This evidence needs to focus on the risk to the public. This includes evidence on the possible abuse or misuse of the medicine. The evidence may include: At The Independent Pharmacy, we offer a range of hay fever and allergy treatments. This includes an alternative corticosteroid and antihistamine nasal sprays, antihistamine tablets, liquid solutions and eye drops designed to relieve hay fever symptoms that affect the eyes and nose as well as the rest of the body. you are taking, or have recently taken another corticosteroid medicine (including eczema creams, asthma inhalers, tablets, injections, nasal sprays, eye or nose drops). Additional risk minimisation measures have been added to the RMP to reflect the GSL classification including: 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 you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your pharmacist or doctor for advice before using this medicine. 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? This provides reassurance that the product will be used and handled safely without the supervision of a pharmacist. 4.6 Wider sale would be a convenienceIf you take too many doses of Benacort® Hayfever Relief, talk to your doctor or pharmacist straight away. 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 Follow the instructions that come with your medicine. Do not use more than the maximum number of sprays in 24 hours.

Patients should commence treatment with two sprays into each nostril each morning. Once symptoms are under control, a maintenance dose of one spray into each nostril each morning may be used. Total daily administration should not exceed four sprays (256 micrograms). When used daily, Benacort Nasal Spray provides lasting, continuous relief, leaving you feeling comfortable, throughout the day and night.

The patient should be informed that the full effect of this medicine is not achieved until after a few day's treatment. Benacort Hayfever Relief will be made available through general retail outlets with the following terms of reclassification: Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the following happen to you, stop using Benacort® Hayfever Relief and get medical advice straight away: ¦ Sudden signs of an allergic reaction such as: ¦ rash, itching, hives or redness of the skin ¦ swelling of the face, lips, mouth, tongue or other parts of the body ¦ shortness of breath, wheezing or difficulty in swallowing or breathing ¦ feeling faint. Other effects which may occur include: Common (may affect up to 1 in 10 people) ¦ nasal irritation (sneezing, dry nose, or stinging in your nose). These can happen straight after using this nasal spray ¦ nose bleeds. Uncommon (may affect up to 1 in 100 people) ¦ muscle cramps. Rare (may affect up to 1 in 1,000 people) ¦ hole in the wall between the nostrils (the nasal septum) ¦ nasal ulcers ¦ change in voice ¦ bruising ¦ blurred vision. Other effects which may occur but it is unknown how often: ¦ glaucoma (increased pressure in the eye) ¦ cataract. 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

If you prefer to use Benacort once a day, use two sprays into each nostril in the morning. Once your symptoms are under control you can reduce the dose to one spray in each nostril in the morning. Budesonide nasal (nose) spray is used to treat cold-like symptoms caused by allergic rhinitis. This is swelling (inflammation) of the inside of your nose that can be brought on by allergies like hay fever. For allergic rhinitis, budesonide nasal spray takes a few days to work. For some people, it can take several weeks to work fully. 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. The nasal spray can take three to four days to build up its effect, so it won't relieve hay fever symptoms straight away. Ideally you want to start using it just before the pollen season starts to help prevent your allergy from developing. However you can also use it to relieve hay fever symptoms that have already started. Key facts about Benacort nasal spray

No major issues have been identified in the assessment of this application for Benacort Hayfever Relief as a GSL medicine based on the following reasons: You or the person who's unwell may also have a rash that's swollen, raised, itchy, blistered or peeling. The patient should be informed that the full effect of Benacort is not achieved until after a few days treatment. Treatment of seasonal rhinitis should, if possible, start before exposure to the allergens. If symptoms are not controlled, or persist for longer than 2 weeks of treatment, medical advice must be sought. This medicine should not be used continuously for longer than 3 months. 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.