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 tumors (benign or malignant).
Known or suspected sex hormone-dependent malignancies.
Undiagnosed vaginal bleeding.
Hypersensitivity to the active substance or to any of the excipient.
Ocular lesions due to ophthalmic vascular disease, such as partial or complete vision loss or defect in visual.
Presence or history of migraine with focal aura.
Breastfeeding or pregnancy.
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