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.
Azelastine hydrochloride/fluticasone propionate Advanz Pharma 137 micrograms/50 micrograms per actuation nasal spray suspension
⚠ 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 Azelastine hydrochloride, Fluticasone propionate 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
Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray contains two active substances: azelastine hydrochloride and fluticasone propionate. • Azelastine hydrochloride belongs to a group of medicines called antihistamines. Antihistamines work by preventing the effects of substances such as histamine that the body produces as part of an allergic reaction – thus reducing symptoms of allergic rhinitis. • Fluticasone propionate belongs to a group of medicines called corticosteroids which reduces inflammation. Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray is used to relieve the symptoms of moderate to severe seasonal and perennial allergic rhinitis in adults and children aged 12 years and older if the use of either intranasal antihistamine or corticosteroid alone is not considered sufficient. Seasonal and perennial allergic rhinitis are allergic reactions to substances such as pollen (hay fever), house mites, molds, dust or pets. Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray relieves the symptoms of allergies, for example: runny nose, post nasal drip, sneezing and itchy or blocked nose.
2.
What you need to know before you take it
e Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray
Do not use Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray: •
If you are allergic to azelastine hydrochloride or fluticasone propionate or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions Talk to your doctor or pharmacist before using Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray if: • You had a recent operation on your nose. • You have an infection in your nose. Infections of the nasal airways should be treated with antibacterial or antifungal medication. If you are given medication for an infection in your nose you can continue to use Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray to treat your allergies. • You have tuberculosis or an untreated infection. • You have a change in vision or a history of increased ocular pressure, glaucoma and/or cataracts. If this applies to you, you will be closely monitored whilst using Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray. • You suffer from impaired adrenal function. Care must be taken when transferring from systemic steroid treatment to Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray. • You suffer from a severe liver disease. Your risk of suffering from systemic side effects is increased. In these cases your doctor will decide whether you can use Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray. It is important that you take your dose as stated in section 3 below or as advised by your doctor. Treatment with higher than recommended doses of nasal corticosteroids may result in adrenal suppression, a condition that may produce weight loss, fatigue, muscle weakness, low blood sugar, salt cravings, joint pains, depression and darkening of the skin. If this happens your doctor may recommend another medicine during periods of stress or elective surgery. To avoid adrenal suppression your doctor will advise you to take the lowest dose at which effective control of your symptoms of rhinitis is maintained. Taking nasal corticosteroids (such as Azelastine hydrochloride/fluticasone propionate Advanz Pharma) may when taken for a long time cause children and adolescents 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. Contact your doctor if you experience blurred vision or other visual disturbances. If you are unsure whether the above applies to you, talk to your doctor or pharmacist before using Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray. Children This medicine is not recommended for children under 12 years. Other medicines and Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray Tell your doctor or pharmacist, if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat and medicines for the treatment of fungal infections: ketoconazole). 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 or pharmacist for advice before using Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray. Driving and using machines Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray has minor influence on the ability to drive and use machines. Very rarely, you may experience fatigue or dizziness due to the disease itself or when using Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray. In these cases, do not drive or operate machinery. Please be aware that drinking alcohol may enhance these effects. Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray contains benzalkonium chloride This medicine contains 14 micrograms (0.014 mg) benzalkonium chloride in each actuation. Benzalkonium chloride may cause irritation or swelling inside 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 take it
Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray
Always use Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray exactly as your doctor has told you. Check with your doctor or pharmacist, if you are not sure. It is essential to use Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray regularly to gain the full therapeutic benefit. Contact with the eyes should be avoided. Adults and adolescents (12 years and above) • The recommended dose is one spray into each nostril in the morning and evening. Use in children under 12 years • This medicine is not recommended for children under 12 years. Use in renal and hepatic impairment • There are no data in patients with renal and hepatic impairment. Method of administration For nasal use. Read the following instructions carefully and use only as directed.
INSTRUCTION FOR USE Preparing the spray 1. Shake the bottle gently for 5 seconds by tilting it upwards and downwards and then remove the protective cap (see figure 1).
Figure 1 2. 3. 4. 5.
The first time the nasal spray is used, you must prime the pump by squirting it into the air. Prime the pump by putting two fingers on either side of the spray pump and place your thumb on the bottom of the bottle. Press down and release the pump 6 times until a fine mist appears (see figure 2). Now your pump is primed and ready to use.
Figure 2 6.
If the nasal spray has not been used for more than 7 days, you will need to re-prime the pump once by pressing down and releasing the pump.
Using the spray 1. Shake the bottle gently for 5 seconds by tilting it upwards and downwards and then remove the protective cap (see figure 1). 2. Blow your nose to clear your nostrils. 3. Keep your head tilted downwards towards your toes. Do not tilt head backwards. 4. Hold the bottle upright and carefully insert the spray tip into one nostril. 5. Close other nostril with your finger, rapidly press down once and sniff gently at the same time (see figure 3).
6.
Breathe out through your mouth.
Figure 3 7. 8.
Repeat in your other nostril. Breathe in gently, and do not tilt your head back after dosing. This will stop the medicine going into your throat and causing an unpleasant taste (see figure 4).
Figure 4 9. 10.
After each use wipe the spray tip with a clean tissue or cloth and then replace the protective cap. Do not prick the nozzle in case spray is not obtained. Clean the actuator with water.
It is important that you take your dose as advised by your doctor. You should use only as much as your doctor recommends. Duration of treatment Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray is suitable for long-term use. The duration of treatment should correspond to the period of experiencing allergy symptoms. If you use more Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray than you should If you spray too much of this medicine into your nose you are unlikely to have any problems. If you are worried or if you have used doses higher than recommended over a long period, contact your doctor. If
anyone, especially a child, accidentally drinks Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray, contact your doctor or nearest hospital casualty department as soon as possible. If you forget to use Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray Use your nasal spray as soon as you remember, then take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose. If you stop using Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray Do not stop using Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray without asking your doctor, because this puts the success of the treatment at risk. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Seek immediate medical help if you have any of the following symptoms: • Swelling of face, lips, tongue or throat which may cause difficulty in swallowing/breathing and a sudden onset of skin rash. This could be signs of a severe allergic reaction. Please note: This is very rare. Very common side effects (may affect more than 1 in 10 people): • Nosebleed Common side effects (may affect up to 1 in 10 people): • Headache • A bitter taste in your mouth, especially if you tilt your head backwards when you are using the nasal spray. This should go away if you have a soft drink a few minutes after using this medicine. • Unpleasant smell Uncommon side effects (may affect up to 1 in 100 people): • Slight irritation of the inside of the nose. This can cause mild stinging, itching or sneezing. • Nasal dryness, cough, dry throat or throat irritation Rare side effects (may affect up to 1 in 1,000 people): • Dry mouth Very rare side effects (may affect up to 1 in 10,000 people): • Dizziness or drowsiness • Cataract, glaucoma or increased pressure in your eye where you may have a loss of vision and/or red and painful eyes. These side effects have been reported following prolonged treatment with fluticasone propionate nasal sprays. • Damage of the skin and mucous membrane in the nose • Feeling sick, weary, exhausted or weak • Rash, itchy skin or red, raised itchy bumps • Bronchospasm (the narrowing of the airways in the lungs)
Possible side effects
with unknown frequency (frequency cannot be estimated from the available data) • Blurred vision • Sores in the nose
Systemic side effects (side effects concerning the whole body) may occur when this medicine is used at high doses for a long time. These effects are much less likely to occur if you use a corticosteroid nasal spray than if you take corticosteroids by mouth. These effects may vary in individual patients and between different corticosteroid preparations (see section 2). Nasal corticosteroids can affect the normal production of hormones in your body, particularly if you use high doses for a long time. In children and adolescents this side effect can cause them to grow more slowly than others. In rare cases a reduction of the bone density (osteoporosis) was observed, if nasal corticosteroids were administered long-term. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side affects you can help provide more information on the safety of this medicine.
5.
How to store it
Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray
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 bottle label and the outer carton after "EXP". The expiry date refers to the last day of that month. Do not refrigerate or freeze. Shelf life after first opening: Dispose of any unused medicine 1 year after you first open the nasal spray. 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.
Contents of the pack and other information
What Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray contains The active substances are: azelastine hydrochloride and fluticasone propionate. Each g of suspension contains 1 000 micrograms azelastine hydrochloride and 365 micrograms fluticasone propionate. Each actuation (0.14 g) delivers 137 micrograms azelastine hydrochloride (=125 micrograms azelastine) and 50 micrograms fluticasone propionate (=36 micrograms fluticasone). The other ingredients are: disodium edetate, glycerol, cellulose microcrystalline (E 460), carmellose sodium (E 466), polysorbate 80 (E 433), benzalkonium chloride (see section 2 "Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray contains benzalkonium chloride"), phenylethyl alcohol and purified water.
What Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray looks like and contents of the pack Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray is a white, homogenous suspension. Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray comes in an amber coloured, type 1, glass bottle fitted with a spray pump, applicator and a protective cap. The bottle contains 23 g nasal spray, suspension (at least 120 actuations). Azelastine hydrochloride/fluticasone propionate Advanz Pharma nasal spray is presented in a bottle of 25 ml containing 23 g suspension Marketing Authorisation Holder and Manufacturer Advanz Pharma Limited Unit 17 Northwood House Northwood Crescent Dublin 9 D09 V504 Ireland +44 (0)208 588 9131 [email protected] Manufacturer KeVaRo Group Ltd 9 Tsaritsa Eleonora str., office 23, Sofia 1618, Bulgaria. Adalvo Limited Malta Life Sciences Park, Building 1, Level 4, Sir Temi Zammit Buildings, San Gwann, SGN 3000, Malta. This leaflet was last revised in April 2025.
Frequently asked questions about Azelastine hydrochloride/fluticasone propionate Advanz Pharma 137 micrograms/50 micrograms per actuation nasal spray suspension
How do I take Azelastine hydrochloride/fluticasone propionate Advanz Pharma 137 micrograms/50 micrograms per actuation nasal spray suspension?
Azelastine hydrochloride/fluticasone propionate Advanz Pharma 137 micrograms/50 micrograms per actuation nasal spray suspension comes as oral solution containing 137mcg / 50mcg. 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 Azelastine hydrochloride/fluticasone propionate Advanz Pharma 137 micrograms/50 micrograms per actuation nasal spray suspension?
The active substance in Azelastine hydrochloride/fluticasone propionate Advanz Pharma 137 micrograms/50 micrograms per actuation nasal spray suspension is azelastine hydrochloride, fluticasone propionate.
Are there equivalent medicines to Azelastine hydrochloride/fluticasone propionate Advanz Pharma 137 micrograms/50 micrograms per actuation nasal spray suspension?
Medicines with the same active substance, strength and form include: Flomister 137 micrograms / 50 micrograms per actuation nasal spray, suspension, Azelastine hydrochloride / Fluticasone propionate 137 micrograms / 50 micrograms per actuation nasal spray, suspension, Azelastine hydrochloride/Fluticasone propionate 137 microgram/actuation, 50 microgram/actuation Nasal spray suspension. In total there are 5 equivalent products. 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 Azelastine hydrochloride/fluticasone propionate Advanz Pharma 137 micrograms/50 micrograms per actuation 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.
Can I get Azelastine hydrochloride/fluticasone propionate Advanz Pharma 137 micrograms/50 micrograms per actuation nasal spray suspension 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: azelastine hydrochloride, fluticasone propionate
- 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
Relief of symptoms of moderate to severe seasonal and perennial allergic rhinitis in adult and paediatric patients aged 12 years and older if monotherapy with either intranasal antihistamine or glucocorticoid is not considered sufficient.
4.2. Posology and method of administration
Posology
For full therapeutic benefit regular usage is essential.
Contact with the eyes should be avoided.
Adults and adolescents (12 years and older)
One actuation in each nostril twice daily (morning and evening).
Children below 12 years
ADSEGO nasal spray is not recommended for use in children below 12 years of age as safety and efficacy has not been established in this age group.
Elderly
No dose adjustment is required in this population.
Renal and hepatic impairment
There are no data in patients with renal and hepatic impairment.
Duration of treatment
ADSEGO nasal spray is suitable for long-term use.
The duration of treatment should correspond to the period of allergenic exposure.
Method of administration
ADSEGO nasal spray is for nasal use only.
Instruction for use
Preparing the spray:
The bottle should be shaken gently before use for about 5 seconds by tilting it upwards and downwards and the protective cap be removed afterwards. Prior to first use ADSEGO nasal spray must be primed by pressing down and releasing the pump 6 times. If ADSEGO nasal spray has not been used for more than 7 days it must be re-primed once by pressing down and releasing the pump.
Using the spray:
The bottle should be shaken gently before use for about 5 seconds by tilting it upwards and downwards and the protective cap be removed afterwards.
After blowing the nose the suspension is to be sprayed once into each nostril keeping the head tilted downward (see figure below). After use the spray tip is to be wiped and the protective cap to be replaced.
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
During post-marketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing's syndrome and adrenal suppression. Therefore, concomitant use of fluticasone propionate and ritonavir should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side-effects (see section 4.5).
Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses 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).
This medicinal product undergoes extensive first-pass metabolism, therefore the systemic exposure of intranasal fluticasone propionate in patients with severe liver disease is likely to be increased. This may result in a higher frequency of systemic adverse events. Caution is advised when treating these patients.
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.
In general the dose of intranasal fluticasone formulations should be reduced to the lowest dose at which effective control of the symptoms of rhinitis is maintained. Higher doses than the recommended one (see section 4.2) have not been tested for azelastine hydrochloride/fluticasone propionate nasal spray. As with all intranasal corticosteroids, the total systemic burden of corticosteroids should be considered whenever other forms of corticosteroid treatment are prescribed concurrently.
Growth retardation has been reported in children receiving nasal corticosteroids at licensed doses. Since growing up is also given in adolescents it is recommended that the growth of adolescents receiving prolonged treatment with nasal corticosteroids is regularly monitored, too. 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.
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.
Close monitoring is warranted in patients with a change in vision or with a history of increased ocular pressure, glaucoma and/or cataracts.
If there is any reason to believe that adrenal function is impaired, care must be taken when transferring patients from systemic steroid treatment to ADSEGO nasal spray.
In patients who have tuberculosis, any type of untreated infection, or have had a recent surgical operation or injury to the nose or mouth, the possible benefits of the treatment with ADSEGO nasal spray should be weighed against possible risk.
Infections of the nasal airways should be treated with antibacterial or antimycotical therapy, but do not constitute a specific contraindication to treatment with ADSEGO nasal spray.
This medicine contains 0.014 mg benzalkonium chloride in each actuation which is equivalent to 0.1mg / g. Long term use may cause oedema of the nasal mucosa.
4.5. Interaction with other medicinal products and other forms of interaction
Fluticasone propionate
Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after intranasal dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome P450 3A4 in the gut and liver. Hence, clinically significant drug interactions mediated by fluticasone propionate are unlikely.
A drug interaction study in healthy subjects has shown that ritonavir (a highly potent cytochrome P450 3A4 inhibitor) can greatly increase fluticasone propionate plasma concentrations, resulting in markedly reduced serum cortisol concentrations. During post-marketing use, there have been reports of clinically significant drug interactions in patients receiving intranasal or inhaled fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects. Co-treatment with other CYP 3A4 inhibitors, including cobicistat-containing products is also 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.
Studies have shown that other inhibitors of cytochrome P450 3A4 produce negligible (erythromycin) and minor (ketoconazole) increases in systemic exposure to fluticasone propionate without notable reductions in serum cortisol concentrations. Nevertheless, care is advised when co-administering potent cytochrome P450 3A4 inhibitors (e.g. ketoconazole), as there is potential for increased systemic exposure to fluticasone propionate.
Azelastine hydrochloride
No specific interaction studies with azelastine hydrochloride nasal spray have been performed. Interaction studies at high oral doses have been performed. However, they bear no relevance to azelastine nasal spray as given recommended nasal doses result in much lower systemic exposure. Nevertheless, care should be taken when administering azelastine hydrochloride in patients taking concurrent sedative or central nervous medications because sedative effect may be enhanced. Alcohol may also enhance this effect (see section 4.7).
4.6. Fertility, pregnancy and lactation
Fertility
There are only limited data with regards to fertility (see section 5.3).
Pregnancy
There are no or limited amount of data from the use of azelastine hydrochloride and fluticasone propionate in pregnant women. Therefore, ADSEGO nasal spray should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus (see section 5.3)
Lactation
It is unknown whether nasally administered azelastine hydrochloride/metabolites or fluticasone propionate/metabolites are excreted in human breast milk. ADSEGO nasal spray should be used during lactation only if the potential benefit justifies the potential risk to the newborns/infant (see section 5.3).
4.7. Effects on ability to drive and use machines
ADSEGO nasal spray has minor influence on the ability to drive and use machines.
In isolated cases fatigue, weariness, exhaustion, dizziness or weakness that may also be caused by the disease itself, may occur when using ADSEGO nasal spray. In these cases, the ability to drive and use machines may be impaired. Alcohol may enhance this effect.
4.8. Undesirable effects
Commonly, dysgeusia, a substance-specific unpleasant taste, may be experienced after administration (often due to incorrect method of application, namely tilting the head too far backwards during administration).
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as:
Very common
Common
Uncommon
Rare
Very rare
Not known
(≥1/10)
(≥1/100 to <1/10)
(≥1/1 000 to <1/100)
(≥1/10 000 to <1/1 000)
(<1/10 000)
(cannot be estimated from the available data)
Frequency
System Organ Class
Very common
Common
Uncommon
Rare
Very rare
Not known
Immune system disorders
Hypersensitivity including anaphylactic reactions, angioedema (oedema of the face or tongue and skin rash), bronchospasm
Nervous system disorder
Headache, Dysgeusia (unpleasant taste), unpleasant smell
Dizziness, somnolence (drowsiness, sleepiness)
Eye disorders*
Glaucoma, increased intraocular pressure, cataract
Vision blurred (see section 4.4)
Respiratory, thoracic and mediastinal disorders
Epistaxis
Nasal discomfort (including nasal irritation, stinging, itching), sneezing, nasal dryness, cough, dry throat, throat irritation
Nasal septal perforation**, mucosal erosion
Nasal ulcers
Gastrointestinal disorders
Dry mouth
Nausea
Skin and subcutaneous tissue disorders
Rash, pruritus, urticaria
General disorders and administration site conditions
Fatigue (weariness, exhaustion), weakness (see section 4.7)
* A very small number of spontaneous reports have been identified following prolonged treatment with intranasal fluticasone propionate.
** Nasal septal perforation has been reported following the use of intranasal corticosteroids.
Systemic effects of some nasal corticosteroids may occur, particularly when administered at high doses for prolonged periods (see section 4.4).
Growth retardation has been reported in children receiving nasal corticosteroids. Growth retardation may be possible in adolescents, too (see section 4.4).
In rare cases osteoporosis was observed, if nasal glucocorticoids were administered long-term.
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 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
With the nasal route of administration overdose reactions are not anticipated.
There are no data from patients available on the effects of acute or chronic overdosage with intranasal fluticasone propionate.
Intranasal administration of 2 milligrams fluticasone propionate (10 times the recommended daily dose) twice daily for seven days to healthy human volunteers has no effect on hypothalamo-pituitary-adrenal (HPA) axis function.
Administration of doses higher than those recommended over a long period of time may lead to temporary suppression of adrenal function.
In these patients, treatment with ADSEGO nasal spray should be continued at a dose sufficient to control symptoms; the adrenal function will recover in a few days and can be verified by measuring plasma cortisol.
In the event of overdose after incidental oral uptake, disturbances of the central nervous system (including drowsiness, confusion, coma, tachycardia and hypotension) caused by azelastine hydrochloride are to be expected based on the results of animal experiments.
Treatment of these disorders must be symptomatic. Depending on the amount swallowed, gastric lavage is recommended. There is no known antidote.
💬 Ask about this leaflet
Ask anything about Azelastine hydrochloride/fluticasone propionate Advanz Pharma 137 micrograms/50 micrograms per actuation 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.
Medicines containing Azelastine hydrochloride, Fluticasone propionate
- Azelastine hydrochloride / Fluticasone propionate 137 micrograms / 50 micrograms per actuation nasal spray, suspension
- Azelastine hydrochloride/Fluticasone propionate 137 microgram/actuation, 50 microgram/actuation Nasal spray suspension
- Azelastine hydrochloride/Fluticasone propionate Vygoris 137 micrograms /50 micrograms per actuation, Nasal Spray, Suspension
- Azelastine/Fluticasone 137 micrograms/ 50 micrograms per actuation Nasal Spray, Suspension
- Dymista 137 micrograms / 50 micrograms per actuation Nasal Spray
- Dymista Control 137 micrograms/50 micrograms per Actuation Nasal Spray
- Flomister 137 micrograms / 50 micrograms per actuation nasal spray, suspension