Azelastine HCl / Fluticasone Propionate 137 MCGS / 50 MCGS per actuation nasal spray, suspension – patient leaflet, side effects, dosage

1. What Azelastine/Fluticasone

Nasal Spray is and what it is used for

Azelastine/Fluticasone Nasal Spray contains two active substances: azelastine hydrochloride and fluticasone propionate.

• Azelastine hydrochloride belongs to a group of medicines called antihistamines. Antihistamines prevent the effects of substances such as histamine that the body produces as part of an allergic reaction – thus reducing symptoms of allergic rhinitis (inflammation of the inside of the nose caused by a substance you are allergic to).
• Fluticasone propionate belongs to a group of medicines called corticosteroids which reduces inflammation.

Azelastine/Fluticasone Nasal Spray is used to relieve the symptoms of moderate to severe seasonal and perennial allergic rhinitis if the use of either an intranasal antihistamine or corticosteroid alone is not considered sufficient.

Seasonal and perennial allergic rhinitis are allergic reactions to substances such as pollen (hayfever), house mites, moulds, dust or pets.

Azelastine/Fluticasone 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 use Azelastine/Fluticasone Nasal Spray

Do not use Azelastine/Fluticasone 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/Fluticasone Nasal Spray:

• if you had a recent operation on your nose.
• if 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/Fluticasone Nasal Spray to treat your allergies.
• if you have tuberculosis or an untreated infection.
• if 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/Fluticasone Nasal Spray.
• if your adrenal glands do not work properly. Care must be taken when transferring from systemic steroid treatment to Azelastine/Fluticasone Nasal Spray.
• if 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/Fluticasone 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 (your adrenal glands not producing adequate amounts of cortisol), a condition that may result in 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 surgery that is planned ahead.

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/ Fluticasone Nasal Spray) 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/Fluticasone Nasal Spray.

Children

This medicine is not recommended for children under 12 years.

Other medicines and Azelastine/Fluticasone Nasal Spray

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription. Some medicines may increase the effects of Azelastine/ Fluticasone Nasal Spray and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir or 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 this medicine.

Driving and using machines

Azelastine/Fluticasone 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/ Fluticasone Nasal Spray. In these cases, do not drive or operate machinery.

Azelastine/Fluticasone Nasal Spray with alcohol

Please be aware that drinking alcohol may worsen fatigue or dizziness caused by the disease itself or when using Azelastine/Fluticasone Nasal Spray.

Azelastine/Fluticasone Nasal Spray contains benzalkonium chloride

This medicine contains 14 micrograms of benzalkonium chloride in each spray. 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 use Azelastine/Fluticasone Nasal Spray

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

It is essential to use Azelastine/Fluticasone Nasal Spray regularly to gain the full benefit from it.

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 with kidney or liver problems

• There are no data available on the use of Azelastine/ Fluticasone Nasal Spray in patients with kidney or liver problems.

Method of administration

For nasal use only.

Read the following instructions carefully and use only as directed.

Package leaflet: Information for the patient

Azelastine hydrochloride/Fluticasone propionate 137 micrograms/50 micrograms per actuation

nasal spray, suspension

azelastine hydrochloride / fluticasone propionate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

  Continued overleaf INSTRUCTIONS FOR USE

Preparing the nasal spray

If you have a new bottle or a bottle that you have not used for some time, you have to prepare the spray to ensure you get a correct dose. Prepare the spray by following the next steps:

1. 1. Shake the bottle gently by tilting it upwards and downwards and then remove the protective cap.
2. 2.

   Hold the bottle upright and spray into the air;

   • 7 times if you have a new bottle.
   • 3 times if you have not used the bottle for more than 7 days.

Using the nasal spray

1. 1. Shake the bottle gently by tilting it upwards and downwards and then remove the protective cap.
2. 2. Blow your nose to clear your nostrils.
3. 3. Keep your head tilted downwards towards your toes. Do not tilt your head backwards.
4. 4. Hold the bottle upright and carefully insert the spray tip into one nostril.
5. 5. Close the other nostril with your finger, rapidly press down the pump once and sniff gently at the same time
6. 6. Breathe out through your mouth.
7. 7. Repeat step 3 through 5 for the other nostril.

Cleaning the nasal spray

1. 1. It is important to clean the nozzle and protective cap after each use with a clean and dry tissue; otherwise, it may not work properly next time you use it. Do not remove the nozzle!
2. 2. Do not try to unblock the nasal applicator by inserting a pin or another sharp object, because this will damage the applicator and it will no longer dispense the correct dose of medicine. 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/Fluticasone 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/Fluticasone Nasal Spray than you should

If you spray too much of this medicine into your nose you are unlikely to experience 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/Fluticasone Nasal Spray, contact your doctor or nearest hospital casualty department as soon as possible.

If you forget to use Azelastine/Fluticasone 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/Fluticasone Nasal Spray

Do not stop using Azelastine/Fluticasone 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.

Very common side effects (may occur in more than 1 in 10 people):

• Nosebleed

Common side effects (may occur in 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 occur in 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 occur in up to 1 in 1,000 people):

• Dry mouth

Very rare side effects (may occur in up to 1 in 10,000 people):

• Dizziness, drowsiness or sleepiness (somnolence)
• Cataract, glaucoma or increased pressure in your eye because of which you may have loss of vision and/or red and painful eyes. These side effects have been reported following prolonged treatment with fluticasone propionate nasal sprays.

• A hole in the wall inside the nose that separates it into two distinct sides (nasal septal perforation), damage to 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 swallowing/breathing and a sudden onset of skin rash. These could be signs of a severe allergic reaction.

  Please note: This is very rare (less than 1 in 10,000 people).

Side effects with unknown frequency (frequency cannot be estimated from 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 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. Website: 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 Azelastine/ Fluticasone 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 label and carton after EXP. The expiry date refers to the last day of that month. Do not refrigerate or freeze.

Always keep the protective cap on.

The bottle should be used within 6 months after first opening.

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/Fluticasone Nasal Spray contains

• The active substances are azelastine hydrochloride and fluticasone propionate.

  Each gram of suspension contains 1000 micrograms azelastine hydrochloride and 365 micrograms fluticasone propionate.

  Each spray (0.14 g) delivers 137 micrograms azelastine hydrochloride (= 125 micrograms azelastine) and 50 micrograms fluticasone propionate.

• The other ingredients are disodium edetate, glycerol, microcrystalline cellulose (E460i) and carmellose sodium (E466), polysorbate 80 (E433), benzalkonium chloride, phenylethyl alcohol and purified water.

What Azelastine/Fluticasone Nasal Spray looks like and contents of the pack

Azelastine/Fluticasone Nasal Spray is a white suspension contained in an amber glass bottle, fitted with a spray pump and a protective cap. It is available in packs containing 120 sprays.

Marketing Authorisation Holder

Alissa Healthcare Research Ltd

Unit 5, Fulcrum 1, Solent Way,

Whiteley, Fareham, Hampshire PO15 7FE, United Kingdom

Manufacturer

Basic Pharma Manufacturing B.V.

Burgemeester Lemmensstraat 352

6163 JT Geleen

The Netherlands

This leaflet was last revised in March 2025.

_P00⁰¹³ Azelastine Hydrochloride

Calibri 8.5pt

26/03/2025