Hypersensitivity to tibolone or to any ingredient in the product.
Known, past or suspected breast cancer. An increased risk of breast cancer recurrence in the patients has been identified in a placebo controlled trial.
Known or suspected estrogen-dependent malignant tumors, e.g., endometrial cancer.
Undiagnosed genital bleeding.
Untreated endometrial hyperplasia.
Previous idiopathic or recurrent venous thromboembolism (deep venous thrombosis, pulmonary embolism)
Any history of arterial thromboembolic disease, e.g., angina, myocardial infarction, stroke, or transient ischemic attack (TIA).
Acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal.
Porphyria.
Pregnancy or breastfeeding.
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