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

Product Information

When used daily, Benacort Nasal Spray provides lasting, continuous relief, leaving you feeling comfortable, throughout the day and night.

Based on data from inhaled budesonide and the fact that budesonide exhibits linear PK properties within the therapeutic dosage intervals after nasal, inhaled, oral and rectal administrations, at therapeutic dose of budesonide, exposure to the breast-fed child is anticipated to be low. Benacort Hayfever Relief (product licence [PL] 15513/0409) is a copy of the licence for Rhinocort Aqua 64 micrograms, nasal spray (PL 15513/0403) which is a POM. The licence holder for both products, McNeil Products Limited, also owns the licence for Benacort 64 micrograms Nasal Spray (PL 15513/0404), which was reclassified from POM to P in April 2009. 2.3 Who has made the proposal? While the licence for Benacort Hayfever relief was a copy of a product that is classified as POM, there is already an identical product classified as P. Therefore, the MHRA considered that the conditions for P classification had already been met and assessed the application against the General Sales List criterion, as stated in the paragraph above. 4.2 Hazard to health Safety profile Benacort Hayfever Relief will be made available through general retail outlets with the following terms of reclassification:Put the tip of the nozzle into your nostril. Direct the nozzle to the side of the nose, and away from the middle of the nose (the ‘nasal septum’). Spray once (or twice if using the nasal spray once a day). Use the spray in the other nostril in the same way. Note, you do not need to breathe in at the same time as you spray If you do not feel Benacort Nasal Spray is providing you with adequate relief within 7 days you should discuss this with a doctor or pharmacist. You should not use this medication continuously for longer than 1 month. If corticosteroid nasal sprays are used in high doses for long periods of time, they do have the potential to cause side effects similar to those associated with corticosteroids taken by mouth, such as cataracts, raised pressure in the eye or glaucoma, Cushing's syndrome, adrenal suppression and mental health problems. However, these types of side effect are extremely unlikely to occur with this nasal spray, because the amount of budesonide absorbed into the bloodstream from the nose is very low. As a precaution, always use the lowest effective dose needed to control your symptoms, and for the shortest possible time. Budesonide is a non-halogenated glucocorticosteroid with a high local anti-inflammatory action within the respiratory tract. Plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine

based on mechanistic plausibility and extrapolation from other budesonide/corticosteroid formulations.If you're prescribed budesonide, your doctor may advise you to use it for longer. If you forget to use it