Label: information for the user

Amaira 50micrograms/500micrograms/inhalation, powder for inhalation (single dose)

salmeterol/fluticasone propionate

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

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What isAmairaand how it is used

2. What you need to know before starting to use Amaira

3. How to use Amaira

4. Possible adverse effects

5. Storage of Amaira

6. Contents of the package and additional information

Amairacontains two active principles, salmeterol and fluticasone propionate:

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

This medication is used to treat adults and adolescents 12 years of age and older.

The doctor has prescribed this medication to help prevent respiratory problems such as:

• Asthma

or

• Chronic Obstructive Pulmonary Disease (COPD). Salmeterol/fluticasone, in a dose of 50/500micrograms, reduces the number of exacerbations of COPD symptoms.

You must use Amaira every day as recommended by your doctor. This will ensure that the medication acts correctly in controlling your asthma or COPD.

Salmeterol/fluticasonehelps prevent shortness of breath and wheezing. However, Amaira should not be used to relieve a sudden attack of shortness of breath or wheezing. In such a case, you must use your quick-relief medication, such as salbutamol. You should always carry your quick-relief medication with you.

No use Amaira

If you are allergic to salmeterol, fluticasone propionate or to any other component, lactose monohydrate.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with salmeterol/fluticasone if you have:

• Cardiac alterations including rapid or irregular heartbeat
• Hyperthyroidism
• High blood pressure
• Diabetes mellitus (Salmeterol/fluticasone may increase blood sugar levels)
• Low levels of potassium in the blood
• Tuberculosis (TB) now or in the past or other lung infections

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

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

Use of Amaira with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication. The reason is that, in some cases, salmeterol/fluticasone is not suitable to be administered together with other medications.

Inform your doctor if you take any of the following medications, before starting to use salmeterol/fluticasone:

• Beta blockers (such as atenolol, propranolol and sotalol). Beta blockers are used mainly to treat hypertension or other cardiac conditions, such as angina pectoris.
• Medications to treat infections (such as ketoconazole, itraconazole and erythromycin) including some HIV medications (such as ritonavir, medications containing cobicistat). Some of these medications may increase the amount of fluticasone propionate or salmeterol in your body. This may increase your risk of experiencing adverse effects with Amaira, including irregular heartbeat, or may worsen the adverse effects, so your doctor will perform thorough checks if you are taking these medications.
• Corticosteroids (oral or injectable). If you have taken these medications recently, you may increase the risk of salmeterol/fluticasone affecting your adrenal glands.
• Diuretics, also known as medications to urinate, used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medications containing xanthine, such as aminophylline or theophylline. They are often used to treat asthma.

Pregnancy and breastfeeding

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

Driving and operating machinery

Salmeterol/fluticasone is unlikely to affect your ability to drive or operate machinery.

Amaira contains lactose

Amaira contains approximately 13 milligrams of lactose in each dose.This amount normally does not cause problems in people with lactose intolerance. Lactose may contain milk proteins that can cause allergic reactions in patients with a milk protein allergy.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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. In case of doubt, consult your doctor or pharmacist.
• Do not stop taking this medication or reduce your dose without talking to your doctor first.
• Salmeterol/fluticasona must be inhaled through the mouth into the lungs.

The recommended dose is:

For asthma

Adults and adolescents 12 years of age and older

• Amaira 50/500 One inhalation twice a day

For adults with Chronic Obstructive Pulmonary Disease (COPD)

• Amaira 50/500 One inhalation twice a day

Your symptoms may be well controlled using this medication twice a day. If so, your doctor may decide to reduce your dose to once a day. The dose may change 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 applications 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 greater difficulty breathing, see your doctor immediately. You may notice more wheezing or a sense of choking more often or that you have to use your rescue medication more frequently. If any of these things happen, you should continue using salmeterol/fluticasona, but do not increase the number of applications. Respiratory disease can worsen and you could become seriously ill. See your doctor, as you may need additional treatment.

Instructions for use

• Amaira may be different from the inhalers you have used in the past, so it is very important that you use it properly.Your doctor, nurse, or pharmacist should teach 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 use it.

Periodically, they should check how you use it to ensure that you are using the device properly as prescribed. Not using Amaira properly or as prescribed may result in your asthma or COPD not improving as it should.

• This device contains alveoli that contain salmeterol/propionato de fluticasona in powder.
• There is a dose counter on the top of the device that indicates how many doses are left. Counts back to 0. The numbers 5 to 0 will appear in red to warn you that there are few doses left. Once the counter marks 0, your inhaler is empty.

Using your inhaler

1. To open the inhaler, hold it with one hand in a horizontal flat position. Press the red button with your thumb (see figure 1) and slide the purple mouthpiece cover (for 50/500 micrograms) away from you as far as you can with your thumb of the other hand until you hear a "click" (see figure 2). This will open a small hole in the mouthpiece, and place a dose of medication in the mouthpiece.

Figure1Figure2

Be aware that each time you open the mouthpiece cover with a "click", an alveolus opens and the powder is prepared to be inhaled.Therefore,do not open the mouthpiece cover if you do not need to take the medicine, as the alveoli open and the medication is wasted.

1. Keep the inhaler away from your mouth. Breathe out as much as reasonably possible. Do not breathe into the inhaler.

1. Place the mouthpiece in your lips (see figure 3). Take a progressive and intense breath through the inhaler, not through your nose.

Remove the inhaler from your mouth.

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

Breathe out slowly.

Figure3

The inhaler releases your dose of medication in the form of very fine powder. You may not be able to taste or feel the powder.Do not use an additional dose of the inhaler if you do not taste or feel the medication.

1. Close the inhaler to keep it clean, sliding the purple mouthpiece cover (for 50/500 micrograms) back towards you as far as you can. You will hear a "click" (see figure 4). The mouthpiece cover returns to its original position and is reset. The inhaler is now ready for you to take your next scheduled dose.

5.Wash your mouth with water and spit it out, or brush your teeth. This may help you prevent mouth ulcers and sore throat.

Figure4

Cleaning your inhaler

Keep your inhaler clean and dry.

To clean it, pass a dry cloth over the mouthpiece of the inhaler.

If you use more Amaira than you should

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

If you have used large doses of salmeterol/fluticasona for long periods of time, you should ask your doctor or pharmacist for advice. This is because using high concentrations of this medication can reduce the amount of steroid hormones produced by the adrenal glands.

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

If you forget to use Amaira

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

If you interrupt treatment with Amaira

It is very important to use salmeterol/fluticasona every day as instructed.Continue taking it until your doctor tells you to stop. Do not interrupt or abruptly reduce your treatment with salmeterol/fluticasona.This could make your breathing worse.

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

These adverse effects may include any of the following:

• Abdominal pain
• Fatigue and loss of appetite, feeling unwell
• Discomfort and diarrhea
• Weight loss
• Headache or drowsiness
• Low blood sugar levels
• Hypotension and convulsions (seizures)

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

If you have any adverse effect, consult your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe an additional dose of corticosteroids in tablets (such as prednisolone).

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. To reduce the occurrence of side effects, your doctor will prescribe the lowest dose of this combination of medicines that controls your asthma or Chronic Obstructive Pulmonary Disease (COPD).

Allergic reactions: you may notice that your breathing suddenly worsens immediately after using Amaira.You may experience wheezing and coughing or shortness of breath. You may also notice itching, hives (urticaria) and swelling (usually of the face, lips, tongue or throat). You may also feel, suddenly, that your heart is beating very fast, feel like you lose consciousness and dizziness (which can lead to collapse or loss of consciousness).If you experience any of these effects or if they appear suddenly after using Amaira, stop taking this medicineand inform your doctor immediately. Allergic reactions to Amaira are rare (can affect up to 1 in 100 people).

Pneumonia (lung infection) in patients with COPD (common side effect)

Inform your doctorif you have any of the following symptoms while inhalingAmaira, as they may be symptoms of a lung infection:

• Fever or chills
• Increased mucus production, change in mucus color
• Increased coughing or difficulty breathing

The following are other side effects:

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

• Headache, which usually improves as treatment continues.
• A higher number of colds has been reported in patients with Chronic Obstructive Pulmonary Disease (COPD).

Common (can affect up to 1 in 10 people)

• Candidiasis (itching, appearance of yellowish cream-colored ulcers) in the mouth and throat. Also, tongue pain, hoarse voice and throat irritation. Rinsing the mouth with water and spitting it out and/or brushing your teeth immediately after each dose of medicine may help you.

Your doctor may prescribe antifungal medication (for the treatment of fungal infections) for the treatment of candidiasis.

• Pain, inflammation in the joints and muscle pain.
• Muscle cramps.

The following side effects have been reported in patients with Chronic Obstructive Pulmonary Disease (COPD):

• Fractures and osteoporosis.
• sinusitis (inflammation of the sinuses, a feeling of tension or congestion in the nose, cheeks and behind the eyes, sometimes with a pulsating pain).
• Reduction of potassium levels in the blood (you may feel irregular heartbeats, muscle weakness, cramps).

Rare (can affect up to 1 in 100 people)

• Increased blood sugar levels (hyperglycemia). If you have diabetes, you will need to monitor your blood sugar levels more frequently and adjust your usual diabetes treatment as needed.
• Cataracts (opacity of the lens of the eye).
• Very fast heart rate (tachycardia).
• You may feel tremors and a very fast or irregular heart rate (palpitations). These side effects are usually harmless and decrease as treatment continues.
• Chest pain.
• Feeling anxious (mainly occurs in children).
• Sleep disturbances.
• Allergic rash on the skin.

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

• Difficulty breathing or wheezing that worsens immediately after using Amaira. Ifthis happens, stop using the Amaira inhalerand use your rescue inhaler with rapid action to improve your breathingand inform your doctor immediately.
• Salmeterol/fluticasonamay increase the normal production of steroid hormones, particularly if you have been taking high doses for long periods of time. The effects include:
• • Delayed growth in children and adolescents
  • Decreased bone mineral density
  • Glaucoma
  • Weight gain
  • Round face (moon face) (Cushing's syndrome).

Your doctor will regularly monitor you for the occurrence of any of these side effects and ensure that you are taking the lowest dose ofthis combination of medicinesto control your asthma.

• Changes in behavior, such as hyperactivity and irritability (although these effects occur mainly in children).
• Irregular or irregular heartbeats or that the heart has extra beats (arrhythmias). Consult your doctor, but do not stop takingAmairaunless your doctor tells you to.
• Infection caused by fungi in the esophagus (throat), which can cause difficulty swallowing.

Frequency not known, but may also occur:

• Depression or aggression (is more likely to occur in children).
• Blurred vision

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse,even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: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 Amaira after the expiration date that appears on the packaging and on the label of your inhaler after CAD. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 30°C.
• Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Amaira

The active principles are salmeterol and fluticasone propionate.

Each individual inhalation provides a released dose (the dose that comes out of the mouthpiece) of 43micrograms of salmeterol (as xinafoate of salmeterol) and 432micrograms of fluticasone propionate. This corresponds to a pre-dispensed dose of 50micrograms of salmeterol (as xinafoate of salmeterol) and 500micrograms of fluticasone propionate.

The other component is lactose monohydrate(see section2 in “Amaira contains lactose”)(contains milk proteins).

Appearance of the product and contents of the package

• Amairacontains a strip of alveoli filled with white to off-white powder. The aluminum paper protects the inhalation powder from atmospheric effects.
• Each dose is pre-dispensed.
• The white plastic devices with a purple mouthpiece cover (for 50/500micrograms) are found in packages of:

1, 2, 3 or 10×inhalers with60inhalations each.

Only some package sizes may be commercially available.

Marketing Authorization Holder:

Zentiva k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Responsible for manufacturing:

Oy Medfiles Ltd

Volttikatu 5, Volttikatu 8

Kuopio, 70700

Finland

Further information on this medicinal product can be obtained by contacting 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 medicinal product is authorized in the Member States of the European Economic Area with the following names:

Last review date of this leaflet:November 2021

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