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 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?

tablets, including tablets that dissolve on your tongue, capsules and granules – for inflammatory conditions such as Crohn's disease, ulcerative colitis, autoimmune hepatitis and eosinophilic oesophagitis Pharmacotherapeutic group: Decongestants and other nasal preparations for topical use, corticosteroids. ATC code: R01A D05 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 You can buy Benacort without a prescription from pharmacies. It's suitable for adults aged 18 years and over. How does Benacort work? Follow the instructions provided with the nasal spray. You should shake the bottle gently before use. Be careful not to get the spray in your eyes.The maximal duration of treatment is 1 month’s continuous self-care use, before seeking medical advice. take advice from a group (‘stakeholder group’) of health professionals and representatives of people affected by the classification change The post-marketing data from Sweden on adverse events following non-prescription use of budenoside nasal spray between 1999 and 2017 did not raise any concerns which would impact the proposed reclassification to GSL.

Signs and symptoms of systemic corticosteroid effects, including adrenal suppression and growth retardation. you are taking, or have recently taken another corticosteroid medicine (including eczema creams, asthma inhalers, tablets, injections, nasal sprays, eye or nose drops). 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.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 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.

Try and stay indoors and avoid grassy areas when the pollen count is high. The pollen count is a measure of how much pollen is in the air and it’s usually highest on hot, sunny days.Benacort Nasal Spray Patient Information Leaflet: https://www.medicines.org.uk/emc/files/pil.10205.pdf you have ever had a bad reaction to budesonide or any of the other ingredients of this medicine (listed in section 6) 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’)’. Advice that the medicine should not be used continuously for longer than I month without seeking medical advice Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Benacort® Hayfever Relief can affect the way some medicines work, and some medicines can have an effect on Benacort® Hayfever Relief. So, your doctor may wish to monitor you carefully. In particular talk to your doctor or pharmacist if:

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%. The systemic availability of budesonide from this medicine, with reference to the metered dose is 33%. In adults, the maximal plasma concentration after administration of 256 micrograms budesonide from this medicine is 0.64 nM and is reached within 0.7 hours. The AUC after administration of 256 micrograms budesonide from this medicine is 2.7 nmolxh/L in adults. Overall, the safety profile of Benacort Hayfever Relief is considered acceptable for GSL availability. 4.3 Drug interactions Reduced liver function affects the elimination of corticosteroids, causing lower elimination rate and higher systemic exposure. Be aware of possible systemic side effects. you 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 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.

How long to use it for

These can be signs of a serious allergic reaction and may need immediate treatment in hospital. Other side effects Hypersensitivity (Immediate and delayed hypersensitivity reactions including erythema, urticaria, rash, dermatitis, angioedema and pruritus) Advice for patients that they should use the lowest dose at which effective control of symptoms is achieved