Azecort

Package leaflet: Information for the patient

Azecort
(137 micrograms + 50 micrograms)/dose nasal aerosol, suspension
Azelastine hydrochloride + Fluticasone propionate
Please read the entire 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 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 reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Azecort and what is it used for

Azecort 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.

Azecort is used for symptomatic treatment of severe seasonal allergic rhinitis (seasonal allergic inflammation of the nasal mucosa) in adults.
Seasonal allergic rhinitis is a type of allergic reaction to substances such as plant pollens (hay fever).
Azecort relieves symptoms of seasonal allergies, such as nasal discharge, postnasal drip, sneezing, nasal itching, and nasal congestion.

2. Important information before using Azecort

When not to use Azecort:

• 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 Azecort, discuss with your doctor or pharmacist:

• if the patient has recently undergone nasal surgery
• if the patient has a nasal infection. Nasal passage infections should be treated with antibacterial or antifungal medicines. Patients who have been treated for nasal infections may continue to treat seasonal allergies using Azecort.
• if the patient suffers from tuberculosis or has untreated infections
• if the patient is taking or has recently taken other medicines containing corticosteroids
• if the patient has noticed 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 Azecort.
• if the patient has adrenal gland function disorders. Caution should be exercised when switching from systemic steroid therapy to treatment with Azecort.
• if the patient has severe liver disease. In this case, the risk of systemic adverse effects increases.

In these cases, the decision on whether Azecort 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 lead to adrenal suppression, a condition in which reduced body weight, 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 a planned surgical procedure.
To avoid adrenal suppression, the doctor may recommend using the lowest effective dose that still adequately controls symptoms of nasal mucosal inflammation.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
If in doubt whether any of the above conditions apply, consult a doctor or pharmacist before starting to use Azecort.

Children and adolescents
Use of this medicine is not recommended in children and adolescents under 18 years of age.
Long-term use of intranasal corticosteroids may suppress growth rate in children and adolescents.

Azecort with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines may increase the effect of Azecort nasal aerosol, 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 have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
Azecort has minimal 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 the use of Azecort. In such cases, patients should not drive or operate machinery. Be aware that alcohol consumption may worsen these effects.

Azecort 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 a prolonged period. If the patient experiences discomfort during use of the aerosol, inform the doctor or pharmacist.

3. How to use Azecort

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
For optimal benefit, Azecort must be used regularly.
Adults

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

Use in children and adolescents under 18 years of age

• This medicine is not recommended for use in children and adolescents under 18 years of age.

Use in patients with kidney or liver function impairment

• There is no data available regarding use in patients with kidney or liver function impairment.

Method of administration
Nasal administration (use in the nose).
Avoid contact with eyes. Do not swallow.
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 aerosol is being used for the first time, prime the pump by releasing a dose into the air.
3. To prime the pump, place two fingers on either side of the nozzle and the thumb at 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 aerosol 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 nasal passages.
3. Keep your head tilted forward, towards your toes. Do not tilt your head backward.
4. Hold the bottle upright and gently insert the spray tip into one nostril.
5. Block the other nostril with a finger, press the pump quickly once, and at the same time inhale gently (see Figure 3).
6. Exhale through the mouth.

Figure 3

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

Figure 4

9. After each use, wipe the spray tip with a clean tissue or cloth and replace the protective cap.
10. If the aerosol does not spray, do not pierce the spray tip. Wash the spray tip 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
Azecort 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 Azecort
If too large a dose of the nasal spray is used, the likelihood of complications is low. 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 Azecort, contact a doctor or the nearest hospital emergency department immediately.
Missed dose of Azecort
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 Azecort treatment
Do not stop using Azecort 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, this medicine 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, especially if the patient tilts their head backwards when using 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 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, dryness or soreness in the 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 spray containing fluticasone propionate.
• Damage to the skin and mucous membrane of the nose
• 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 onset of skin rash. These may be symptoms of a severe allergic reaction. Note: These symptoms occur very rarely.

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 for a prolonged period, systemic 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 treatment. These effects may vary between individual patients and depending on the corticosteroid medicine used (see section 2). Nasally administered corticosteroids may affect normal hormone production processes in the body, especially when used long-term in high doses. In children and adolescents, these side effects may cause a reduction in growth rate. Cases of decreased bone density (osteoporosis) have been rarely observed with long-term use of intranasal corticosteroids.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side 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
Side effects can also be reported directly to the Marketing Authorisation Holder.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Azecort medicine

Keep this medicine out of 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 stated month.
Do not store in the refrigerator or freeze.
Shelf life after first opening of the bottle: Unused medicine should be discarded 6 months after first opening of the nasal aerosol.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What the medicine Azecort 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 Azecort looks like and contents of the pack
Azecort is a white, homogeneous suspension.
Azecort is available in an amber glass bottle with a spray pump, nasal applicator, and cap, packed in a cardboard box.
The 10 ml bottle contains 6.4 g of nasal aerosol in the form of a suspension (at least 28 doses).
The 25 ml bottle contains 23 g of nasal aerosol in the form of a suspension (at least 120 doses).
Azecort 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 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 on this medicinal product, please contact
the representative of the marketing authorisation holder:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00
This medicinal product is authorised for sale in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: