Metamizole sodium

There are insufficient data available on the use of metamizole sodium in pregnant women. Metamizole sodium crosses the placental barrier. In animal studies, metamizole sodium showed no teratogenic effects. Due to lack of adequate experience in humans, during the 1st and 2nd trimester of pregnancy metamizole sodium should only be taken after careful medical assessment of the benefit-risk balance.

Although metamizole sodium is only a weak inhibitor of prostaglandin synthesis, the possibility of premature occlusion of the ductus arteriosus (ductus Botalli) and perinatal complications due to a reduction in platelet aggregation in the mother and child cannot be excluded. Metamizole sodium is thus contraindicated during the last trimester of pregnancy.

The metabolites of metamizole sodium are excreted into the breast milk, and breast-feeding must therefore be avoided during intake/administration and for at least 48 hours after the last intake/administration of metamizole sodium.

Metamizole sodium can have influence on the ability to drive and use machines. In the recommended dose range, no impairment of the ability to concentrate or of responsiveness is known. As a central active component is postulated for metamizole sodium, and overdose can lead to central adverse reactions, the possibility of impairment should be considered, at least at higher doses, and operating machinery, driving vehicles and other hazardous activities should be avoided. This particularly applies in combination with alcohol.