AZELASTINE/FLUTICASONE TEVA 137 micrograms/50 micrograms/application NASAL SPRAY SUSPENSION

Introduction

Leaflet: information for the patient

Azelastine/Fluticasone Teva 137 micrograms/50 micrograms/spray suspension for nasal spray

Azelastine hydrochloride / fluticasone propionate

Read the entire leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Azelastine/Fluticasone Teva and what is it used for
2. What you need to know before taking Azelastine/Fluticasone Teva
3. How to use Azelastine/Fluticasone Teva
4. Possible side effects

5 Storage of Azelastine/Fluticasone Teva

1. Package contents and additional information

1. What is Azelastine/Fluticasone Teva and what is it used for

Azelastine/Fluticasone contains two active substances: azelastine hydrochloride and fluticasone propionate.

• Azelastine hydrochloride belongs to a group of medications called antihistamines. Antihistamines work by preventing the effects of substances such as histamine, produced by the body as part of an allergic reaction; in this way, it reduces the symptoms of allergic rhinitis.
• Fluticasone propionate belongs to a group of medications called corticosteroids, which reduce inflammation.

Azelastine/Fluticasone is used to relieve the symptoms of moderate to severe seasonal allergic rhinitis and perennial allergic rhinitis, if treatment with an antihistamine or intranasal corticosteroid alone is considered insufficient.

Seasonal or perennial allergic rhinitis are allergic reactions to substances such as pollen (hay fever), house dust mites, molds, dust, or domestic animals.

Azelastine/Fluticasone relieves the symptoms of allergies, such as: runny nose, postnasal drip, sneezing, itching, or nasal congestion.

2. What you need to know before taking Azelastine/Fluticasone Teva

Do not use Azelastine/Fluticasone Teva

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Azelastine/Fluticasone if:

?? You have recently undergone surgery or have a nose or mouth wound.

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

In these cases, your doctor will decide if you can use azelastine/fluticasone.

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 medication during periods of stress or selective surgery. Do not use it if you are taking sedative medications or medications for the central nervous system.

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 Azelastine/Fluticasone Teva) 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 that 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 azelastine/fluticasone.

Children

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

Other medications and Azelastine/Fluticasone Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription.

Some medications may increase the effects of azelastine/fluticasone, so your doctor will closely monitor you if you are taking these medications (including some for HIV: ritonavir, cobicistat, and medications for the treatment of fungal infections: ketoconazole).

Do not use it if you are taking sedative medications or medications for the central nervous system.

Pregnancy and breastfeeding

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

Driving and using machines

Azelastine/fluticasone 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 azelastine/fluticasone. In these cases, do not drive or operate machinery. Note that alcohol consumption can enhance these effects.

Azelastine/Fluticasone Teva contains benzalkonium chloride

This medication contains 14 micrograms of benzalkonium chloride per spray.

Benzalkonium chloride may cause irritation or inflammation of the nasal mucosa, especially with long-term treatments.

Tell your doctor or pharmacist if you experience discomfort when using the spray.

3. How to use Azelastine/Fluticasone Teva

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

It is essential that the use of azelastine/fluticasone be regular for the therapeutic benefit to be complete.

Avoid contact with the eyes.

Adults and adolescents (over 12 years)

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

Use in children under 12 years

• This medication 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. Shake the bottle gently 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, pressing and releasing it. Shake the bottle gently for 5 seconds, tilting it from top to bottom, and then remove the protective cap (see figure 1) and pump and release the pump once.

Spray method

1. Shake the bottle gently 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 medication from reaching your throat, causing an unpleasant taste (see figure 4).

Figure 4

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

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

Duration of treatment

Azelastine/Fluticasone Teva is suitable for prolonged use. The duration of treatment corresponds to the period during which you experience allergic symptoms.

If you use more Azelastine/Fluticasone Teva than you should

If you apply more of this medication to your nose than you should, it is unlikely that you will have any problems. If in 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 Azelastine/Fluticasone Teva, consult your doctor immediately or go to the nearest medical center, or call the Toxicology Information Service. Phone (91) 562 04 20, indicating the medication and the amount ingested.

If you forget to use Azelastine/Fluticasone Teva

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 missed doses.

If you stop treatment with Azelastine/Fluticasone Teva

Do not stop treatment without consulting your doctor, as this may put the success of your treatment at risk.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience 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 medication.
• Unpleasant odor.

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 pressure in the eye, with possible vision loss and/or redness and eye pain. These side effects have been observed with prolonged treatment with fluticasone propionate nasal sprays.
• Lesions of the skin and mucous membranes 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
• Ulcers in the nose

When this medication is administered at high doses for a prolonged period, systemic side effects (side effects that affect the entire 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 used at high doses 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 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 Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Azelastine/Fluticasone Teva

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the bottle and packaging after "EXP". The expiration date is the last day of the month indicated.

Do not refrigerate or freeze.

Expiration after opening: Discard any unused medication 6 months after first opening the nasal spray.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Azelastina/Fluticasona Teva Composition

• The active ingredients are azelastine hydrochloride and fluticasone propionate.

Each ml 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 (equivalent to 125 micrograms of azelastine) and 50 micrograms of fluticasone propionate.

• The other excipients are disodium edetate, glycerol (E422), microcrystalline cellulose, sodium carmellose, polysorbate 80, benzalkonium chloride, phenylethyl alcohol, and water for injectable preparations.

Product Appearance and Container Content

Azelastina/Fluticasona Teva is a white nasal spray suspension presented in an amber glass bottle, equipped with a spray pump, an applicator, and a protective cap.

Each 25 ml bottle contains 23 g of nasal spray suspension (at least 120 applications).

Each container contains a bottle with 23 g of nasal spray suspension or a multiple container that contains 3 bottles with 23 g, each, of nasal spray suspension.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5, Haarlem,

2031 GA,

Netherlands

Manufacturer

Teva Czech Industries s.r.o.

Ostravská 305/29

Opava-Komárov 747 70

Czech Republic

Local Representative

Teva Pharma, S.L.U.

c/Anabel Segura, 11 Edificio Albatros B, 1ª planta

Alcobendas 28108 Madrid,

Spain

This medicinal product is authorized in the Member States of the European Economic Areaand in the United Kingdom (Northern Ireland)under the following names:

Germany: Azelastin/Fluticason-ratiopharm 137 μg/50 μg pro Sprühstoß Nasenspray, Suspension

Austria: Allergobene 137 Mikrogramm/50 Mikrogramm pro Sprühstoß Nasenspray, Suspension

Bulgaria: Duonase 137 micrograms/50 micrograms per actuation nasal spray, suspension

Czech Republic: Azelastin/Flutikason TEVA

Denmark: Duonasa

Estonia: Azelastine/Fluticasone Teva

Spain: Azelastina/Fluticasona Teva 137 micrograms/50 micrograms/application nasal spray suspension

Finland: Duonasa 125 microg + 50 microg /annos nenäsumute, suspensio

France: AZELASTINE HYDROCHLORIDE/FLUTICASONE PROPIONATE TEVA 137microgrammes/50 microgrammes, suspension pour pulvérisation nasale

Croatia: Rhinaz 137 mikrograma/50 mikrograma po potisku, sprej za nos, suspenzija

Ireland: Duonase 137 micrograms/50 micrograms per actuation, nasal spray, suspension

Iceland: Duonasa

Lithuania: Azelastine/Fluticasone Teva 137 mikrogramai/50 mikrogramu/spusnyje nosies purškalas (suspensija)

Latvia: Azelastine/Fluticasone Teva 137 mikrogrami/50 mikrogrami izsmidzinajuma deguna aerosols, suspensija

Netherlands: Azelastine/Fluticasonpropionaat Teva 137 microgram/50 microgram per verstuiving, neusspray, suspensie

Norway: Azelastine hydrochloride/Fluticasone Teva

Poland: Duonasal

Portugal: Azelastina + Fluticasona Teva

Sweden: Azelastin/Flutikason Teva

Slovakia: Azelastín/Flutikazón Teva 137/50 mikrogramov

Date of the last revision of thisleaflet:August 2023

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

You can access detailed and updated information about this medicinal product by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89443/P_89443.html