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The recommendations were originally made by the EMA's Pharmacovigilance Risk Assessment Committee PRAC at its meeting of March, after a careful evaluation of the available evidence on the benefits and risks of such medicines. Domperidone-containing medicines have been authorised nationally in individual Member States of the EU for the treatment of nausea and vomiting of various causes but also for the management of symptoms such as bloating, discomfort and heartburn. The CMDh confirmed by majority the PRAC recommendation that domperidone-containing medicines should remain available and may continue to be used in the EU for the management of the symptoms of nausea and vomiting, but that the recommended dose should be reduced to 10 mg up to three times daily by mouth for adults and adolescents weighing 35 kg or more. These patients may also be given the medicine as suppositories of 30 mg twice daily. Products licensed in children and adolescents weighing less than 35 kg should be given by mouth at a dose of 0. The medicine should not normally be used for longer than one week.
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