How does it work?

Tibolone is a synthetic steroid which mimics the activity of oestrogen and progesterone (female sex hormones) 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 menopause. In addition low levels of oestrogen can cause distressing symptoms such as hot flushes, mood swings, reduced sex drive and vaginal dryness. Tibolone when taken by mouth is broken down into three compunds which act in a similar way to the natural oestrogen and progesterone found in the body. The balance of hormones is in the body is therefore restored, and the symptoms of menopause are reduced and osteoporosis is prevented.

What is it used for?

Hot flushes and sweating caused by hormonal disturbances during the menopause

Used to help prevent the development of osteoporosis

Warning!

A woman is considered fertile for 2 years after her last menstrual period if she is under 50, or for 1 year if over 50. HRT does not provide contraception for women who fall within this group. If a potentially fertile women takes HRT and contraception is required, non-hormonal methods (eg condoms) are necessary.

Missed pill: if you forget to take a pill, take it as soon as you remember, and the next one at your normal time. If you are 12 hours or more late, another contraceptive method (e.g. condoms) should be used for the next seven days, whilst continuing with normal pill taking. Read the instructions on your pack carefully regarding missed pills.

It is advisable to undergo periodic medcial examinations during prolonged treatment with steroids.

Treatment with this medicine should be discontinued if liver function tests are abnormal or in the development of yellow colouration of the skin caused by blocked bile ducts (cholestatic jaundice).

Some women taking this medicine will experience mid-cycle bleeding. However, if this should start after three months of treatment or is persistent, it should be investigated.

In women experiencing a natural menopause, this medicine should not be taken in the period immediately preceeding the menopause in order not to disturb the regularity of the cycle.

Use with caution in

Decreased kidney function

Diabetes mellitus

Epilepsy

High blood cholesterol levels

History of liver disease

Liver disease

Obesity

Personal or family history of blood clots in the veins (venous thromboembolism)

Treatment of migraine

Not to be used in

Breastfeeding

Cancer that is responsive to female hormones (oestrogen dependent neoplasia) eg endometrial cancer

Cardiovascular disorders e.g. thrombophlebitis

Disease of the blood vessels in and around the brain (cerebrovascular disease)

Pregnancy

Severe liver disease

Vaginal bleeding of unknown cause

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 in pregnancy. Seek medical advice from your doctor.

Significant amounts of this medicine may pass into breast milk. It should not be used by breastfeeding mothers. Discuss this with 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.

Rash

Depression

Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain

Visual disturbances

Pain in the muscles (myalgia)

Weight changes

Headache

Swelling of the legs and ankles due to excess fluid retention (peripheral oedema)

Dizziness

Growth of facial hair

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.

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