PENTASA should be used with caution during pregnancy and lactation and only if the potential benefits outweigh the possible hazards in the opinion of the physician. The underlying condition itself (Inflammatory bowel disease/IBD) may increase risks for the pregnancy outcome.
Pregnancy: Mesalazine is known to cross the placental barrier and its concentration in umbilical cord plasma is lower than the concentration in maternal plasma. The metabolite acetyl-mesalazine is found at similar concentrations in umbilical cord and maternal plasma. There are no adequate and well controlled studies of PENTASA use in pregnant women. Limited published human data on mesalazine show no increase in the overall rate of congenital malformations. Some data show an increased rate of preterm birth, stillbirth, and low birth weight; however, these adverse pregnancy outcomes are also associated with active inflammatory bowel disease.
Blood disorders (pancytopenia, leucopenia, thrombocytopenia, anaemia) have been reported in newborns of mothers being treated with PENTASA.
SR tab, PR tab, PR granules: Animal studies on oral mesalazine do not indicate direct or indirect harmful effects with respect to pregnancy, embryo-foetal development, parturition or postnatal development.
In one single case after long-term use of a high dose of mesalazine (2 - 4 g, orally) during pregnancy, renal failure in a neonate was reported.
Breastfeeding: Mesalazine is excreted in breast milk. The mesalazine concentration in breast milk is lower than in maternal blood, whereas the metabolite acetyl-mesalazine appears in similar or increased concentrations. No controlled studies with PENTASA during breast-feeding have been carried out. Hypersensitivity reactions like diarrhoea in the infant cannot be excluded. If the infant develops diarrhoea, breast-feeding should be discontinued.
SR tab, PR tab, PR granules: There is limited experience of the use of oral mesalazine in lactating women.
Fertility: Animal data on mesalazine show no effect on male and female fertility.