Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation

Pregnancy
There are only very limited data available from the use of sulpiride in pregnant women. The safety of sulpiride during human pregnancy has not been established.
Sulpiride crosses the placenta. Studies in animals are insufficient with respect to reproductive toxicity (see section 5.3).
The use of sulpiride is not recommended during pregnancy and in women of child bearing potential not using effective contraception, unless the benefits justify the potential risks.
Neonates exposed to antipsychotics, including Modal and Modal Forte, during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery (see section 4.8). There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.
Breastfeeding
Sulpiride is excreted into breastmilk in rather large amounts, far above the accepted value of 10 % of the maternal weight-adjusted dosage in some cases, but blood concentrations in breastfed infants have not been evaluated. There is insufficient information on the effects of sulpiride in newborns/infants. A decision must be made whether to discontinue breast-feeding or to abstain from sulpiride therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility
A decrease in fertility linked to the pharmacological effects of the drug (prolactin mediated effect) was observed in treated animals.