AMAIRA 50 micrograms/500 micrograms Inhalation Powder (single dose)

2. What you need to know before you use Amaira

Do not use Amaira

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

Warnings and precautions

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

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

Consult 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 using, have recently used, or might use any other medicines. The reason is that, in some cases, salmeterol/fluticasone propionate is not suitable to be taken with other medicines.

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

• Beta-blockers (such as atenolol, propranolol, and sotalol). Beta-blockers are mainly 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 may increase your risk of experiencing side effects with Amaira, including irregular heartbeats, or may worsen side effects, so your doctor will monitor you closely if you are taking these medicines.
• Corticosteroids (oral or injectable). If you have taken these medicines recently, you may be at increased risk of salmeterol/fluticasone propionate affecting 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 have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

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

Amaira contains lactose

Amaira contains approximately 13 milligrams of lactose in each dose. This amount is not expected to cause problems in people with lactose intolerance. Lactose may contain milk proteins that can cause allergic reactions in patients with cow's milk protein allergy.

3. How to use Amaira

Follow the instructions for administration of this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask 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 you are unsure, ask your doctor or pharmacist.
• Do not stop taking this medicine or reduce the dose without talking to your doctor first.
• Salmeterol/fluticasone propionate should 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 medicine twice a day. If this is the case, your doctor may decide to reduce your dose to once a day. The dose may change to:

• once at night if you have night-time symptoms,
• once in the morning if you have day-time symptoms.

It is very important that you follow your doctor's instructions about how many applications and how often you should take your medicine.

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

If your asthma gets worse or you have more difficulty breathing, see your doctor immediately. You may notice more wheezing or shortness of breath more often, or you may need to use your rapid-acting "rescue" medication more frequently. If any of these things happen, you should continue using salmeterol/fluticasone propionate, but do not increase the number of applications. Your respiratory disease may worsen, and you may 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 correctly. 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 correctly, 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 correctly as prescribed. Not using Amaira properly or as prescribed may result in your asthma or COPD not improving as it should.

• This device contains blisters that contain salmeterol/fluticasone propionate in powder form.
• There is a dose counter on the top of the device that shows how many doses are left. It counts down to 0. The numbers from 5 to 0 will appear in red to warn you that there are few doses left. Once the counter reaches 0, your inhaler is empty.

Using your inhaler

1. To open the inhaler, hold it with one hand in a horizontal 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 possible with the 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 medicine in the mouthpiece.

Figure 1 Figure 2

Be aware that each time you open the mouthpiece cover with a "click", a blister is opened, and the powder is prepared for inhalation. Therefore, do not open the mouthpiece cover if you do not need to take the medicine, as the blisters will open, and medicine will be wasted.

1. Hold the inhaler away from your mouth. Breathe out as much as you can. Do not breathe into the inhaler.

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

Take the inhaler out of your mouth.

Hold your breath for about 10 seconds or as long as you can.

Breathe out slowly.

Figure 3

The inhaler releases its dose of medicine in the form of a 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 medicine.

1. Close the inhaler to keep it clean, sliding the purple mouthpiece cover (for 50/500 micrograms) back to its original position. You will hear a "click" (seefigure4). The mouthpiece cover returns to its original position and is reset. The inhaler is now ready for you to take your next scheduled dose.

1. Then 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 mouthpiece of the inhaler with a dry cloth.

If you use more Amaira than you should

It is very important to use the inhaler exactly as you have been told. If you accidentally take more doses than recommended, talk to your doctor or pharmacist. You may notice that your heart beats faster than normal, and you may feel shaky. You may also feel dizzy, have a headache, weakness, and pain in your joints.

If you have used high doses of salmeterol/fluticasone propionate for long periods, you should ask your doctor or pharmacist for advice. 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to use Amaira

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

If you stop using Amaira

It is very important that you use salmeterol/fluticasone propionate every day as your doctor has told you. Continue to take it until your doctor tells you to stop. Do not stop or suddenly reduce your treatment withsalmeterol/fluticasone propionate.This could make your breathing worse.

Additionally, if you stop taking salmeterol/fluticasone propionate suddenly or reduce your dose, you may (very rarely) experience problems with your adrenal glands (adrenal insufficiency), which can sometimes cause side effects.

These side effects may include any of the following:

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

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

If you experience any side effects, talk to 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 further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. To reduce the appearance of adverse 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 suffer from wheezing and coughing or shortness of breath. You may also notice itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or throat). You may also feel that your heart is beating very fast, feel like you are losing 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 takingthis medicineand inform your doctor immediately. Allergic reactions to Amaira are rare (they can affect up to 1 in 100 people).

Pneumonia (lung infection) in patients with COPD (frequent adverse effect)

Tell your doctorif you have any of the following symptoms while inhaling Amaira, because they could be symptoms of a lung infection:

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

The following are other adverse effects:

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

• Headache, which usually improves with continued treatment.
• An increase in the number of colds has been reported in patients with Chronic Obstructive Pulmonary Disease (COPD).

Common (may affect up to 1 in 10people)

• Candidiasis (itching, appearance of yellowish-white ulcers) in the mouth and throat. Also, pain in the tongue, hoarse voice, 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 the treatment of candidiasis, your doctor may prescribe antifungal medication (for the treatment of fungal infections).

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

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

• Bruises and fractures.
• Sinusitis (a feeling of tension or congestion in the nose, cheeks, and behind the eyes, sometimes with a throbbing pain).
• Decreased potassium levels in the blood (you may feel irregular heartbeats, muscle weakness, cramps).

Uncommon (may affect up to 1 in 100people)

• Increased blood sugar (glucose) levels (hyperglycemia). If you have diabetes, you will need to check your blood sugar levels more frequently and adjust your usual diabetic treatment if necessary.
• Cataracts (opacity of the eye lens).
• Very fast heart rate (tachycardia).
• Feeling 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 1,000people)

• Difficulty breathing or wheezing that worsens immediately after using Amaira. Ifthis happens, stop using the Amaira inhaler. Use your rapid-acting "rescue" inhaler to improve your breathing and inform your doctor immediately.
• Salmeterol/fluticasone may increase the normal production of steroid hormones, particularly if you have been taking high doses for long periods. The effects include:
• • Growth delay 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 appearance of any of these adverse effects and ensure that you are taking the lowest dose of this combination of medicines to control your asthma.

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

Frequency not known, but may also occur:

• Depression or aggression (it is more likely that these effects will occur in children).
• Blurred vision

Reporting of Adverse Effects

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

5. Conservation of Amaira

• Keep this medicine out of the sight and reach of children.
• Do not use Amaira after the expiration date that appears on the case 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 thrown away through wastewater or household waste. Deposit the containers and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Amaira

The active ingredients are salmeterol and fluticasone propionate.

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

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

Appearance of the Product and Package Contents

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder:

Zentiva k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Manufacturer:

Oy Medfiles Ltd

Volttikatu 5, Volttikatu 8

Kuopio, 70700

Finland

You can request more information about this medicine 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:November 2021

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