Dymista
(Azelastine Hydrochloride/Fluticasone Propionate)

What Dymista is and what it is used for

Dymista Nasal Spray contains two active substances: azelastine hydrochloride and fluticasone propionate.
• Azelastine hydrochloride belongs to a group of 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 allergic rhinitis.
• Fluticasone propionate belongs to a group of medicines called corticosteroids which reduces inflammation. Dymista Nasal Spray is used to relieve the symptoms of moderate to severe seasonal and perennia allergic rhinitis if the use of either 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. Dymista Nasal Spray relieves the symptoms of allergies, for example: runny nose, post nasal drip, sneezing and itchy or blocked nose

How to take Dymista

Always use Dymista Nasal Spray exactly as your doctor has told you. Check with your doctor or pharmacist, if you are not sure. It is essential to use Dymista Nasal Spray regularly to gain the full therapeutic benefit. 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 in renal and hepatic impairment
• There are no data in patients with renal and hepatic impairment. Method of administration For nasal use.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 Dymista 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 Dymista 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 than rec ­ ommended 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 dose. If you stop using Dymista Nasal Spray Do not stop using Dymista Nasal Spray without ask ­ ing 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.

Possible side effects

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 na ­ sal 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) 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/breathing and a sudden onset of skin rash. This could be signs of a severe allergic 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 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 produc ­ tion of hormones in your body, particularly if you use high doses for a long time. In children and adoles ­ cents this side effect can cause them to grow more slowly than others. In rare cases a reduction of the bone density (osteo ­ porosis) 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 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

How to Store Dymista

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 unused medicine 6 months after you first open the 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