Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation

Pregnancy
No systematically gained experience on administration of sulthiame in humans during pregnancy is available. In experimental animal studies, embryotoxic effects have been revealed (see also section 5.3). In general, an increased risk of malformations has been observed after administration of antiepileptic drugs, which can be increased by the simultaneous administration of different antiepileptic drugs. Therefore, the administration of Ospolot® during pregnancy and in women of childbearing age, who do not use contraception, is not recommended.
In case of pregnancy, the lowest seizure-controlling dose of Ospolot should be given, as far as possible in monotherapy. Prenatal diagnostic measures for the early detection of damage (high- resolution ultrasound and alpha-fetoprotein determination) are recommended. In no case treatment with antiepileptic drugs should be discontinued without medical advice, as uncontrolled seizures can have serious consequences for both the mother and the unborn child.

Lactation
It is not known if sulthiame passes into breast milk. Since a risk for the newborn cannot be excluded, sulthiame should not be used during lactation