Dimista

Package Leaflet: Information for the Patient

Dymista

(137 micrograms + 50 micrograms)/dose, nasal spray, suspension
Azelastine hydrochloride + Fluticasone propionate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 symptoms 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.

Contents of the Package 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, and thus 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 and perennial allergic rhinitis, if other nasal products containing only an antihistamine or a corticosteroid are not considered sufficient.

Seasonal and perennial allergic rhinitis is an allergic reaction to substances such as pollen (hay fever), house dust mites, mold spores, pet hair, or feathers. Dymista relieves allergy symptoms such as runny nose, nasal discharge, sneezing, itching, and nasal congestion.

2. Important information before using Dymista

When not to 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

Before using Dymista, tell your doctor or pharmacist:

• If you have recently had nasal surgery.
• If you have a nasal infection. The infection should be treated with antibacterial or antifungal medicines. People who have been treated with medicines for a nasal infection can still be treated for allergies with Dymista.
• If you have tuberculosis or an untreated infection.
• If you notice a change in vision or have a history of increased intraocular pressure, glaucoma, and/or cataracts. People with these conditions will be closely monitored while using Dymista.
• If you have adrenal gland problems. Caution is advised when switching from systemic steroid treatment to Dymista therapy.
• If you have severe liver disease. This may increase the risk of systemic side effects.

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

It is important to use the medicine as prescribed by your doctor. Using higher doses of nasal corticosteroids than recommended may result in reduced adrenal gland function, which can lead to a decrease in weight, fatigue, muscle weakness, low blood sugar, increased salt requirements, joint pain, depression, and darker skin pigmentation. In such cases, your doctor may prescribe another medicine during stress or planned surgery.

To avoid reduced adrenal gland function, your doctor may prescribe the lowest effective dose of Dymista to control your allergic rhinitis symptoms.

In children and adolescents, long-term use of nasal corticosteroids (such as Dymista) may affect growth rate. Your doctor will regularly check your child's growth and ensure they use the lowest effective dose.

If you experience blurred vision or other vision disturbances, contact your doctor.

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

Children

Dymista is not recommended for children under 12 years of age.

Dymista and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, including those obtained without a prescription.

Some medicines may increase the effects of Dymista nasal spray, and your doctor may recommend close monitoring if you are taking such medicines (including certain HIV medicines: ritonavir, cobicistat, and antifungal medicines: ketoconazole).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Dymista has a minor influence on the ability to drive and use machines.

Rarely, drowsiness and dizziness may occur, which may be caused by the disease itself or the use of Dymista. In such cases, do not drive or operate machinery. Be aware that drinking alcohol may increase these effects.

Dymista contains benzalkonium chloride.

This medicine contains 14 micrograms of benzalkonium chloride per actuation, which is equivalent to 0.014 mg/0.14 g. Benzalkonium chloride may cause nasal irritation or swelling, especially with prolonged use.

If you experience discomfort during use, tell your doctor or pharmacist.

3. How to use Dymista

Always use Dymista exactly as your doctor has told you.

In case of doubt, consult your doctor or pharmacist.

To get the most benefit from the treatment, Dymista must be used regularly.

Avoid contact with the eyes.

Adults and adolescents (12 years and older)

• Use one dose in each nostril in the morning and evening.

Use in children under 12 years

• Dymista is not recommended for children under 12 years of age.

Use in patients with renal and hepatic impairment

• There are no data available for use in patients with renal and hepatic impairment.

Method of administration

Nasal administration.

Read the instructions carefully and use the medicine only as directed.

INSTRUCTIONS FOR USE

Preparing the spray

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

Figure 1

• 2. If the nasal spray is used for the first time, prime the pump by releasing a dose into the air.
• 3. Prime the pump by placing two fingers on either side of the pump and your thumb on the bottom of the bottle.

• 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 for 5 seconds, moving it up and down, then remove the protective cap (see Figure 1).
• 2. Blow your nose to clear your nostrils.
• 3. Tilt your head forward towards your toes. Do not tilt your head backwards.
• 4. Hold the bottle upright and gently place the tip of the nozzle in one nostril.
• 5. Close the other nostril with your finger, press the pump quickly once, and at the same time, take a gentle breath in (see Figure 3).
• 6. Breathe out through your mouth.

Figure 3

• 7. Repeat the same steps for the other nostril.
• 8. After using the medicine, take gentle breaths and do not tilt your head backwards. This will help prevent the medicine from going down the back of your throat and causing an unpleasant taste (see Figure 4).

Figure 4

• 9. After each use, wipe the nozzle tip with a clean tissue or cloth and replace the protective cap.
• 10. If the spray does not spray, do not try to unblock the nozzle. Wash the nozzle tip with water.

It is essential to use the prescribed dose. Only use the dose prescribed by your doctor.

Duration of treatment

Dymista can be used for a long time. The duration of treatment should match the period during which allergy symptoms occur.

Using a higher dose of Dymista than recommended

If you use too much nasal spray, there is a small chance of side effects. Consult your doctor if you are concerned or if you have been using a higher dose than recommended for a long time. If someone, especially a child, accidentally swallows Dymista, contact a doctor or the nearest hospital emergency department immediately.

Missing a dose of Dymista

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

Stopping treatment with Dymista

Do not stop using Dymista without consulting your doctor, as this may lead to a lack of treatment effectiveness.

If you have any further questions about using 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 (may affect more than 1 in 10 people):

• Nosebleeds

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 administration of the nasal spray. This taste should disappear if you drink a non-alcoholic beverage a few minutes after using the medicine
• Unpleasant odor

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

• Mild irritation inside the nose. This may cause a feeling of tingling, itching, or sneezing
• Dryness in the nose, cough, dry throat, or throat irritation

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

• Dry mouth

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

• Dizziness or drowsiness
• Cataracts, glaucoma, or increased eye pressure, which may cause vision loss and/or eye redness and pain. These side effects have been reported after long-term use of nasal sprays containing fluticasone propionate.
• Skin and nasal mucosa damage
• General malaise, feeling tired, exhausted, or weak
• Rash, itching, or redness of the skin, itchy blisters on the skin
• Bronchospasm (narrowing of the airways)

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

• Swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or breathing, and sudden appearance of 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

If the medicine is used in high doses for a long time, systemic side effects (affecting the whole body) may occur. The likelihood of this is much lower when using nasal corticosteroids than when taking oral corticosteroids. These side effects may vary between patients and with different corticosteroid medicines (see section 2).

Nasal corticosteroids may affect the normal production of hormones in the body, especially when used for a long time in high doses. In children and adolescents, these side effects may cause growth retardation.

In rare cases, decreased bone density (osteoporosis) has been observed when corticosteroids are used nasally for a long time.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the national reporting system (see below).

Side effects can be reported to the Department of Drug Safety, 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

Side effects can also be reported to the marketing authorization holder.

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 stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Do not store in the refrigerator or freeze.

Shelf-life after first opening the bottle: Do not use Dymista after 6 months of first opening the nasal spray.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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.

After each actuation (0.14 g), 137 micrograms of azelastine hydrochloride (= 125 micrograms of azelastine) and 50 micrograms of fluticasone propionate are released.

The other ingredients are disodium edetate, glycerol, microcrystalline cellulose, sodium carmellose, 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 brown glass bottle with a pump spray, nasal applicator, and protective cap in a cardboard box.

The 25 ml bottle contains 23 g of nasal spray suspension (at least 120 doses).

Dymista is available in:

• Packs containing 1 bottle with 23 g of nasal spray suspension.
• Packs 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:

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Germany

Haupt Pharma Amareg GmbH

Donaustaufer Str. 378

93055 Regensburg

Germany

Mylan Hungary Kft

H-2900 Komárom

Mylan utca 1

Hungary

For further information, contact the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

tel.: 22 546 64 00

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

Date of last revision of the package leaflet: 08/2024