Dymol

Package leaflet: Information for the patient

Dymol, (137 micrograms + 50 micrograms)/dose nasal spray, suspension
Azelastini hydrochloridum + Fluticasoni propionas
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please 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 someone else, even if their symptoms are the same.
• If you experience any adverse effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Dymol is and what it is used for
2. Important information before using Dymol
3. How to use Dymol
4. Possible side effects
5. How to store Dymol
6. Contents of the pack and other information

1. What Dymol is and what it is used for

Dymol 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.

Dymol 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 pollens (hay fever), house dust mites, mould spores, dust, or pet dander.
Dymol helps relieve allergy symptoms such as nasal discharge, postnasal drip, sneezing, nasal itching, and nasal congestion.

2. Important information before using Dymol

When not to use Dymol

• 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 Dymol, discuss this 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 using Dymol.
• If the patient has tuberculosis or 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 Dymol.
• If the patient has adrenal gland function disorders. Caution should be exercised when switching from systemic steroid therapy to treatment with Dymol.
• If the patient has severe liver disease. In such cases, the risk of systemic adverse effects increases.

In these situations, the decision on whether Dymol can be used will be made by the treating physician.
It is important that the patient uses the medicine at the dose indicated below in section 3 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 levels, increased salt craving, joint pain, depression, and darkening of the skin 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 Dymol that still adequately controls symptoms of nasal mucosal inflammation.
In children and adolescents, long-term use of intranasal corticosteroids (such as Dymol) may slow growth rate. The doctor will regularly monitor the child's growth and ensure that the child is receiving the lowest effective dose.
If the patient experiences blurred vision or other visual disturbances, medical advice should be sought.
If in doubt whether any of the above conditions apply, consult a doctor or pharmacist before starting treatment with Dymol.

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

Dymol and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including over-the-counter medicines and those planned for future use.
Some medicines may increase the effect of Dymol 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: ketoconazole).

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

Driving and operating machinery
Dymol has minor influence on the ability to drive and operate machinery.
Very rarely, fatigue and dizziness may occur, which could be caused either by the underlying illness or by Dymol treatment. In such cases, driving and operating machinery should be avoided. Be aware that alcohol consumption may worsen these effects.

Dymol 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.

3. How to use Dymol

This medicine should always be used exactly as directed by a doctor or pharmacist. In case of doubt,
consult a doctor or pharmacist.
For optimal benefit, Dymol must be used regularly.
Avoid contact with the eyes.

Adults and adolescents (aged 12 years and older)

• It is recommended to use one dose 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 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 the thumb supporting 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 the nose to clear the nasal passages.
3. Keep the head tilted forward, towards the toes. Do not tilt the head backward.
4. Hold the bottle upright and gently insert the spray 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 the mouth.

Figure 3

7. Repeat the same procedure for the other nostril.
8. After administering the medicine, breathe in gently and do not tilt the 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 spray 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 the doctor. Only use the dosage recommended by your doctor.

Duration of treatment
Dymol 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 Dymol
If too much nasal medicine is used, the likelihood of complications is low. However, consult a 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 Dymol, contact a doctor or the nearest hospital emergency department immediately.

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

Stopping Dymol treatment
Do not stop using Dymol without consulting your doctor, due to the risk of reduced treatment effectiveness.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
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.

Other adverse effects include:
Very common adverse effects (may occur in more than 1 in 10 people):

• Nosebleeds

Common adverse effects (may occur in less than 1 in 10 people):

• Headache
• Bitter taste in the mouth, especially if the patient tilts their head backward during administration of the nasal spray. This taste should disappear if the patient drinks a non-alcoholic beverage a few minutes after using the medicine
• Unpleasant odour

Uncommon adverse effects (may occur in less than 1 in 100 people):

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

Rare adverse effects (may occur in less than 1 in 1,000 people):

• Dryness in the mouth

Very rare adverse effects (may occur in less than 1 in 10,000 people):

• Dizziness or drowsiness
• Cataract, glaucoma or increased eye pressure, which may lead to loss of vision and/or redness and eye pain. These adverse effects have been reported after prolonged use of nasal spray containing fluticasone propionate
• Damage to the skin and nasal mucosa
• 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)

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

• Blurred vision
• Nasal mucosal ulceration

When the medicine is used in high doses over a long period, systemic adverse 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 adverse effects may cause growth suppression.
Rare cases of decreased bone density (osteoporosis) have been observed with long-term nasal administration of corticosteroids.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can 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, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Dymol medicine

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle and the carton,
following: EXP. The expiry date refers to the last day of the stated month.
Do not store in the refrigerator or freeze.
Period of validity after first opening the bottle: Unused medicine should be discarded 6 months after
first opening the nasal aerosol bottle.
Medicines must 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 the medicine Dymol 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 actuation of the pump (0.14 g) delivers 137 micrograms of azelastine hydrochloride
(corresponding to 125 micrograms of azelastine) and 50 micrograms of fluticasone propionate.
The other ingredients are: disodium edetate, glycerol, microcrystalline cellulose, sodium carboxymethylcellulose,
polysorbate 80, benzalkonium chloride, phenylethyl alcohol, and purified water.

What Dymol looks like and contents of the pack
Dymol is a white, homogeneous suspension.
Dymol is available in an amber glass bottle with a metering spray pump, nasal applicator, and protective cap,
packaged in a cardboard box.
The 10 ml bottle contains 6.4 g of nasal aerosol in the form of a suspension (providing at least 28 doses).
The 25 ml bottle contains 23 g of nasal aerosol in the form of a suspension (providing at least 120 doses).
Dymol is available in:

• Packs containing 1 bottle with 6.4 g of nasal aerosol as a suspension
• Packs containing 1 bottle with 23 g of nasal aerosol as a suspension
• Multipacks containing 10 bottles, each with 6.4 g of nasal aerosol as a suspension
• Multipacks containing 3 bottles, each with 23 g of nasal aerosol as a suspension

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris 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. / Mylan Hungary Ltd
Mylan utca 1
2900 Komárom
Hungary
Madaus GmbH
Lütticher Straße 5
53842 Troisdorf
Germany

For further information on this medicine, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel.: +48 22 546 64 00

This medicine is authorised in the European Economic Area under the following names: