AZERIX 137/50 micrograms/application nasal spray suspension

2. What you need to know before taking Azerix

Do not use Azerix

• If you are allergic to azelastine hydrochloride or fluticasone propionate or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine if:

• You have recently undergone nasal surgery.
• You have a nasal infection. Nasal respiratory infections should be treated with antibiotics or antifungals. If you have been given medication for a nasal infection, you can continue using this medicine to treat your allergy.
• You have tuberculosis or an untreated infection.
• You have changes in vision or a history of elevated eye pressure, glaucoma, and/or cataracts. If you have some of these diseases, you will be closely monitored during the use of this medicine.
• You have impaired adrenal function. Caution should be exercised when switching from systemic steroid treatment to this medicine.
• You have severe liver disease. The risk of systemic side effects will increase.

In these cases, your doctor will decide if you can use this medicine.

It is essential that you take the dose indicated in section 3 or the dose indicated by your doctor. Treatment with higher doses of corticosteroids than recommended may lead to adrenal suppression, which can cause weight loss, fatigue, muscle weakness, low blood sugar levels, salt cravings, joint pain, depression, and skin darkening. If you experience any of these side effects, your doctor may recommend another medicine during periods of stress or elective surgery.

To avoid adrenal suppression, your doctor will advise you to take the lowest dose that maintains effective control of rhinitis symptoms.

The use of nasal corticosteroids (such as this medicine) may cause slower growth in children and adolescents when used for a long period. The doctor will regularly monitor the growth of children and ensure they take the lowest effective dose possible.

Contact your doctor if you experience blurred vision or other visual disturbances.

If you are not sure if you are in any of the above situations, consult your doctor or pharmacist before using this medicine.

Children

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

Other medicines and Azerix

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine, including those obtained without a prescription.

Some medicines may increase the effects of this medicine, so your doctor may want to monitor you closely if you are taking these medicines (including some for HIV: ritonavir, cobicistat, and medicines for the treatment of fungal infections: ketoconazole).

Pregnancy andbreastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

This medicine has a minimal influence on the ability to drive and use machines.

Very rarely, you may experience fatigue or dizziness due to the disease itself or during the use of this medicine. In these cases, do not drive or operate machinery. Note that alcohol consumption can enhance these effects.

Azerix contains benzalkonium chloride

This medicine contains 14 micrograms (0.014 mg) of benzalkonium chloride per application.

Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for long periods of treatment. Inform your doctor or pharmacist if you feel discomfort when using the spray.

3. How to take Azerix

Follow the administration instructions of this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

It is essential that the use of this medicine is regular for the therapeutic benefit to be complete.

Avoid contact with the eyes.

Adults and adolescents (12 years and older)

• The recommended dose is one application in each nostril in the morning and at night.

Use in children under 12 years

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

Use in case of renal and hepatic insufficiency

• There are no data available in patients with renal and hepatic insufficiency.

Method of administration

Nasal route.

Read the following instructions carefully and use the product only as indicated.

INSTRUCTIONS FOR USE

Preparation of the spray

1. Gently shake the bottle for 5 seconds, tilting it from top to bottom, and then remove the protective cap (see figure 1).

Figure 1

1. The first time you use the nasal spray, you need to activate the pump by spraying it into the air.
2. Activate the pump by placing two fingers on either side of the spray pump and placing your thumb on the base of the bottle.
3. Pump and release the pump 6 times, until a fine spray appears (see figure 2).
4. Now, the pump is activated and ready to use.

Figure 2

1. If you have not used the nasal spray for more than 7 days, you will need to reactivate the pump by pressing and releasing it.

Spray method

1. Gently shake the bottle for 5 seconds, tilting it from top to bottom, and then remove the protective cap (see figure 1).
2. Blow your nose to clear your nostrils.
3. Keep your head tilted forward. Do not tilt your head back.
4. Keep the bottle upright and carefully insert the tip of the spray into one nostril.
5. Close the other nostril with your finger, pump quickly once, and at the same time, make a gentle inhalation (see figure 3).
6. Breathe through your mouth.

Figure 3

1. Repeat the operation in the other nostril.
2. Breathe gently, and do not tilt your head back after application. This prevents the medicine from reaching your throat, causing an unpleasant taste (see figure 4).

Figure 4

1. After each use, clean the tip of the spray with a tissue or clean cloth, and replace the protective cap.
2. Do not pinch the nozzle if the spray is not obtained. Clean the valve with water.

It is essential that you use the prescribed dose. Use only the amount recommended by your doctor.

Duration of treatment

This medicine is suitable for prolonged use. The duration of treatment corresponds to the period during which you experience allergic symptoms.

If you use more Azerix than you should

If you apply more of this medicine to your nose than you should, it is unlikely that you will have any problems. In case of doubt, or if you have used a higher dose than recommended for a long time, consult your doctor. If a person, especially a child, accidentally drinks this medicine, consult your doctor immediately or go to the nearest medical center.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Azerix

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

If you stop treatment with Azerix

Do not stop treatment with this medicine without consulting your doctor, as it may put your treatment at risk.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Very common side effects (may affect more than 1 in 10 people):

• Nasal bleeding.

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 the use of the nasal spray. This taste should disappear if you drink a soft drink a few minutes after using this medicine.
• Unpleasant smell.

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

• Mild irritation of the inside of the nose, which can cause mild itching, itching, or sneezing.
• Nasal dryness, cough, throat dryness, 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, with possible vision loss and/or eye redness and pain. These side effects have been observed with prolonged treatment with fluticasone propionate nasal sprays.
• Skin and mucous membrane lesions of the nose.
• Feeling of discomfort, fatigue, exhaustion, or weakness.
• Rash, redness, or itching of the skin, hives.
• Bronchospasm (narrowing of the airways in the lungs).

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

• Swelling of the face, lips, tongue, or throat, which may make swallowing/breathing difficult and sudden appearance of rash on the skin.These could be signs of a severe allergic reaction. Note that this is very rare.

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

• Blurred vision.
• Nasal ulcers.

When this medicine is administered at high doses for a prolonged period, systemic side effects (side effects that affect the whole body) may occur. The likelihood of these effects is much lower if a nasal corticosteroid spray is used instead of oral corticosteroids. These effects may vary between individual patients and between different corticosteroid preparations (see section 2).

Corticosteroid nasal sprays may affect the normal production of hormones in your body, especially if high doses are used for a long time. In children and adolescents, this side effect may cause slower growth.

In rare cases, a reduction in bone density (osteoporosis) occurs when corticosteroids are administered nasally for a long period.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Azerix

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

Do not use this medicine after the expiration date stated on the label of the bottle and on the carton after "EXP". The expiration date is the last day of the month indicated.

Do not refrigerate or freeze.

Expiration after first opening: Discard any unused medicine 1 year after opening the nasal spray for the first time.

Medicines should not be disposed of through wastewater or household waste. Deposit the containers and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Azerix

The active ingredients are: azelastine hydrochloride and fluticasone propionate.

Each gram of suspension contains 1,000 micrograms of azelastine hydrochloride and 365 micrograms of fluticasone propionate.

Each application (0.14 g) releases 137 micrograms of azelastine hydrochloride (= 125 micrograms of azelastine) and 50 micrograms of fluticasone propionate (= 36 micrograms of fluticasone).

The other ingredients (excipients) are: disodium edetate, glycerol, microcrystalline cellulose (E 460), sodium carmellose (E 466), polysorbate 80 (E 433), benzalkonium chloride (see section 2 "Azerix contains benzalkonium chloride"), phenylethyl alcohol, and purified water.

Appearance of the product and package contents

This medicine is a homogeneous white suspension.

This medicine is presented in a 23 g amber glass bottle (Type I) with a spray pump, applicator, and protective cap.

The bottle contains 23 g of nasal spray suspension (at least 120 applications).

This medicine is presented in a 25 ml bottle with 23 g of suspension or a multiple pack containing 3 bottles, each with 23 g of suspension.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Especialidades Farmacéuticas Centrum, S.A.

C/ Sagitario, 14

03006 Alicante

Spain

Tel.: 965286700

Fax: 965286434

Email: [email protected]

Manufacturer

Kevaro Group Ltd

Ulitsa Tsaritsa Eleonora 9 Office 23, floor 5

1618 Sofia,

Bulgaria

Or

Adalvo Limited

Sir Temi Zammit Buildings

4 Malta Life Sciences Park Building 1 Level

San Gwann 3000

Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Finland Azerix 137 mikrog. + 50 mikrog./annos, nenäsumute, suspensio

Spain Azerix 137 micrograms/50 micrograms/dose nasal spray suspension

Date of the last revision of thisleaflet:November 2024.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).