New rules for medicines with codeine


From 1 February 2018, low-dose codeine (≤ 15 mga) will no longer be available over the counter (OTC).

The affected products include low-dose codeine in combination with paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief, and some preparations for the management of cold and flu symptoms.

The decision to up-schedule all codeine products was made by the Therapeutic Goods Administration (TGA). An extensive risk–benefit analysis and consultation concluded that OTC medicines containing codeine have little additional analgesic benefit compared with similar medicines without codeine, but are associated with higher health risks.

The change represents an opportunity for GPs and pharmacists to help people who have been using OTC codeine find alternative treatments that are effective and have a more favourable safety profile for each individual.

For more information download the TGA factsheet.

For factsheets in community languages visit the NPS Medicinewise website at

Health professional who require further information can visit the TGA codeine information hub.

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