Dienille Use In Pregnancy & Lactation

Dienille is not indicated during pregnancy.
If pregnancy occurs during medication with oral contraceptives, the preparation should be withdrawn immediately. Based on extensive epidemiological studies descendants of women taking combined oral contraceptives before their pregnancy are not threatened by higher risk for congenital malformations, nor exert combined oral contraceptives teratogenic effects on the offspring when taken in the early phase of pregnancy before pregnancy is realized. Such studies have not been carried out with Dienille.
Since there are only limited data about the use of Dienille during pregnancy, its negative effect on pregnancy or on the fetus and on the newborn cannot be established, no epidemiological data are available about this.
Animal studies have revealed reproduction toxicity during pregnancy and lactation (see Pharmacology: Toxicology: Preclinical safety data under Actions). Effects on humans are unknown. Based on the available studies taking combined oral contraceptives during pregnancy does not hint at teratogenic effects.
The use of combined oral contraceptives during lactation may lead to a reduction in the volume of milk produced and to a change in its composition. Minute amounts of the active substances and /or excipients are excreted with the milk, possibly affecting the newborn. Mothers who are breast-feeding are advised not to take Dienille.