetic steroid drug used for hormone replacement therapy. It mimics the activity of the female sex hormones oestrogen and progesterone and the androgen testosterone in the body. Oestrogen is the main sex hormone in the female body. Certain parts of the body, such as the vagina, bones and breasts, rely on oestrogens to function normally. When the levels of oestrogen are low, these tissues can slowly degenerate, as is experienced during and following the menopause. In addition, low levels of oestrogen can cause distressing symptoms such as hot flushes, night sweats, mood swings or depressed mood, reduced sex drive and vaginal dryness. Oestrogen levels decrease naturally during the menopause, but also decrease following a hysterectomy and in women taking drugs called gonadorelin analogues, eg leuprorelin for endometriosis. When taken by mouth, tibolone is broken down into three compounds that act in a similar way to the natural oestrogen, progesterone and testosterone found in the body. This helps restore the balance of hormones in the body and reduces the symptoms of menopause, whether natural or otherwise. Tibolone is also sometimes used to prevent osteoporosis in postmenopausal women. The declining level of oestrogen at menopause can affect the bones, causing them to become thinner and more prone to breaking. Tibolone's oestrogenic effect can help prevent bone loss and fractures that may occur in women in the years after menopause. However, it is only used as a second-line option for women at high risk of fractures who cannot take other drugs that are licensed for preventing osteoporosis. Women considered to be at high risk of developing fractures following the menopause include those who have had an early menopause, those with a family history of osteoporosis, those who have had recent prolonged corticosteroid therapy, those with a small thin frame, and smokers. Women experiencing a natural menopause should not start treatment with this drug until twelve months after their last natural menstrual bleed. This is because the drug may cause irregular menstrual bleeding if it is started sooner than this. Women who have had a surgical menopause or are taking gonadorelin analogues can start treatment immediately.

Treatments

* Relieving the symptoms of oestrogen deficiency in women who have gone through the menopause. * Prevention of osteoporosis in women who have gone through the menopause and are at high risk of fractures, but cannot take other drugs used to prevent osteoporosis.

What side effects can this drug cause?

* Vaginal bleeding or spotting * Vaginal discharge * Vaginal thrush * Vaginal itching * Breast pain * Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain * Rash or itching * Seborrhoeic dermatitis * Abnormal hair growth * Dizziness * Headache/migraine * Weight gain * Visual disturbances such as blurred vision * Excessive fluid retention in the body tissues, resulting in swelling * Pain in the muscles and joints * Depression * Alteration in results of liver function tests * Irregular brown patches on the skin, usually of the face * Blood clots in the blood vessels