Dymista

• Used to relieve moderate to severe symptoms of allergies
• Nasal spray
• Suitable for long-term use
• Also suitable for children aged 12 and above

Dymista Nasal Spray is used to relieve symptoms of moderate to severe allergic rhinitis. The nasal spray contains two active ingredients:

• Azelastine hydrochloride (medicine that counteracts allergic reactions in the body).
• Fluticasone propionate (an antiinflammatory medicine).

These substances relieve the symptoms of allergies, such as a blocked nose, runny nose, sneezing and post-nasal drip (when mucus from your nose or sinuses drips down the back of your throat).

Dymista can be used for both seasonal allergic rhinitis (such as hay fever) and non-seasonal allergies (allergic reactions to substances such as house mites, moulds, dust or pets).

Before using the nasal spray for the first time you need to prepare the spray for use. To do so, follow the instructions in the package leaflet.

Instructions for use:

• Shake the bottle gently for five seconds. Then remove the protective cap.
• Blow your nose to clear your nostrils.
• Keep your head tilted downwards towards your toes. Do not tilt head backwards.
• Hold the bottle upright and carefully insert the spray tip into one nostril.
• Close other nostril with your finger, rapidly press down once and sniff gently at the same time.
• Breathe out through your mouth.
• 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.
• After each use wipe the spray tip with a clean tissue or cloth and then replace the
• protective cap.

Do not use the nasal spray after six months of opening.

Avoid contact with the eyes. Dymista Nasal Spray is suitable for long-term use. The duration of treatment should correspond to the period of experiencing allergy symptoms.

Dosage

Dosage varies per person and is determined by a doctor depending on the symptoms. The general dosage guidelines are as follows:

• Adults and adolescents aged 12 and above: One spray into each nostril in the morning and evening.

This medicine is not recommended for children under 12 years of age.

Alcohol/driving

Very rarely, you may experience fatigue or dizziness due to the disease itself or when using Dymista Nasal Spray. In these cases, do not drive or operate machinery. Please be aware that drinking alcohol may enhance these effects.

If you use too much/forget to use/stop using Dymista

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 Dymista Nasal Spray, contact your doctor or nearest hospital casualty department as soon as possible.

If you forget to use Dymista 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 one.

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

Do not use Dymista if you are allergic to any of the ingredients in this medicine (see section ‘What Dymista contains').

When should this medicine be used with caution?

Talk to your doctor or pharmacist before taking 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 Dymista Nasal Spray to treat your allergies.
• You have tuberculosis (a serious bacterial disease in the lungs or throat that can be infectious) 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.

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. For more information on adrenal suppression, see the package leaflet.

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.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Other medicines and Dymista

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

Contact your doctor or pharmacist if:

• You are taking medicines for HIV (the virus that causes AIDS), such as ritonavir.
• You are taking medicines for the treatment of fungal infections, such as ketoconazole.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects of Dymista include:

Very common (may affect more than 1 in 10 people):

• Nose bleeds.

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

• Dry mouth.

For a complete list of possible side effects, see the package leaflet. If you experience side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Seek immediate medical help if you have any signs of a severe allergic reaction (see the package leaflet for more information). Please note: this is very rare.

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.

Read the package leaflet before use. The official package leaflet of Dymista is available for download here.