Prospecto:information for the patient

Azelastina/Fluticasona Teva 137 micrograms/50 micrograms/application nasal spray

Hidrocloruro de azelastina/ propionato de fluticasona

Read this prospectus carefully before starting to use this medication,because it contains important information for you.

-Keep this prospectus, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribedonlyto you, and you must not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

• If you experience adverse effects,consult your doctor or pharmacist,eveniftheyare not listed in this prospectus. See section 4.

1.What isAzelastina/Fluticasona Tevaand for what it is used

2.What you need to knowbeforestarting touseAzelastina/Fluticasona Teva

3.How to useAzelastina/Fluticasona Teva

4.Possible adverse effects

5Storage ofAzelastina/Fluticasona Teva

6.Contents of the package and additional information

Azelastina/Fluticasonacontains two active substances: azelastine hydrochloride and fluticasone propionate.

• Azelastine hydrochloride belongs to a group of medicines called antihistamines. Antihistamines act by preventing the effects of substances such as histamine, produced by the body 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.

Azelastina/Fluticasona 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, moulds, dust or domestic animals.

Azelastina/Fluticasona relieves allergy symptoms, for example: runny nose, postnasal drip, sneezing, itching or nasal congestion.

Do not use Azelastina/Fluticasona Teva

• if you are allergic to hydrochloride of azelastine or propionate of fluticasone 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 Azelastina/Fluticasona if:

??You have recently undergone an operation or have a nose or mouth injury.

• 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 may continue to use azelastine/fluticasone to treat your allergy.
• You have tuberculosis or an untreated infection.
• You have vision changes or a history of high intraocular pressure, glaucoma, and/or cataracts. If you have any of these conditions, you will be closely monitored during the use of azelastine/fluticasone.
• You have adrenal function impairment. You should be cautious when switching from systemic steroid treatment to azelastine/fluticasone.
• You have severe liver disease. The risk of systemic adverse effects will increase.

Your doctor will decide whether you can use azelastine/fluticasone in these cases.

It is essential to take the recommended dose in section 3 or the dose prescribed by your doctor. Treatment with higher doses of corticosteroid nasal sprays than recommended may lead to adrenal suppression, which can cause weight loss, fatigue, muscle weakness, low blood glucose levels, salt cravings, joint pain, depression, and skin darkening. If you experience any of these adverse effects, your doctor may recommend another medication during periods of stress or selective surgery. Do not use it if you are taking sedatives or central nervous system medications.

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

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

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

If you are unsure whether you are in any of the above situations, consult your doctor or pharmacist before using azelastine/fluticasone.

Children

This medication is not recommended for children under 12 years old.

Other medications and Azelastina/Fluticasona Teva

Inform 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 perform close monitoring if you are taking these medications (including some for HIV: ritonavir, cobicistat, and medications for fungal infections: ketoconazole).

Do not use it if you are taking sedatives or central nervous system medications.

Pregnancy and breastfeeding

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

Driving and operating machinery

Azelastine/fluticasone has a minimal influence on the ability to drive and operate machinery.

Very rarely, you may experience fatigue or drowsiness 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 may enhance these effects.

Azelastina/Fluticasona Teva contains benzalkonium chloride

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

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

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of 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 nasal fossa, in the morning and at night.

Use in children under 12 years

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

Use in case of renal and hepatic insufficiency

• No data is available in patients with renal and hepatic insufficiency.

Administration form

Nasal route.

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

USAGE INSTRUCTIONS

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 the nasal spray is used, the pump must be activated by spraying into the air.
2. Activate the pump by placing two fingers on either side of the spray pump and your thumb on the base of the bottle.
3. Pulse 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 the nasal spray has not been used for more than 7 days, the pump will need to be reactivated by pressing and releasing it once.Shake the bottle gently for 5 seconds, tilting it from top to bottom, and then remove the protective cap (see Figure 1) and pulse 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 the nasal fossae.
3. Keep your head tilted forward. Do not tilt your head back.
4. Hold the bottle upright and carefully insert the spray tip into one nasal fossa.
5. Close the other nasal fossa with your finger, pulse quickly once, and at the same time, take a gentle breath (see Figure 3).
6. Breathe through your mouth.

Figure 3

1. Repeat the procedure in the other nasal fossa.
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 clean tissue or cloth and replace the protective cap.
2. Do not pierce the nozzle if the spray does not come out. Clean the valve with water.

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

Treatment duration

Azelastine/Fluticasone Tevais suitable for long-term use. The treatment duration 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, it is unlikely that you will experience any problems. In case of doubt, or if you have used a higher dose than recommended for a long period, consult your doctor. If someone, especially a child, accidentally ingests Azelastine/Fluticasone Teva, consult your doctor immediately or go to the nearest medical center, or call the Toxicological 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 compensate for the missed doses.

If you interrupt treatment with Azelastine/Fluticasone Teva

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

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

Like all medicines, this medicine may 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 while using the nasal spray. This taste should disappear if you drink a soft drink a few minutes after using this medicine.
• Unpleasant odor.

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

• Mild irritation of the inside of the nose, which may cause mild burning, itching, or sneezing.
• Nasal dryness, cough, dry throat, or throat irritation.

Uncommon 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):

• Drowsiness 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 treatments with nasal sprays of fluticasone propionate.
• Skin and mucous membrane lesions in the nose.
• Feeling unwell, fatigue, exhaustion, or weakness.
• Rash, redness, or itching of the skin, urticaria.
• Bronchospasm (constriction of the airways of 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/respiration difficult and sudden appearance of rash on the skin.These may be signs of a severe allergic reaction.Be aware that this is very rare.

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

• Blurred vision
• Nose ulcers

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

Nasal corticosteroids may affect normal hormone production in your body, especially if high doses are used for a long time. In children and adolescents, this side effect may cause them to grow more slowly.

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

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears on the bottle and packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not refrigerate or freeze.

Expiration date after opening: Dispose of any unused portion of the medication 6 months after first opening the nasal spray pump.

Medicines should not be thrown down the drains or in the trash. Deposit the containers and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

Azelastina/Fluticasona Teva Composition

• The active ingredients are azelastine hydrochloride and fluticasone propionate.

Each milliliter 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 sodium edetate, glycerol (E422), microcrystalline cellulose, sodium carmelose, polisorbate 80, benzalkonium chloride, phenylethyl alcohol, and water for injection preparations.

Product Appearance and Packaging Content

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

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

Each package contains a bottle with 23 g of nasal spray suspension or a multiple package containing 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, 1st floor

Alcobendas 28108 Madrid,

Spain

This medicine is authorized in the European Economic Area and in the United Kingdom (Northern Ireland)with the following names:

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

Austria: Allergobene 137 Mikrogramm/50 Mikrogramm pro Sprühtoß 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 microgramos/50 microgramos/aplicación suspension para pulverización nasal

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

Last review date of this prospectus:August 2023

More detailed information about this medicine is available on the website of the {Spanish Agency of Medicines and Medical Devices (AEMPS)} (http://www.aemps.gob.es/)

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