BMA Concise Guide to Medicine & Drugs

Tibolone

Brand name Livial

Used in the following combined preparations None

QUICK REFERENCE

Drug group Hormone replacement therapy

Overdose danger rating Low

Dependence rating Low

Prescription needed Yes

Available as generic No

GENERAL INFORMATION

Tibolone is a female sex hormone used to treat menopausal symptoms, such as sweating, depressed mood, and decreased sex drive, and is particularly effective in controlling hot flushes. It is usually only advised for short-term use.

The drug is taken continuously, and, since it has both oestrogenic and progestogenic activity (unlike most other available types of HRT), the treatment does not require a cyclical course of progestogen to be taken as well.

Side effects are rare, and tibolone does not cause withdrawal bleeding in postmenopausal women. The drug is sometimes used in the treatment of osteoporosis when other drugs are inappropriate or ineffective.

INFORMATION FOR USERS

Your drug prescription is tailored for you. Do not alter dosage without checking with your doctor.

How taken/used Tablets.

Frequency and timing of doses Daily, preferably at the same time each day. Swallow the tablets whole – do not chew.

Adult dosage range 2.5mg daily.

Onset of effect You may notice improvement of symptoms within a few weeks but the best results are obtained when the drug is taken for at least 3 months.

Duration of action A few days.

Diet advice None.

Storage Keep in original container at room temperature out of the reach of children. Protect from light.

Missed dose Take as soon as you remember.

Stopping the drug Do not stop the drug without consulting your doctor; symptoms may recur.

Exceeding the dose An occasional unintentional extra dose is unlikely to be a cause for concern. If several tablets are taken together, they may cause a stomach upset. Notify your doctor.

POSSIBLE ADVERSE EFFECTS

Tibolone is well tolerated and the incidence of adverse effects is low. Vaginal bleeding is more likely if it is less than one year since the menopause. For this reason, the drug is not recommended if less than 12 months have passed since your last period. If you do experience vaginal bleeding or discharge with tibolone, consult your doctor. Other side effects include weight gain, ankle swelling, dizziness, stomach upset, facial hair growth, and acne. Discuss with your doctor if these are severe or if you have headaches or visual problems. If jaundice occurs, you should stop taking the drug and consult your doctor promptly.

INTERACTIONS

Some anticonvulsants Phenytoin, phenobarbital, primidone, and carbamazepine can accelerate the metabolism of tibolone and so decrease blood levels of the drug and its effectiveness.

Rifampicin This can accelerate the metabolism of tibolone and so decrease blood levels of the drug and its effectiveness.

Warfarin Tibolone may increase the anticoagulant effect of warfarin.

SPECIAL PRECAUTIONS

Be sure to tell your doctor if:

· You have long-term liver or kidney problems.

· You suffer from porphyria.

· You have diabetes.

· You have had breast cancer.

· You have a history of heart attacks or stroke.

· You have a high cholesterol level.

· You have had previous venous thrombosis.

· You have vaginal bleeding.

· You have had a period in the last 12 months.

· You are taking other medicines.

Pregnancy Not prescribed.

Breast-feeding Not prescribed.

Infants and children Not prescribed.

Over 60 No special problems.

Driving and hazardous work No problems expected.

Alcohol No known problems.

PROLONGED USE

Tibolone is only advised for short-term use around the menopause because it carries an increased risk of breast cancer, venous thrombosis, heart attack, and stroke. Tibolone carries a smaller risk of these than other forms of HRT, but it is still only recommended for short-term use.

Monitoring Periodic examination by your doctor is advised.