No examples of interactions between Tibolone and other medicines have been reported in clinical practice. However, the following potential interactions should be considered on a theoretical basis: Enzyme-inducing compounds such as barbiturates, carbamazepine, hydantoins, and rifampicin may enhance the metabolism of Tibolone and thus decrease its therapeutic effect. Since Tibolone may increase blood or fibrinolytic activity (lower fibrinogen levels; higher AT III, plasminogen, and fibrinolytic activity values), it may enhance the effect of anticoagulants.
Occasionally, vaginal bleeding or spotting may occur, mainly during the first months of treatment. Other adverse effects are headache and migraine, oedema, dizziness, pruritus, increase in body weight, nausea, abdominal pain, rash, and depression.
Tibolone tablet is contraindicated during pregnancy. If pregnancy occurs during medication with this tablet, treatment should be withdrawn immediately. For this tablet no clinical data on exposed pregnancies are available. Tibolone tablet is contraindicated in lactating women.
In patients with renal dysfunction, history of liver disease, epilepsy, migraine, hypercholesterolemia, impaired carbohydrate metabolism, diabetes mellitus and cholestatic jaundice.
The acute toxicity of Tibolone in animals is very low. Therefore, toxic symptoms are not expected to occur if several tablets are taken simultaneously. In cases of acute overdose - nausea, vomiting, and withdrawal bleeding in females may develop. Symptomatic treatment can be given if necessary.
Drugs for menopausal symptoms: Hormone replacement therapy
Keep in a cool & dry place. Protect from light. Keep out of the reach of children.
