Dymista 137 micrograms/50 micrograms/dose nasal spray suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dymista

137 micrograms/50 micrograms/dose,

nasal spray suspension

Azelastine hydrochloride / fluticasone propionate

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Dymista is and what it is used for.
2. What you need to know before using 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, which the body produces as part of an allergic reaction; thus, they reduce the symptoms of allergic rhinitis.
• Fluticasone propionate belongs to a group of medicines called corticosteroids, which reduce inflammation.

Dymista is used to relieve symptoms of moderate to severe seasonal allergic rhinitis and perennial allergic rhinitis when treatment with either an antihistamine or an 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 such as rhinorrhea, post-nasal drip, sneezing, nasal itching, or nasal congestion.

2. What you need to know before using Dymista

Do not use Dymista:

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

Warnings and precautions

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

• You have recently had nasal surgery.

• You have a nasal infection. Nasal infections should be treated with antibacterial or antifungal medicines. If you have been prescribed medication for a nasal infection, you may continue using Dymista to treat your allergy.

• You have tuberculosis or an untreated infection.

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

• You have impaired adrenal function. Caution is required when switching from systemic steroid therapy to Dymista.

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

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

It is important that you take the dose indicated in section 3 or as prescribed by your doctor. Treatment with doses higher than recommended for nasal corticosteroids may lead to adrenal suppression, which can cause weight loss, fatigue, muscle weakness, low blood sugar levels, salt craving, joint pain, depression, and skin darkening. If you experience any of these adverse effects, your doctor may recommend an alternative treatment during periods of stress or elective surgery.

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

The use of nasal corticosteroids (such as Dymista) may cause slower growth in children and adolescents when used long-term. The doctor will regularly monitor children's growth and ensure they receive the lowest effective dose possible.

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

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

Children

The use of this medicine is not recommended in children under 12 years of age.

Using Dymista with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Some medicines may increase the effects of Dymista, so your doctor will monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat, and antifungal medications: ketoconazole).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

Very rarely, you may experience fatigue or dizziness due to the underlying illness or while using Dymista. In such cases, do not drive or operate machinery. Be aware that alcohol consumption may worsen these effects.

Dymista contains benzalkonium chloride.

This medicine contains 14 micrograms of benzalkonium chloride per spray.

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

3. How to use Dymista

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

It is essential that Dymista is used regularly in order to achieve full therapeutic benefit.

Avoid contact with the eyes.

Adults and adolescents (over 12 years of age)

? The recommended dose is one spray into each nostril in the morning and one spray into each nostril in the evening.

Use in children under 12 years of age

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

Use in patients with renal or hepatic impairment

No data are available in patients with renal or hepatic impairment.

Method of administration

Nasal use.

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

INSTRUCTIONS FOR USE

Priming the spray

1. Gently shake the bottle for 5 seconds by tilting it up and down, then remove the protective cap (see Figure 1).

Figure 1

1. The first time the nasal spray is used, the spray pump must be primed by spraying into the air.
2. Prime the pump by placing two fingers on either side of the spray pump and placing your thumb on the base of the bottle.
3. Press and release the pump 6 times until a fine mist appears (see Figure 2).
4. The pump is now primed and ready for use.

Figure 2

1. If the nasal spray has not been used for more than 7 days, the pump must be re-primed by pressing and releasing it again.

Spraying technique

1. Gently shake the bottle for 5 seconds by tilting it up and down, then remove the protective cap (see Figure 1).
2. Blow your nose to clear the nasal passages.
3. Tilt your head forward slightly. Do not tilt your head backward.
4. Hold the bottle upright and carefully insert the spray nozzle into one nostril.
5. Close the other nostril with your finger, press the pump once quickly, and at the same time inhale gently (see Figure 3).
6. Breathe through your mouth.

Figure 3

1. Repeat the procedure in the other nostril.
2. Breathe gently and do not tilt your head backward after administration. This helps prevent the medicine from running down your throat, which may cause an unpleasant taste (see Figure 4).

Figure 4

1. After each use, wipe the spray nozzle with a clean tissue or cloth and replace the protective cap.
2. Do not pierce the nozzle if spray is not obtained. Clean the valve with water.

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

Duration of treatment

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 medicine into your nose, it is unlikely that you will experience any problems. If in doubt, or if you have used a higher dose than recommended for a prolonged period, consult your doctor. If someone, especially a child, accidentally swallows Dymista, contact your doctor or go immediately to the nearest medical center, or call the Toxicology Information Service at telephone number (91) 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to use Dymista

Use the nasal spray as soon as you remember, then take your next dose at the usual time. Do not use a double dose to make up for a missed dose.

If you stop using Dymista

Do not stop treatment without consulting your doctor, as this may compromise the success of your treatment.

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

4. Possible adverse effects

Like all medicines, Dymista may cause adverse effects, although not everyone experiences them.

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

• Nasal bleeding.

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

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

Uncommon adverse effects (may affect up to 1 in 100 people):

• Mild irritation inside the nose, which may cause slight stinging, itching, or sneezing.
• Nasal dryness, cough, dry throat, or throat irritation.

Rare adverse effects (may affect up to 1 in 1,000 people):

• Dry mouth.

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

• Dizziness or drowsiness.

• Cataracts, glaucoma, or increased eye pressure, possibly leading to vision loss and/or redness and eye pain. These adverse effects have been observed with prolonged treatment using nasal sprays containing fluticasone propionate.

• Skin and nasal mucosa lesions.

• Feeling of malaise, fatigue, exhaustion, or weakness.

• Rash, redness or itching of the skin, urticaria.

• Bronchospasm (narrowing of the airways in 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 or breathing difficult, and sudden onset of skin rash. These could be signs of a severe allergic reaction. Note that this is very rare.

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• Blurred vision
• Nasal ulcers

When this medicine is administered at high doses over a prolonged period, systemic adverse effects (adverse effects affecting the whole body) may occur. The likelihood of such effects is much lower when using a nasal corticosteroid spray compared to oral corticosteroids. These 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 adverse effect may result in slower growth.

In rare cases, reduced bone density (osteoporosis) may occur when corticosteroids are administered via the nasal route over a long period.

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dymista

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

Do not use this medicine after the expiry date stated on the bottle and carton after "EXP". The expiry date refers to the last day of the month indicated.

Do not refrigerate or freeze.

Expiry after first opening: Discard any unused portion of the medicine 6 months after first opening the nasal spray.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dymista

The active substances are: azelastine hydrochloride and fluticasone propionate. Each gram of suspension contains 1,000 micrograms of azelastine hydrochloride and 365 micrograms of fluticasone propionate.

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

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

Nature of the product and contents of the container

Dymista is a homogeneous white suspension.

Dymista is supplied 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 sprays). The 25 ml bottle contains 23 g of nasal spray suspension (at least 120 sprays).

Dymista is available in the following pack presentations:

• Pack containing one bottle with 6.4 g of nasal spray suspension.

• Pack containing one bottle with 23 g of nasal spray suspension.

• Multipack containing 10 bottles, each with 6.4 g of nasal spray suspension.

• Multipack containing 3 bottles, each with 23 g of nasal spray suspension.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

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 further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria Dymista Nasenspray
Bulgaria Dymista
Cyprus Dymista Ρινικ? εκν?φωμα
Czech Republic Dymistin 137 mikrogramu / 50 mikrogramu, nosní sprej, suspenze
Denmark Dymista
Estonia Dymista
Finland Dymista nenäsumute
France Dymistalin Suspension pour pulvérisation nasale
Germany Dymista Nasenspray 137 Mikrogramm/50 Mikrogramm pro Sprühstoß Nasenspray, Suspension
Greece Dymista Ρινικ? εκν?φωμα
Hungary Dymista Szuszpenziós orrspray
Iceland Dymista Nefúði
Ireland Dymista Nasal Spray
Italy Dymista
Latvia Dymista 137 mikrogrami/50 mikrogrami deva deguna aerosols, suspensija
Liechtenstein Dymista Nasenspray
Lithuania Dymista 137 mikrogramai/50 mikrogramu / dozeje nosies purškalas
Luxembourg Dymista Neusspray / Suspension pour pulvérisation nasale / Nasenspray
Malta Dymista Nasal Spray
Norway Dymista nesespray
Poland Dymista
Portugal Dymista Spray nasal
Romania Dymista 137 micrograme / 50 micrograme /doza spray nazal suspensie
Slovakia Dymista nosová aerodisperzia
Slovenia Dymista 137 mikrogramov / 50 mikrogramov na vpih pršilo za nos, suspenzija
Spain Dymista suspensión pulverización nasal
Sweden Dymista Nässpray, suspension (1mg/g; 0.365 mg/g)
United Kingdom (Northern Ireland) Dymista Nasal Spray

Date of the most recent revision of this leaflet: February 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): https://www.aemps.gob.es