Dymista Nasal Spray

Do not use Dymista Nasal Spray:

• If you are allergic to azelastine hydrochloride or fluticasone propionate or any of the other ingredients of this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before using Dymista 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    Dymista 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 Dymista Nasal Spray.
• You suffer from impaired adrenal function. Care must be taken when transferring from systemic steroid treatment to Dymista 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 Dymista Nasal Spray.
It is important that you take your dose 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 Dymista) 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 Dymista Nasal Spray.

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.

The active substances are: azelastine hydrochloride and fluticasone propionate. Each g of suspension contains 1000 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.

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

Like all medicines Dymista Nasal Spray can cause side effects, although not everybody gets them.

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)