Package leaflet: Information for the patient

Dymista 137 micrograms / 50 micrograms per actuation, Nasal Spray, Suspension

Azelastine hydrochloride/fluticasone propionate

Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor 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 or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

1. What Dymista is and what it is used for

Dymista 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 is used to relieve the symptoms of moderate to severe seasonal and perennial 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 relieves the symptoms of allergies, for example: runny nose, post nasal drip, sneezing and
itchy or blocked nose.

2. What you need to know before you use Dymista

Do not use Dymista:

 If you are allergic to azelastine hydrochloride or fluticasone propionate or any of the other
ingredients of this medicine (listed in section 6).

Warnings and precautions

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

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 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.

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

Other medicines and Dymista

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 Dymista 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).

Pregnancy and breast-feeding

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 Dymista.

Driving and using machines

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

Dymista contains benzalkonium chloride

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

3. How to use Dymista

Always use Dymista exactly as your doctor has told you. Check with your doctor or pharmacist, if
you are not sure.

It is essential to use Dymista 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.

Read the following instructions carefully and use only as directed.

INSTRUCTION FOR USE

Preparing the spray
1. Shake the bottle gently for 5 seconds by tilting it upwards and downwards and then remove the
protective cap (see figure 1).

Figure 1

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 (see figure 2).
5. Now your pump is primed and ready to use.

Figure 2
  

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 (see figure 1).
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 (see
figure 3).
6. Breathe out through your mouth.

Figure 3

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 (see figure 4).

Figure 4
  

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.

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

If you use more Dymista 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 recommended over a long period, contact your
doctor. If anyone, especially a child, accidentally drinks Dymista, contact your doctor or nearest
hospital casualty department as soon as possible.

If you forget to use Dymista

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

Do not stop using Dymista without asking 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.

4. Possible side effects

Like all medicines Dymista 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)

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 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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via HPRA
Pharmacovigilance, Website: www.hpra.ie. By reporting side effects, you can help provide more
information on the safety of this medicine.

5. 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.

6. Contents of the pack and other information

What Dymista contains

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.

What Dymista looks like and contents of the pack

Dymista is a white, homogenous suspension.
  

Dymista comes in an amber coloured glass bottle fitted with a spray pump, applicator and a protective
cap.
The 10 ml bottle contains 6.4 g nasal spray, suspension (at least 28 actuations). The 25 ml bottle
contains 23 g nasal spray, suspension (at least 120 actuations).
Dymista is presented in:
Packs containing 1 bottle with 6.4 g nasal spray, suspension
Packs containing 1 bottle with 23 g nasal spray, suspension
Multipacks comprising 10 bottles, each containing 6.4 g nasal spray, suspension
Multipacks comprising 3 bottles, each containing 23 g nasal spray, suspension.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan IRE Healthcare Limited,
Unit 35/36, Grange Parade,
Baldoyle Industrial Estate,
Dublin 13,
Ireland

Manufacturer
MEDA Pharma GmbH & Co. KG
Benzstraße 1
D-61352 Bad Homburg
Germany

This medicinal product is authorised in the Member States of the EEA under the following
names:

Austria Dymista Nasenspray Latvia Dymista 137

mikrogrami/50
mikrogrami devā deguna
aerosols, suspensija
Bulgaria Dymista Liechtenstein Dymista Nasenspray
Cyprus Dymista Ρινικό εκνέφωμα Lithuania Dymista 137
mikrogramai/50
mikrogramų / dozėje
nosies purškalas
(suspensija)
Czech Republic Dymistin 137 mikrogramů / 50 Luxembourg Dymista Neusspray /
mikrogramů, nosní sprej, Suspension pour
suspenze pulvérisation nasale /
Nasenspray
Denmark Dymista Malta Dymista Nasal Spray
Estonia Dymista Norway Dymista nesespray
Finland Dymista nenäsumute Poland Dymista
France Dymistalin Suspension pour Portugal Dymista Spray nasal
pulvérisation nasale
Germany Dymista Nasenspray 137 Romania Dymista 137
Mikrogramm/50 Mikrogramm micrograme / 50
pro Sprühstoß micrograme /doza spray
Nasenspray, Suspension nazal suspensie
Greece Dymista Ρινικό εκνέφωμα Slovak Republic Dymista nosová
aerodisperzia
  

Hungary Dymista Szuszpenziós orrspray Slovenia Dymista 137

mikrogramov / 50
mikrogramov na vpih
pršilo za nos, suspenzija
Iceland Dymista Nefúði Spain Dymista suspensión
pulverización nasal
Ireland Dymista, 137 micrograms / Sweden Dymista Nässpray,
50 micrograms per actuation suspension (1mg/g;
Nasal Spray, Suspension 0.365 mg/g)
Italy Dymista United Kingdom Dymista Nasal Spray

This leaflet was last revised in October 2020