AZANESON

Package leaflet: Information for the patient

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them 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.

Contents of the leaflet

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

1. What Azaneson is and what it is used for

Azaneson 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 during an allergic reaction – thereby reducing the symptoms of allergic rhinitis (inflammation inside the nose caused by a substance to which the patient is allergic).
• Fluticasone propionate belongs to a group of medicines called corticosteroids, which reduce inflammation.

Azaneson is used to relieve symptoms of moderate to severe seasonal and perennial allergic rhinitis when treatment with other intranasal medicines containing either an antihistamine or a corticosteroid alone is considered insufficient.
Seasonal and perennial allergic rhinitis are types of allergic reactions to substances such as: pollen (hay fever), house dust mites, mould spores, dust, or pet dander.
Azaneson relieves allergy symptoms such as nasal discharge, postnasal drip, sneezing, itching, or nasal congestion.

2. Important information before using Azaneson

When not to use Azaneson:

• 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 Azaneson, discuss the following with your doctor or pharmacist:

• If the patient has recently undergone nasal surgery.
• If the patient has an infection in the nose. Infections of the nasal passages should be treated with antibacterial or antifungal medicines. Patients who have been treated for nasal infections may continue to treat their allergy with Azaneson.
• If the patient has tuberculosis or an untreated infection.
• 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 Azaneson.
• If the patient has adrenal gland function disorders. Caution is advised when switching from systemic steroid therapy to treatment with Azaneson.
• If the patient has severe liver disease. This increases the risk of systemic adverse effects.

In such cases, the decision on whether Azaneson can be used will be made by the doctor.
It is important to use the medicine at the dose indicated in section 3 below or as directed by the
attending physician. Intranasal use of corticosteroids in doses higher than recommended may
suppress adrenal function (the adrenal glands do not produce adequate amounts of cortisol), a condition
that may lead to weight loss, fatigue, muscle weakness, low blood sugar, increased salt craving,
joint pain, depression, and darkening of the skin. 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 that
still controls symptoms of nasal mucosal inflammation.
In children and adolescents, long-term intranasal use of corticosteroids (such as Azaneson) may
slow down the rate of growth. The doctor will regularly monitor the child's growth and ensure that
the child is taking the lowest effective dose possible.
Contact your doctor if the patient experiences blurred vision or other visual disturbances.
If in doubt whether any of the above conditions apply to the patient, consult a doctor or pharmacist
before starting treatment with Azaneson.
Children
This medicine is not recommended for children under 12 years of age.
Azaneson and 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, including those available without a
prescription.
Some medicines may increase the effect of Azaneson, and the doctor may recommend careful
monitoring of the patient's condition if such medicines are taken (including certain drugs used in
HIV infection: ritonavir or cobicistat, and antifungal drugs: ketoconazole).
Pregnancy and breastfeeding
If the patient is pregnant or 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 using machines
Azaneson has a minor influence on the ability to drive and use machines.
Very rarely, fatigue or dizziness may occur, which may be caused by the disease itself or by the use
of Azaneson. In such cases, the patient should not drive or operate machinery.
Azaneson and alcohol
Be aware that drinking alcohol may worsen feelings of fatigue or dizziness caused by the disease
itself or by the use of Azaneson.
Azaneson contains benzalkonium chloride
This medicine contains 14 micrograms of benzalkonium chloride per spray. Benzalkonium
chloride may cause irritation or swelling inside the nose, especially if used for a prolonged period.
Inform your doctor or pharmacist if the patient experiences discomfort while using the aerosol.

3. How to use Azaneson

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.
For optimal treatment results, Azaneson must be used regularly.
Avoid contact with the eyes.

Adults and adolescents (aged 12 years and older)

• One sprayed dose into each nostril in the morning and evening is recommended.

Use in children under 12 years of age

• Use of this medicine is not recommended in children under 12 years of age.

Use in patients with renal or hepatic impairment

• There is no data available on the use of Azaneson 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
If the nasal spray is being used for the first time, or if it has not been used for a period of time, the pump must be primed to ensure delivery of the correct dose. To do this, perform the following steps:

1. Gently shake the bottle with an up-and-down motion, then remove the protective cap.
2. Hold the bottle upright and spray the medicine into the air by pressing and releasing the pump:
   • 7 times, if the spray is used for the first time.
   • 3 times, if the spray has not been used for more than 7 days.

Using the spray

1. Gently shake the bottle with an up-and-down motion, then remove the protective cap.
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 carefully insert the spray nozzle into one nostril.
5. Block the other nostril with a finger, press the pump once quickly, and at the same time inhale gently.
6. Breathe out through your mouth.
7. Repeat steps 3 to 5 for the other nostril.

Cleaning the spray nozzle

1. It is important to wipe the spray nozzle and protective cap with a clean, dry tissue after each use. Otherwise, the spray may not function properly the next time it is used. Do not remove the spray nozzle!
2. Do not attempt to unblock the nozzle by inserting a pin or other sharp object, as this may damage the device and prevent it from delivering the correct dose.

It is important to use the dose prescribed by your doctor. Always follow the dosage instructions given by your doctor.
Duration of treatment
Azaneson may be used long-term. The duration of treatment should correspond to the period during which allergy symptoms occur.
Overdose of Azaneson
If too high a dose of this nasal medicine is used, the likelihood of complications is low. However, consult your doctor if you have any concerns or if a higher than recommended dose has been used for a prolonged period. If anyone, especially a child, accidentally swallows Azaneson, contact a doctor or the nearest hospital emergency department immediately.
Missed dose of Azaneson
Use the nasal spray as soon as you remember, then take the next dose at the usual time. Do not use a double dose to make up for a missed dose.
Stopping Azaneson treatment
Do not stop using Azaneson without consulting your doctor, as this may result in loss of treatment effectiveness.
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 less 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 odour

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

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

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

• Dryness in the mouth

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

• Dizziness, drowsiness or fatigue
• 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.
• Damage to the internal nasal wall dividing the nasal cavity into two parts (nasal septum perforation), damage to the skin and nasal mucosa
• Malaise, feeling of tiredness, exhaustion or weakness
• Rash, itching or redness of the skin, itchy skin blisters
• 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 are very rare (affecting less than 1 in 10,000 people).

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

• Blurred vision
• Ulceration of the nasal mucosa

Systemic side effects (side effects affecting the whole body) may occur when this medicine is used in high doses over a long period of time. The likelihood of such effects is significantly lower with corticosteroids administered as a nasal spray compared to oral corticosteroid therapy. These side 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 at high doses. In children and adolescents, these side effects may cause a slowing of 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 unlisted side effects not mentioned in this leaflet, inform 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 to the marketing authorization holder.

Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Azaneson

Keep this medicine out of the 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 freeze.
Always replace the protective cap.
Shelf life 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. Such measures help protect the environment.

6. Contents of the pack and other information

What Azaneson 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 (0.14 g) delivers 137 micrograms of azelastine hydrochloride (= 125 micrograms of azelastine) and 50 micrograms of fluticasone propionate.
• Other ingredients are: disodium edetate, glycerol, microcrystalline cellulose (E460i) and sodium carboxymethylcellulose (E466), polysorbate 80 (E433), benzalkonium chloride, phenylethyl alcohol and purified water.

What Azaneson looks like and contents of the pack
Azaneson is a white suspension. Azaneson is available in an amber glass bottle equipped with a metering pump and a protective cap.
The bottle contains at least 120 doses of medication, packed in a cardboard box.
Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. +48 42 22 53 100
Manufacturer
Basic Pharma Manufacturing B.V.
Burgemeester Lemmensstraat 352
6163 JT Geleen
The Netherlands
This medicinal product is authorised in the member countries of the European Economic Area under the following names:
The Netherlands: Azelastine / fluticasonpropionaat Aflofarm
Poland: Azaneson