Livial tablets contain the active ingredient tibolone, which is a synthetic steroid medicine used for hormone replacement therapy (HRT). It mimics the activity of the female sex hormones oestrogen and progesterone and the androgen testosterone in the body.
Pharmacist - M.B.A. (Public Health) D.I.C.
What is it used for? Relieving the…
What is it used for?
- Relieving the symptoms of oestrogen deficiency (eg hot flushes, decreased sex drive, depression) 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 medicines used to prevent osteoporosis.
How does it work?
- Livial tablets contain the active ingredient tibolone, which is a synthetic steroid medicine used for hormone replacement therapy (HRT). 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 (surgical menopause) and in women taking medicines 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 medicines 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 (eg prednisolone), those with a small thin frame, and smokers.
- Women experiencing a natural menopause should not start treatment with this medicine until twelve months after their last natural menstrual bleed. This is because the medicine 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.
How do I take it?
- One tablet should be taken once a day, at the same time each day.
- The tablet can be taken either with or without food. Swallow it with a drink.
- If you forget to take your tablet at your usual time and it is less than 12 hours late, take it as soon as you remember. If it is more than 12 hours late, leave out the missed dose and take your next dose as usual when it is due. Do not take a double dose to make up for a missed dose.
- Missing a dose increases the risk of experiencing vaginal bleeding or spotting.
- Keep taking this medicine every day until your doctor tells you to stop. Your doctor will prescribe the lowest dose to treat your symptoms for as short a time as necessary.
Use with caution in
- Women with a close family history of breast cancer (eg mother or sister has had the disease).
- Women with a history of benign breast lumps (fibrocystic breast disease).
- Women with a history of fibroids in the womb.
- Women with a history of endometriosis or overgrowth of the lining of the womb (endometrial hyperplasia).
- Women with a family history of blood clots in the veins (venous thromboembolism, eg deep vein thrombosis or pulmonary embolism).
- Women taking medicines to prevent blood clots (anticoagulants), eg warfarin.
- Women with a condition called systemic lupus erythematosus, which involves long-term inflammation of skin and some internal organs.
- Women with a personal or family history of recurrent miscarriage.
- Women who are obese.
- Women with severe varicose veins.
- Women with a history of high blood pressure (hypertension).
- Heart failure.
- Women with raised levels of fats called triglycerides in the blood (hypertriglyceridaemia).
- Women with a history of liver disease, eg liver cancer.
- Women with decreased kidney function.
- Women with diabetes.
- Women with a history of gallstones.
- Women with a history of migraines or severe headaches.
- Women with a history of an ear disorder that may cause hearing loss (otosclerosis).
Women with a history of irregular brown patches appearing on the skin, usually of the face, during pregnancy or previous use of hormone preparations such as contraceptive pills (chloasma). Women with a tendency to this condition should minimise their exposure to the sun or UV light while taking HRT.
Not to be used in
- Women with known, suspected or a past history of breast cancer.
- Women with known or suspected cancer in which growth of the cancer is stimulated by oestrogen, eg cancer of the lining of the womb (endometrial cancer).
- Women with untreated overgrowth of the lining of the womb (endometrial hyperplasia).
- Women with vaginal bleeding where the cause is not known.
- Women with a blood clot in a vein of the leg (deep vein thrombosis) or in the lungs (pulmonary embolism), or a past history of these conditions.
- Women with blood disorders that increase the risk of blood clots in the veins, eg antiphospholipid syndrome, factor V Leiden, protein C or protein S deficiency.
- Women with a history of angina.
- Women who have had a heart attack.
- Women who have had a stroke or mini-stroke (transient ischaemic attack or TIA).
- Women with active liver disease or a history of liver disease if liver function has not returned to normal.
- Rare inherited blood disorders called porphyrias.
- Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Livial tablets contain lactose).
- This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- This medicine should not be used by women who are pregnant or breastfeeding. You should stop taking this medicine and consult your doctor immediately if you get pregnant during treatment.
- A woman is considered fertile for two years after her last menstrual period if she is under 50, or for one year if over 50. HRT does not provide contraception for women who fall within this group. If you could get pregnant while taking this HRT, you should use a non-hormonal method of contraception (eg condoms or contraceptive foam). Seek further medical advice from your doctor.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. See also the warnings above. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Common (affect between 1 in 10 and 1 in 100 people)
- Vaginal bleeding or spotting. See warning section above.
- Vaginal discharge.
- Vaginal itching.
- Vaginal thrush.
- Breast tenderness.
- Abnormal hair growth (hypertrichosis).
- Weight gain.
- Abdominal or pelvic pain.
- Thickening of the lining of the uterus (endometrium).
Uncommon (affect between 1 in 100 and 1 in 1000 people)
- Fluid retention, resulting in swelling (oedema).
- Nipple pain.
- Rash or itching.
- Seborrhoeic dermatitis.
- Visual disturbances such as blurred vision.
- Pain in the muscles and joints.
- Alteration in results of liver function tests.
- Irregular brown patches on the skin, usually of the face (chloasma).
- Blood clots in the blood vessels.
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.