Nuromol dual action pain relief tablets, which contain 200mg ibuprofen and 500mg paracetamol in each tablet, should not be moved to the general sales list (GSL), the Royal Pharmaceutical Society (RPS) has said.
The medicine, manufactured by Reckitt, is used for the temporary relief of mild-to-moderate pain that has not been relieved by either ibuprofen or paracetamol when used individually.
Responding to a public consultation by the Medicines and Healthcare products Regulatory Agency (MHRA) — which asked for views on the reclassification if the medicine from Pharmacy (P) status to GSL — the RPS said it had “concerns about the safety” of such a move.
In its response, the RPS said: “We are concerned about the potential for people to confuse the product with paracetamol alone and take the standard paracetamol dose of two tablets four times a day.”
The Society added that such confusion could cause patient harm – an issue that had not been considered in the MHRA consultation.
The patient information leaflet for Nuromol instructs the user to take one tablet with water and food, up to three times a day.
Noting that patients should try individual ibuprofen or paracetamol first, before trying Nuromol, the RPS said: “We believe that people should consult a healthcare professional when initial GSL products have failed; this should be part of identifying any concerns and red flags.”
As a result, placing Nuromol on the GSL should not form part of the care pathway, the response document concluded.
The consultation, which ran from 13 May until 3 June 2021, was undertaken after the Commission on Human Medicines advised that Nuromol could be available as a medicine subject to general sale.
The MHRA is now analysing the consultation responses.