Prospect: information for the patient

Inhalok Airmaster50 micrograms/250 micrograms/inhalation, powder for inhalation (single dose)

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

salmeterol/fluticasone propionate

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this prospect. See section 4.

This medication contains 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 12 hours.
• Fluticasone propionate is a corticosteroid that reduces inflammation and irritation in the lungs.

This medication is indicated for the treatment of adults and adolescents 12 years of age and older.

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

• Asthma.

or

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

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

Inhalok Airmaster helps prevent shortness of breath and wheezing. However, this medication should not be used to relieve a sudden attack of shortness of breath or wheezing. In such a case, you must use your rescue medication with rapid action, such as salbutamol. You should carry your rescue medication with rapid action with you at all times.

Do not use this medication

• if you areallergicto salmeterol, fluticasone propionate or to any of the other ingredients in this medication, lactose monohydrate.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment if you have:

• heart problems, including rapid or irregular heartbeat,
• hyperthyroidism,
• high blood pressure,
• diabetes mellitus (salmeterol/fluticasone may increase blood sugar levels),
• low potassium levels in the blood,
• active tuberculosis (TB) today 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 Inhalok Airmaster with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medication. This is because, in some cases, this medication should not be administered with or other medications.

Inform your doctor if you take any of the following medications before starting to use this medication:

• β-blockers (such as atenolol, propranolol, and sotalol). β-blockers are used mainly to treat hypertension or other heart conditions.
• Medications to treat infections (such as ketoconazole, itraconazole, and erythromycin), including some HIV medications (such as ritonavir, 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 this medication, including irregular heartbeat, or may worsen the adverse effects, so your doctor will perform close monitoring if you are taking these medications.
• Corticosteroids (oral or injectable). If you have taken these medications recently, you may increase the risk of this medication affecting your adrenal gland.
• Diuretics, also known as medications to urinate, used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medications containing xanthine. They are often used to treat asthma.

Pregnancy and breastfeeding

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

Driving and operating machinery

This medication is unlikely to affect your ability to drive or operate machinery.

Inhalok Airmastercontains lactose

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Always 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 this medication 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.
• This medication must be inhaled through the mouth into the lungs.

The recommended dose is:

For asthma

Adults and adolescents 12 years and older

• Inhalok Airmaster 50/250One inhalation twice a day
• Inhalok Airmaster 50/500One inhalation twice a day

For adults with Chronic Obstructive Pulmonary Disease (COPD)

• Inhalok Airmaster 50/500One 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 this medication 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 feeling of choking more often or that you need to use your rescue medication more frequently. If any of these things happen, you should continue using this medication, but do not increase the number of applications. Your respiratory disease may worsen and seriously harm you. See your doctor, as you may need additional treatment.

Instructions for use

• Inhalok Airmaster may be different from other 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 administer the dose you need. If you have not received this training, please ask your doctor, nurse, or pharmacist to teach you how to use the inhaler correctly, especially before you use it for the first time.

Periodically, they should check how you use it to ensure that you are using the device correctly and as prescribed. Not using this medication 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 powder.
• There is a dose counter on the top of the device that indicates how many doses are left. It 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 flat and level position. Press the red button with your thumb (see Figure 1) and turn the mouthpiece cover of pink (for the 50/250 microgram dose) or purple (for the 50/500 microgram dose) color, moving it away from you with the other hand's thumb until you hear a "click" (see Figure 2). This will open a small hole in the mouthpiece and place a dose of your medication in the mouthpiece.

Figure 1Figure 2

Each time the mouthpiece cover opens with a "click", an alveolus in the blister inside opens and the powder is prepared to be inhaled. Do not open the mouthpiece cover if you do not need the medication, as this opens the alveolus and wastes medication.

1. Keep the inhaler away from your mouth. Breathe out as much as possible. Do not breathe into the inhaler.
2. Place the mouthpiece in your lips (see Figure 3).Breathe in progressively and uninterruptedly 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.

Figure 3

The inhaler releases your medication dose as a very fine powder. You may or may not taste or feel the powder.Do not use an extra dose of the inhaler if you do not feel or taste the medication.

1. After rinsing your mouth with water and spitting it out and/or brushing your teeth. This may help prevent mouth ulcers and sore throat.

Figure 4

Cleaning your inhaler

Keep your inhaler dry and clean.

If necessary, you can clean the mouthpiece of your inhaler with a dry cloth or tissue.

If you use more Inhalok Airmaster than you should

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

If you have used large doses for long periods of time, please consult your doctor or pharmacist. This is because high concentrations of this medication can reduce the amount of steroid hormones produced by the adrenal gland.

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

If you forget to use Inhalok Airmaster

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 Inhalok Airmaster

It is very important to use this medication every day as indicated. Continue taking it until your doctor tells you to stop. Do not abruptly stop your treatment with this medication. This may worsen your breathing.

Additionally, if you stop taking this medication suddenly or reduce your dose, you may (very rarely) cause problems with your adrenal gland (adrenal insufficiency), which sometimes causes adverse effects.

These adverse effects may include any of the following:

• Stomach 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., an accident or injury), infection, or surgery, adrenal insufficiency may worsen and you may experience any of the adverse effects listed above.

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

If you have any doubts about the use of this medication, consult 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 medicine that controls your asthma or chronic obstructive pulmonary disease (COPD).

Allergic reactions: you may notice that your breathing suddenly worsens immediately after using this medicineafter using this medicine. 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 are losing consciousness, and dizziness (which can lead to collapse or loss of consciousness).If you experience any of these side effects or if they appear suddenly after using this medicine, stop taking it and inform your doctor immediatelyimmediately. Allergic reactions to salmeterol/fluticasone are rare (affect less than 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 inhaling this medicine, 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 (may affect more than 1 in 10 people)

• Headache, which usually improves as treatment continues.
• An increase in the number of colds in patients with chronic obstructive pulmonary disease (COPD) has been reported.

Common (may affect less than 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.

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

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

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

• Fractures and osteoporosis.
• Inflammation of the sinuses (sensation 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, and cramps).

Rare (may affect less than 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 (may affect less than 1 in 1,000 people)

• Difficulty breathing (or wheezing) that worsens immediately after using this medicine. If this happens, stop using this medicine. Use your rescue inhaler for quick action to improve your breathingand inform your doctor immediately.
• This medicine may 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
  • Rounded face (moon-shaped) (Cushing's syndrome)

Your doctor will regularly monitor any of these side effects and ensure that you are taking the lowest dose of salmeterol/fluticasone to control your asthma.

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

Unknown frequency, but may also occur:

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

Reporting 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 prospectus. 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 label and on the packaging after CAD. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofInhalok Airmaster

• The active ingredients are salmeterol and fluticasone propionate.

Inhalok Airmaster 50 micrograms/250 micrograms

Each inhalation provides a released dose (the dose that comes out of the mouthpiece) of 45 micrograms of salmeterol (as salmeterol xinafoate) and 229 micrograms of fluticasone propionate. This corresponds to a pre-dispensed dose of 50 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate.

Inhalok Airmaster 50 micrograms/500 micrograms

Each 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 pre-dispensed dose of 50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of fluticasone propionate.

• The other component is lactose monohydrate (See Section 2: Inhalok Airmaster contains lactose) (which contains milk proteins).

Appearance of Inhalok Airmaster and contents of the package

• The inhaler contains a strip of aluminum paper with blisters filled with white to off-white powder. The sheet protects the powder for inhalation from the effects of the atmosphere.
• Each dose is pre-dispensed.
• The white plastic devices with pink mouthpiece cover (for 50/250 micrograms doses) or mauve (for 50/500 micrograms doses) are packaged in cardboard boxes that contain:
• • 1, 2, 3, or 10 × inhaler(s), each containing 60 inhalations.
  • Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible for Manufacturing

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for Manufacturing

Oy Medfiles Ltd.

Volttikatu 5,

Kuopio, 70700 Finland

or

Oy Medfiles Ltd.

Volttikatu 8,

Kuopio, 70700 Finland

or

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

Pabianice, 95-200 Poland

or

STADA Arzneimittel AG

Stadastr. 2 – 18,

61118 Bad Vilbel

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Last update of the summary of product characteristics: April 2021

The 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.gob.es/

You can access the detailed and updated information on how to administer this medicinal product by scanning with your smartphone the QR code included in the packaging. You can also access this information at the following internet address:https://cima.aemps.es/info/85847orhttps://cima.aemps.es/info/85848