POM to P switch for nasal spray
Sudafed Plus Blocked Nose 1mg/50mg/ml nasal spray has been considered “sufficiently safe to be sold as a pharmacy medicine” by the MHRA.
On 3 August it was announced that the topical decongestant will be available from pharmacies without prescription after the application for a POM to P switch was put forward by manufacturer McNeil Products Limited.
The nasal spray is for the symptomatic relief of nasal congestion associated with sinusitis, influenza, the common cold, allergic and non-allergic rhinitis (vasomotor rhinitis), other upper respiratory tract allergies in adults and children aged 12 years and over.
The MHRA also noted that of the two active ingredients – xylometazoline hydrochloride and dexpanthenol – the former is “already available as a GSL medicine”.
“It is unlikely that there would be an increased risk of incorrect use as a P medicine where there is a greater control over the supply of the product,” added the organisation. “The addition of dexpanthenol in this combination product is unlikely to increase the risk of any indirect dangers occurring, such as the risk of delaying a diagnosis of an underlying condition, as the proposed indication is already treated in a GSL setting by xylometazoline nasal sprays.”
Read the full report here.