Reckitt Benckiser (RB) is calling for its Nurofen 400mg oral powder sachets to be reclassified from a P to a GSL medicine.

The 400mg ibuprofen lysine sachets posed no increased risk to patients compared with the 200mg tablets, available as a GSL medicine, because the majority of users took double the tablet dose, the manufacturer has argued in an application to the MHRA.

Patients would not overdose because of clear labeling on the packaging and because it was "conventional" for only one sachet to be taken at a time, according to its proposals under consultation this month.

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	RB launched the ibuprofen sachets - the only ones available in the UK – in 2011. The company said that although pharmacists provided "valuable assistance" to patients choosing combination products containing the NSAID, "limited help" was needed when it concerned standard forms.

"Considering the licensed indications of the product, its uniqueness in the range and its pack size availability, the risk to the consumer is minimal," it said.

The manufacturer had also argued that sachets containing 1,000mg of paracetamol were available in the UK as a GSL treatment despite the maximum allowable tablet being 500mg. Its Nurofen oral sachets would be an "appropriate alternative", it said.

Ibuprofen 400mg sachets had been available over the counter in Europe for the past 20 years and its formulation had a similar safety profile to tablets and capsules, it added.

Each pack contains eight sachets. The maximum daily dosage is one ibuprofen 400mg sachet three times daily, intended for up to a five-day, short-term use, compared to 10 days for 200mg tablets.

RB applied for the reclassification and therefore there were no other expert views included in the consultation, the MHRA said. Any responses can be sent to the MHRA by Friday (January 31).