Livial

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.

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.

Warning!

Women taking any form of HRT should have regular medical and gynaecological check-ups. Your need for continued HRT should be reviewed with your doctor at least once a year.
It is important to be aware that all women using HRT have an increased risk of being diagnosed with breast cancer compared with women who don't use HRT. This risk needs to be weighed against the personal benefits to you of taking HRT. There is more detailed information about the risks and benefits associated with HRT in the factsheet about the menopause linked above. You should discuss these with your doctor before starting HRT. Women on HRT should have regular breast examinations and mammograms and should examine their own breasts regularly. Report any changes in your breasts to your doctor or nurse.
It is important to be aware that women using HRT have a slightly increased risk of stroke and of blood clots forming in the veins (eg deep vein thrombosis/pulmonary embolism) compared with women who don't use HRT. The risk is higher if you have existing risk factors (eg personal or family history, smoking, obesity, certain blood disorders - see cautions below) and needs to be weighed against the personal benefits to you of taking HRT. There is more detailed information about the risks and benefits associated with HRT in the factsheet about the menopause linked above. Discuss these with your doctor before starting treatment. It is not currently known if tibolone carries the same risk of blood clots as other forms of HRT. However it is associated with a slightly increased risk of stroke.
The risk of blood clots forming in the veins (thromboembolism) while taking HRT may be temporarily increased if you experience major trauma, have surgery, or are immobile for prolonged periods of time (this includes travelling for over five hours). For this reason, your doctor may recommend that you stop taking HRT for a period of time (usually four to six weeks) prior to any planned surgery, particularly abdominal surgery or orthopaedic surgery on the lower limbs, or if you are to be immobile for long periods. The risk of blood clots during long journeys may be reduced by appropriate exercise during the journey and possibly by wearing elastic hosiery. Discuss this with your doctor.
You may get some breakthrough bleeding or spotting in the first few months of taking this medicine. Missing a dose may increase the chance of this. If you are still experiencing any bleeding after six months of taking this medicine, or if breakthrough bleeding or spotting starts after this time, or after you have stopped taking this medicine, you should consult your doctor so that it can be investigated. This is because HRT, including tibolone, has been associated with a slightly increased risk of endometrial cancer. This risk needs to be weighed against the personal benefits to you of taking HRT and you should discuss this with your doctor before you start treatment.
Stop taking this medicine and inform your doctor immediately if you experience any of the following symptoms while taking this medicine: stabbing pains or swelling in one leg; pain on breathing or coughing; coughing up blood; breathlessness; sudden chest pain; sudden numbness affecting one side or part of the body; fainting; worsening of epilepsy; migraine or severe headaches; visual disturbances; severe abdominal complaints; increased blood pressure; itching of the whole body; yellowing of the skin or eyes (jaundice); or severe depression.
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 a potentially fertile women is taking HRT but also requires contraception, a non-hormonal method (eg condoms or contraceptive foam) should be used.

Use with caution in

Close family history of breast cancer (eg mother, sister or grandmother has had the disease)
History of benign breast lumps (fibrocystic breast disease)
History of fibroids in the womb
History of endometriosis
History of overgrowth of the lining of the womb (endometrial hyperplasia)
Personal or family history of blood clots in the veins (venous thromboembolism, eg deep vein thrombosis or pulmonary embolism)
Blood disorders that increase the risk of blood clots in the veins, eg antiphospholipid syndrome, factor V Leiden
Women taking medicines to prevent blood clots (anticoagulants), eg warfarin
Long-term inflammation of skin and some internal organs (systemic lupus erythematosus)
Personal or family history of recurrent miscarriage
Severe obesity
Varicose veins
Smokers
History of high blood pressure (hypertension)
Raised levels of fats called triglycerides in the blood (hypertriglyceridaemia)
History of liver disease, eg liver cancer
Decreased kidney function
Heart failure
History of diabetes
History of gallstones
History of migraines or severe headaches
History of epilepsy
History of asthma
History of an ear disorder that may cause hearing loss (otosclerosis)
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

Pregnancy
Breastfeeding
Known, suspected or past history of breast cancer
Known or suspected cancer in which growth of the cancer is stimulated by oestrogen, eg cancer of the lining of the womb (endometrial cancer)
Untreated overgrowth of the lining of the womb (endometrial hyperplasia)
Vaginal bleeding of unknown cause
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 where the cause is unknown
History of angina
Women who have had a heart attack
Women who have had a stroke or mini-stroke (transient ischaemic attack or TIA)
Active liver disease
History of liver disease when liver function has not returned to normal
Hereditary blood disorders known as 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 medical advice from your doctor.

Side effects

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. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

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 (hypertrichosis)
Dizziness
Headache/migraine
Weight gain
Visual disturbances such as blurred vision
Excessive fluid retention in the body tissues, resulting in swelling (oedema)
Pain in the muscles and joints
Depression
Alteration in results of liver function tests
Irregular brown patches on the skin, usually of the face (chloasma)
Blood clots in the blood vessels (eg, DVT, pulmonary embolism, heart attack, stroke - see warnings above)

The side effects listed above may not include all of the side effects reported by the drug'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.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

The following medicines may potentially reduce the blood levels and effect of this medicine, which could result in recurrence of symptoms or irregular bleeding:

antiepileptic medicines such as carbamazepine, phenytoin, phenobarbital and primidone
barbiturates such as amobarbital
rifamycin antibiotics such as rifabutin and rifampicin.

Some women with diabetes may need small adjustments in their dose of insulin or antidiabetic tablets while taking this medicine. You should monitor your blood sugar and seek advice from your doctor or pharmacist if your blood sugar control seems to be altered after starting this medicine.