Azelastine/fluticasone Teva 137 micrograms/50 micrograms per application nasal spray suspension

Package leaflet: Information for the user

Introduction

Package 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 you start using this medicine, because it contains important information for you.

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

Contents of the leaflet

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

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

3. How to use Azelastine/Fluticasone Teva

4. Possible side effects

5. Storage of Azelastine/Fluticasone Teva

6. Contents of the pack and other information

1. What Azelastina/Fluticasona Teva is and what it is used for

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

• Azelastine hydrochloride belongs to a group of medicines called antihistamines. Antihistamines work by preventing the effects of substances such as histamine, which the body produces as part of an allergic reaction; thus, they reduce the symptoms of allergic rhinitis.
• Fluticasone propionate belongs to a group of medicines called corticosteroids, which reduce inflammation.

Azelastina/Fluticasona is used to relieve symptoms of moderate to severe seasonal allergic rhinitis and perennial allergic rhinitis, when treatment with either 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 such as rhinorrhea, post-nasal drip, sneezing, nasal itching, or nasal congestion.

2. What you need to know before using 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 ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before using Azelastine/Fluticasone Teva if:

?? You have recently undergone surgery or have a nasal or oral wound.

• You have a nasal infection. Nasal infections should be treated with antibacterial or antifungal medications. If you have been prescribed medication for a nasal infection, you may continue using azelastine/fluticasone to treat your allergy.
• You have tuberculosis or an untreated infection.
• You have vision changes or a history of increased intraocular pressure, glaucoma, and/or cataracts. If you have any of these conditions, you will be closely monitored during treatment with azelastine/fluticasone.
• You have impaired adrenal function. Caution is advised when switching from systemic steroid therapy to azelastine/fluticasone.
• You have severe liver disease. The risk of systemic adverse effects may be increased.

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

It is important that you take the dose indicated in section 3 or as prescribed by your doctor. Treatment with doses higher than recommended for nasal corticosteroids 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 adverse effects, your doctor may recommend alternative medication during periods of stress or elective surgery. Do not use this medicine if you are taking sedatives or medications acting on the central nervous system.

To avoid adrenal suppression, your doctor will advise you to take the lowest dose that effectively controls your rhinitis symptoms.

The use of nasal corticosteroids (such as Azelastine/Fluticasone Teva) may result in slower growth in children and adolescents when used long-term. Your doctor will regularly monitor the growth of children and ensure they receive the lowest effective dose.

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

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

Children

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

Other medicines and Azelastine/Fluticasone Teva

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Some medicines may increase the effects of azelastine/fluticasone, so your doctor will closely monitor you if you are taking these medications (including certain HIV treatments: ritonavir, cobicistat, and antifungal medications such as ketoconazole).

Do not use this medicine if you are taking sedatives or medications for the central nervous system.

Pregnancy and breastfeeding

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

Driving and using machines

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

Very rarely, you may experience fatigue or dizziness due to the underlying illness or during treatment with azelastine/fluticasone. In such cases, do not drive or operate machinery. Be aware that alcohol consumption may worsen these effects.

Azelastine/Fluticasone Teva contains benzalkonium chloride

This medicine contains 14 micrograms of benzalkonium chloride per 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.

3. How to use Azelastine/Fluticasone Teva

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

It is essential that azelastine/fluticasone is used regularly in order for the full therapeutic benefit to be achieved.

Avoid contact with the eyes.

Adults and adolescents (over 12 years of age)

• The recommended dose is one spray into each nostril in the morning and one spray into each nostril in the evening.

Use in children under 12 years of age

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

Use in case of renal and hepatic impairment

• No data are available in patients with renal or hepatic impairment.

Method of administration

For nasal use.

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

INSTRUCTIONS FOR USE

Preparing the spray

1. Gently shake the bottle for 5 seconds by tilting it up and down, then remove the protective cap (see Figure 1).

Figure 1

1. The first time the nasal spray is used, the pump must be primed by spraying into the air.
2. Prime the pump by placing two fingers on either side of the spray pump and your thumb on the base of the bottle.
3. Press and release the pump 6 times until a fine mist appears (see Figure 2).
4. The pump is now primed and ready for use.

Figure 2

1. If the nasal spray has not been used for more than 7 days, the pump must be re-primed. Gently shake the bottle for 5 seconds by tilting it up and down, then remove the protective cap (see Figure 1), and press and release the pump once.

Spraying technique

1. Gently shake the bottle for 5 seconds by tilting it up and down, then remove the protective cap (see Figure 1).
2. Blow your nose to clear the nasal passages.
3. Keep your head tilted forward (towards your feet). Do not tilt your head backwards.
4. Hold the bottle upright and carefully insert the spray nozzle into one nostril.
5. Close the other nostril with your finger, press the pump once quickly, and at the same time, inhale gently (see Figure 3).
6. Breathe through your mouth.

Figure 3

1. Repeat the procedure in the other nostril.
2. Breathe gently and do not tilt your head backwards after administration. This helps prevent the medicine from running down your throat, which may cause an unpleasant taste (see Figure 4).

Figure 4

1. After each use, wipe the spray nozzle with a clean tissue or cloth, and replace the protective cap.
2. Do not pierce the nozzle if no spray is obtained. Clean the valve with water.

It is important 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 long-term 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 medicine into your nose, it is unlikely that you will experience any problems. If in doubt, or if you have used more than the recommended dose for a prolonged period, consult your doctor. If someone, especially a child, accidentally swallows Azelastine/Fluticasone Teva, contact your doctor immediately, go to the nearest medical center, or call the Toxicology Information Service at telephone number (91) 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to use Azelastine/Fluticasone Teva

Use the nasal spray as soon as you remember, then take your next dose at the usual time. Do not use a double dose to make up for a missed dose.

If you stop using Azelastine/Fluticasone Teva

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

• Nasal bleeding.

Common adverse effects (may affect up to 1 in 10 people):

• Headache.
• Bitter taste in the mouth, especially if you tilt your head backwards during use of the nasal spray. This taste should disappear if you drink a soft drink a few minutes after using this medicine.
• Unpleasant odour.

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

• Mild irritation inside the nose, which may cause slight stinging, itching or sneezing.
• Nasal dryness, cough, dry throat or throat irritation.

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

• Dry mouth.

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

• Dizziness or drowsiness.
• Cataracts, glaucoma or increased eye pressure, possibly leading to vision loss and/or redness and eye pain. These adverse effects have been observed with prolonged treatment with fluticasone propionate nasal sprays.
• Skin and nasal mucosa lesions.
• Feeling unwell, tiredness, exhaustion or weakness.
• Rash, redness or itching of the skin, urticaria.
• 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 or breathing difficult, and sudden appearance of a skin rash. These could be signs of a severe allergic reaction. Please note that this is very rare.

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

• Blurred vision
• Nasal ulcers

When this medicine is administered at high doses over a prolonged period of time, systemic adverse effects (adverse effects affecting the whole body) may occur. The likelihood of such effects is much lower when using a nasal corticosteroid spray compared to oral corticosteroids. These effects may vary between individual patients and between different corticosteroid preparations (see section 2).

Nasal corticosteroids 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 adverse effect may result in slower growth.

In rare cases, reduced bone density (osteoporosis) may occur when corticosteroids are administered by nasal route over a long period of time.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Azelastine/Fluticasone Teva

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, following “EXP”. The expiry date refers to the last day of the month indicated.

Do not refrigerate or freeze.

Expiry after first opening: Discard any unused portion of the medicine 6 months after first opening the nasal spray.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Azelastine/Fluticasone Teva

• The active substances are azelastine hydrochloride and fluticasone propionate.

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

Each spray (0.14 g) delivers 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 injections.

Appearance of the medicine and contents of the pack

Azelastine/Fluticasone 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 (providing at least 120 sprays).

Each pack contains one bottle with 23 g of nasal spray suspension or multiple packs containing 3 bottles, each with 23 g of nasal spray suspension.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5, Haarlem,

2031 GA,

The 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 medicine is authorized in the European Economic Area member states and 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 microgramos/50 microgramos/aplicación suspensión 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

The 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 most recent review of this summary: August 2023

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/89443/P_89443.html