Pregnancy & Lactation : הריון/הנקה

4.6       Fertility, pregnancy and lactation

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 section 5.3).

Visabelle must not be administered to pregnant women because there is no need to treat endometriosis during pregnancy.

Lactation

Treatment with Visabelle 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 Visabelle 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 Visabelle. However, Visabelle is not a contraceptive.

If contraception is required a non-hormonal method should be used (See section 4.2).

Based on available data, the menstrual cycle returns to normal within 2 months after cessation of treatment with Visabelle.