Azelastine hydrochloride / Fluticasone propionate 137 micrograms / 50 micrograms per actuation nasal spray, suspension

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Azelastine/Fluticasone Nasal Spray is and what it is used for
2. What you need to know before you use Azelastine/Fluticasone Nasal Spray
3. How to use Azelastine/Fluticasone Nasal Spray
4. Possible side effects
5. How to store Azelastine/Fluticasone Nasal Spray
6. Contents of the pack and other information

Talk to your doctor or pharmacist before using this medicine 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 this medicine 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 this medicine.
• You suffer from impaired adrenal function. Care must be taken when transferring from systemic steroid treatment to this medicine.
• 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 this medicine.

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/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 this medicine.

This medicine is not recommended for children under 12 years.

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/Fluticasone 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).

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.

This medicine 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 this medicine. In these cases, do not drive or operate machinery. Please be aware that drinking alcohol may enhance these effects.

This medicine contains 14 micrograms benzalkonium chloride in each spray, which is equivalent to 0.014mg / 0.14g. 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.

• The recommended dose is one spray into each nostril in the morning and evening.

• This medicine is not recommended for children under 12 years.

• There are no data in patients with renal and hepatic impairment.

For nasal use.

Read the following instructions carefully and use only as directed.

Preparing the spray

1. Shake the bottle gently for 5 seconds by tilting it upwards and downwards and then remove the protective cap.
2. The first time the nasal spray is used, you must prime the pump by squirting it into the air.
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. Press down and release the pump 6 times until a fine mist appears.
5. Now your pump is primed and ready to use.
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.
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.

6. Breathe out through your mouth.
7. Repeat in your other nostril.
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.
9. After each use wipe the spray tip with a clean tissue or cloth and then replace the protective cap.
10. 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.

This medicine is suitable for long-term use. The duration of treatment should correspond to the period of experiencing allergy symptoms.

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 this medicine, contact your doctor or nearest hospital casualty department as soon as possible.

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.

Do not stop using this medicine without asking your doctor, because this puts the success of the treatment at risk.

• 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 (these may affect more than 1 in 10 people):

• Nosebleed

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

• Dry mouth

Very rare side effects (these 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)

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.

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.

The active substances are: azelastine hydrochloride and fluticasone propionate.

Each gram of suspension contains 989 micrograms azelastine hydrochloride and 361 micrograms fluticasone propionate.

Each actuation (0.14g) delivers 137 micrograms azelastine hydrochloride (equivalent to 125 micrograms azelastine) and 50 micrograms fluticasone propionate.

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

Azelastine/Fluticasone Nasal Spray is a white, homogenous suspension.

This medicine comes in an amber coloured glass bottle fitted with a spray pump, applicator and a protective cap.

The 25ml bottle contains 23g nasal spray, suspension (at least 120 actuations).

This medicine is presented in:

A pack containing 1 bottle with 23g nasal spray, suspension