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Pregnancy: There are no adequate and well-controlled trials of Monofer in pregnant women. A careful risk/benefit evaluation is therefore required before use during pregnancy and Monofer should not be used during pregnancy unless clearly necessary.
Iron deficiency anaemia occurring in the first trimester of pregnancy can in many cases be treated with oral iron. Treatment with Monofer should be confined to second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the foetus.
Breast-feeding: A clinical study showed that transfer of iron from Monofer to human milk was very low. At therapeutic doses of Monofer no effects on the breastfeed newborns/infants are anticipated.
Fertility: There are no data on the effect of Monofer on human fertility. Fertility was unaffected following Monofer treatment in animal studies (see Pharmacology: Toxicology: Preclinical safety data under Actions).
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