Tibolone

Tibolone is a type of hormone replacement therapy (HRT) that contains a synthetic (artificial) hormone. Your body breaks down tibolone to make substances that work in a similar way to the hormones oestrogen, progesterone and testosterone.

Tibolone helps to improve menopause symptoms, such as hot flushes, low mood and vaginal dryness or irritation.

Menopause is when your periods stop due to lower hormone levels. It usually affects women between the ages of 45 and 55, but it can happen earlier. It affects anyone who has periods.

Your hormone levels also fall if you have surgery to remove your ovaries, or if you take medicines called gonadorelin analogues, such as leuprorelin for endometriosis.

Tibolone helps restore your hormone levels.

It can also be prescribed to help stop your bones getting thinner after the menopause (osteoporosis).

Tibolone works in a similar way to taking combined HRT containing oestrogen and progestogen. Some studies have suggested it may not be as effective as combined HRT as it may not increase your oestrogen levels as much.

It's only suitable if you had your last period more than a year ago (post-menopause). However, if you've had surgery to remove your ovaries or you're taking gonadorelin analogues you can start taking it straight away.

Tibolone is only available on prescription. It comes as tablets.

You can usually take tibolone if you:

• have menopause symptoms and had your last period more than 1 year ago
• had your last period more than 1 year ago and are at high risk of fractures, and cannot take other medicines for preventing osteoporosis
• have had menopause caused by surgery to remove your ovaries
• are taking medicines called gonadorelin analogues for endometriosis

Tibolone is not suitable for everyone. To make sure it's safe for you, tell your doctor if you:

• have ever had an allergic reaction to tibolone or any other medicine
• have ever had breast cancer, are having tests for breast cancer, or are considered high risk due to family history
• have a type of cancer that is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you're having tests for this
• have any unexplained vaginal bleeding
• have too much thickening of the womb lining (endometrial hyperplasia) that is not being treated
• have ever had a blood clot in a vein (thrombosis), such as in your legs (deep vein thrombosis) or your lungs (pulmonary embolism)
• have a condition that affects how your blood clots, such as protein C, protein S, or antithrombin deficiency
• have or recently had a condition caused by blood clots in the arteries, such as a heart attack, stroke or angina
• have ever had liver disease and your liver function tests are not back to normal
• have a rare inherited condition called porphyria
• have a rare inherited problem of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
• are pregnant or breastfeeding

The usual dose of tibolone is one 2.5mg tablet, taken once a day.

Swallow your tablet whole with a drink of water. Do not chew or crush it.

It's best to take it at the same time each day.

You can take it before or after food.

How long you take tibolone for depends on your symptoms. It's common to take it for 2 to 5 years to treat menopause symptoms, but sometimes you may need to take it for longer.

How long you take HRT for depends on the benefits and risks to you. Ask your doctor for advice.

If you forget to take your tibolone, take it as soon as you remember, unless it's more than 12 hours since your dose was due. In this case, skip the missed dose and take your next dose at the usual time.

Do not take 2 doses to make up for a missed dose.

Missing your dose can sometimes cause vaginal bleeding or spotting.

If you often forget doses, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicines.

Taking an extra dose of tibolone is unlikely to harm you. If you're worried, talk to a doctor or pharmacist for advice.

Talk to your doctor if you're thinking of stopping taking tibolone. They may suggest that you reduce your dose gradually, to help prevent your menopause symptoms coming back.

If you're having problems with side effects, your doctor might suggest changing your dose, or switching to another type of HRT.

These common side effects of tibolone happen in more than 1 in 100 people. There are things you can do to help cope with them:

This usually improves after 4 to 6 weeks as your body gets used to the medicine.

Speak to a doctor if it lasts longer than this or is very painful. You may need to switch to a different type of HRT.

If you notice a lump or changes in your breasts after a few months of taking tibolone, contact your doctor for advice.

Try to rest and relax. It can help to eat and drink slowly and have smaller and more frequent meals. Putting a heat pad or covered hot water bottle on your stomach may also help.

If you're in a lot of pain, speak to your pharmacist or doctor.

If this bothers you, talk to your doctor about whether another type of HRT might be more suitable.

A pharmacist can also advise on products to remove unwanted hair.

Do not use perfumed soaps or washes around your vagina.

If you have thrush, ask a pharmacist to recommend a medicine, or speak to your doctor.

These symptoms should get better after a month or two. Speak to your doctor if they do not improve or they get worse, as you may need to change to a different type of HRT.

Tibolone can sometimes cause weight gain. However it's also common to put on weight around the time of the menopause and as you get older, so it might not be your medicine that's causing it.

Eating a healthy, balanced diet and regular exercise will help you keep to a healthy weight.

Speak to a pharmacist or doctor if the advice on how to cope does not help and a side effect is still bothering you or does not go away.

Call a doctor or call 111 straight away if any of these rare but serious side effects happen to you:

• the whites of your eyes turn yellow, or your skin turns yellow, although this may be less obvious on brown or black skin – this could be a sign of liver problems
• you suddenly have a migraine-type headache or severe headache
• you get pain, redness or swelling in one of your legs, usually in your calf – this could be a sign of a blood clot or deep vein thrombosis (DVT)

Speak to a GP if:

• you have a lump or changes in your breasts, especially dimpling of the skin, changes in the nipple or any lumps you can see or feel – this could be a sign of breast cancer
• you get continued vaginal bleeding or any changes in vaginal bleeding after you've been taking tibolone for more than 6 months – this could be a sign of womb cancer

It's important to attend your breast screening (mammogram) appointments while you're taking HRT.

• you have pain in your chest and breathlessness – this could be a sign of a blood clot in your lungs (pulmonary embolism) or heart problems
• you have difficulty speaking or moving your arm or leg, or your face has dropped on one side – this could be a sign of a stroke

Do not drive to A&E. Ask someone to drive you or call 999 and ask for an ambulance.

Bring all the medicines you take with you.

In rare cases, it's possible to have a serious allergic reaction (anaphylaxis) to tibolone.

Call 999 now if:

• your lips, mouth, throat or tongue suddenly become swollen
• you're breathing very fast or struggling to breathe (you may become very wheezy or feel like you're choking or gasping for air)
• your throat feels tight or you're struggling to swallow
• your skin, tongue or lips turn blue, grey or pale (if you have black or brown skin, this may be easier to see on the palms of your hands or soles of your feet)
• you suddenly become very confused, drowsy or dizzy
• someone faints and cannot be woken up
• a child is limp, floppy or not responding like they normally do (their head may fall to the side, backwards or forwards, or they may find it difficult to lift their head or focus on your face)

You or the person who's unwell may also have a rash that's swollen, raised, itchy, blistered or peeling.

These can be signs of a serious allergic reaction and may need immediate treatment in hospital.

These are not all the side effects of tibolone. For a full list see the leaflet inside your medicines packet.

Tibolone should not be taken during pregnancy.

If you're pregnant, then your levels of oestrogen and progesterone will be high and you will not need to take tibolone.

Although it is not thought that tibolone will harm your baby, there is very little information available on the safety of this medicine in pregnancy.

If you get pregnant while taking tibolone, stop taking the medicine and speak to your doctor or midwife.

Tibolone should not be taken while breastfeeding.

There is no information about whether taking tibolone while breastfeeding can affect your baby or how much milk you produce. Until we know more, it's best not to take it.

If you do need a medicine, talk to your doctor. They may be able to recommend other medicines to manage your symptoms that are more suitable to take while breastfeeding.

Tibolone does not act as contraception.

Even if you think that you have gone through the menopause, there's a small chance that you could still get pregnant.

If you're under 50 years old, you're advised to use contraception for at least 2 years after your last period. If you're over 50 years old, you're advised to use contraception for at least 1 year. Discuss this with your doctor or family planning practitioner.

Tell your doctor if you're:

• trying to get pregnant
• pregnant
• breastfeeding

There are some medicines that may affect how tibolone works.

Tell your doctor or pharmacist if you're taking any of these medicines before you start taking tibolone:

• medicines that help to prevent blood clots, such as warfarin
• medicines for epilepsy, such as phenytoin or carbamazepine
• medicines for tuberculosis, such as rifampicin

There are several different herbal products sold to help relieve menopause symptoms. These include evening primrose oil, soya, red clover, black cohosh, ginseng and St John's wort.

St John's wort may stop tibolone from working as well.

It's not possible to say that other herbal remedies and supplements are safe to take with tibolone. They are not tested in the same way as pharmacy or prescription medicines. They're generally not tested for the effect they can have on other medicines.

All of these products might affect other medicines you're taking, so it's important to check with your doctor or pharmacist before starting to take them.

Tell your doctor or pharmacist if you're taking any other medicines, including herbal remedies, vitamins or supplements.