Home > Direct healthcare professional communication. Nurofen Plus (codeine/ibuprofen): Serious clinical harms, including renal tubular acidosis and severe hypokalaemia, following prolonged use of codeine/ibuprofen at higher than recommended doses due to codeine dependence.

[Health Products Regulatory Authority] Direct healthcare professional communication. Nurofen Plus (codeine/ibuprofen): Serious clinical harms, including renal tubular acidosis and severe hypokalaemia, following prolonged use of codeine/ibuprofen at higher than recommended doses due to codeine dependence. (24 Oct 2022)

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External website: https://www.hpra.ie/homepage/medicines/safety-noti...


Notice for healthcare professionals.

Reckitt Benckiser Ireland Ltd in agreement with the European Medicines Agency and the Health Products Regulatory Authority (HPRA) would like to inform you of the following:
Summary
• Cases of severe hypokalaemia and renal tubular acidosis have been reported typically following prolonged use of codeine/ibuprofen at higher than recommended doses in patients who have become dependent on the codeine component.
• Renal tubular acidosis should be considered in patients taking Nurofen Plus with unexplained hypokalaemia and metabolic acidosis, symptoms of which include reduced levels of consciousness and generalised weakness.
• Other serious clinical harms including gastrointestinal perforations, gastrointestinal haemorrhages, severe anaemia and renal failure have been reported in association with cases of abuse and dependence for codeine/ ibuprofen combinations, some of which have been fatal.
• Patients should be informed of the risks and signs of addiction/dependence with Nurofen Plus and the potential serious clinical harms as a result.
• Patients should be advised to speak to their doctor or pharmacist if they experience signs of addiction/dependence with Nurofen Plus

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