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Because safety in the use during pregnancy has not been established, EPADEL S900 should only be administered when therapeutic benefit is judged to outweigh the risk in women who are or may be pregnant.
It is desirable not to administer EPADEL S900 in lactating women. When it is administered for compelling reasons, breastfeeding should be avoided. (Excretion into breast milk has been reported in animal studies [rats].)
