Prospect: information for the patient

Dymista

137 micrograms/50 micrograms/application,

nasal spray suspension

Hidrocloruro de azelastina / propionato de fluticasona

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect.Seesection4.

Content in this prospect:

1.What Dymista is and for what it is used.

2.What you need to know before starting to useDymista.

3.How to use Dymista.

4.Possible adverse effects.

5.Storage of Dymista.

6.Contents of the package and additional information.

Dymista contains two active substances: azelastine hydrochloride and fluticasone propionate.

• Azelastine hydrochloride belongs to a group of medicines called antihistamines. Antihistamines act by preventing the effects of substances such as histamine, produced by the body as part of an allergic reaction; thereby reducing the symptoms of allergic rhinitis.
• Fluticasone propionate belongs to a group of medicines called corticosteroids, which reduce inflammation.

Dymista is used to relieve the symptoms of moderate to severe seasonal allergic rhinitis and perennial allergic rhinitis, if treatment with an antihistamine or intranasal corticosteroid alone is considered insufficient.

Seasonal or perennial allergic rhinitis are allergic reactions to substances such as pollen (hay fever), house dust mites, moulds, dust or domestic animals.

Dymista relieves allergy symptoms, for example:runny nose, postnasal drip, sneezing, itching or nasal congestion.

No use Dymista:

If you are allergic to hydrochloride azelastine or fluticasone propionate, or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Dymista if:

You have recently undergone nasal surgery.

You have a nasal infection. Nasal infections should be treated with antibiotics or antifungals. If you have been given medication for a nasal infection, you may continue to use Dymista to treat your allergy.

You have tuberculosis or an untreated infection.

You have changes in vision or a history of elevated intraocular pressure, glaucoma, and/or cataracts. If you have any of these conditions, you will be closely monitored during the use of Dymista.

You have adrenal function impairment. Caution should be exercised when switching from systemic steroid treatment to Dymista.

You have severe liver disease. The risk of systemic adverse effects will be increased.

In these cases, your doctor will decide if you can use Dymista.

It is essential to take the indicated dose in section 3 or the dose prescribed by your doctor. Treatment with doses higher than the recommended corticosteroid nasal doses may lead to adrenal suppression, which can cause weight loss, fatigue, muscle weakness, low blood glucose levels, salt craving, joint pain, depression, and skin darkening. If you experience any of these adverse effects, your doctor may recommend another medication during periods of stress or selective surgery.

To avoid adrenal suppression, your doctor will advise you to take the lowest dose that maintains effective control of your rhinitis symptoms.

The use of nasal corticosteroids (such as Dymista) may cause slower growth in children and adolescents when used for a long period. Your doctor will regularly monitor the growth of children and ensure they take the minimum effective dose.

Contact your doctor if you experience blurred vision or other visual disturbances.

If you are unsure if you are in any of the above situations, consult your doctor or pharmacist before using Dymista.

Children

This medication is not recommended for use in children under 12 years old.

Use of Dymista with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Some medications may increase the effects of Dymista, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat, and medications for fungal infections: ketoconazole).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Dymista has a minimal influence on the ability to drive and operate machinery.

Very rarely, you may experience fatigue or drowsiness due to the underlying disease or during the use of Dymista. In these cases, do not drive or operate machinery. Note that alcohol consumption may exacerbate these effects.

Dymista contains benzalkonium chloride.

This medication contains 14 micrograms of benzalkonium chloride in each spray.

This medication may cause irritation or inflammation of the nasal mucosa, especially with long-term treatment, due to benzalkonium chloride. If such a reaction is suspected (persistent nasal congestion), a nasal medication without this excipient should be used whenever possible.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

It is essential that the use of Dymista be regular for the therapeutic benefit to be complete.

Avoid contact with the eyes.

Adults and adolescents (over 12 years)

The recommended dose is one application in each nasal fossa, in the morning and at night.

Use in children under 12 years

This medication is not recommended for use in children under 12 years.

Use in cases of renal and hepatic insufficiency

No data is available for patients with renal and hepatic insufficiency.

Administration form

Nasal route.

Read the following instructions carefully and use the product only as indicated.

USAGE INSTRUCTIONS

Preparation of the spray

1. Shake the bottle gently for 5 seconds, tilting it from top to bottom, and then remove the protective cap (see Figure 1).

Figure 1

2.The firsttime the nasal spray is used, the pump must be activated by spraying into the air.

3. Activate the pump by placing two fingers on either side of the spray pump and placing the thumb on the base of the bottle.

4. Press and release the pump 6 times until a fine spray appears (see Figure 2).

5. Now, the pump is activated and ready to use.

Figure 2

6. If the nasal spray has not been used for more than 7 days, the pump will need to be reactivated by pressing and releasing it.

Spray method

1. Shake the bottle gently for 5 seconds, tilting it from top to bottom, and then remove the protective cap (see Figure 1).

2. Clear the nasal fossae by blowing your nose.

3. Keep your head tilted forward. Do not tilt your head back.

4. Hold the bottle upright and carefully insert the spray tip into one nasal fossa.
5. Cover the other nasal fossa with your finger, press the pump once quickly, and at the same time, take a gentle breath (see Figure 3).

6. Breathe through your mouth.

Figure 3

7. Repeat the procedure in the other nasal fossa.

8. Breathe gently and do not tilt your head back after application. This prevents the medication from reaching your throat, causing an unpleasant taste (see Figure 4).

Figure 4

9. After each use, clean the spray tip with a clean cloth or tissue, and replace the protective cap.

10. Do not pierce the nozzle if you do not get the spray. Clean the valve with water.

It is essential that you use the prescribed dose. Use only the amount recommended by your doctor.

Treatment duration

Dymista is suitable for long-term use. The duration of treatment corresponds to the period during which you experience allergic symptoms.

If you use more Dymista than you should

If you apply more of this medication to your nose, it is unlikely that you will experience any problems. In case of doubt, or if you have used a higher dose than recommended for a long period, consult your doctor. If a person, especially a child, accidentally ingests Dymista,consult your doctor immediately or go to the nearest medical center, or call the Toxicological Information Service. Phone (91) 562 04 20, indicating the medication and the amount ingested.

If you forget to use Dymista

Use the nasal spray as soon as you remember and then administer the next dose at the usual time. Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with Dymista

Do not stop treatment without consulting your doctor, as this may put your treatment at risk.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Dymista can cause side effects, although not everyone will experience them.

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

• Nasal bleeding.

Common side effects (may affect up to 1 in 10 people):

• Headache.
• Bitter taste in the mouth, especially if you tilt your head back during use of the nasal spray. This taste should disappear if you drink a soft drink a few minutes after using this medicine.
• Unpleasant odor.

Rare side effects (may affect up to 1 in 100 people):

• Mild irritation of the inside of the nose, which may cause mild burning, itching, or sneezing.
• Nasal dryness, cough, dry throat, or throat irritation.

Uncommon side effects (may affect up to 1 in 1,000 people):

• Mouth dryness.

Very rare side effects (may affect up to 1 in 10,000 people):

• Dizziness or drowsiness.

• Cataracts, glaucoma, or increased eye pressure, with possible vision loss and/or eye redness and pain. These side effects have been observed with prolonged treatment with nasal sprays of fluticasone propionate.
• Skin and mucous membrane lesions in the nose.
• Feeling unwell, fatigue, exhaustion, or weakness.
• Rash, redness, or itching of the skin, urticaria.
• Bronchospasm (constriction of the airways of the lungs).

Seek immediate medical attention if you develop any of the following symptoms:

• Swelling of the face, lips, tongue, or throat, which may make swallowing/respiration difficult and sudden appearance of rash on the skin.These may be signs of a severe allergic reaction.Note that this is very rare.

Side effects of unknown frequency (frequency cannot be estimated from available data)

• Blurred vision
• Nose ulcers

When this medicine is administered at high doses for a prolonged period of time, systemic side effects (side effects that affect the entire body) may occur. The likelihood of these side effects occurring is much lower if a nasal corticosteroid spray is used instead of oral corticosteroids. These side effects may vary between individual patients and between different corticosteroid preparations (see section 2).

Nasal corticosteroids may affect the normal production of hormones in your body, especially if high doses are used for a long time. In children and adolescents, this side effect may cause slower growth.

In rare cases, a reduction in bone density (osteoporosis) occurs when corticosteroids are administered nasally for a long period of time.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle and packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not refrigerate or freeze.

Expiration date after opening: Dispose of any unused portion of the medication 6 months after first opening the nasal spray pump.

Medicines should not be thrown down the drain or in the trash. Deposit the containers and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

Composition of Dymista

The active ingredients are: azelastine hydrochloride and fluticasone propionate.Each gram of suspension contains1,000 micrograms of azelastine hydrochloride and 365 micrograms of fluticasone propionate.

Each application (0.14 g) releases 137 micrograms of azelastine hydrochloride (=125 micrograms of azelastine) and 50 micrograms of fluticasone propionate.

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

Appearance of the product and contents of the package

Dymistais a homogeneous white suspension.

Dymista is presented in an amber glass bottle, equipped with a spray pump, an applicator, and a protective cap.

The 10 ml bottle contains 6.4 g of nasal spray suspension (at least 28 applications). The 25 ml bottle contains 23 g of nasal spray suspension (at least 120 applications).

Dymista has the following presentations:

Bottle with 6.4 g of nasal spray suspension.

Bottle with 23 g of nasal spray suspension.

Multi-pack containing 10 bottles with 6.4 g each of nasal spray suspension

Multi-pack containing 3 bottles with 23 g each of nasal spray suspension

Not all package sizes may be marketed.

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

Mylan Hungary Kft,

H-2900 Komárom,

Mylan utca 1,

Hungary

or

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

(Germany)

or

Haupt Pharma Amareg GmbH

Donaustaufer Str. 378

93055 Regensburg

(Germany)

or

Madaus GmbH

Lütticher Straße 5

53842 Troisdorf

Germany

For more information about this medication, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the European Economic Area and in the United Kingdom (Northern Ireland)with the following names:

AustriaDymista Nasenspray

BulgariaDymista

CyprusDymistaΡινικ?εκν?φωμα

Czech RepublicDymistin 137 mikrogramu / 50 mikrogramu, nosní sprej, suspenze

DenmarkDymista

EstoniaDymista

FinlandDymista nenäsumute

FranceDymistalin Suspension pour pulvérisation nasale

GermanyDymista Nasenspray 137 Mikrogramm/50 Mikrogramm pro Sprüh­stoß
Nasenspray, Suspen­sion

GreeceDymista Ρινικ? εκν?φωμα

HungaryDymista Szuszpenziós orrspray

IcelandDymista Nefúði

IrelandDymista Nasal Spray

ItalyDymista

LatviaDymista 137 mikrogrami/50 mikrogrami deva deguna aerosols, suspensija

LiechtensteinDymista Nasenspray

LithuaniaDymista 137 mikrogramai/50 mikrogramu / dozeje nosies purškalas

LuxembourgDymista Neusspray / Suspension pour pulvérisation nasale / Nasenspray

MaltaDymista Nasal Spray

NorwayDymista nesespray

PolandDymista

PortugalDymista Spray nasal

RomaniaDymista 137 micrograme / 50 micrograme /doza spray nazal suspensie

SlovakiaDymista nosová aerodisperzia

SloveniaDymista 137 mikrogramov / 50 mikrogramov na vpih pršilo za nos, suspenzija

SpainDymista suspensión pulverización nasal

SwedenDymista Nässpray, suspension (1mg/g; 0.365 mg/g)

United Kingdom (Northern Ireland)Dymista Nasal Spray

Last review date of this leafletFebruary 2019

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es