Đăng xuất
Fertility and pregnancy: A decrease in fertility related to the pharmacological effects of the product (effect mediated by prolactin) has been observed in animals treated with sulpiride.
Animal studies do not suggest direct or indirect harmful effects with respect to pregnancy, embryo/foetal development and/or postnatal development.
In humans, there are limited clinical data in pregnant women treated with sulpiride. In most cases of foetal and neonatal disorders reported during treatment with sulpiride during pregnancy, alternative explanations could be suggested which seem more likely.
Therefore, due to limited experience sulpiride is not recommended during pregnancy.
If sulpiride is used during pregnancy, appropriate monitoring of the newborn should be considered to monitor the safety profile of sulpiride.
Newborns who have been exposed to antipsychotic medicines (including sulpiride) during the third trimester of pregnancy may present with extrapyramidal side effects and/or withdrawal symptoms that may vary in severity and duration after birth, and therefore close monitoring is advised. Cases of agitation, hypertonia, hypotonia, tremor, drowsiness, difficulty breathing and eating disorders have been reported.
Breast-feeding: Sulpiride is excreted in human milk. Therefore, breast-feeding is not recommended during treatment with sulpiride.
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