Tibolone should be used with caution in: asthma, kidney disease, liver disease, fitting (epilepsy), gallstones, high blood pressure, migraine headache, diabetes, otosclerosis (a hearing problem), the rare disease systemic lupus erythematosus (SLE), fibroids (growths) in the womb (uterus), endometriosis (tissue that lines the womb grows in other areas outside the womb), patients with high levels of cholesterol in their blood (hypercholesterolaemia), women who are bleeding from the vagina, women with relatives who have had blood clots, women whose close relatives have had breast cancer or cancer of the lining of the womb, patients who are overweight, women who are not very active because of major surgery, injury or illness.
It should not be used in: women who have ever had an allergic reaction to tibolone, lactose or other sugars or to any other ingredient in the medicine, women taking oestrogen hormone replacement therapy (HRT), women with a history of breast cancer or known or suspected to have breast cancer, women who have had any other cancers that are dependent on hormones for growth, women who have had a stroke or mini-stroke (transient ischaemic attack), heart disease, blood circulation disorders including clotting problems, bleeding from the vagina that has not been investigated by a doctor, severe liver disease, the inherited condition porphyria, endometrial hyperplasia (abnormal growth of the lining of the womb), pregnancy, breast-feeding, Lapp lactase deficiency or poor absorption of glucose-galactose.
Also see list of precautions and interactions
Store below 25ºC but not in the fridge.
Tibolone is used to mimic the activity of the naturally occurring female sex hormones oestrogen and progestogen in the body. It helps to restore the natural balance of these hormones.
It is a female sex hormone, sometimes known as a hormone replacement therapy (HRT). Tibolone is broken down in the body to make hormones and it then has an effect similar to combined HRT (a type of HRT containing the female hormones oestrogen and progestogen).
It is used to relieve symptoms that start to occur when the female body no longer produces certain hormones such as oestrogen. This may occur after the menopause, also known as the change of life, or after surgery to remove the ovaries. Tibolone may also be used to stop your bones from becoming brittle.
In general this drug is used to treat symptoms associated with a lack of oestrogen in women who have gone through the menopause (change of life) more than one year ago.
Benefits of being on this drug can include replacement of lost hormones leading to an improvement in a number of symptoms including hot flushes, night sweats, dryness or irritation of the vagina and reduced sex drive. Tibolone can also reduce the likelihood of your bones becomes brittle and breaking by preventing the bone disease osteoporosis.
Listed below are the typical uses of tibolone.
- Prevention of bone fractures in women
- Treatment of symptoms associated with low levels of the hormone oestrogen in women.
On occasion your doctor may prescribe this medicine to treat a condition not on the above list. Such conditions are listed below.
HOW TO USE/TAKE
How often do I take it?
- Take this medication by mouth usually once a day, with or without food. Swallow the tablet whole with some water.
- It is important that you see your doctor for regular check-ups (at least once a year) whilst you are taking tibolone. You should also go for regular breast screening and cervical smear tests and check yourself regularly for any breast changes such as dimpling of the skin, changes in the nipples and lumps. If you have started the menopause you should not take tibolone until 12 months after your last natural period.
- Use this medication regularly in order to get the most benefit from it.
- Remember to use it at the same time each day - unless specifically told otherwise by your doctor.
- It may take up to a few weeks before the full benefit of this drug takes effect.
- Certain medical conditions may require different dosage instructions as directed by your doctor.
- Dosage is based on your age, medical condition, response to therapy, and use of certain interacting medicines.
Do I need to avoid anything?
- Tibolone is not known to have an effect on a patient's ability to drive or operate machinery. Consult your doctor or pharmacist for more details.
When can I stop?
- It is important to continue taking this medication even if you feel well, unless your doctor tells you to stop.
TIBOLONE SIDE EFFECTS
- Stomach problems
- Pain in the abdomen
- Breast pain
- Change in weight
- Bleeding from the vagina or spotting
- Hair growth on the face
- Swelling of hands and feet (oedema)
- Feeling dizzy
- Migraine headache
- Feeling depressed
- Painful muscles and joints
- Skin problems
- Problems with eyesight
- Itching and irritation of the vagina
- Vaginal infection (including thrush)
- Increased vaginal secretions
- Thickening of the lining of the womb or cervix
- Loss of memory (amnesia, if HRT is started over the age of 65 )
- Changes in liver tests (revealed on blood testing)
If any of these persist or you consider them severe then inform your doctor or pharmacist. Further information about other side effects can be found in the patient information leaflet.
Tell your doctor immediately if you develop any of the following symptoms:
- High blood pressure
- Pain in your chest that spreads to your arm or neck
- Skin or whites of the eyes become yellow (jaundice)
- Migraine or severe headache with or without eyesight problems
- Painful swelling in your leg, sudden chest pain or difficulty breathing
- Bleeding or spotting from the vagina that continues for more than 6 months and starts after you've been on tibolone for a while and continues if you stop tibolone (this may be a sign of endometrial thickening)
- Dimpling of the skin on your breasts, changes in your nipples or lumps that you can see or feel.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
The Yellow Card Scheme allows you to report suspected side effects from any type of medicine (which includes vaccines, herbals and over the counter medicines) that you are taking. It is run by the medicines safety watchdog called the Medicines and Healthcare products Regulatory agency (MHRA). Please report any suspected side effect on the Yellow Card Scheme website.
Before taking tibolone, tell your doctor or pharmacist if you are allergic to it; or to other hormone replacement therapies (HRT); or if you have any other allergies.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: ever had an allergic reaction to tibolone, lactose or other sugars or to any other ingredient in the medicine, are taking oestrogen hormone replacement therapy (HRT), a history of breast cancer or are known or suspected to have breast cancer, had any other cancers that are dependent on hormones for growth, had a stroke or mini-stroke (transient ischaemic attack), heart disease, blood circulation disorders including clotting problems, bleeding from the vagina that has not been investigated by a doctor, severe liver disease, the inherited condition porphyria, endometrial hyperplasia (abnormal growth of the lining of the womb), pregnancy, breastfeeding, Lapp lactase deficiency or poor absorption of glucose-galactose.
Before using this medication, tell your doctor or pharmacist your medical history, especially any of the following asthma, kidney disease, liver disease, fitting (epilepsy), gallstones, high blood pressure, migraine headache, diabetes, otosclerosis (a hearing problem), the rare disease systemic lupus erythematosus (SLE), fibroids (growths) in the womb (uterus), endometriosis (tissue that lines the womb grows in other areas outside the womb), high levels of cholesterol in your blood (hypercholesterolaemia), bleeding from the vagina, have relatives who have had blood clots, have close relatives who have had breast cancer or cancer of the lining of the womb, are overweight, have had one or more miscarriage, are not very active because of major surgery, injury or illness.
Before having surgery, tell your doctor or dentist that you are taking this medication.
Does alcohol intake affect this drug?
- Alcohol is not known to affect tibolone.
The elderly: tibolone can be used in the elderly.
Pregnancy and breastfeeding - please ensure you read the detailed information below
Tibolone is not safe to take if you are, or are planning to become, pregnant.
It is sensible to limit use of medication during pregnancy whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.
If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.
Tibolone is not safe to take if you are breastfeeding.
It is sensible to limit use of medication during breastfeeding whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.
If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.
This drug should not be used with the following medications because very serious, possibly fatal interactions may occur:
Before using this medication, tell your doctor or pharmacist of all prescription and non-prescription/herbal products you may use, especially of:
- Drugs that thin the blood such as warfarin
- Herbal remedies that contain St John’s wort
This information does not contain all possible interactions. Therefore, before using tibolone, tell your doctor or pharmacist of all the products you use.
Symptoms of overdose include feeling sick or being sick and vaginal bleeding.
If you think you, or someone you care for, might have accidentally taken more than the recommended dose of tibolone or intentional overdose is suspected, contact your local hospital, GP or if in England call 111. In Scotland call NHS 24. In Wales, call NHS Direct Wales. In the case of medical emergencies, always dial 999.
If you miss a dose, take it as soon as you remember, unless you are more than 12 hours late. If you are more than 12 hours late, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.