The European Medicines Agency (EMA) has recommended uniformly setting the maximum single dose of oral metamizole medicines at 1,000 mg for patients aged 15 years and older, with a maximum daily dose of 4,000 mg. The EMA also recommends that the maximum daily dose of injectable metamizole should be set at 5,000 mg.
The recommendations follow a review carried out by the EMA’s Committee for Medicinal Products for Human Use (CHMP) at the request of the Polish medicines regulatory authority which was concerned about the substantial differences in the recommendations on the use of metamizole in different EU countries, given the risks of serious side effects.
The EMA has also recommended harmonising guidance on contraindications to use during pregnancy and breastfeeding. The review found little to suggest problems in early pregnancy, and single doses in the first six months might be acceptable if other analgesics cannot be used. However, there was some evidence of effects on the kidneys and circulation of the foetus if the medicine is used in the last trimester, and the medicine should therefore not be used in this period. As a precaution, it is also recommended that metamizole should not be used during breastfeeding.