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

£9.9£99Clearance
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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

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). Special care is required in the treatment of patients transferred from oral corticosteroids to this medicine where disturbances of the hypothalamic-pituitary-adrenal (HPA) axis could be expected.If you forget to use your spray, use it as soon as you remember, unless it's almost time for your next dose. If this happens, skip the missed dose and have your next one at the usual time. 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. To use the spray, please follow the directions below. You can find more information in the Patient Information Leaflet. 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.

Try to remember to use budesonide spray regularly, even if your symptoms are controlled. If you forget a dose at your usual time, take it as soon as you remember unless your next dose is due. If your next dose is due then have the dose which is due and leave out the forgotten one. Do not 'double up' to make up for a missed dose. Do not use more than two sprays into each nostril in a day. Do not use it continuously for more than 1 month. If you have budesonide nasal spray on prescription, your doctor will tell you how often to use it and when to change your dose. 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. McNeil Products Ltd, applied to make Benacort Hayfever Relief available as a GSL medicine for sale through general retail outlets. 3. Proposed Terms of Reclassification 3.1 What are the details of this change?Talk to your doctor or pharmacist if your hay fever hasn't improved after 14 days of using Benacort. 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. Overall, the safety profile of Benacort Hayfever Relief is considered acceptable for GSL availability. 4.3 Drug interactions c. The nozzle needs to be wiped with a clean tissue after use and the protective cap replaced. The bottle should be stored in an upright position. Additional risk minimisation measures have been added to the RMP to reflect the GSL classification including:

Raised plasma concentrations of and enhanced effects of corticosteroids have been observed in women also treated with oestrogens and contraceptive steroids, but no effect has been observed with this medicine and concomitant intake of low dose combination oral contraceptives. 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. 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? They have severe or frequent nose bleeds, or have had recent nose ulcers or nose surgery or a nose injury that has not healed. The patient should be informed that the full effect of this medicine is not achieved until after a few day's treatment.Using the nasal spray twice a day: If you prefer, you can use one spray into each nostril every morning and evening. If your symptoms improve, reduce this to one spray into each nostril in the morning. 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

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