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Pregnancy: There is no or limited data available (less than 300 pregnancy outcomes) on the use of sulbutiamine in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). As a precautionary measure, it is preferable to avoid the use of ARCALION during pregnancy.
Breastfeeding: It is unknown whether sulbutiamine/metabolites are excreted in human milk.
A risk to the newborns/infants cannot be excluded.
ARCALION should not be used during breast-feeding.
Fertility: There is no available data regarding the effects of sulbutiamine on fertility.
