Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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 Fluticasone furoate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for
Avamys (fluticasone furoate) belongs to a group of medicines called glucocorticoids. Avamys works to decrease inflammation caused by allergy (rhinitis) and therefore reduce symptoms of allergy. Avamys nasal spray is used to treat symptoms of allergic rhinitis including stuffy, runny or itchy nose, sneezing and watery, itchy or red eyes, in adults and children aged 6 years and over. Allergy symptoms can occur at specific times of the year and be caused by allergy to pollen from grass or trees (hayfever), or they can occur all year round and be caused by allergy to animals, house-dust mites or moulds to name some of the most common. 2.
e Avamys
Do not use Avamys
Do not use in children under 6 years old. Taking Avamys: • may when taken for a long time cause children to grow more slowly. The doctor will check your child's height regularly, and make sure he or she is taking the lowest possible effective dose. •
may cause eye conditions such as glaucoma (increase in pressure in the eye) or cataracts (clouding of the lens of the eye). Tell your doctor if you had these conditions in the past, or if you notice blurred vision or other visual disturbances while you are taking Avamys.
Other medicines and Avamys Tell your doctor or pharmacist if you are taking, or have recently taken, or might take any other medicines, including medicines obtained without a prescription. It is especially important to tell your doctor if you are taking, or have recently taken any of the following medicines: • steroid tablets or injected steroids • steroid creams • medicines for asthma • ritonavir or cobicistat, used to treat HIV • ketoconazole, used to treat fungal infections Your doctor will assess whether you should take Avamys with these medicines. Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Avamys. Avamys should not be used at the same time with other nasal sprays containing steroids. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not use Avamys if you are pregnant, or planning to become pregnant, unless your doctor or pharmacist tells you to. Do not use Avamys if you are breast feeding unless your doctor or pharmacist tells you to. Driving and using machines Avamys is unlikely to affect your ability to drive and use machines. Avamys contains benzalkonium chloride This medicine contains 8.25 micrograms of benzalkonium chloride per spray (27.5 micrograms). Benzalkonium chloride may cause irritation or swelling inside of the nose, especially if used for a long time. Tell your doctor or pharmacist if you feel discomfort when using the spray. 3.
How to use Avamys
Always use this medicine exactly as your doctor or pharmacist has told you. Don't exceed the recommended dose. Check with your doctor or pharmacist if you're not sure.
2
When to use Avamys • Use once a day • Use at the same time each day. This will treat your symptoms throughout the day and night. How long Avamys takes to work Some people will not feel the full effects until several days after first using Avamys. However, it is usually effective within 8 to 24 hours of use. How much to use Adults and children 12 years and over • The usual starting dose is 2 sprays in each nostril once every day. • Once symptoms are controlled you may be able to decrease your dose to 1 spray in each nostril, once every day. Children 6 to 11 years • The usual starting dose is 1 spray in each nostril once a day. • If symptoms are very bad your doctor may increase the dose to 2 sprays in each nostril once every day until the symptoms are under control. It may then be possible for the dose to be reduced to 1 spray in each nostril once every day.
the nasal spray Avamys has virtually no taste or smell. It is sprayed into the nose as a fine mist. Be careful not to get any spray into your eyes. If you do, rinse your eyes with water. There is a step-by-step guide to using the nasal spray after Section 6 of this leaflet. Follow the guide carefully to get full benefit from using Avamys
See Step-by-step guide to using the nasal spray, after Section 6. If you use more Avamys than you should Talk to your doctor or pharmacist. If you forget to use Avamys If you miss a dose, take it when you remember. If it is nearly the time for your next dose, wait until then. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, or if you have any discomfort using the nasal spray ask your doctor or pharmacist or nurse. 4.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Allergic reactions: get a doctor's help straight away 3
Allergic reactions to Avamys are rare and affect less than 1 person in 1,000. In a small number of people, allergic reactions can develop into a more serious, even life-threatening problem if not treated. Symptoms include:
4
5.
Avamys
Keep this medicine out of the sight and reach of children. It is best to store your Avamys nasal spray upright. Always keep the cap on. Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of the month. Avamys nasal spray should be used within 2 months after first opening. Do not refrigerate or freeze. 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 protect the environment.
6.
What Avamys contains The active substance is fluticasone furoate. Each spray delivers 27.5 micrograms of fluticasone furoate. The other ingredients are glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water (see section 2). What Avamys looks like and contents of the pack The medicine is a white nasal spray suspension contained in an amber glass bottle, fitted with a pump. The bottle is in an off-white plastic casing with a light blue cap and side-actuated lever. The casing has a window for viewing the bottle contents. Avamys is available in pack sizes 30, 60 and 120 sprays. Not all pack sizes may be marketed. Marketing Authorisation Holder Marketing authorisation: GlaxoSmithKline UK Limited 79 New Oxford Street London WC1A 1DG United Kingdom Manufacturer: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) Harmire Road Barnard Castle County Durham DL12 8DT United Kingdom Glaxo Wellcome S.A. 5
Avenida de Extremadura 3 09400 Aranda de Duero Burgos Spain Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only) Please be ready to give the following information: Product name
Avamys 27.5 micrograms per spray nasal spray suspension
Reference numbers
19494/0269
This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in 11/2025 Trade marks are owned by or licensed to the GSK group of companies. © 2025 GSK group of companies or its licensor.
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STEP-BY-STEP GUIDE TO USING THE NASAL SPRAY What the nasal spray looks like The nasal spray comes in an amber glass bottle inside a plastic casing – see picture a. It will contain either 30, 60 or 120 sprays, depending on the pack size that has been prescribed for you.
The window in the plastic casing lets you see how much Avamys is left in the bottle. You will be able to see the liquid level for a new 30 or 60 spray bottle, but not in a new 120 spray bottle because the liquid level is above the window.
Six important things you need to know about using the nasal spray •
Avamys comes in an amber glass bottle. If you need to check how much is left hold the nasal spray upright against a bright light. You will then be able to see the level through the window.
•
When you first use the nasal spray you will need to shake it vigorously with the cap on for about 10 seconds. This is important as Avamys is a thick suspension that becomes liquid when you shake it well – see picture b. It will only spray when it becomes liquid.
7
•
The mist-release button must be pressed firmly all the way in, to release the mist through the nozzle – see picture c.
•
If you have difficulty pressing the button with your thumb, you can use two hands – see picture d
•
Always keep the cap on the nasal spray when you are not using it. The cap keeps the dust out, seals in the pressure and stops the nozzle from blocking up. When the cap is in place the mistrelease button cannot be pressed accidentally.
•
Never use a pin or anything sharp to clear the nozzle. It will damage the nasal spray
Preparing the nasal spray for use You must prepare the nasal spray: •
before you use it for the first time
•
if you have left the cap off for 5 days or the intranasal device has not been used for 30 days or more.
8
Preparing the nasal spray helps to make sure you always get the full dose of medicine. Follow these steps: 1
Shake the nasal spray vigorously with the cap on for about 10 seconds.
2 Remove the cap by squeezing firmly on the sides of the cap with your thumb and forefinger- see picture e.
3
Hold the nasal spray upright, then tilt and point the nozzle away from you.
4 Press the button firmly all the way in. Do this at least 6 times until it releases a fine mist of spray into the air – see picture f.
The nasal spray is now ready for use. Using the nasal spray 1
Shake the nasal spray vigorously.
2
Remove the cap.
3
Blow your nose to clear your nostrils, then tilt your head forward a little bit.
4
Place the nozzle in one of your nostrils – see picture g. Point the end of the nozzle slightly outwards, away from the centre ridge of your nose. This helps to get the medicine to the correct part of your nose.
5
Press the button firmly all the way in, while you breathe in through your nose – see picture h.
9
6
Take the nozzle out and breathe out through your mouth.
7
If your dose is 2 sprays in each nostril repeat steps 4 to 6.
8
Repeat steps 4 to 7 to treat the other nostril.
9
Replace the cap on the nasal spray.
Cleaning the nasal spray After each use: 1
Wipe the nozzle and inside of the cap with a clean, dry tissue – see pictures i and j.
2
Do not use water to clean it.
3
Never use a pin or anything sharp on the nozzle.
4
Always replace the cap once you have finished.
If the nasal spray does not seem to be working: •
Check you still have medicine left. Look at the level through the window. If the level is very low there may not be enough left to work the nasal spray.
•
Check the nasal spray for damage
•
If you think the nozzle may be blocked, don't use a pin or anything sharp to clear it.
•
Try to reset it by following the instructions under 'Preparing the nasal spray for use'.
•
If it is still not working, or if it produces a jet of liquid, take the nasal spray back to the pharmacy to get advice. 10
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Avamys 27.5 micrograms/spray, nasal spray suspension comes as oral solution containing 27.5mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Avamys 27.5 micrograms/spray, nasal spray suspension is fluticasone furoate.
Medicines with the same active substance, strength and form include: Furamist 27,5 micrograms/spray, nasal spray suspension, Relioz 27.5 micrograms/spray, nasal spray suspension. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Avamys 27.5 micrograms/spray, nasal spray suspension, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Avamys is indicated in adults, adolescents and children (6 years and over)
Avamys is indicated for the treatment of the symptoms of allergic rhinitis.
Posology
Adults and adolescents (12 years and over)
The recommended starting dose is two spray actuations (27.5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 110 micrograms).
Once adequate control of symptoms is achieved, dose reduction to one spray actuation in each nostril (total daily dose 55 micrograms) may be effective for maintenance.
The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Children (6 to 11 years of age)
The recommended starting dose is one spray actuation (27.5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 55 micrograms).
Patients not adequately responding to one spray actuation in each nostril once daily (total daily dose, 55 micrograms) may use two spray actuations in each nostril once daily (total daily dose, 110 micrograms).
Once adequate control of symptoms is achieved, dose reduction to one spray actuation in each nostril once daily (total daily dose, 55 micrograms) is recommended.
For full therapeutic benefit regular, scheduled usage is recommended. Onset of action has been observed as early as 8 hours after initial administration. However, it may take several days of treatment to achieve maximum benefit, and the patient should be informed that their symptoms will improve with continuous regular use (see section 5.1). The duration of treatment should be restricted to the period that corresponds to allergenic exposure.
Children under 6 years of age
The safety and efficacy of Avamys in children under the age of 6 years has not been established. Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made.
Elderly Patients
No dose adjustment is required in this population (see section 5.2).
Renal Impairment
No dose adjustment is required in this population (see section 5.2).
Hepatic Impairment
No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Method of administration
Avamys nasal spray is for administration by the intranasal route only.
The intranasal device should be shaken before use. The device is primed by pressing the mist release button for at least six spray actuations (until a fine mist is seen), whilst holding the device upright. Re-priming (approximately 6 sprays until a fine mist is seen) is only necessary if the cap is left off for 5 days or the intranasal device has not been used for 30 days or more.
The device should be cleaned after each use and the cap replaced.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Systemic corticosteroid effects
Systemic effects of nasal corticosteroid may occur, particularly at high doses prescribed 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). Treatment with higher than recommended doses of nasal corticosteroids may result in clinically significant adrenal suppression. If there is evidence for higher than recommended doses being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Fluticasone furoate 110 micrograms once daily was not associated with hypothalamic-pituitary-adrenal (HPA) axis suppression in adult, adolescent or paediatric subjects. However the dose of intranasal fluticasone furoate should be reduced to the lowest dose at which effective control of the symptoms of rhinitis is maintained. As with all intranasal corticosteroids, the total systemic burden of corticosteroids should be considered whenever other forms of corticosteroid treatment are prescribed concurrently.
If there is any reason to believe that adrenal function is impaired, care must be taken when transferring patients from systemic steroid treatment to fluticasone furoate.
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.
Growth retardation
Growth retardation has been reported in children receiving nasal corticosteroids at licensed doses. A reduction in growth velocity has been observed in children treated with fluticasone furoate 110 micrograms daily for one year (see section 4.8 and section 5.1). Therefore, children should be maintained on the lowest possible efficacious dose which delivers adequate symptom control (see section 4.2). It is recommended that the growth of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid if possible, to the lowest dose at which effective control of symptoms is maintained. In addition, consideration should be given to referring the patient to a paediatric specialist (see section 5.1).
Patients on ritonavir
Concomitant administration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate (see section 4.5).
Excipients
This medicinal product contains benzalkonium chloride. Long-term use may cause oedema of the nasal mucosa.
Interaction with CYP3A inhibitors
Fluticasone furoate is rapidly cleared by extensive first pass metabolism mediated by the cytochrome P450 3A4.
Based on data with another glucocorticoid (fluticasone propionate), that is metabolised by CYP3A4, coadministration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate.
Caution is recommended when co-administering fluticasone furoate with potent CYP3A inhibitors including cobicistat-containing products as an increase in the risk of systemic side effects is expected. Co-administration 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. In a drug interaction study of intranasal fluticasone furoate with the potent CYP3A4 inhibitor ketoconazole there were more subjects with measurable fluticasone furoate concentrations in the ketoconazole group (6 of the 20 subjects) compared to placebo (1 out of 20 subjects). This small increase in exposure did not result in a statistically significant difference in 24 hour serum cortisol levels between the two groups.
The enzyme induction and inhibition data suggest that there is no theoretical basis for anticipating metabolic interactions between fluticasone furoate and the cytochrome P450 mediated metabolism of other compounds at clinically relevant intranasal doses. Therefore, no clinical studies have been conducted to investigate interactions of fluticasone furoate on other drugs.
Pregnancy
There are no adequate data from the use of fluticasone furoate in pregnant women. In animal studies glucocorticoids have been shown to induce malformations including cleft palate and intra-uterine growth retardation. This is not likely to be relevant for humans given recommended nasal doses which results in minimal systemic exposure (see section 5.2). Fluticasone furoate should be used in pregnancy only if the benefits to the mother outweigh the potential risks to the foetus or child.
Breast-feeding
It is unknown whether nasal administered fluticasone furoate is excreted in human breast milk.
Administration of fluticasone furoate to women who are breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
Fertility
There are no fertility data in humans.
Avamys has no or negligible influence on the ability to drive and use machines.
Summary of the safety profile
The most commonly reported adverse reactions during treatment with fluticasone furoate are epistaxis, nasal ulceration and headache. The most serious undesirable effects are rare reports of hypersensitivity reactions, including anaphylaxis (less than 1 case per 1000 patients).
Tabulated list of adverse reactions
There were over 2700 patients treated with fluticasone furoate in safety and efficacy studies for seasonal and perennial allergic rhinitis. Paediatric exposure to fluticasone furoate in safety and efficacy studies in seasonal and perennial allergic rhinitis included 243 patients 12 to <18 years, 790 patients 6 to <12 years and 241 patients 2 to <6 years.
Data from large clinical trials were used to determine the frequency of adverse reactions.
The following convention has been used for the classification of frequencies: Very common ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1000 to <1/100; Rare ≥1/10,000 to <1/1000; Very rare <1/10,000; Not known (cannot be estimated from the available data).
Immune system disorders
Rare
Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria.
Nervous system disorders
Common
Headache.
Not known
Dysgeusia, ageusia, anosmia
Eye disorders
Not known
Transient ocular changes (see Clinical experience), vision blurred (see also section 4.4)
Respiratory, thoracic and mediastinal disorders
Very common
*Epistaxis
Common
Nasal ulceration, dyspnoea**
Uncommon
Rhinalgia, nasal discomfort (including nasal burning, nasal irritation, and nasal soreness), nasal dryness.
Very rare
Nasal septum perforation
Not known
Bronchospasm, dysphonia, aphonia
Musculoskeletal and connective tissue disorders (Children)
Not known
***Growth retardation (see Clinical experience).
Description of selected adverse reactions
Epistaxis
*Epistaxis was generally mild to moderate in intensity. In adults and adolescents, the incidence of epistaxis was higher in longer-term use (more than 6 weeks) than in short-term use (up to 6 weeks).
Systemic effects
Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods (see section 4.4). Growth retardation has been reported in children receiving nasal corticosteroids.
**Dyspnoea cases were reported in more than 1% of patients during clinical trials with fluticasone furoate; similar rates were also observed in placebo groups.
Paediatric population
The safety in children under 6 years has not been well established. Frequency, type and severity of adverse reactions observed in the paediatric population are similar to those in the adult population.
Epistaxis
*In paediatric clinical studies of up to 12 weeks duration the incidence of epistaxis was similar between patients receiving fluticasone furoate and patients receiving placebo.
Growth retardation
***In a one-year clinical study assessing growth in pre-pubescent children receiving 110 micrograms of fluticasone furoate once daily, an average treatment difference of -0.27 cm per year in growth velocity was observed compared to placebo (see Clinical efficacy and safety).
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:
United Kingdom
The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
In a bioavailability study, intranasal doses of up to 2640 micrograms per day were administered over three days with no adverse systemic reactions observed (see section 5.2).
Acute overdose is unlikely to require any therapy other than observation.
Ask anything about Avamys 27.5 micrograms/spray, nasal spray suspension. 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.
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