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The metabolism of budesonide is primarily mediated by CYP3A enzymes. Co-treatment with CYP3A inhibitors, e.g. itraconazole, ketoconazole, clarithromycin, HIV protease inhibitors e.g. atazanavir, indinavir, nelfinavir, ritonavir and saquinavir, and cobicistat-containing products, is expected to increase the risk of systemic side effects (see section 4.4). The combination of this medicine with potent CYP3A inhibitors 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. This is of limited clinical importance for short-term (1-2 weeks) treatment with itraconazole or ketoconazole or other potent CYP3A inhibitors, but should be taken into consideration during long-term treatment. If this medicine is co-administered with anti-fungals (such as itraconazole and ketoconazole), the period between treatments should be as long as possible. A reduction of the budesonide dose should be considered. Benacort Hayfever Relief for Adults 64 micrograms, nasal spray is a medicine sprayed inside the nose for the treatment of seasonal allergic rhinitis (hayfever) in adults aged 18 years and over. 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. 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
They have severe or frequent nose bleeds, or have had recent nose ulcers or nose surgery or a nose injury that has not healed. Advice that the medicine should not be used continuously for longer than I month without seeking medical advice 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.
It's most effective to start using Benacort a few days before you expect to get symptoms, for example before the start of the pollen season. Then keep using it regularly every day while you're still being exposed to the type of pollen that gives you hay fever.
The pattern of adverse events during the period concerned did not raise any concerns which would affect the proposed reclassification to GSL. 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.Always read the label. Ask your pharmacist for advice. At the recommended dosage, BENADRYL ® products do not cause drowsiness in the majority of sufferers. Blurred vision. Tell your doctor if you notice any changes in your vision while using Benacort nasal spray.
Signs and symptoms of systemic corticosteroid effects, including adrenal suppression and growth retardation. The post-marketing data covering the period from 1 May 2017 to 30 April 2018 and the period from 1 May 2018 to 30 April 2019 showed that the number of adverse events reported was low in relation to the amount of product used and the majority of adverse events reported were non-serious, easily managed and known to be associated with the product. 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. Do not use more than two sprays into each nostril in a day. Do not use it continuously for more than 1 month. It can take up to a couple of days before the full effects of Benacort Nasal Spray can be felt, but with regular use, the relief this medicine offers is significant and long-lasting.
How to use it
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. Reduced liver function affects the elimination of corticosteroids, causing lower elimination rate and higher systemic exposure. Be aware of possible systemic side effects. 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? Talk to your doctor or pharmacist if your hay fever hasn't improved after 14 days of using Benacort.
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