The Medicine Healthcare and Regulatory Authority (MHRA) has taken the decision to reclassify the legal status for Benacort Hayfever Relief for Adults 64 micrograms nasal spray from POM to GSL. The MHRA has made this decision with the following terms of reclassification:
- For use in the nose in the form of a nasal spray.
- For the treatment of seasonal allergic rhinitis (hayfever).
- Maximum strength: 64 micrograms per actuation (spray).
- Maximum dose: 132 micrograms per nostril (264 micrograms).
- Maximum daily dose: 132 micrograms per nostril (264 micrograms).
- Maximum duration of treatment: 1 month.
- Maximum pack size: 10 mls (60 actuations).
Commenting on their website the MHRA have said the following:
“The MHRA considers that there is no reason to believe that there is a higher risk of misuse for Benacort Hayfever Relief compared to other corticosteroid nasal sprays that are already classified as GSL. There is no evidence of abuse of these products since they were reclassified to GSL.
“GSL medicines for the treatment of hayfever have been available for decades. Therefore, a patient’s ability to self-diagnose hayfever has already been established.
“Instructions about who should not use the product, and warnings and precautions for when using it are on the label and PIL. The maximum duration of continuous use before seeking medical advice has been limited to one month, which has been emphasised clearly on the product information. Patients are advised to seek professional advice if symptoms are not controlled or persist for longer than 7 days. These limitations on use are considered safe enough for users to self-treat their condition without masking any underlying serious conditions or delaying the amount of time it takes for them to seek further advice from a healthcare professional. They are also consistent with the limitations on use for other GSL corticosteroid nasal sprays.
“The 60-actuation (spray) pack size provides a maximum of 30 days treatment (at the minimum daily dose), which is not greater than the maximum length of treatment of other GSL corticosteroid nasal sprays and aligns with the maximum recommended length of continuous treatment (at minimum dose) before seeking medical advice.
“No major issues have been identified in the assessment of this application for Benacort Hayfever Relief as a GSL medicine based on the following reasons:
- The treatment of hayfever is very common with two other intranasal corticosteroids available to treat this condition in the GSL setting. Non-sedating antihistamine tablets and liquids are also available. Patients can self-diagnose hayfever when purchasing these products so it would be considered reasonable that patients who wish to purchase Benacort Hayfever Relief can correctly diagnose themselves with hayfever.
- The proposed indication, route of administration, duration of treatment and maximum pack size are in line with the two GSL intranasal corticosteroids currently available.
- Since the reclassification of other corticosteroid nasal sprays, no additional safety concerns have been raised as a result of their availability as GSL products.
“The treatment of hayfever is a well-established GSL indication within the UK environment. Consumers are used to buying hayfever treatments including nasal sprays on self-selection in a general retail outlet. The MHRA accepts that the wider availability of Benacort Hayfever Relief would be beneficial to patients as it would allow access to another corticosteroid nasal spray in the GSL setting.”
This circular is being shared under the Open Government Copyright licence.