Pregnancy: There are no adequate data on the use of Salofalk in pregnant women. However, data on a limited number of exposed pregnancies indicate no adverse effect of mesalazine on pregnancy or on the health of the fetus/newborn child. To date, no other relevant epidemiological data are available. In one single case after long-term use of high dose mesalazine (2-4g, orally) during pregnancy, renal failure in a neonate was reported.
Animal studies on oral mesalazine do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/fetal development, parturition or postnatal development.
Salofalk should only be used during pregnancy if the potential benefit outweighs the possible risk.
Breastfeeding: N-acetyl-5-aminosalicylic acid and to a lesser degree mesalazine are secreted in breast milk. Only limited experience during lactation in women is available to date. Hypersensitivity reactions such as diarrhoea in infant cannot be excluded. Therefore Salofalk should only be used during breast-feeding if the potential benefit outweighs the possible risk. If the infant develops diarrhoea, the breast-feeding should be discontinued.