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Women of child bearing potential and pregnancy: There are no or limited amount of data from the use of dronedarone in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). MULTAQ is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: It is unknown whether dronedarone and its metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of dronedarone and its metabolites in milk. A risk to the newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from MULTAQ therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: Dronedarone was not shown to alter fertility in animal studies.
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