Sermion Use In Pregnancy & Lactation

Pregnancy: Nicergoline did not cause reproductive toxicity in pregnant rats and rabbits. Studies have not been conducted in pregnant women. Given the approved indications, the use of nicergoline in pregnant and lactating women is unlikely. Nicergoline should only be used during pregnancy if the potential benefit to the patient justifies the potential risk to the fetus.
30 mg film-coated tablet: Although nicergoline has shown no teratogenic activity in toxicological studies, it is recommended to use the drug in pregnancy only if strictly necessary.
Lactation: It is not known if nicergoline is excreted in breast milk in humans. Therefore, the use of nicergoline is not recommended during breastfeeding.
Fertility: Nicergoline did not affect fertility in a study in male rats. However, nicergoline decreased fertility in female rats administered 50 mg/kg/day (8 times the maximum recommended human dose of 60 mg/day on a mg/m² basis) (see Pharmacology: Toxicology: Preclinical safety data under Actions).
The clinical implications of the animal findings (at supratherapeutic doses) in human patients are not known.