On December 22, 2020 the Medicines Healthcare and Regulatory Authority (MHRA) published a public assessment report reclassifying Allevia 120mg (fexofenadine) from a prescription only medicine (POM) to general sales list (GSL).
Fexofenadine is a non-sedating antihistamine, used to relieve symptoms of allergy such as hay fever, blocked nose and itchy or watery eyes.
Fexofenadine is a second-generation antihistamine that selectively antagonises H1 receptors on the surface of cells on multiple different organ systems. Second-generation antihistamines have less affinity for cholinergic and alpha-adrenergic receptors and therefore do not display the same anticholinergic side effects as the older first-generation antihistamines, such as dry mouth, constipation, drowsiness and sedation.(1)
Reclassification of fexofenadine
Having been used extensively for over 20 years, the MHRA said that the safety profile of Allevia has been well established, therefore making the product suitable for reclassification to GSL. Symptoms of hay fever are also easily recognised and often self-limiting and it is expected that if symptoms were to persist, patients would seek medical advice.(2)
Allevia 120mg is indicated for the relief of symptoms of seasonal allergic rhinitis, at a dose of 120mg once daily for adults and children over 12 years.(2)
Fexofenadine will remain a POM in the following preparations:(2)
- 30mg twice daily for symptoms associated with seasonal allergic rhinitis children aged 6-11 years
- 180mg once daily for symptomatic relief of chronic idiopathic urticaria for adults and children over 12 years.
What are the side effects?
Side effects are similar to those of other non-prescription medicines and are often self-limiting, such as dizziness, drowsiness, headache and nausea.(3)
Non-sedating antihistamines cause less sedation and psychomotor impairment than the older antihistamines, although sedation can still occur but is usually minimal. This is because non-sedating antihistamines are less lipophilic than sedating antihistamines and therefore penetrate the blood brain barrier to a lesser extent.(1)
Interactions and cautions
Fexofenadine can interact with indigestion remedies containing aluminium and magnesium, so it is recommended to leave at least two hours between doses.(2)
The bioavailability of fexofenadine can be reduced if taken with apple, orange or grapefruit juice.(1)
Fexofenadine should be administered with care to elderly individuals with impaired kidney or liver function, or individuals with a history of heart disease. These individuals should speak to their pharmacist or doctor before taking fexofenadine.(3)
Although there is no evidence of teratogenicity, manufacturers advise against use of fexofenadine in pregnant women. Fexofenadine is also present in breast milk, and although not thought to be harmful, should also be avoided in women who are breastfeeding.(3)
More information on the reclassification of Allevia 120mg can be found on the Public Assessment Report.
References
- Craun KL, Schury MP (2020) Fexofenadine [Updated 2020 Nov 20]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing
- Gov.uk (2020) PAR: Reclassification of Allevia 120mg tablets from prescription only medicine (POM) to General Sales List (GSL)
- British National Formulary (2021) Fexofenadine hydrochloride
