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MHRA1March 21 2016

A consultation on changing the legal category of Ibuprofen Seven Plus 200mg/5ml Oral Suspension from prescription only medicine (POM) to pharmacy only (P) is underway.

Ibuprofen 100mg/5ml suspension is available without prescription, but the Commission on Human Medicines has now advised that a 200mg/5ml strength can be made available as a P medicine.

Setting out its proposals, the medicines regulator, the MHRA, has flagged up a potential risk of confusion over the different strengths as no other OTC ibuprofen 200mg/5ml preparations are available at the moment. “The risk is that a parent/carer, who may be used to giving quantities of suspension suitable for the 100mg/5ml product, might give twice the dose to a child if they give the same amount of this product,” says the consultation document ARM 91.

To address this concern, “the company has proposed appropriate risk minimisation measures to manage the risk of confusion. This will be done by clear warnings on the leaflet and label, and by adding the words, ‘double strength’ clearly highlighted to the outer box and to the label on the bottle itself.

“Additionally, as a P medicine, this product will be supplied only from pharmacies under the supervision of a pharmacist and therefore pharmacy staff can provide additional advice on correct use.”

Ibuprofen Seven Plus 200mg/5ml Oral Suspension is made by Pinewwood Laboratories, and is licensed for rheumatic or muscular pain, headache, dental pain, feverishness, symptoms of cold and influenza in children aged 7-12 years.

The consultation runs until April 4.

Links:

MHRA announcement

MHRA ARM 91 consultation document

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