The UK medicine regulator has approved the combined paracetamol and ibuprofen medicine, Nuromol, for general sale (GSL).

It comes after a public consultation by the Medicines and Healthcare products Regulatory Agency (MHRA), which was launched in May.

The move means patients will no longer need to visit a pharmacy to access Nuromol.

The Royal Pharmaceutical Society has said it has ‘concerns about the safety’ of the reclassification as it removes ‘vital interactions’ between the patient and pharmacist.

The drug, which contains 200mg of ibuprofen and 500mg of paracetamol per tablet, is used for pain relief for mild to moderate pain when either medicine by itself has not provided pain relief.

Nuromol was initially classed as a pharmacy medicine (P) in 2010 when it was first licensed, however the MHRA said in its consultation that it hoped making this medicine more widely available would make it a better option than codeine or dihydrocodeine for patients, both of which are ‘more liable to be misused and lead to addiction’.

But, RPS president Claire Anderson said the body had concerns about the move.

She said: ‘By moving this combination product from P to GSL, vital interactions with pharmacists are lost and the patients will not be supported with health and medicines advice tailored to their individual needs.

‘We have concerns about the safety of making this combination product available as a general sales item. Ibuprofen is contraindicated in several patients, including those with kidney or liver failure, and there are also many times when it should be used with caution, for example in the first and third trimester of pregnancy.’

She added: ‘Our aim as RPS is to ensure patients get the most from their medicines. To facilitate this, we advocate that patients must be able to self-care with the support of the professional expertise and judgment of a pharmacist, and the P category of medicines helps facilitate this interaction. This is especially important when a product contains more than one medicine, such as Nuromol.’

Nick Kaye, vice chair at the NPA, added that pharmacists were there to help patients get the most out of their medicines as well as minimise the risk of harm.

He said: 'If used inappropriately, medicines can bring harm as well as heal, even medicines you can pick up from a supermarket shelf or a pound shop.

'We are concerned that a move to general sale of Nuromol will lose the vital intervention around medicines that pharmacists often make when interacting with patients.'

Dosing concerns

The MHRA said 13 responses to the consultation had been received, which ‘have not raised any new safety concerns with respect to reclassification’.

However, within the consultation responses, there was some concern about the risk of people who were familiar with the four-daily dosing of paracetamol taking Nuromol four times a day, which would be more than the maximum daily dose of ibuprofen.  

In response, the MHRA said this would ‘not result in ibuprofen toxicity’.

The MHRA consultation said: ‘If a user did take the product incorrectly four times a day, this is within the prescribing limits for ibuprofen and would not result in ibuprofen toxicity.

‘As the pack size is limited to 16 tablets, treatment is limited to three days, and the label and leaflet clearly state the dose, CHM [Commission on Human Medicines] considered that the risk of overdose is minimised acceptably.’

Other concerns were raised about dosing intervals and that people may take it as a first-line treatment when it is not intended to be.

In response, the MHRA said the label would make it clear that it was only to be taken after first trying paracetamol or ibuprofen first, and that this was in a prominent position on the pack.

It added: ‘It is accepted that users can ignore the warning if they choose but they can also ignore advice given by the pharmacist at point of sale and when the product is available in their homes if they choose. Therefore, this risk is not considered to be any higher than if the product was classified as P.’

Dr Sarah Branch, director of vigilance and risk management of medicines at the MHRA, said the MHRA was ‘committed to improving access to medicinal products for self-care where it is safe to do so’.

She added: ‘Wider availability of medicinal products and improved patient access and choice remain high on the health agenda.

‘This reclassification to general sales list will help people to manage their pain where paracetamol or ibuprofen alone have not provided adequate pain relief.’

Earlier this year, two progesterone-only pills were reclassified to become available for sale without a prescription from pharmacies.

Pharmacists welcomed this news, saying it was a ‘step in the right direction’.