Azaneson

Leaflet accompanying the packaging: patient information

Azaneson

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

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not mentioned in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Azaneson and what is it 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 packaging and other information

1. What is Azaneson and what is it 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 as part of an allergic reaction - thus 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 the symptoms of seasonal and perennial allergic rhinitis of moderate to severe severity, if the use of other nasal sprays containing only an antihistamine or corticosteroid is considered insufficient.

2. Important information before using Azaneson

When not to use Azaneson:

• If the patient is allergic to azelastine hydrochloride or fluticasone propionate, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Azaneson, you should discuss this with your doctor or pharmacist:

• If the patient has recently undergone nasal surgery.
• If the patient has a nasal infection. Nasal infections should be treated with antibacterial or antifungal medicines. People who have been given medicines for a nasal infection can still treat their allergy with Azaneson.
• If the patient has tuberculosis or an untreated infection.
• If the patient notices a change in vision or has been diagnosed with increased intraocular pressure, glaucoma, and/or cataract. People with these conditions will be closely monitored while using Azaneson.
• If the patient has adrenal gland problems. Caution is advised when switching from systemic steroid therapy to Azaneson treatment.
• If the patient has severe liver disease. This increases the risk of systemic side effects.

In such cases, the doctor will decide whether Azaneson can be used.

Children

Azaneson is not recommended for use in children under 12 years of age.

Azaneson and other medicines

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

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

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

Azaneson with alcohol

Be aware that drinking alcohol may increase the feeling of tiredness or dizziness caused by the disease or the use of Azaneson.

Azaneson contains benzalkonium chloride

This medicine contains 14 micrograms of benzalkonium chloride in each spray.

3. How to use Azaneson

This medicine should always be used exactly as your doctor has told you.

Adults and adolescents (12 years and older)

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

Use in children under 12 years

• Azaneson is not recommended for use in children under 12 years of age.

Use in patients with renal or hepatic impairment

• There are no data on the use of Azaneson in patients with renal or hepatic impairment.

Method of administration

For nasal use only.

INSTRUCTIONS FOR USE

Preparing the nasal spray

If the nasal spray is used for the first time or the medicine has not been used for some time, you need to prepare the pump to get the correct dose.

• 1. Gently shake the bottle, moving it up and down, then remove the protective cap.
• 2. Hold the bottle upright and spray the medicine into the air, 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 nasal spray

• 1. Gently shake the bottle, moving it up and down, then remove the protective cap.
• 2. Blow your nose to clear your nostrils.
• 3. Tilt your head forward towards your toes. Do not tilt your head back.
• 4. Hold the bottle upright and carefully place the tip of the nozzle in one nostril.
• 5. Block the other nostril with your finger, quickly press the pump once, and breathe in gently at the same time.

• 6. Breathe out through your mouth.
• 7. Repeat steps 3 to 5 for the other nostril.

Cleaning the nozzle

• 1. It is important to clean the nozzle tip and protective cap with a clean and dry tissue after each use. Otherwise, the spray may not work properly next time. Do not remove the nozzle tip!
• 2. Do not try to unblock the nozzle tip by inserting a needle or other sharp object, as this will damage it and it will no longer deliver the correct dose.

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

Duration of treatment

Azaneson can be used for a long time.

Use of a higher than recommended dose of Azaneson

In case of using too much of this medicine, there is a small likelihood of any complications.

Missing a dose of Azaneson

Use the nasal spray as soon as you remember, and use the next dose at the usual time.

Stopping the use of Azaneson

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

4. Possible side effects

Like all medicines, Azaneson 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 while spraying the medicine into your nose.
• Unpleasant smell

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

• Mild irritation inside the nose.
• Dryness in the nose, cough, dryness in the throat, or irritation of the throat.

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

• Dryness in the mouth.

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

• Dizziness, drowsiness, or sleepiness.
• Cataract, glaucoma, or increased pressure in the eye, which may cause loss of vision and/or redness and eye pain.
• Damage to the nasal septum, damage to the skin and mucous membrane of the nose.
• Feeling unwell, tiredness, exhaustion, or weakness.
• Rash, itching, or redness of the skin, itchy blisters on the skin.
• Bronchospasm (narrowing of the airways).

You should seek medical attention immediately if you experience any of the following symptoms:

• Swelling of the face, lips, tongue, or throat, which may cause difficulty in swallowing or breathing, as well as sudden appearance of skin rash.These may be symptoms of a severe allergic reaction. These symptoms occur very rarely (less than 1 in 10,000 people).

Side effects with unknown frequency (cannot be estimated from the 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 for a long time.

5. How to store Azaneson

Keep this medicine out of the sight and reach of children.

6. Contents of the packaging and other information

What Azaneson contains

• The active substances are azelastine hydrochloride and fluticasone propionate.
• The other ingredients are disodium edetate, glycerol, microcrystalline cellulose, and sodium carmellose, polysorbate 80, benzalkonium chloride, phenylethyl alcohol, and purified water.

What Azaneson looks like and contents of the pack

Azaneson is a white suspension.

Marketing authorisation holder

Aflofarm Farmacja Polska Sp. z o.o.

Manufacturer

Basic Pharma Manufacturing B.V.

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Netherlands: Azelastine / fluticasonpropionaat Aflofarm

Poland: Azaneson