Pregnancy: There is limited data from the use of dienogest in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Dienogest must not be administered to pregnant women because there is no need to treat endometriosis during pregnancy.
Lactation: Treatment with dienogest during lactation is not recommended. It is unknown whether dienogest is excreted in human milk. Data in animals have shown excretion of dienogest in rat milk. A decision must be made whether to discontinue breast-feeding or to abstain from dienogest therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: Based on the available data, ovulation is inhibited in the majority of patients during treatment with dienogest. However, dienogest is not a contraceptive. If contraception is required, a non-hormonal method should be used (see Precautions).
Based on available data, the menstrual cycle returns to normal within 2 months after cessation of treatment with dienogest.
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