DYMISTA

Package leaflet: Information for the patient

Warning! Keep this 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 this leaflet carefully before using the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet

1. What is Dymista and what is it 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 is Dymista and what is it 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 only an antihistamine or a corticosteroid is considered insufficient.
Seasonal and perennial allergic rhinitis is a type of allergic reaction to substances such as: plant pollens (hay fever), house dust mites, mould spores, dust, or pet dander.
Dymista relieves allergy symptoms such as nasal discharge, postnasal drip, sneezing, 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 treatment with 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 allergy treatment with Dymista.
• If the patient has tuberculosis or has untreated infections.
• If the patient experiences 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 disorders. Caution should be exercised when switching from systemic steroid therapy to treatment with Dymista.
• If the patient has severe liver disease. In such cases, the risk of systemic adverse effects may be increased.

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 lowest effective dose of Dymista that still controls nasal inflammation symptoms adequately.
In children and adolescents, long-term use of intranasal corticosteroids (such as Dymista) may reduce the growth rate. The doctor will regularly monitor the child's growth and ensure that the lowest effective dose is used.
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 treatment with Dymista.

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

Dymista and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take, including those available without a prescription.
Some medicines may increase the effect of Dymista nasal spray, and the doctor may recommend careful monitoring if the patient is taking such medicines (including certain HIV medications: ritonavir, cobicistat, and antifungal agents such as 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. Very rarely, fatigue and dizziness may occur, which may be caused by the disease itself or by using Dymista. In such cases, patients should 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, equivalent to 0.014 mg/0.14 g. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for prolonged periods.
If the patient experiences discomfort while using the spray, inform the doctor or pharmacist.

3. How to use Dymista

Dymista should always be used exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
For the 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 spray into 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
Nasal administration.
Please read the following instructions carefully and use the medicine exactly as directed.

INSTRUCTIONS FOR USE

Preparing the aerosol

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 on 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 aerosol

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 nostrils.
3. Keep your head tilted forward, facing downward toward your toes. Do not tilt your head backward.
4. Hold the bottle upright and gently insert the nozzle into one nostril.
5. Close the other nostril with a 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 for the other nostril.
8. After administering the medicine, continue to breathe gently through your nose and do not tilt your head backward. This helps prevent the medicine from running down the throat and causing an unpleasant taste (see Figure 4).

Figure 4

9. After each use, wipe the nozzle with a clean tissue or cloth and replace the protective cap.
10. If the spray does not discharge, do not pierce the nozzle. Wash the 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 long-term. The duration of treatment should correspond to the period during which allergy symptoms occur.

Use of more than the recommended dose of Dymista
If too much nasal spray is used, the likelihood of side effects is low. However, consult your doctor if you are concerned or if a higher than recommended dose has 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 the next dose at your usual time. Do not use a double dose to make up for a missed dose.

Stopping Dymista treatment
Do not stop using Dymista without consulting your doctor, as this may result in reduced 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 will experience 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, particularly 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 pain in the eyes. These side effects have been reported after long-term use of nasal spray 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
• Ulceration of the nasal mucosa

When the medicine is used in high doses over a long period of time, 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 depending on the corticosteroid used (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 slowed growth rate.
In rare cases, decreased bone density (osteoporosis) has been observed with long-term use of corticosteroids administered intranasally.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Do not store in the refrigerator. Do not freeze.
Usable period after first opening the bottle: 6 months.
Medicines must 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 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 25 ml amber glass type I bottle with a spray pump, nasal applicator made of polypropylene, and a protective cap, packed in a cardboard box.
The 25 ml bottle contains 23 g of nasal suspension aerosol (providing at least 120 doses).
Dymista is available in:

• Packs containing 1 bottle with 23 g of nasal suspension aerosol.
• Multipacks containing 3 bottles, each with 23 g of nasal suspension aerosol.

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

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

Manufacturer:
Mylan Hungary Kft., Mylan utca 1., 2900 Komárom, Hungary
MEDA Pharma GmbH & Co. KG, Benzstr. 1, 61352 Bad Homburg, Germany
Haupt Pharma Amareg GmbH, Donaustaufer Str. 378, 93055 Regensburg, Germany
Madaus GmbH, Luetticher Strasse 5, 51101 Koeln, Troisdorf, 53842 Nordrhein-Westfalen, 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 Romania, the country of export: 11003/2018/03
11003/2018/04

Parallel Import Licence Number: 402/25

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