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Pregnancy: The administration of dienogest during pregnancy is contraindicated. If pregnancy occurs during treatment with dienogest, further intake must be stopped (see Contraindications).
The data from a limited number of cases of exposure during pregnancy demonstrate that dienogest does not show adverse effects on pregnancy or on the health of the fetus/newborn. No significant epidemiological data have been obtained to date. Animal studies reveal no special risks on pregnancy, embryonic/fetal development, birth, or development after birth for humans.
Dienogest must not be administered to pregnant women because there is no need to treat endometriosis during pregnancy.
Lactation: It is not known if dienogest is excreted in human milk. However, data have shown that dienogest is excreted into milk in rats. Dienogest is contraindicated during breastfeeding (see Contraindications).
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