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As there are no adequate and well-controlled studies in pregnant women, this drug should be used only if clearly needed. The use of this drug in late pregnancy is not recommended because of the effects on the foetal cardiovascular system.
Since safety of the use of this preparation in pregnancy, during lactation, or in the childbearing age has not been established, use of the drug in such patients requires that the potential benefits of the drug be weighed against its possible hazard to the mother and child.
