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

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Inhalok Airmaster 50 micrograms/250 micrograms per inhalation, powder for inhalation (single dose)

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

salmeterol/fluticasone propionate

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Inhalok Airmaster is and what it is used for

This medicine 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 indicated for the treatment of adults and adolescents aged 12 years and older.

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

• Asthma

or

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

You must use this medicine every day as directed by your doctor. This will ensure the medicine works properly to control your asthma or COPD.

Inhalok Airmaster helps prevent breathlessness and wheezing. However, this medicine 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 must always carry your fast-acting rescue medication with you.

2. What you need to know before using Inhalok Airmaster

Do not use this medicine

• if you are allergic to salmeterol, fluticasone propionate, or any of the other ingredients 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,
• high blood pressure,
• diabetes mellitus (salmeterol/fluticasone may increase blood sugar levels),
• low potassium levels 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 must not be used in children under 12 years of age.

Use of Inhalok Airmaster with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. The reason is that, in some cases, this medicine should not be taken together 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 mostly used to treat high blood pressure or other heart conditions.
• Medicines to treat infections (such as ketoconazole, itraconazol, 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 adverse effects with this medicine, 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 recently taken these medicines, it may increase the risk of this medicine affecting your adrenal gland.
• Diuretics, also known as water tablets, used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthines. 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

It is unlikely that this medicine will affect your ability to drive or operate machinery.

Inhalok Airmaster contains lactose

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

3. How to use Inhalok Airmaster

Always follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The recommended dose is:

For asthma

Adults and adolescents aged 12 years and older

• Inhalok Airmaster 50/250: One inhalation twice daily
• Inhalok Airmaster 50/500: 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 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 medicine.

If you are using this medicine 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 should continue using this medicine, but do not increase the number of inhalations. Your respiratory condition may worsen 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 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, please ask your doctor, nurse, or pharmacist to show you how to use the inhaler properly, especially before using it for the first time.

Your technique should be checked periodically to ensure you are using the device correctly and as prescribed. Failure to use this medicine properly or as prescribed may result in your asthma or COPD not improving as expected.

• 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 will appear in red to warn you that few doses remain. Once the counter shows 0, your inhaler is empty.

Using your inhaler

1. To open the inhaler, hold it in one hand in a flat, level position. Press the red button with your thumb (see Figure 1) and rotate the pink mouthpiece cover (for the 50/250 microgram dose) or mauve (for the 50/500 microgram dose) away from you using 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 your medicine into the mouthpiece.

Figure 1 Figure 2

Each time the mouthpiece cover is opened with a "click," a blister compartment inside 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 blister and waste medicine.

2. Keep the inhaler away from your mouth. Breathe out as much as you comfortably can. Do not breathe into the inhaler.
3. Place the mouthpiece in your mouth (see Figure 3). Breathe in steadily and continuously through the inhaler, not through your nose.

Remove the inhaler from your mouth.

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

Breathe out slowly.

Figure 3

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

4. Close the inhaler to maintain cleanliness by rotating the pink mouthpiece cover (for the 50/250 microgram dose) or mauve (for the 50/500 microgram dose) back toward you until it clicks into place. You will hear a "click" (see Figure 4). The mouthpiece cover has returned to its original position and is reset. The inhaler is now ready for your next dose.

5. Rinse your mouth with water after use, 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 may 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 exactly as instructed. If you have accidentally taken a higher dose than recommended, 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 over long periods of time, seek advice from your doctor or pharmacist. This is because high concentrations 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 at: 91 562 04 20, stating the medicine and the amount taken.

If you forget to use Inhalok Airmaster

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

If you stop using Inhalok Airmaster

It is very important that you use this medicine every day as prescribed. Continue taking it until your doctor tells you to stop. Do not stop treatment with this medicine abruptly, as this could cause your breathing to worsen.

Additionally, if you suddenly stop taking this medicine or reduce your dose, you could (very rarely) develop problems with your adrenal gland (adrenal insufficiency), which may sometimes cause 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, 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 experience any adverse effects, consult your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe an additional dose of corticosteroid tablets during that time (such as prednisolone).

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. To reduce the occurrence 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 experience wheezing, coughing, or shortness of breath. You may also notice itching, rash (urticaria), or swelling (usually of the face, lips, tongue, or throat). You may also suddenly feel that your heart is beating very fast, feel faint, or dizzy (which may lead to collapse or loss of consciousness). If you experience any of these effects or if they occur suddenly after using this medicine, stop taking it and contact your doctor immediately. Allergic reactions to salmeterol/fluticasone are uncommon (affecting fewer than 1 in 100 people).

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

Inform your doctor if you experience any of the following symptoms while inhaling this medicine, as they could be signs of a lung infection:

• Fever or chills
• Increased mucus production, change in mucus color
• Worsening cough or increased difficulty breathing

Other adverse effects listed below:

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

• Headache, which usually improves with continued treatment.
• Increased incidence of colds has been reported in patients with chronic obstructive pulmonary disease (COPD).

Common (may affect less than 1 in 10 people)

• Oral and throat candidiasis (itching, yellowish creamy lesions). 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 (for treatment of fungal infections).

• Joint pain, joint swelling, and muscle pain.
• Muscle cramps.

The following adverse effects have been reported in patients with chronic obstructive pulmonary disease (COPD):

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

Uncommon (may affect less than 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycaemia). If you have diabetes, your blood sugar levels will need to be monitored more frequently, and your usual diabetes treatment may need to be adjusted if necessary.
• 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 anxious (occurs mainly in children).
• Sleep disorders.
• Allergic skin rash.

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

• Breathing difficulties (or wheezing) that worsen immediately after using this medicine. If this happens, stop using this medicine. Use your fast-acting "rescue" inhaler to improve your breathing and contact 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. 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 regularly monitor for any of these adverse effects and ensure you are taking the lowest effective 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.

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

5. Storage of Inhalok Airmaster

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label and on the packaging after EXP. The expiry date refers to the last day of the month indicated.
• Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of any containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Inhalok Airmaster

• The active substances are salmeterol and fluticasone propionate.

Inhalok Airmaster 50 micrograms/250 micrograms

Each 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 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 delivers a released dose (the dose exiting 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 pack

• The inhaler contains an aluminium strip with blisters filled with white to off-white powder. The foil protects the inhaled powder from atmospheric effects.
• Each dose is pre-dispensed.
• The white plastic devices with a pink mouthpiece cover (for the 50/250 microgram dose) or mauve mouthpiece cover (for the 50/500 microgram dose) are packaged in cardboard boxes containing:
  • 1, 2, 3 or 10 × inhaler(s), each containing 60 inhalations.
  • Only certain 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

Eurofins BioPharma Product Testing Finland Oy
Volttikatu 5,
Kuopio, 70700 Finland

or

Eurofins BioPharma Product Testing Finland Oy
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

or

Kymos S.L.
Ronda De Can Fatjo 7b
Parc Tecnologic Del Valles
Cerdanyola Del Valles, 08290
Spain

or

Pharmaprogress S.R.L
Via Emilia Romagna,
28/30/32
Monsano, 60030
Italy

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

Date of the most recent review of this leaflet: April 2021

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