Tibolone tablets

About tibolone

Tibolone works by mimicking the activity of the female sex hormones, oestrogen and progesterone. It also has some male hormone (androgen) effects. Tibolone helps to restore the balance of female hormones in women who have a lack of oestrogen; it helps to ease symptoms such as hot flushes and night sweats. You will only be prescribed it if these symptoms seriously interfere with your daily life.

Tibolone is also prescribed to help prevent 'thinning' of the bones (osteoporosis). It is only suitable for women who have been through the menopause, and providing there have been at least 12 months since the last natural period. It is prescribed when other, more preferred, treatments are not suitable.

Before taking tibolone

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking tibolone it is important that your doctor or pharmacist knows:

• If you (or a close family member) have had breast cancer.

• If you have had a cancer that you have been told is hormone-dependent.

• If you have any unexplained vaginal bleeding.

• If you have liver disease, or if you have any problems with the way your kidneys work.

• If you know you have high levels of fat (triglycerides or cholesterol) in your blood.

• If you have ever had a blood clot in your leg or lungs, or if you have had inflammation of a vein (thrombophlebitis).

• If you have angina, or if you have had a heart attack or stroke.

• If there is a possibility you might be pregnant.

• If you have diabetes mellitus.

• If you have migraines, or migraine-like headaches.

• If you have epilepsy.

• If you have gallstones.

• If you have a rare inherited blood condition, called porphyria.

• If you are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.

• If you have ever had an allergic reaction to a medicine.

How to take tibolone

• Before you start taking the tablets, read the manufacturer's printed information leaflet from inside your pack. The manufacturer's leaflet will give you more information about tibolone and a full list of the side-effects which you may experience from taking it.

• Take one 2.5 mg tablet every day. You may take tibolone at whatever time of day you find easiest to remember, but try to take your doses at the same time of day, each day. You can take the tablets before or after meals. You may find it helps to swallow the tablet with a drink of water.

• If you forget to take 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, leave out the forgotten dose and take your next tablet at the usual time. Do not take two tablets together to make up for a missed dose.

Getting the most from your treatment

• Studies have shown that tibolone is associated with a small increased risk of both stroke and endometrial cancer. It may also be associated with an increased risk of breast cancer. Before you take tibolone, your doctor will discuss with you the benefits of the treatment versus its risks. Your doctor will then continue to consider the benefits and risks as you carry on taking the tablets. This is to make sure that the treatment remains suitable for you.

• Although tibolone is usually suited to short-term use, you will be invited for regular check-ups during treatment. Remember to keep these appointments so that your doctor can check on your progress.

• It is also important that you go for any regular breast screening and cervical smear tests. Check your breasts regularly for any skin changes, dimpling and lumps. If you notice any changes, speak with your doctor as soon as possible.

• If you are due to have an operation, tell the person carrying out the treatment that you are taking tibolone. Your treatment may need to be stopped for a while, especially if you are not expected to be fully mobile for a time. This is to reduce the risk of a blood clot.

• If you are taking tibolone to prevent 'thinning' of the bones (osteoporosis), there are a number of lifestyle measures that will also help slow down bone loss. Exercise stimulates bone-making cells, which strengthens your bones, so try to take some regular weight-bearing exercise (such as brisk walking, aerobics, dancing, or running). If you smoke, you should try to stop. Also, you should try to cut down on your alcohol intake if you drink more than two units of alcohol daily.

Can tibolone cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with tibolone. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.

If you experience any other symptoms which you think may be due to the medicine, speak with your doctor or pharmacist.

How to store tibolone

• Keep all medicines out of the sight and reach of children.

• Store in a cool, dry place, away from direct heat and light.

Important information about all medicines