Dienogest should not be used in the presence of any of the conditions listed as follows, which are partially derived from information on other progesterone-only preparations. Should any of the conditions appear during the use of dienogest, treatment must be discontinued immediately: active venous thromboembolic disorder; arterial and cardiovascular disease, past or present (e.g., myocardial infarction, cerebrovascular accident, ischemic heart disease); diabetes mellitus with vascular involvement; presence or history of severe hepatic disease as long as liver function values have not returned to normal; presence or history of liver tumours (benign or malignant); known or suspected sex hormone-dependent malignancies; undiagnosed vaginal bleeding; hypersensitivity to the active substance or to any of the excipients listed.