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Pregnancy: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of itopride in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of itopride during pregnancy.
Lactation: Itopride is excreted in breast milk of animals, but there is insufficient information on the excretion of itopride in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from itopride therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
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