New codeine advice and warnings to minimise addiction risk

The MHRA announced new warnings and guidance about over-the-counter (OTC) medicines containing codeine and dihydrocodeine on 3 September, aimed at minimising the risk of addiction and overuse.

The changes are:

  • Indications relating to colds, flu, coughs and sore throats, and minor painful conditions, will be removed.
  • The remaining indications will be for the short-term treatment of acute, moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.
  • Patient Information Leaflets (PILs) and labels will state that the products are only for short-term use – up to three days – for the treatment of moderate, acute pain and that they can cause addiction or overuse headache if used continuously for more than this. On the front of the pack, a prominent warning will be displayed: “Can cause addiction. For three days use only”.
  • PILs will also contain information about the warning signs of addiction.
  • All packs containing codeine or dihydrocodeine OTC medicines, including effervescent formulations, with more than 32 will no longer be available as P products.
  • The advertising and promotion code of practice will be updated to reflect these indications and warnings and to remove all reference to painkilling power and strength.