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Pregnancy: For esomeprazole, clinical data on exposed pregnancies are insufficient. With the racemic mixture, omeprazole, data on a larger number of exposed pregnancies from epidemiological studies indicate no malformative nor foetotoxic effect. Animal studies with esomeprazole do not indicate direct or indirect harmful effects with respect to embryonal/fetal development. Animal studies with the racemic mixture do not indicate direct or indirect harmful effects with respect to pregnancy, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.
Breastfeeding: It is not known whether esomeprazole is excreted in human breast milk. No studies in lactating women have been performed. Therefore Emanera should not be used during breast-feeding.
