January 8, 2022

Combined paracetamol and ibuprofen tablets reclassified for general sale despite concerns

A combined pain reliever with ibuprofen and paracetamol, Nuromol (Reckitt), has been approved for general sale by the Medicines and Health Products Regulatory Agency (MHRA).

The announcement August 16, 2021 comes despite concerns from pharmacy representatives about potential patient confusion regarding dosages and reduced interactions between pharmacists and patients.

Nuromol, each tablet of which contains 200 mg ibuprofen and 500 mg paracetamol, is intended for the temporary relief of mild to moderate pain such as migraine, back pain and menstrual pain, or for the relief of symptoms of the common cold and influenza, when paracetamol or ibuprofen alone did not provide adequate pain relief.

Following a public consultation, which ran from May 13, 2021 to June 3, 2021, and a review by the Commission for Medicinal Products for Human Use, Nuromol was reclassified from a pharmacy drug (P) to a General Sales List (GSL) drug, which means it is available without the need to visit a pharmacy.

Sarah Branch, director of drug vigilance and risk management at MHRA, said the reclassification “will help people manage their pain where paracetamol or ibuprofen alone has not provided adequate relief from pain. pain”.

“Greater availability of medicines and improving patient access and choice remain a priority for health. The MHRA is committed to improving access to medicines for self-care where it is safe to do so, ”she added.

However, in its response to the June 2021 public consultation, the Royal Pharmaceutical Society (RPS) expressed “concern” about the potential for people to mistake the product for paracetamol alone and take the standard dose of paracetamol from two tablets four times a year. daytime.

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

Commenting on the reclassification, Claire Anderson, President of RPS, reiterated the Company’s concern, saying that “vital interactions” with pharmacists would be lost by moving the combined product from P to GSL, and patients would not be supported by pharmacists. advice on health and medication. tailored to their individual needs.

“We have concerns about the safety of making this combination product available as a general sale item,” she said.

“Ibuprofen is contraindicated in many patients, including those with renal or hepatic impairment, and there are also many times it must be used with caution, for example in the first and third trimesters of the pregnancy.

“We are also concerned that people may mistake the product for paracetamol alone and take the standard dose of paracetamol of two tablets four times a day. This has the potential to cause harm to patients. “

Anderson added that the Company’s goal is to make sure patients “get the most out of” their medications.

“To facilitate this, we advocate that patients are able to look after themselves with the support of the professional expertise and judgment of a pharmacist, and Category P drugs help facilitate this interaction. This is especially important when a product contains more than one drug, such as Nuromol.

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

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