Sudafed Plus Blocked Nose 1mg/50mg/ml nasal spray solution is to be made available over the counter, the Medicines and Healthcare Products Regulatory Agency (MHRA) has said.

The MHRA said it considered the product ‘sufficiently safe’ to be switched from a Prescription Only Medicine (POM) to a Pharmacy (P) medicine.

McNeil Products Limited applied to change the legal status of the product, which can be used for the symptomatic relief of nasal congestion associated with the common cold, influenza, sinusitis, allergic and non-allergic rhinitis (vasomotor rhinitis), and other upper respiratory tract allergies in adults and children aged 12 years and over.

The nasal spray solution contains xylometazoline hydrochloride 1mg/ml (0.1% w/v) and dexpanthenol 50mg/ml (5% w/v), both of which have been available for many years.

In its public assessment report, MHRA said the risks associated with xylometazoline were ‘already well documented’, and the most recent data provided by McNeil ‘did not demonstrate any new concerns or issues which would make this product unsuitable in a P setting’.

It said that data European countries which marketed the product as a non-prescription medicine supported this and that, as xylometazoline nasal spray was already available as a General Sales List (GSL) medicine, it was unlikely that there would be an increased risk of incorrect use.

The report also said that the maximum approved pack size (10ml) was not likely to result in a prolonged use of the medicine.

There was also not considered to be an increased risk of overdose, it added, and there was no evidence that the product was frequently and to a very wide extent used incorrectly, that it had any abuse potential or that increased access likely to increase this risk.

The change was also deemed to not have the potential of increasing the risk of drug dependence.

The Commission on Human Medicines (CHM) supported the conclusion that the nasal spray could be approved for P availability.

The Pharmacist has contacted the MHRA to confirm when the reclassification will come into force.

This comes after MHRA gave the green light for certain HRT vaginal tablets will be available over the counter without a GP prescription.