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Pregnancy: There are no adequate data on the use of fenofibrate during pregnancy. Animal studies have not demonstrated any teratogenic effects. Embryotoxic effects were observed at doses in the range of maternal toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown. Therefore, LIPANTHYL PENTA 145 should only be used during pregnancy after a careful benefit/risk assessment.
Lactation: It is unknown whether fenofibrate and/or its metabolites are excreted in human milk. A risk to the suckling child cannot be excluded. Consequently, LIPANTHYL PENTA 145 should not be used during breast-feeding.
Fertility: Reversible effects on fertility have been observed in animal studies (see Pharmacology: Toxicology: Preclinical safety data under Actions).
There are no clinical data on fertility from the use of LIPANTHYL PENTA 145.
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