Pregnancy: There are no adequate data from 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 foetus/newborn child. To date no other relevant epidemiologic data are available. In one single case after long-term use of a high dose mesalazine (2-4 g, 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, embryonal/foetal 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 excreted in breast milk. Only limited experience during lactation in women is available to date. Hypersensitivity reactions, like diarrhoea in the infant, can not be excluded.
Therefore, Salofalk should only be used during breastfeeding if the potential benefit outweighs the possible risk. If the suckling neonate develops diarrhoea, the breastfeeding should be discontinued.