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

2. What you need to know before you start using Inhalok Airmaster

Do not use this medicine

• if you are allergicto salmeterol, fluticasone propionate, or any other component of this medicine, lactose monohydrate.

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment if you have:

• heart problems, including fast or irregular heartbeat,
• overactive thyroid gland,
• high blood pressure,
• diabetes mellitus (salmeterol/fluticasone may increase blood sugar levels),
• low potassium levels 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 medicine should not be used in children under 12 years of age.

Using Inhalok Airmaster with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because, in some cases, this medicine should not be used with other medicines.

Inform your doctor if you are taking any of the following medicines before starting to use this medicine:

• β-blockers (such as atenolol, propranolol, and sotalol). β-blockers are mainly used to treat high blood pressure or other heart conditions.
• Medicines for treating infections (such as ketoconazole, itraconazole, and erythromycin), including some medicines for HIV (such as ritonavir, 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 this medicine, including irregular heartbeats, or may worsen side effects. Your doctor will closely monitor you if you are taking these medicines.
• Corticosteroids (oral or injectable). If you have taken these medicines recently, you may be at increased risk of this medicine affecting your adrenal gland.
• Diuretics, also known as water pills, used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthine. 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

This medicine is unlikely to affect your ability to drive or use machines.

Inhalok Airmaster contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to use Inhalok Airmaster

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

• Use this medicine 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.
• This medicine should be inhaled through the mouth into the lungs.

The recommended dose is:

For asthma

Adults and adolescents 12 years and older

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

For adults with Chronic Obstructive Pulmonary Disease (COPD)

• Inhalok Airmaster 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 medication.

If you are using this medicine 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 fast-acting rescue medication more frequently. If any of these things happen, you should continue to use this medicine, but do not increase the number of applications. Your respiratory disease may get worse, and you may become seriously ill. 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 correctly. 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 medicine 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 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 flat and level position. Press the red button with your thumb (see Figure 1) and turn the pink (for the 50/250 microgram dose) or purple (for the 50/500 microgram dose) mouthpiece cover away from you with the thumb of your other hand until you hear a "click" (see Figure 2). This will open a small hole in the mouthpiece and place a dose of your medicine in the mouthpiece.

Figure 1 Figure 2

Each time the mouthpiece cover is opened with a "click", a blister compartment in the interior is opened, and the powder is prepared for inhalation. Do not open the mouthpiece cover if you do not need the medicine, as this will open the compartment and waste the medicine.

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

Breathe out slowly.

Figure 3

The inhaler releases its dose of medicine 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 medicine.

1. Close the inhaler to keep it clean, by turning the pink (for the 50/250 microgram dose) or purple (for the 50/500 microgram dose) mouthpiece cover back towards you until it clicks (see Figure 4). The mouthpiece cover has been returned to its original position and reset. The inhaler is now ready for you to take your next dose.

1. Afterward, rinse your mouth with water and spit it out and/or brush your teeth. This may help prevent mouth ulcers and hoarseness.

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 directed. If you have accidentally taken a larger dose 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, feel weak, or have joint pain.

If you have used high doses for long periods, ask your doctor or pharmacist for advice. This is because high levels of this medicine may reduce the amount of steroid hormones produced by the adrenal gland.

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

If you forget to use Inhalok Airmaster

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

If you stop using Inhalok Airmaster

It is very important that you use this medicine every day as directed. Keep taking it until your doctor tells you to stop. Do not stop using this medicine suddenly. This could make your breathing worse.

Additionally, if you stop taking this medicine suddenly or reduce the dose, you may (very rarely) experience problems with your adrenal gland (adrenal insufficiency), which can sometimes cause side effects.

These side effects may include:

• Stomach pain

• Tiredness and loss of appetite, feeling unwell
• Discomfort and diarrhea
• 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., an 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 during this time (such as prednisolone).

If you have any further questions on 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 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 medicine. You may suffer from wheezing and coughing or shortness of breath. You may also notice itching, rash (hives), and swelling (usually of the face, lips, tongue, or throat). You may also suddenly feel that your heart is beating very fast, feel like you are losing consciousness, and feel dizzy (which can lead to collapse or loss of consciousness). If you experience any of these effects or if they appear suddenly after using this medicine, stop taking it and inform your doctor immediately. Allergic reactions to salmeterol/fluticasone are rare (affect less than 1 in 100 people).

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

Inform your doctorif you have any of the following symptoms while inhaling this medicine, 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 10 people)

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

Common (may affect less than 1 in 10 people)

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

Uncommon (may affect less than 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycemia). If you have diabetes, you will need to monitor 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 as treatment continues.
• Chest pain.
• Feeling of anxiety (occurs mainly in children).
• Sleep disorders.
• Allergic skin rash.

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 rapid-acting "rescue" inhaler to improve your breathing and 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. 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 any of these adverse 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 do so.
• Fungal infection in the esophagus (throat), which can 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Inhalok Airmaster

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiration date shown on the label and on the packaging after CAD. The expiration date is the last day of the month indicated.
• Do not store above 30°C.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Inhalok Airmaster

• The active ingredients are salmeterol and fluticasone propionate.

Inhalok Airmaster 50 micrograms/250 micrograms

Each inhalation provides a delivered 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 delivered 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 Package Contents

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: April 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.gob.es/

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