BENACORT® Nasal Spray – 24hr Hay Fever Relief – Alcohol Free – Fragrance Free – Budesonide Nasal Spray – 60 Sprays, 10ml

Product Information

The pattern of adverse events during the period concerned did not raise any concerns which would affect the proposed reclassification to GSL. 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. Self-diagnosis The Global post-marketing data between December 2013 to April 2017 and USA Post-marketing data from 01 January 2016 to 30 April 2017 (which is mostly data on non-prescription use) did not raise any concerns which would affect the proposed reclassification to GSL. It can take up to a couple of days before the full effects of Benacort Nasal Spray can be felt, but with regular use, the relief this medicine offers is significant and long-lasting.

This nasal spray is used to treat adults with inflammation in the nose caused by an allergy to pollen (hayfever). Using the nasal spray once a day: The recommended dose is two sprays into each nostril in the morning. If your symptoms improve, reduce this to one spray into each nostril in the morning.Hay fever causes irritation, inflammation and excess mucus in the nose, which is what causes congestion, itching, sneezing and running of the nose. Each spray of Benacort contains a measured dose of the corticosteroid Budesonide. It helps ease symptoms of hay fever by reversing these effects, improving the swelling and reducing mucus production. In animal reproduction studies, corticosteroids such as budesonide have been shown to induce malformations (cleft palate, skeletal malformations). However these animal experimental results do not appear to be relevant in humans at the recommended doses.

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. Risk of misdiagnosis or delayed diagnosis of a more serious conditionyou are, or have recently been, using any other product containing a corticosteroid, including creams, ointments, tablets, asthma medicines, eye drops or other nasal sprays or drops