Dymista
(Azelastine Hydrochloride/Fluticasone Propionate)
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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
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