December 2, 2022

Double-acting ibuprofen and paracetamol tablets should not be released for general sale, RPS says


Nuromol dual-acting painkiller tablets, which contain 200 mg of ibuprofen and 500 mg of paracetamol in each tablet, should not be moved to the general sales list (GSL), the Royal Pharmaceutical Society (RPS) said.

The drug, manufactured by Reckitt, is used for the temporary relief of mild to moderate pain that was not relieved by ibuprofen or paracetamol when used individually.

Respond to a public consultation by the Medicines and Health Products Regulatory Agency (MHRA) – which sought advice on the drug’s reclassification from pharmacy (P) status to GSL – the RPS said it had “concerns about the security “of such a movement.

In its response, the RPS said, “We are concerned that people may mistake the product for paracetamol alone and take the standard paracetamol dose of two tablets four times a day.”

The Company added that such confusion could cause harm to patients – an issue that was not addressed during the MHRA consultation.

The Patient Information Leaflet for Nuromol instructs the user to take one tablet with food and water, up to three times a day.

Noting that patients should try individual ibuprofen or paracetamol first before trying Nuromol, the RPS said, “We believe people should consult a healthcare practitioner when initial GSL products have failed; this should be part of identifying concerns and red flags. “

As a result, the placement of Nuromol on the GSL should not be part of the care pathway, the response document concluded.

The consultation, which May 13 to June 3, 2021, was undertaken after the Commission for Medicinal Products for Human Use indicated that Nuromol may be available as a drug for general sale.

The MHRA is currently analyzing the responses to the consultation.