Salofalk Use In Pregnancy & Lactation

Pregnancy: Tablet: There are no adequate data on the use of Salofalk 500 mg enteric coated tablets 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. Salofalk 500 mg Enteric-coated tablet should only be used during pregnancy on medical advise since only the doctor can undertake the necessary assessment of likely benefits versus the potential risks.
Granules: There are no adequate data on the use of mesalazine 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 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, embryonic/foetal development, parturition or postnatal development.
Salofalk granules should only be used during pregnancy if the potential benefit outweighs the possible risk.
Breast-feeding: Tablet: Only limited experience is available on the use of mesalazine-containing drugs during breast-feeding. The active substance is excreted in small amount into breast milk. Therefore, hypersensitivity reactions in the infant cannot be ruled out. To date, these have merely consisted of single cases of diarrhea. If the baby develops diarrhea during the use of Salofalk while breast-feeding, breast-feeding should be discontinued.
The patient should only use Salofalk 500 mg enteric coated tablets during breast-feeding, if the doctor tells the patient to since only the doctor can undertake the necessary assessment of likely benefits versus the potential risks.
Granules: 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, cannot be excluded. Therefore, Salofalk granules should only be used during breastfeeding if the potential benefit outweighs the possible risk. If the infant develops diarrhoea, the breastfeeding should be discontinued.