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There are no adequate data from the use of pinaverium bromide in pregnant women. Animal studies are insufficient with respect to effects on pregnancy or embryonal/foetal development or parturition or postnatal development. The potential risk for humans is unknown. Dicetel should not be used during pregnancy unless clearly necessary.
Furthermore, the presence of bromine should be taken into account. Administration of pinaverium bromide at the end of the pregnancy can affect the new-born neurologically (hypotony, sedation).
There is insufficient information on the excretion of Dicetel in human or animal breast milk. Physico-chemical and available pharmacodynamic/toxicological data on Dicetel point to excretions in breast milk and a risk to the suckling child cannot be excluded. Dicetel should not be used during breast-feeding.
