The allergy and hayfever medicine Allevia (fexofenadine hydrochloride) 120mg tablets have been moved from a prescription-only medicine (POM) to the General Sales List (GSL), the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.
The antihistamine is used for relief of symptoms associated with seasonal allergic rhinitis (SAR), or hayfever, in adults and children aged 12 years and over.
In a Public Assessment Report published on 22 December 2020, the MHRA said that the manufacturer, Aventis Pharma Limited, had proposed making the medicine available through the GSL in pack sizes of 30 tablets. The MHRA had, it said, agreed that the product was “sufficiently safe to be sold on general sale”.
It added that fexofenadine “has been available as a POM for over 20 years and therefore its activity and safety profile are well established, and no further investigation of the side effects is required”.
Fexofenadine will remain a POM in two other forms: 180mg tablets for relief of symptoms associated with chronic idiopathic urticaria in adults and adolescents aged 12 years or older, and 30mg tablets for relief of symptoms associated with SAR in children aged 6–11 years.
A spokesperson for the Royal Pharmaceutical Society said that “although we are supportive of widening access to medicines when safe and appropriate, we believe that usually medicines should be reclassified as a pharmacy medicine first.
“With pharmacy medicines, pharmacists are on hand to deal with questions, for example from older people, individuals with impaired kidney or liver function, or individuals with history of heart disease.”