Salofalk Use In Pregnancy & Lactation

Pregnancy: Tablet/Enema: There are no adequate data from the use of Salofalk 500mg tablets/enemas 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/fetal development, parturition or postnatal development. Salofalk 500mg tablets/enemas should only be used during pregnancy if the potential benefit outweighs the possible risk.
Breastfeeding: Tablet/Enema: 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 such as diarrhoea in the infant, cannot be excluded. Therefore, Salofalk 500mg/enemas 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.