Allenasal Duo 137 micrograms / 50 micrograms per actuation nasal spray – patient leaflet, side effects, dosage

1. What Alleduo Nasal Spray is and what it is used for

• Alleduo Nasal Spray contains two active substances: azelastine hydrochloride and fluticasone propionate.

•

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 hayfever.

•

medicines called corticosteroids which reduce inflammation.

Alleduo Nasal Spray is used to relieve the symptoms of moderate to severe hayfever in adults if the use of either antihistamine nasal spray or corticosteroid nasal spray alone is not considered sufficient.

Moderate to severe hayfever is an allergic reaction to substances such as pollen where sleep and/or daily living activities are affected (impairment of studies, work, leisure or sport) or symptoms are considered troublesome.

Alleduo Nasal Spray relieves the symptoms of hayfever, for example: runny nose, sneezing, itchy or blocked nose and red, itchy or watery eyes.

If you experience symptoms other than those associated with hayfever, speak to your doctor.

This product should only be used by adults aged

2. What you need to know before you use Alleduo Nasal Spray

Do not use Alleduo 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 Alleduo Nasal Spray spray if:

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your nose.

•

or sinuses. 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 Alleduo Nasal Spray to treat your hayfever.

• You have tuberculosis or an untreated infection.

•

increased pressure in the eye, glaucoma and/ or cataracts. If this applies to you, you will be closely monitored whilst using Alleduo nasal spray.

• You have recently been treated with injected steroids, or you have been taking oral steroids

•

risk of suffering side effects affecting the whole body is increased.

In these cases your doctor will decide whether you can use Alleduo Nasal Spray.

It is important that you take your dose as stated in section 3 or as advised by your pharmacist. Treatment with higher than recommended doses of nasal corticosteroids may result in adrenal

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, after serious injuries or before surgery.

Your doctor or pharmacist will advise you to use the lowest dose at which effective control of your hayfever symptoms is maintained.

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 Alleduo Nasal Spray.

Children and adolescents

This medicine is not recommended for children and adolescents under 18 years of age. Other medicines and Alleduo Nasal Spray

Tell your doctor or pharmacist, if you are taking, have recently taken or might take any of the following medicines:

• Corticosteroid medicines (including eczema creams, asthma inhalers, tablets, injections, nasal sprays, and eye or nose drops)
• Medicines for HIV (e.g. ritonavir, cobicistat)
• Medicines for the treatment of fungal infections (e.g. ketoconazole)
• Medicines that may make you sleepy (e.g. diazepam, nitrazepam, zolpidem).

Some medicines may increase the effects of Alleduo Nasal Spray and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you ask your doctor or pharmacist for advice before using Alleduo Nasal Spray.

Driving and using machines

Alleduo 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 Alleduo Nasal Spray. In these cases, do not drive or operate machinery. Please be aware that drinking alcohol may enhance these effects.

Alleduo Nasal Spray contains benzalkonium chloride

Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for feel discomfort when using the spray.

3.

How to use Alleduo Nasal Spray

Always use Alleduo Nasal Spray exactly as described in this leaflet or as your doctor or

Use in adults 18 years and older

The recommended dose is one spray into each nostril in the morning and evening. Do not use more than 2 sprays in each nostril a day. pharmacist has told you. Check with your doctor or pharmacist, if you are not sure.

For therapeutic benefit whilst experiencing hayfever symptoms, using regularly in line with the instructions is essential.

Do not use continuously for more than without consulting your doctor

Stop taking Alleduo Nasal Spray and contact your doctor if your symptoms do not improve or are not well controlled within 7 days. Use only in the nose.

Contact with the eye should be avoided. Do not swallow.

Use in children and adolescents

This medicine should not be used in children

Read the following instructions carefully and use only as directed.

INSTRUCTION FOR USE

Preparing the spray

1.

tilting it upwards and downwards and then remove the protective cap (see figure 1).

Figure 1

1. 2. The first time the nasal spray is used, you must prime the pump by squirting it into the air.
2. 3. Prime the pump by putting two fingers on either side of the spray pump and place your thumb on the bottom of the bottle.

4.

1. 5. Now your pump is primed and ready to use.

Figure 2

1. 6. If the nasal spray has not been used for more pump once by pressing down and releasing the pump.

Using the spray

1.

tilting it upwards and downwards and then remove the protective cap (see figure 1).

1. 2. Blow your nose to clear your nostrils.
2. 3. Keep your head tilted downwards towards your toes. Do not tilt head backwards.
3. 4. Hold the bottle upright and carefully insert the spray tip into one nostril.
4. 5. Close other nostril with your finger, rapidly press down once and sniff gently at the same time (see figure 3).
5. 6. Breathe out through your mouth.

Figure 3

1. 7. Repeat in your other nostril.
2. 8.

   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 3).

9.

tissue or cloth and then replace the protective cap (see figure 4).

10.

Do not prick the nozzle in case spray is not obtained. Clean the nasal applicator (actuator) with water.

It is important that you take your dose as advised. You should use only as much as your doctor recommends.

Each bottle Alleduo Nasal Spray should be used by one patient only, for hygienic reasons.

If you use more Alleduo 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

accidentally drinks Alleduo nasal spray, contact your doctor or nearest hospital casualty department as soon as possible.

If you forget to use Alleduo Nasal Spray

Use your nasal spray as soon as you remember, then take the next dose at the usual time. Do not

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.

Very common side effects (may affect more

• Nosebleed
• 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

  medicine.

• Unpleasant smell
• Slight irritation of the inside of the nose. This can cause mild stinging, itching or sneezing.
• Nasal dryness, cough, dry throat or throat irritation
• Dry mouth
• Dizziness or drowsiness

• Cataract, glaucoma or increased pressure in

  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)

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/

  reaction. Please note: This is very rare.

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

are much less likely to occur if you use

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,

(osteoporosis) was observed, if nasal corticosteroids were administered long-term.

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 side effects, you can help provide more information on the safety of this medicine.

5. How to store Alleduo 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 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 Alleduo Nasal Spray contains

The active substances are: azelastine hydrochloride and fluticasone propionate.

fluticasone propionate.

spray

The other ingredients are: disodium edetate, glycerol, cellulose microcrystalline, carmellose sodium, polysorbate 80, benzalkonium chloride, phenylethyl alcohol and purified water. See end

What Alleduo Nasal Spray looks like and contents of the pack

homogenous suspension.

Alleduo Nasal Spray comes in an amber Alleduo Nasal Spray is a white,

Alleduo Nasal Spray is presented in a bottle

Marketing Authorisation Holder and Manufacturer

Opella,

Reading,

Berkshire,

UK.

Manufacturer:

KeVaRo Group Ltd

Sofia 1618,

Bulgaria.

This leaflet was last updated in 07/2026.

For electronic version of this leaflet scan the QR code. This paper leaflet might not be the latest version and thus different to the electronic leaflet, which is the last updated version available.

MORE INFO

1507322R00 (at least 120 sprays).