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

Product Information

The RMP for this product considered the main risks associated with the product and proposed additional warnings on the labelling and PIL about the symptoms which a patient should seek further advice from a doctor or pharmacist. The MHRA considers that apart from this, no further risk minimisation measures are need for this application. 6. Reasons for not seeking advice from the Commission on Human Medicines The full name of the medicine is Benacort Hayfever Relief for Adults 64 micrograms, nasal spray. In this document, we will call it ‘Benacort Hayfever Relief’. Also ask your doctor or pharmacist's advice if you feel better before 7 days but are not sure if you can stop.

Keep using it regularly every day to keep your hay fever under control. You can use Benacort for up to three months. The summary of product characteristics includes the interaction of Benacort Hayfever Relief with several medicines. If a patient is on any of the medicines that interact with Benacort Hayfever Relief, patients are alerted to the interaction on the label and patient information leaflet ( PIL). If symptoms persist or are not adequately controlled after 7 days of treatment patients should consult their doctor or pharmacist. This medicine should not be used continuously for longer than 1 month without seeking medical advice.They have severe or frequent nose bleeds, recent nose ulcers or nose surgery or a nose injury that has not healed. They have severe or frequent nose bleeds, or have had recent nose ulcers or nose surgery or a nose injury that has not healed. When you first start using budesonide, it is usual to use either two sprays into each nostril each morning, or one spray into each nostril twice a day. Your doctor or pharmacist will tell you which is right for you. Once your symptoms are controlled, you may be advised to reduce this to just one spray into both nostrils once a day. Treatment with budesonide may be continued for up to three months, but your doctor will advise you how long is right for you.

Benacort Nasal Spray offers effective prevention and relief from symptoms of pollen allergies or hay fever that specifically affect the nose. These symptoms include: If your symptoms improve while using Benacort you can keep using it for as long are you are exposed to the allergen, but don't use it continuously for more than three months without seeing your doctor. What are the side effects of Benacort nasal spray? 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?Although there is insufficient evidence to confirm it, there is a possible risk of damage to the nasal septum (the middle of the inside of the nose) associated with use of the product. To minimise this possible risk, the following warning has been included in the PIL: Put the tip of the nozzle into 1 nostril, being careful to keep it pointing towards the side of the nostril and not the middle (nasal septum). 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.

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. b. Holding the bottle upright, with one finger held on either side of the nozzle, the patient should insert the tip of the nozzle into one nostril. The nozzle should be directed to the side of the nose, and away from the middle of the nose (the nasal septum). The nozzle should be pressed down once or twice depending on the dose required. The spray should then be administered into the other nostril in the same way. Note: it is not necessary to inhale at the same time as spraying.

Reduced liver function affects the elimination of corticosteroids, causing lower elimination rate and higher systemic exposure. Be aware of possible systemic side effects. 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. In cases of clinically significant adrenal suppression, additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Since the reclassification of other corticosteroid nasal sprays, no additional safety concerns have been raised as a result of their availability as GSL products. The most common side effects are nosebleeds and sneezing, stinging sensation or dryness in the nose after using the spray.