Dymista

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Dymista, (137 micrograms + 50 micrograms)/dose nasal spray, suspension
Azelastine hydrochloride + Fluticasone propionate
Please read the entire leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Dymista is and what it is used for
2. Important information 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 action of substances such as histamine, which the body produces 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 symptoms of moderate to severe seasonal and perennial allergic rhinitis when treatment with other intranasal medicinal products containing either an antihistamine or a corticosteroid alone is considered insufficient.
Seasonal and perennial allergic rhinitis is a type of allergic reaction to substances such as: plant pollen (hay fever), house dust mites, mould spores, dust, or pet dander.
Dymista relieves allergy symptoms such as nasal discharge, postnasal drip, sneezing, nasal itching, and nasal congestion.

2. Important information before using Dymista

When not to use Dymista:

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

Warnings and precautions
Before starting to use Dymista, discuss the following with your doctor or pharmacist:

• If the patient has recently undergone nasal surgery.
• If the patient has a nasal infection. Infections of the nasal passages should be treated with antibacterial or antifungal medications. Patients who have been treated for nasal infections may continue to treat allergies using Dymista.
• If the patient has tuberculosis or an untreated infection.
• If the patient has experienced changes in vision or has previously been diagnosed with increased intraocular pressure, glaucoma, and/or cataracts. Such patients will be closely monitored during treatment with Dymista.
• If the patient has adrenal gland function disorders. Caution should be exercised when switching from systemic steroid therapy to treatment with Dymista.
• If the patient has severe liver disease. In this case, the risk of systemic adverse effects increases.

In these situations, the decision on whether Dymista can be used will be made by the treating physician.
It is important that the patient uses the medicine at the dose indicated in section 3 below or as directed by the treating physician.
Using intranasal corticosteroids at doses higher than recommended may suppress adrenal function, a condition in which weight loss, fatigue, muscle weakness, low blood sugar, increased salt craving, joint pain, depression, and darker skin pigmentation may occur. In such cases, the doctor may recommend taking another medicine during periods of stress or before planned surgical procedures.
To avoid adrenal suppression, the doctor may recommend using the medicine at the lowest dose that maintains effective control of nasal mucosal inflammation symptoms.
In children and adolescents, long-term use of intranasal corticosteroids (such as Dymista) may slow growth velocity. The doctor will regularly monitor the child's growth and ensure that the medicine is used at the lowest effective dose.
If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.
If in doubt whether any of the above conditions apply, consult a doctor or pharmacist before starting to use Dymista.

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

Dymista and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to take, including those available without a prescription.
Some medicines may increase the effect of Dymista nasal spray, and your doctor may recommend careful monitoring if you are taking such medicines (including certain HIV medications: ritonavir, cobicistat, and antifungal agents: ketoconazole).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
Dymista has a minor influence on the ability to drive and operate machinery.
Fatigue and dizziness occur very rarely and may be caused either by the underlying illness or by the use of Dymista. In such cases, driving and operating machinery should be avoided. Be aware that alcohol consumption may worsen these effects.

Dymista contains benzalkonium chloride.
This medicine contains 14 micrograms of benzalkonium chloride per spray, equivalent to 0.014 mg/0.14 g. Benzalkonium chloride may cause nasal irritation or swelling, especially if used for prolonged periods.
If the patient experiences discomfort during use of the spray, inform the doctor or pharmacist.

3. How to use Dymista

Dymista must always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
For treatment to be most effective, Dymista must be used regularly.
Avoid contact with the eyes.

Adults and adolescents (aged 12 years and older)

• It is recommended to use one dose in each nostril in the morning and 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

• There is no data available regarding use in patients with renal or hepatic impairment.

Method of administration
For nasal use only.
Please read the following instructions carefully and use the medicine exactly as directed.

INSTRUCTIONS FOR USE
Priming the spray

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

Figure 1

2. If the nasal spray is being used for the first time, prime the pump by releasing a dose into the air.
3. Hold the bottle with two fingers on either side of the pump and your thumb at the bottom.
4. Press and release the pump 6 times until a fine mist is produced (see Figure 2).
5. The pump is now primed and ready for use.

Figure 2

6. If the nasal spray has not been used for more than 7 days, re-prime the pump by pressing and releasing it once.

Using the spray

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

Figure 3

7. Repeat the same procedure in the other nostril.
8. After administering the medicine, breathe gently and do not tilt your head backward. This helps prevent the medicine from running down the back of your throat and causing an unpleasant taste (see Figure 4).

Figure 4

9. After each use, wipe the spray nozzle with a clean tissue or cloth and replace the protective cap.
10. If the spray does not dispense, do not pierce the nozzle. Clean the spray nozzle with water.

It is important to use the dose prescribed by your doctor. Always follow the dosage instructions given by your doctor.
Duration of treatment
Dymista may be used for long-term treatment. The duration of treatment should correspond to the period during which allergy symptoms occur.

Overdose of Dymista
If too much nasal spray is used, the risk of complications is low. However, consult your doctor if you have any concerns or if doses higher than recommended have been used for a prolonged period. If anyone, especially a child, accidentally swallows Dymista, contact a doctor or the nearest hospital emergency department immediately.

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

Stopping Dymista
Do not stop using Dymista without consulting your doctor, as this may reduce the effectiveness of treatment.

If you have any further questions about the use of this medicine, consult 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 (may affect more than 1 in 10 people):

• Nosebleeds

Common side effects (may affect fewer than 1 in 10 people):

• Headache
• Bitter taste in the mouth, especially if the patient tilts their head backwards when administering the nasal spray. This taste should disappear if the patient drinks a non-alcoholic beverage a few minutes after using the medicine
• Unpleasant smell

Uncommon side effects (may affect fewer than 1 in 100 people):

• Slight irritation inside the nose. This may cause mild stinging, itching or sneezing
• Dryness in the nose, cough, dry throat or sore throat

Rare side effects (may affect fewer than 1 in 1,000 people):

• Dry mouth

Very rare side effects (may affect fewer than 1 in 10,000 people):

• Dizziness or drowsiness
• Cataract, glaucoma or increased intraocular pressure, which may lead to loss of vision and (or) redness and eye pain. These side effects have been reported after long-term use of nasal sprays containing fluticasone propionate.
• Skin and nasal mucosa damage
• Malaise, feeling of fatigue, exhaustion or weakness
• Rash, itching or redness of the skin, itchy blisters on the skin
• Bronchospasm (narrowing of the lower airways)

Seek immediate medical help if any of the following symptoms occur:

• Swelling of the face, lips, tongue or throat, which may cause difficulty in swallowing and (or) breathing, and sudden appearance of a skin rash. These may be symptoms of a severe allergic reaction. Note: these symptoms are very rare.

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

• Blurred vision
• Nasal mucosal ulceration

When the medicine is used in high doses for a prolonged period, systemic side effects (side effects affecting the whole body) may occur. The likelihood of such effects is considerably lower with corticosteroids administered as a nasal spray than with oral corticosteroid therapy. These effects may vary between individual patients and with different corticosteroid medicines (see section 2).
Nasally administered corticosteroids may affect normal hormone production processes in the body, especially when used long-term at high doses. In children and adolescents, these side effects may cause a reduction in growth rate.
In rare cases, decreased bone density (osteoporosis) has been observed with long-term use of intranasal corticosteroids.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Dymista

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store in a refrigerator. Do not freeze.
Shelf life after first opening the bottle: 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Dymista contains
The active substances in Dymista are: azelastine hydrochloride and fluticasone propionate.
Each gram of suspension contains 1000 micrograms of azelastine hydrochloride and 365
micrograms of fluticasone propionate.
Each spray actuation (0.14 g) delivers 137 micrograms of azelastine hydrochloride (= 125 micrograms of azelastine) and 50 micrograms of fluticasone propionate.
The other ingredients are: disodium edetate, glycerol, microcrystalline cellulose, sodium croscarmellose,
polysorbate 80, benzalkonium chloride, phenylethyl alcohol, and purified water.

What Dymista looks like and contents of the pack
Dymista is a white, homogeneous suspension.
Dymista is available in a Type I brown glass bottle with a spray pump, a nasal applicator made of PP, and a protective cap, packed in a cardboard box.
The 25 ml bottle contains 23 g of nasal aerosol in the form of a suspension (providing at least 120 doses).
Dymista is available in:

• Packs containing 1 bottle with 23 g of nasal aerosol in the form of a suspension.
• Packs containing 3 bottles, each with 23 g of nasal aerosol in the form of a suspension.

For further information about this medicine, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Spain, the country of export:
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin, Ireland

Manufacturers:
Mylan Hungary Kft., Mylan utca 1, H-2900 Komárom, Hungary
MEDA Pharma GmbH & Co. KG, Benzstrasse 1, 61352 Bad Homburg, Germany
Haupt Pharma Amareg GmbH, Donaustaufer Str. 378, 93055 Regensburg, Germany
Madaus GmbH, Lütticher Straße 5, 53842 Troisdorf, Germany

Parallel Importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw, Poland

Marketing Authorisation Number in Spain, the country of export: 693703.7
Parallel Import Authorisation Number: 332/25

This medicine is authorised for sale in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names: