EU rules on formulations containing sodium

George and colleagues call for medicines regulatory agencies to deal with the sodium content of drugs and suggest that drugs should be labelled with their sodium content in the same way that food is.1 They note, incorrectly, that drug manufacturers are not required to label formulations containing sodium with their sodium content.

Since 2001 in the EU, manufacturers have been legally required to list all excipients on the packaging and package leaflet of parenteral, ophthalmic, and topical (including inhaled, nasal, rectal) drugs.2 3 For all other drugs, excipients with a recognised action must be listed, if this information is essential for safe and effective use. For oral drugs, the sodium content must be stated if the product contains 1 mmol or more per dose.4 The requirement applies to prescription and over-the-counter drugs.

The NHS funded UK Medicines Information (UKMI) service has produced a document for healthcare professionals that lists the sodium content of selected drugs, including those containing 1 mmol sodium or more per dose. It is updated every two years and is freely available (www.evidence.nhs.uk). UKMI pharmacists realise that it can be difficult for prescribers and community pharmacists to access information on sodium content at the time of prescribing or supply, and the document was created to help them choose the preparation with the lowest sodium content from a selection of similar products. The document includes effervescent, dispersible, and soluble analgesics; preparations to treat indigestion, colds, flu, diarrhoea, and constipation; and other miscellaneous soluble preparations.