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Pregnancy: Administration during pregnancy should be avoided unless there are compelling reasons for therapy with Nefecon. There are only few data of pregnancy outcomes after oral administration of budesonide in humans. Although data on the use of inhaled budesonide in a large number of exposed pregnancies indicate no adverse effect, the maximal concentration of budesonide in plasma is expected to be higher in association with treatment with Nefecon compared to inhaled budesonide. In pregnant animals budesonide, like other glucocorticosteroids, has been shown to cause abnormalities of fetal development (see Pharmacology: Toxicology: Preclinical safety data under Actions). The relevance of this to man has not been established.
Therefore, Nefecon should not be used during pregnancy unless the clinical condition of the woman requires treatment with budesonide. The expected benefits for the pregnant woman have to be weighed against the potential risk for the fetus.
Budesonide was found to cross the placental barrier. The relevance of this observation to humans has not been established.
Hypoadrenalism may occur in neonates exposed to glucocorticosteroids in utero; carefully observe neonates for signs and symptoms of hypoadrenalism.
Breast-feeding: Budesonide is excreted in breast milk.
Lactation studies have not been conducted with oral budesonide, including Nefecon, and no information is available on the effects of the medicinal product on the breast-fed infant or the effects of the medicinal product on milk production. A risk to the breast-fed infant cannot be excluded.
If Nefecon is used when a mother is breast-feeding, a decision must be made whether to discontinue breast-feeding or to discontinue/abstain from budesonide therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: There are no data on the effect of budesonide on human fertility. There were no effects on fertility in rats after treatment with budesonide.
