Amaira 50 micrograms/250 micrograms/inhalation, powder for inhalation (single dose)

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amaira 50 micrograms/100 micrograms/inhalation, powder for inhalation (single dose)

Amaira 50 micrograms/250 micrograms/inhalation, powder for inhalation (single dose)

salmeterol/fluticasone propionate

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet; 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 may 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.

Leaflet contents

1. What Amaira is and what it is used for
2. What you need to know before using Amaira
3. How to use Amaira
4. Possible side effects
5. How to store Amaira
6. Contents of the pack and other information

1. What Amaira is and what it is used for

Amaira contains two active substances, salmeterol and fluticasone propionate:

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways in the lungs open, making it easier to breathe in and out. The effects last for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces inflammation and irritation in the lungs.

This medicine is used to treat adults and adolescents aged 12 years and older.

Your doctor has prescribed this medicine to help prevent breathing problems such as:

• Asthma

You should use Amaira every day as directed by your doctor. This will ensure that the medication works properly to control your asthma.

Salmeterol/fluticasone helps prevent breathlessness and wheezing. However, Amaira must not be used to relieve a sudden attack of breathlessness or wheezing. In such cases, you must use your fast-acting "rescue" medication, such as salbutamol. You should always carry your fast-acting rescue medication with you.

2. What you need to know before using Amaira

Do not use Amaira

If you are allergic to salmeterol, fluticasone propionate, or any of the other ingredients, or lactose monohydrate.

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with salmeterol/fluticasona if you have:

• Heart problems, including rapid or irregular heartbeat
• Overactive thyroid
• High blood pressure
• Diabetes mellitus (salmeterol/fluticasone may increase blood sugar levels)
• Low levels of potassium in the blood
• Tuberculosis (TB) currently or in the past, or other lung infections

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

• Children
• This medicine should not be used in children under 12 years of age.

Using Amaira with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because, in some cases, salmeterol/fluticasone may not be suitable to be taken together with certain other medicines.

Inform your doctor if you are taking any of the following medicines before starting salmeterol/fluticasone:

• Beta-blockers (such as atenolol, propranolol, and sotalol). Beta-blockers are mostly used to treat high blood pressure or other heart conditions, such as angina.
• Medicines to treat infections (such as ketoconazole, itraconazole, and erythromycin), including some medicines for HIV (such as ritonavir, medicines containing cobicistat). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in your body. This could increase your risk of side effects from Amaira, including irregular heartbeats, or make side effects worse. Your doctor will monitor you closely if you are taking these medicines.
• Corticosteroids (oral or injectable). If you have recently taken these medicines, there may be an increased risk that salmeterol/fluticasone could affect your adrenal glands.
• Diuretics, also known as 'water pills', used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthines, such as aminophylline or theophylline. These are often used to treat asthma.

Pregnancy and breastfeeding

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

Driving and using machines

Salmeterol/fluticasone is unlikely to affect your ability to drive or use machines.

Amaira contains lactose

Amaira contains approximately 13 milligrams of lactose per dose. This amount is generally not problematic for people with lactose intolerance. However, lactose may contain milk proteins that could cause allergic reactions in patients allergic to cow's milk protein.

3. How to use Amaira

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

• Use Amaira every day, until your doctor tells you to stop. Do not take more than the recommended dose. If in doubt, consult your doctor or pharmacist.
• Do not stop taking this medicine or reduce your dose without first speaking to your doctor.
• Salmeterol/fluticasone must be inhaled through the mouth into the lungs.

The recommended dose is:

Adults and adolescents aged 12 years and older

• Amaira 50/100 One inhalation twice daily
• Amaira 50/250 One inhalation twice daily

Your symptoms may become well controlled by using this medicine twice daily. If so, your doctor may decide to reduce your dose to once daily. The dose may then be changed to:

• once at night if you have nocturnal symptoms,
• once in the morning if you have diurnal symptoms.

It is very important that you follow your doctor's instructions on how many inhalations and how often you should take your medication.

If you are using Amaira to treat asthma, your doctor will want to monitor your symptoms regularly.

If your asthma worsens or you have increasing difficulty breathing, see your doctor immediately. You may notice more wheezing or breathlessness more often, or find that you need to use your fast-acting rescue medication more frequently. If any of these occur, you must continue using salmeterol/fluticasone, but do not increase the number of inhalations. Your respiratory condition may worsen and you could become seriously ill. See your doctor, as you may need additional treatment.

Instructions for use

• Amaira may be different from inhalers you have used before, so it is very important that you use it correctly. Your doctor, nurse, or pharmacist should show you how to use your inhaler. This training is important to ensure that you receive the dose you need**. If you have not received this training, ask your doctor, nurse, or pharmacist to show you how to use the inhaler properly, especially if it is the first time you are using it.**

Your technique should be checked periodically to ensure you are using the device correctly as prescribed. Using Amaira incorrectly or not as prescribed may result in your asthma not improving as it should.

• This device contains blisters containing salmeterol/fluticasone propionate in powder form.
• There is a dose counter on the top of the device indicating how many doses remain. It counts down to 0. Numbers from 5 to 0 appear in red to warn you that few doses remain. Once the counter reaches 0, your inhaler is empty.

Using your inhaler

1. To open the inhaler, hold it horizontally in one hand. Press the red button with your thumb (see Figure 1) and slide the light pink (for 50/100 micrograms) or pink (for 50/250 micrograms) mouthpiece cover away from you as far as possible using the thumb of your other hand until you hear a "click" (see Figure 2). This will open a small orifice in the mouthpiece and place a dose of medication into the mouthpiece.

Figure 1 Figure 2

Note that each time you open the mouthpiece cover with a "click," a blister opens and the powder is prepared for inhalation. Therefore, do not open the mouthpiece cover unless you need to take your medicine, as this opens the blisters and wastes medication.

2. Keep the inhaler away from your mouth. Breathe out as much as you reasonably can. Do not breathe into the inhaler.

3. Place the mouthpiece in your mouth (see Figure 3). Breathe in progressively and deeply through the inhaler, not through your nose.

Remove the inhaler from your mouth.

Hold your breath for about 10 seconds, or as long as possible.

Breathe out slowly.

Figure 3

The inhaler releases your dose of medication as a very fine powder. You may not be able to taste or feel the powder. Do not take an additional dose from the inhaler if you do not taste or feel the medication.

4. Close the inhaler to keep it clean by sliding the light pink (for 50/100 micrograms) or pink (for 50/250 micrograms) mouthpiece cover toward you as far as possible. You will hear a "click" (see Figure 4). The mouthpiece cover returns to its original position and resets. The inhaler is now ready for your next scheduled dose.

5. After use, rinse your mouth with water and spit it out, or brush your teeth. This may help prevent mouth ulcers and hoarseness.

Figure 4

Cleaning your inhaler

Keep your inhaler clean and dry.

To clean it, wipe the inhaler mouthpiece with a dry tissue.

If you use more Amaira than you should

It is very important to use the inhaler exactly as instructed. If you accidentally take more than the recommended dose, consult your doctor or pharmacist. You may notice your heart beating faster than normal and feel tremors. You may also experience dizziness, headache, muscle weakness, and joint pain.

If you have used large doses of salmeterol/fluticasone for prolonged periods, you should seek advice from your doctor or pharmacist. This is because using high concentrations of this medicine may reduce the amount of steroid hormones produced by the adrenal glands.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to use Amaira

Do not take a double dose to make up for missed doses. Take the next dose at your usual time.

If you stop using Amaira

It is very important that you use salmeterol/fluticasone every day as prescribed. Continue taking it until your doctor tells you to stop. Do not interrupt or abruptly reduce your treatment with salmeterol/fluticasone. This could cause your breathing to worsen.

Additionally, if you stop taking salmeterol/fluticasone suddenly or reduce your dose, you could (very rarely) develop problems with your adrenal glands (adrenal insufficiency), which sometimes causes adverse effects.

These adverse effects may include any of the following:

• Stomach pain
• Tiredness and loss of appetite, feeling unwell
• Nausea and diarrhea
• Weight loss
• Headache or drowsiness
• Low blood sugar levels
• Low blood pressure and seizures (fits)

When your body is under stress due to fever, trauma (e.g., a traffic accident or injury), infection, or surgery, adrenal insufficiency may worsen, and you could experience any of the adverse effects listed above.

If you experience any adverse effects, consult your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe an additional dose of corticosteroid tablets (such as prednisolone).

If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them. To reduce the occurrence of adverse effects, your doctor will prescribe the lowest dose of this combination of medicines that controls your asthma.

Allergic reactions: you may notice that your breathing suddenly worsens immediately after using Amaira. You may experience wheezing, cough, or shortness of breath. You may also notice itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or throat). You may also suddenly feel that your heart is beating very fast, feel dizzy, or feel like you are losing consciousness (which may lead to collapse or loss of awareness). If you experience any of these effects, or if they occur suddenly after using Amaira, stop taking this medicine and contact your doctor immediately. Allergic reactions to Amaira are uncommon (may affect up to 1 in 100 people).

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

• Headache, which usually improves with continued treatment.

Common (may affect up to 1 in 10 people)

• Oral candidiasis (itching, yellow-cream-colored sores) in the mouth and throat. Also, tongue pain, hoarseness, and throat irritation. Rinsing your mouth with water and spitting it out and/or brushing your teeth immediately after each dose of medicine may help. For treatment of candidiasis, your doctor may prescribe antifungal medication (to treat fungal infections).
• Joint pain and swelling, and muscle pain.
• Muscle cramps.

Uncommon (may affect up to 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycemia). If you have diabetes, it will be necessary to monitor your blood sugar levels more frequently and adjust your usual diabetes treatment if needed.
• Cataracts (clouding of the eye's lens).
• Very fast heart rate (tachycardia).
• Tremors and a fast or irregular heartbeat (palpitations). These adverse effects are usually harmless and decrease with continued treatment.
• Chest pain.
• Feeling of anxiety (occurs mainly in children).
• Sleep disorders.
• Allergic skin rash.

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

• Difficulty breathing or wheezing that worsens right after using Amaira. If this happens, stop using the Amaira inhaler. Use your fast-acting "rescue" inhaler to improve your breathing and contact your doctor immediately.
• Salmeterol/fluticasone may increase the body's normal production of steroid hormones, particularly if you have been taking high doses for long periods of time. Effects include:
  • Delayed growth in children and adolescents
  • Decreased bone mineral density
  • Glaucoma
  • Weight gain
  • Rounded face (moon face) (Cushing's syndrome).

Your doctor will monitor you regularly for the appearance of any of these adverse effects and ensure you are taking the lowest dose of this combination of medicines needed to control your asthma.

• Changes in behavior, such as hyperactivity and irritability (although these effects occur mainly in children).
• Irregular or uneven heartbeats, or extra heartbeats (arrhythmias). Consult your doctor, but do not stop taking Amaira unless your doctor tells you to.
• Fungal infection in the esophagus (throat), which may cause difficulty swallowing.

Frequency not known, but may also occur:

• Depression or aggression (these effects are more likely to occur in children).
• Blurred vision

Reporting of adverse effects

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

5. Storage of Amaira

• Keep this medicine out of the sight and reach of children.
• Do not use Amaira after the expiry date stated on the carton and on the label of your inhaler after EXP. The expiry date is the last day of the month indicated.
• Do not store above 30 °C.
• Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amaira

The active substances are salmeterol and fluticasone propionate.

Amaira 50 micrograms/100 micrograms

Each individual inhalation delivers a released dose (the dose exiting the mouthpiece) of 47 micrograms of salmeterol (as salmeterol xinafoate) and 92 micrograms of fluticasone propionate. This corresponds to a predispensed dose of 50 micrograms of salmeterol (as salmeterol xinafoate) and 100 micrograms of fluticasone propionate.

Amaira 50 micrograms/250 micrograms

Each individual inhalation delivers a released dose (the dose exiting the mouthpiece) of 45 micrograms of salmeterol (as salmeterol xinafoate) and 229 micrograms of fluticasone propionate. This corresponds to a predispensed dose of 50 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate.

The other component is lactose monohydrate (see section 2, "Amaira contains lactose") (contains milk proteins).

Appearance of the product and contents of the pack

• Amaira contains a strip of blisters filled with white to off-white powder. The aluminium foil protects the inhalation powder from atmospheric effects.
• Each dose is predispensed.
• The white plastic devices with a light pink mouthpiece cap (for 50/100 micrograms) or pink mouthpiece cap (for 50/250 micrograms) are available in packs of:

1, 2, 3 or 10 × inhalers with 60 inhalations each.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder:

Zentiva k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Manufacturer:

Eurofins BioPharma Product Testing Finland Oy, Volttikatu 5,

Kuopio, 70700

Finland

Eurofins BioPharma Product Testing Finland Oy

Volttikatu 8

Kuopio, 70700

Finland

Kymos S.L.

Ronda Can Fatjo 7, Edificio B

Parc Tecnologic del Vallès

Cerdanyola del Vallès, 08290

Spain

PHARMAPROGRESS S.R.L.

Via Emilia Romagna,

28-30-32

60030 Monsano AN,

Italy

PharmaTan Kft

Kenderfoldek utcája, 3

Csongrád, 6640

Hungary

Further information on this medicine is available upon request from the local representative of the Marketing Authorization Holder: Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1

28224 Pozuelo de Alarcón, Madrid

Spain

This medicine is authorized in the European Economic Area member states under the following names:

Austria	Everio Airmaster
Belgium	Brecur Airmaster 50 microgram/100 microgram/dose, inhalation powder, pre-dispensed Brecur Airmaster 50 microgram/250 microgram/dose, inhalation powder, pre-dispensed Brecur Airmaster 50 microgrammes/100 microgrammes/dose, powder for inhalation in single-dose container Brecur Airmaster 50 microgrammes/250 microgrammes/dose, powder for inhalation in single-dose container Brecur Airmaster 50 Mikrogramm/100 Mikrogramm single-dose powder for inhalation Brecur Airmaster 50 Mikrogramm/250 Mikrogramm single-dose powder for inhalation
Bulgaria	Брекур Еърмастър 50 микрограма/100 микрограма/доза, инхалационен прах, преддозиран Брекур Еърмастър 50 микрограма/250 микрограма/доза, инхалационен прах, преддозиран
Slovakia	Everio Airmaster 50 mikrogramov/100 mikrogramov Everio Airmaster 50 mikrogramov/250 mikrogramov
Spain	Amaira 50 micrograms/100 micrograms/inhalation, powder for inhalation (single dose) Amaira 50 micrograms/250 micrograms/inhalation, powder for inhalation (single dose)
Estonia	Everio Airmaster
France	FLUTICASONE PROPIONATE/SALMETEROL ZENTIVA 100 micrograms/50 micrograms/dose, powder for inhalation in single-dose container FLUTICASONE PROPIONATE/SALMETEROL ZENTIVA 250 micrograms/50 micrograms/dose, powder for inhalation in single-dose container
Hungary	Fluzalto Airmaster 50 mikrogramm/100 mikrogramm/adagonként adagolt inhalációs por Fluzalto Airmaster 50 mikrogramm/250 mikrogramm/adagonként adagolt inhalációs por
Ireland	Bronx Airmaster
Latvia	Everio Airmaster 50/100 mikrogrami/deva inhalācijas pulveris, dozēts Everio Airmaster 50/250 mikrogrami/deva inhalācijas pulveris, dozēts
Lithuania	Everio Airmaster 50/100 mikrogramų/dozėje dozuoti įkvepiamieji milteliai Everio Airmaster 50/250 mikrogramų/dozėje dozuoti įkvepiamieji milteliai
Poland	Neuair Airmaster
Czech Republic	Everio Airmaster
Romania	Everio Airmaster 50 micrograme/100 micrograme pulbere de inhalat unidoză Everio Airmaster 50 micrograme/250 micrograme pulbere de inhalat unidoză
Sweden	Neuair Airmaster

Date of the last review of this leaflet: November 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/.