MHRA approves POM to P switch for Sudafed Plus Blocked Nose nasal spray
The topical decongestant product Sudafed Plus Blocked Nose 1mg/50mg/ml nasal spray will be available from pharmacies without a prescription following the MHRA’s decision to reclassify it.
The medicines regulator announced yesterday (August 3) that it had approved an application for a POM to P switch from manufacturer McNeil Products Limited.
The product is indicated for the symptomatic relief of nasal congestion associated with the common cold, influenza, sinusitis, allergic and non-allergic rhinitis (vasomotor rhinitis), other upper respiratory tract allergies in adults and children aged 12 years and over.
The MHRA said it “considers this product sufficiently safe to be sold as a pharmacy medicine,” noting that of the two active ingredients – xylometazoline hydrochloride and dexpanthenol – the former is “already available as a GSL medicine”.
It said: “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.
“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.”