Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Benacort Hayfever Relief for Adults 64 micrograms, nasal spray
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Budesonide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for 2. What you need to know before you use Benacort® Hayfever Relief 3. How to use Benacort® Hayfever Relief 4. Possible side effects 5. How to store Benacort® Hayfever Relief 6. Contents of the pack and other information
1 What Benacort® Hayfever Relief is and what it is used for
This nasal spray contains a medicine called budesonide. This belongs to a group of steroid medicines called 'corticosteroids'. ■ Corticosteroids help to reduce inflammation. ■ This nasal spray is used to treat adults with inflammation in the nose caused by an allergy to pollen (hayfever). Symptoms may include sneezing and/or a runny, itchy or blocked nose. ■ Regular use of this nasal spray can reduce inflammation in the nose and help relieve these symptoms. If your allergy is also causing eye problems, you may need to take another medicine as well.
What you need to know before you take it
e Benacort® Hayfever Relief
This medicine is suitable for most people, but a small number of people should not use it. If you are unsure, talk to your doctor or pharmacist.
Do not use Benacort® Hayfever Relief if: ■ you have ever had a bad reaction to budesonide or any of the other ingredients of this medicine (listed in section 6) ■ you are under 18 years of age ■ you are taking HIV medicines (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir or cobicistatcontaining products). Warnings and Precautions Talk to your pharmacist or doctor before using BenacortTM Hayfever Relief if: ■ you have had recent nose ulcers, nose surgery or you have a nose injury that has not healed properly ■ you get heavy or frequent nose bleeds ■ you have TB (tuberculosis), a chest infection, chicken pox or measles, or you have been in contact with somebody who has TB, chicken pox or measles ■ you have ever had increased pressure in the eye (glaucoma), or cataracts ■ you have an eye infection ■ you have diabetes ■ you have liver problems. Talk to your pharmacist or doctor if you get any of the following while using Benacort® Hayfever Relief: ■ blurred vision or other visual problems ■ any signs of an infection, such as a fever that won't go away. Operations or during times of stress Tell your doctor that you are using Benacort® Hayfever Relief if: ■ you are about to have an operation or during times of stress. Your doctor may ask you to take steroid tablets as well, particularly if you have been taking a high dose of this nasal spray, or a similar medicine, for a long time. Other medicines and Benacort® Hayfever Relief Do not use Benacort® Hayfever Relief if: ■ you are taking HIV medicines (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir or cobicistatcontaining products).
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: ■ you are taking medicines to treat fungal infections (such as itraconazole or ketoconazole). ■ you are taking antibiotics (such as clarithromycin). ■ you are taking oestrogens such as hormone replacement therapy or contraceptives ('the pill'). ■ you are taking, or have recently taken another corticosteroid medicine (including eczema creams, asthma inhalers, tablets, injections, nasal sprays, eye or nose drops).
Pregnancy, breast-feeding and fertility ■ 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. ■ If you get pregnant while using Benacort® Hayfever Relief, talk to your doctor straight away. Driving and using machines Benacort® Hayfever Relief may cause blurred vision. If affected, do not drive or use any machinery. Some ingredients can cause problems This product contains Potassium sorbate (E202) which may cause local skin reactions, (e.g. contact dermatitis).
How to take it
Benacort® Hayfever Relief
Always use this medicine exactly as described in this leaflet, or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How much Benacort® Hayfever Relief to use The recommended starting dose is two sprays into each nostril in the morning. Once your symptoms improve, you may be able to reduce this to one spray in each nostril in the morning. However, if your symptoms return, you can go back to the original starting dose. ■ Do not use more than 4 sprays in a day. ■ Only use in the nose. ■ Do not swallow. How long to use the nasal spray for Use this nasal spray regularly. Keep using it until you are no longer exposed to whatever is causing your allergy. ■ You may not feel the medicine working for the first few days. It takes a few days to feel the full protective effect of this nasal spray, ■ Talk to a doctor or pharmacist if you do not feel better, or if you feel worse after 7 days. ■ Do not use this nasal spray continuously for longer than 1 month, unless your doctor tells you to. Use in children Benacort® Hayfever Relief should not be used in children and adolescents under 18 years. Instructions for use
1. Priming the nozzle Before using this nasal spray for the first time you must prime the nozzle (this means, fill it with the medicine). To do this: a) Shake the bottle and remove the protective cap. b) Hold the bottle upright as shown in the picture. c) Pump the nozzle up and down 5 to 10 times, spraying into the air until you see an even mist.
The priming effect remains for about 24 hours. If you leave a gap of more than a day before the next dose, you will need to prime the nozzle again. This time, spray into the air just once.
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2. Using Benacort® Hayfever Relief a) Blow your nose. b) Shake the bottle. Then, remove the protective cap. c) Hold the bottle as shown in the picture. d) Put the tip of the nozzle into one nostril, as shown. 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'). Spray once or twice depending on your required dose. 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. e) Wipe the nozzle with a clean tissue and replace the protective cap f) Store the bottle upright
3. Cleaning the nozzle It is best to clean the plastic nozzle of this nasal spray regularly. Also clean it if you notice that the spray is not coming out as it should. If this happens, first check the nozzle is primed with medicine (see 'Priming the nozzle'). If after priming the nozzle again the pump is still not working, clean the nozzle as follows: ■ Remove the plastic nozzle with a clean tissue and wash it in warm (not hot) water. ■ Rinse the nozzle thoroughly, dry it, and then replace it on the top of the bottle. ■ Never try to unblock the nozzle by using a pin or other sharp object. ■ Prime the nozzle again (by filling it with medicine) before use. If you use more Benacort® Hayfever Relief than you should It is important that you take your dose as stated in this leaflet. If you take too many doses of Benacort® Hayfever Relief, talk to your doctor or pharmacist straight away. If you forget to use Benacort® Hayfever Relief If you forget to take a dose, take it as soon as you remember. However, if it is almost time to take the next dose, wait until then. Do not take a double dose to make up for a forgotten dose.
4 Possible side effects
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. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting
Possible side effects
, you can help provide more information on the safety of this medicine.
How to store it
Benacort® Hayfever Relief
Keep this medicine out of the sight and reach of children. ■ Do not use this medicine after the expiry date which is stated on the carton or label. The expiry date refers to the last day of that month. ■ Do not store above 30°C. ■ Do not freeze or store in the fridge. ■ Store the bottle in an upright position. ■ Use within 2 months of opening the bottle. You may find it helpful to write on this leaflet when you first open the bottle: Date bottle opened ……………………………………….. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment. ■
Contents of the pack and other information
What Benacort® Hayfever Relief contains ■ The active ingredient is budesonide. This nasal spray contains 64 micrograms of budesonide in each spray. ■ The other ingredients are disodium edetate, potassium sorbate (E202), glucose (anhydrous), microcrystalline cellulose (E460), carboxymethylcellulose sodium (E466), polysorbate 80 (E433), hydrochloric acid and purified water. ■ Each bottle of this nasal spray contains 60 sprays. What Benacort® Hayfever Relief looks like and contents of the pack Benacort® Hayfever Relief is a liquid nasal spray available in a 10ml brown glass bottle. Each bottle is fitted with a spray pump and contains 60 sprays. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder for Benacort® Hayfever Relief is McNeil Products Limited, High Wycombe, Buckinghamshire, HP12 4EG, UK. Benacort® Hayfever Relief is manufactured by McNeil AB, Norrbroplatsen 2, 251 09, Helsingborg, Sweden. This leaflet was last revised: March 2021. More about Hayfever Hayfever is thought to affect more than one in five people in the UK at some point in their lives. What are the symptoms? Symptoms of hayfever include sneezing, a runny, itchy or blocked nose and itchy eyes. What are the causes? Hayfever is caused when a person has an allergic reaction to pollen. When the tiny particles of pollen come into contact with your mouth, nose, eyes and throat, they cause an irritation and inflammation which triggers an allergic reaction. Avoiding exposure 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.
Frequently asked questions about Benacort Hayfever Relief for Adults 64 micrograms, nasal spray
How do I take Benacort Hayfever Relief for Adults 64 micrograms, nasal spray?
Benacort Hayfever Relief for Adults 64 micrograms, nasal spray comes as nasal spray containing 64mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Benacort Hayfever Relief for Adults 64 micrograms, nasal spray?
The active substance in Benacort Hayfever Relief for Adults 64 micrograms, nasal spray is budesonide.
Are there equivalent medicines to Benacort Hayfever Relief for Adults 64 micrograms, nasal spray?
Medicines with the same active substance, strength and form include: Benacort 64 micrograms Nasal Spray. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Benacort Hayfever Relief for Adults 64 micrograms, nasal spray, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Benacort Hayfever Relief for Adults 64 micrograms, nasal spray without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: budesonide
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment of seasonal allergic rhinitis (hayfever) in adults aged 18 years and over. This medicine provides symptomatic relief from nasal congestion, runny nose, sneezing, itchy nose and associated sinus discomfort.
4.2. Posology and method of administration
Posology
Adults aged 18 years and over, including the elderly
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).
If symptoms recur patients should revert to the starting dose. The lowest dose at which effective control of symptoms is achieved should be used.
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.
Patients should be reminded of the importance of taking this medicine regularly.
The patient should be informed that the full effect of this medicine is not achieved until after a few day's treatment.
Paediatric population: This medicine should not be used in children and adolescents under 18 years of age.
Method of administration
For nasal inhalation.
For further details on how to administer the medicine, see Section 6.6.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Patients taking HIV medicines including atazanavir, indinavir, nelfinavir, ritonavir, saquinavir or cobicistat-containing products (see section 4.4).
4.4. Special warnings and precautions for use
Patients should consult a pharmacist or doctor before using this medicine if:
• They are using a corticosteroid product for conditions such as asthma, allergies or skin rash
• They currently have or have been exposed to someone who has tuberculosis, chicken pox or measles.
• They have fungal or viral infections of the airways.
• They have severe or frequent nose bleeds, recent nose ulcers or nose surgery or a nose injury that has not healed.
• They have ever been diagnosed with glaucoma or cataracts.
• They have an eye infection or diabetes.
Patients should consult a pharmacist or doctor if they develop signs or symptoms of an infection, such as persistent fever, while taking this medicine.
Concomitant treatment of seasonal allergic rhinitis may sometimes be necessary to counteract eye symptoms caused by the allergy.
Reduced liver function affects the elimination of corticosteroids, causing a lower elimination rate and higher systemic exposure. This may lead to possible systemic side effects.
Systemic effects of intranasal corticosteroids may occur, particularly at high doses when used for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Potential systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
In cases of clinically significant adrenal suppression, additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
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.
This product contains Potassium sorbate (E202) which may cause local skin reactions, (e.g. contact dermatitis).
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
The long-term effects of intranasal glucocorticosteroids in children are not fully known. This medicine should not be used for children or adolescents under 18 years of age.
4.5. Interaction with other medicinal products and other forms of interaction
This medicine has not been observed to interact with any drug used for the treatment of rhinitis.
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, are expected to increase the risk of systemic side effects (see section 4.4). Concomitant use of this product with HIV medicines is contraindicated (see section 4.3). 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. The interaction 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 or ketoconazole), the period between treatments should be as long as possible. A reduction of the budesonide dose should be considered
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.
Because adrenal function may be suppressed, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values).
4.6. Fertility, pregnancy and lactation
Pregnancy
Results from prospective epidemiological studies and from worldwide post marketing experience indicate no increased risk for overall congenital malformations from the use of inhaled or intranasal budesonide during early pregnancy.
Breastfeeding
Budesonide is excreted in breast milk. At therapeutic doses of this medicine no effects on the breast-fed infant are anticipated since maternal systemic exposure after intranasal administration is low, so minimal exposure to intranasal budesonide in breast-fed infants is expected. This medicine may therefore be considered for use during breastfeeding.
Maintenance treatment with inhaled budesonide (200 or 400 micrograms twice daily) in asthmatic nursing women results in negligible systemic exposure to budesonide in breast-fed infants. In a pharmacokinetic study, the estimated daily infant dose was 0.3% of the daily maternal dose for both dose levels, and the average plasma concentration in infants was estimated to be 1/600th of the concentrations observed in maternal plasma, assuming complete infant oral bioavailability. Budesonide concentrations in infant plasma samples were all less than the limit of quantification.
Based on data from inhaled budesonide and the fact budesonide exhibits linear PK properties within the therapeutic dosage intervals after nasal, inhaled, oral and rectal administrations at therapeutic doses of budesonide, exposure to the breast-fed child is anticipated to be low.
As with other drugs the administration of this medicine during pregnancy or breastfeeding requires that the benefits for the mother are weighed against the risk for the foetus or nursing infant. This medicine should not be used during pregnancy or breast-feeding without first consulting a doctor or pharmacist.
4.7. Effects on ability to drive and use machines
This medicine may have a moderate influence on the ability to drive and use machines. This medicine may cause blurred vision, patients should therefore be cautioned about engaging in activities such as driving a car or operating machinery, until they have established their own response to the drug.
4.8. Undesirable effects
Adverse drug reactions (ADRs) identified during clinical trials and post-marketing experience with budesonide are listed below by System Organ Class (SOC). The frequencies are defined in accordance with current guidance, as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10 000 and <1/1000), very rare (<1/10 000) and not known (cannot be estimated from the available data).
ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available or 2) when incidence is unavailable, frequency category is listed as Not known.
System Organ Class (SOC)
Frequency
Adverse Drug Reaction (Preferred Term)
Immune system disorders
Uncommon
Hypersensitivity (Immediate and delayed hypersensitivity reactions including erythema, urticaria, rash, dermatitis, angioedema and pruritus)
Rare
Anaphylactic reaction
Endocrine disorders
Rare
Signs and symptoms of systemic corticosteroid effects, including adrenal suppression and growth retardation
Eye disorders
Rare
Vision, blurred (see also section 4.4)
Not known
Cataract
Raised intraocular pressure or Glaucoma
Respiratory, thoracic and mediastinal disorders
Common
Epistaxis
Haemorrhagic secretion
Nasal discomfort (sneezing, stinging and dryness)
Rare
Dysphonia
Nasal septum perforation
Nasal ulcer
Musculoskeletal and connective tissue disorders
Uncommon
Muscle spasms
General disorders and and administration site conditions
Very rare
Mucosal ulceration
Injury, poisoning and procedural complications
Rare
Contusion*
* based on mechanistic plausibility and extrapolation from other budesonide/ corticosteroid formulations.
In rare cases, signs or symptoms of systemic glucocorticosteroid side effects such as Cushing's syndrome, Cushingoid features, psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children), may occur with intranasal glucocorticosteroids, probably depending on dose, exposure time, concomitant and previous corticosteroid exposure, and individual sensitivity (see section 4.4).
Paediatric population
Growth retardation has been reported in children receiving intranasal steroids.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Acute overdose with this medicine even in excessive doses, is not expected to be a clinical problem.
Inhalation of high doses of corticosteroids may lead to suppression of the hypothalamic-pituitary-adrenal (HPA) axis function.
💬 Ask about this leaflet
Ask anything about Benacort Hayfever Relief for Adults 64 micrograms, nasal spray. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
Medicines containing Budesonide
- Benacort 64 micrograms Nasal Spray
- Budelin Novolizer 200 micrograms per actuation inhalation powder
- Budenofalk 2mg/dose rectal foam
- Budenofalk 3mg gastro-resistant capsules
- Budenofalk 4mg suppositories
- Budenofalk 9mg gastro-resistant granules
- Budesonide 0.5mg nebuliser suspension
- Budesonide 1mg nebuliser suspension
- Budesonide CR 3 mg Capsules
- Budesonide Dr. Falk Pharma 4 mg suppositories
- Cortiment 9 mg, prolonged release tablets
- Easyhaler Budesonide 100 mcg
- Easyhaler Budesonide 200 mcg
- Easyhaler Budesonide 400mcg