No specific studies in pregnant or lactating women have been conducted, and therefore Otinova® should be used with caution. To be absolutely certain you should avoid using Otinova® during pregnancy and when breast-feeding. Burow’s solution however, which Otinova® contains, has been used for a long time and is described in the pharmacopoeia. The use, effectiveness and safety of Burow’s solution is documented in several clinical studies. We know of no reports describing adverse effects in pregnant or lactating women. The probability that Otinova® could affect foetal development or pass into breast milk is considered very small.