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Government consulting on reclassifying Nuromol as General Sales medicine


By Isabel Shaw
Reporter

17 May 2021

The UK medicines regulator is seeking views on whether the painkiller Nuromol Dual Action Pain Relief should be made available without the need to visit a pharmacy.

The public consultation, launched last week (13 May) by the Medicines and Healthcare products Regulatory Agency (MHRA), proposes that 200mg and 500mg tablets of Nuromol be available for purchase without the supervision of a pharmacist.

It comes after the Commission on Human Medicines (CHM) advised that the painkiller can be available as a General Sales medicine.

Nuromol contains both paracetamol and ibuprofen and is currently available in pharmacies as a P medicine.

The consultation document said that one of the key issues to address was ‘how people will be able to choose the product as second line’ – over paracetamol or ibuprofen alone – without the advice of a pharmacist.

Reckitt Benckiser Healthcare – the licence holder for Nuromol – has proposed to add ‘a prominent statement’ on the front of the pack indicating that the product should only be used after trying ibuprofen and paracetamol first, the document said.

‘This proposal was accepted by CHM on the condition that there were additional measures in the Risk Management Plan to manage the risk of people not using the product as second line treatment, including an appropriate study carried out before approval of the reclassification application to demonstrate that the product would be used as second-line treatment for pain relief,’ it added.

The consultation closes on 3 June 2021.

Dr Sarah Branch, director of vigilance and risk management of medicines at the MHRA, said: ‘Every response received will help us gain a better picture of whether people think Nuromol can be made available safely without the need to visit a pharmacy.

‘We want to hear from as many people as possible, and therefore we urge people to respond to our consultation and let us know their views.’


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