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

Product Information

The MHRA considers this product sufficiently safe to be sold on general sale. This report outlines the evidence that the MHRA reviewed and which led to the decision to approve the application. 2.1 What is in Benacort Hayfever Relief? 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? Benacort Nasal Spray is manufactured by Johnson and Johnson and is available as either a 60 or 120-spray bottle. It can be used once or twice a day for up to one month, by adults over the age of 18 years including the elderly. Gently shake the bottle, remove the cap and keep upright. Pump the nozzle until it starts to spray mist.

Allergic reactions such as rash, itching, hives or swelling of the face or tongue. Stop using Benacort and get medical advice if you think you've had an allergic reaction to it. Patients should consult a physician if they develop signs or symptoms of an infection, such as persistent fever, while taking this medicine.

Budesonide is moderately lipophilic and systemic exposure is primarily due to its rapid absorption through the nasal mucosa. The systemic bioavailability of budesonide following intranasal administration is 6 to 16%. you are about to have an operation or during times of stress. Your doctor may ask you to take steroid tablets as well, particularly if you have been taking a high dose of this nasal spray, or a similar medicine, for a long time. Before using this medicine for the first time the nozzle must be primed (filled with the medicine). To do this the bottle should be shaken and the protective cap removed. The bottle should then be held upright and the nozzle pumped up and down several times (5-10 times) spraying into the air, until an even mist is seen. The priming effect remains for approximately 24 hours. If a longer period of time passes before the next dose is taken, the nozzle must be loaded with medicine again. This time it is sufficient to spray just once into the air. Co-treatment with CYP3A inhibitors including cobicistat-containing products is expected to increase the risk of systemic side effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side effects. Reduced liver function affects the elimination of corticosteroids, causing a lower elimination rate and higher systemic exposure. This may lead to possible systemic side effects.

If you prefer to use Benacort twice a day, use one spray into each nostril in the morning and one spray into each nostril in the evening.

Cetirizine Tablets and Solution - over-the-counter, non-drowsy. For children and adults from 2 years. Patients are advised to seek professional advice if their symptoms worsen or do not improve after 7 days Speak with your doctor or pharmacist before using Benacort Nasal Spray if any of the following apply: If you are using the spray for hay fever, your doctor may recommend that you start using it 2-3 weeks before the hay fever season starts. This is because it takes a few days of treatment before you feel the full effect, so starting before the pollen count rises will help to prevent symptoms from developing. 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. 5. Further details on the application 5.1 Risk Management Plan

The comparison of post-marketing safety data from when the product was available only on prescription and when it has been available as a P medicine did not raise concerns which would affect the proposed reclassification to GSL. Adverse events Wipe the nozzle with a clean tissue and replace the protective cap. Store the bottle in an upright position Paediatric population: This medicine should not be used in children and adolescents under 18 years of age. you are taking HIV medicines (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir or cobicistatcon­taining products).To avoid the risk of injury, direct the nozzle to the side of the nose, and away from the middle of the nose (the ‘nasal septum’)’. Benacort won't relieve your hay fever straight away - you have to use it regularly for a few days for it to build up an effect. 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 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. The pattern of adverse events during the period concerned did not raise any concerns which would affect the proposed reclassification to GSL.