Pregnancy must be excluded. The administration of Diane-35 is contraindicated during pregnancy and lactation. If pregnancy occurs during medication with Diane-35, the preparation is to be withdrawn immediately. Previous use of Diane-35, however, is not a reason for a termination of pregnancy.
Cyproterone acetate is transferred into the milk of lactating women. Approximately 0.2 % of the maternal dose can be transferred to the breast-fed infant, which corresponds to a dose of approximately 1 μg/kg.
During lactation, approximately 0.02 % of the daily maternal dose of ethinyl estradiol can be absorbed by the neonate via breast milk.