Neuair airmaster

Patient Information Leaflet: Instructions for Use

Neuair Airmaster, (50 micrograms + 500 micrograms)/dose, inhalation powder,
divided
Salmeterolum + Fluticasoni propionas
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

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

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

Neuair Airmaster contains two active substances: salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways open, making it easier for air to flow into and out of the lungs. Its effect lasts for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and irritation in the lungs.

Neuair Airmaster is used to treat adults and adolescents aged 12 years and older.
Your doctor has prescribed this medicine to prevent breathing problems associated with:

• asthma, or
• chronic obstructive pulmonary disease (COPD). Neuair Airmaster, at a dose of 50 micrograms + 500 micrograms, reduces the frequency of COPD exacerbations.

To ensure proper control of asthma or COPD, Neuair Airmaster must be used every day as directed by your doctor.
Neuair Airmaster helps prevent breathlessness and wheezing. However, it should not be used to relieve sudden attacks of breathlessness or wheezing. If such an attack occurs, a fast-acting bronchodilator, such as salbutamol, should be used immediately. You should always carry such a medicine with you.

2. Important information before using Neuair Airmaster

When not to use Neuair Airmaster

• if the patient is allergic to salmeterol, fluticasone propionate, or lactose monohydrate, an excipient of the medicine.

Warnings and precautions
Before starting treatment with Neuair Airmaster, talk to your doctor, pharmacist, or nurse if the patient has:

• heart disease, including irregular or rapid heartbeat,
• hyperthyroidism,
• high blood pressure,
• diabetes (Neuair Airmaster may increase blood glucose levels),
• low blood potassium levels,
• active or previously treated tuberculosis or other lung infections.

If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Children
Do not use this medicine in children under 12 years of age.
Neuair Airmaster and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Neuair Airmaster should not be used with certain medicines.
Before starting treatment with Neuair Airmaster, inform your doctor if the patient is taking any of the following medicines:

• Medicines from the beta-blocker group (e.g. atenolol, propranolol, and sotalol). Beta-blockers are commonly used to treat high blood pressure or other heart conditions such as angina.
• Medicines used to treat infections (e.g. ketoconazole, itraconazole, and erythromycin), including certain medicines used to treat HIV (e.g. ritonavir, drugs containing cobicistat). Some of these medicines may increase the levels of fluticasone propionate or salmeterol in the body. This may increase the risk of adverse effects of Neuair Airmaster, including irregular heartbeat, or may worsen existing side effects. Your doctor may wish to closely monitor the patient's condition when taking such medicines.
• Corticosteroids (taken orally or by injection). If the patient has recently taken such medicines, this may increase the risk of adrenal suppression caused by Neuair Airmaster.
• Diuretics used to treat high blood pressure.
• Other bronchodilator medicines (such as salbutamol).
• Medicines containing xanthine derivatives, such as aminophylline and theophylline, commonly used in the treatment of asthma.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Driving and operating machinery
It is unlikely that Neuair Airmaster will affect the ability to drive or operate machinery.
Neuair Airmaster contains lactose
Neuair Airmaster contains approximately 13 milligrams of lactose monohydrate per dose. The amount of lactose in this medicine usually does not cause problems in people with lactose intolerance. The excipient lactose contains small amounts of milk proteins which may cause allergic reactions.

3. How to use Neuair Airmaster

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

• Neuair Airmaster should be taken daily until your doctor advises otherwise. Do not take more than the prescribed dose. If in doubt, consult your doctor or pharmacist.
• Do not stop using Neuair Airmaster or reduce the dose without consulting your doctor.
• Neuair Airmaster should be inhaled into the lungs through the mouth.

Recommended dose
Bronchial asthma
Adults and adolescents aged 12 years and older

• Neuair Airmaster (50 micrograms + 500 micrograms)/dose: one inhalation twice daily.

Adults with chronic obstructive pulmonary disease (COPD)

• Neuair Airmaster (50 micrograms + 500 micrograms)/dose: one inhalation twice daily.

If asthma symptoms are well controlled while using Neuair Airmaster twice daily, your doctor may recommend reducing the frequency of Neuair Airmaster to once daily. The dose may be administered:

• once daily in the evening, if symptoms occur at night,
• once daily in the morning, if symptoms occur during the day.
  It is very important that your doctor instructs you how many inhalations to take and how often.

If you are using Neuair Airmaster for asthma, your doctor will regularly monitor your symptoms.
If asthma symptoms worsen or breathing becomes more difficult, contact your doctor immediately.
You may experience increased wheezing, more frequent chest tightness, or may need to use a higher dose of a fast-acting inhaled medicine to help you breathe. In any of these situations, continue using Neuair Airmaster, but do not increase the number of inhalations.
Your symptoms may worsen and your condition may deteriorate. Contact your doctor, as you may require additional treatment.

Instructions for use

• Neuair Airmaster may differ from inhalers you have used previously, so it is very important to use it correctly. Your doctor, nurse, or pharmacist should instruct you on how to use the inhaler properly. This training is essential to ensure you receive the required dose. If you have not received this training, ask your doctor, nurse, or pharmacist to demonstrate the correct use of the inhaler, especially before first use. They should also periodically check that you are using the inhaler correctly. Using Neuair Airmaster differently from your doctor’s instructions may result in the medicine not providing the expected improvement in asthma or COPD.
• The inhaler contains blisters with salmeterol and fluticasone propionate in powder form.
• The inhaler is equipped with a dose counter indicating how many doses remain in the inhaler. The counter displays the number of doses down to 0. Numbers from 5 to 0 appear in red to warn that only a few doses of medicine remain in the inhaler. When the counter shows 0, the inhaler is empty.

Using the inhaler

1. To open the inhaler, hold it in one hand parallel to the floor. Press the red button with your thumb (see Fig. 1) and rotate the violet (for 50/500 micrograms) mouthpiece cover away from you until it stops and you hear a "click" (see Fig. 2). After this step, a small opening in the mouthpiece becomes visible and a dose of medicine is placed in the mouthpiece.

Fig. 1 Fig. 2
Note: Each time the mouthpiece cover is opened with a "click," a blister inside opens and the next dose of powder becomes ready for inhalation. Therefore, do not open the mouthpiece cover unless you are ready to take your medicine, as this will open the next blister and result in loss of medicine.

2. Hold the inhaler away from your mouth and breathe out calmly and fully. Do not breathe out into the inhaler.
3. Place the mouthpiece in your mouth (see Fig. 3). Breathe in deeply and slowly through your mouth—not through your nose—from the inhaler. Remove the inhaler from your mouth. Hold your breath for about 10 seconds, or as long as is comfortable without causing discomfort. Then breathe out slowly.

Fig. 3
The inhaler delivers the medicine as a very fine powder. You may, but do not necessarily, feel the powder. Do not take an additional dose from the inhaler if you do not taste or feel the medicine.

4. Close the inhaler to keep it clean by rotating the violet (for 50/500 micrograms) mouthpiece cover back toward you until it stops. You will hear a "click" (see Fig. 4). The mouthpiece cover is now returned to its original position. The inhaler is now ready for the next scheduled dose.

5. After inhaling the medicine, rinse your mouth with water and spit it out and/or brush your teeth. This may help prevent hoarseness and oral thrush.

Fig. 4

Cleaning the inhaler
Keep the inhaler dry and clean.
If necessary, wipe the mouthpiece of the inhaler with a dry cloth or tissue.

Accidentally using more Neuair Airmaster than prescribed
It is important to use the inhaler exactly as instructed. If you accidentally use more than the prescribed dose, inform your doctor or pharmacist. Symptoms may include: faster than normal heartbeat, tremors, dizziness, headache, muscle weakness, and joint pain.
If higher doses are used for a prolonged period, contact your doctor or pharmacist for advice, as high doses of Neuair Airmaster may reduce the production of steroid hormones by the adrenal glands.

If you miss a dose of Neuair Airmaster
Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time.

Stopping treatment with Neuair Airmaster
It is very important to take Neuair Airmaster every day as prescribed. Continue taking the medicine until your doctor advises you to stop. Do not suddenly stop using Neuair Airmaster or reduce the dose, as your symptoms may worsen.
Additionally, abruptly stopping or reducing the dose of Neuair Airmaster may (very rarely) cause adrenal gland dysfunction (adrenal insufficiency), which may lead to adverse effects.

These adverse effects may include any of the following:

• abdominal pain,
• fatigue and loss of appetite, nausea,
• vomiting and diarrhoea,
• weight loss,
• headache and drowsiness,
• low blood sugar,
• low blood pressure and seizures.

When the body is under stress due to fever, injury (such as a car accident), infection, or surgery, adrenal insufficiency may worsen and any of the adverse effects listed above may occur.
If you experience any of these adverse effects, inform your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe additional corticosteroids in tablet form (e.g. prednisolone).

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
To reduce the risk of adverse effects, your doctor will prescribe the lowest dose of this medicine that provides control of asthma or COPD.
Allergic reactions: The patient may experience sudden breathing difficulties immediately after
using Neuair Airmaster. Worsening of wheezing, cough, or shortness of breath may occur, as well as itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or throat). A sensation of very rapid heartbeat, weakness, or dizziness (which may lead to collapse or loss of consciousness) may also occur. If any of these symptoms occur, including sudden onset after using Neuair Airmaster, stop using Neuair Airmaster immediately and contact your doctor without delay. Allergic reactions to Neuair Airmaster occur uncommonly (may occur in fewer than 1 in 100 people).
Lung infection (pneumonia) in patients with chronic obstructive pulmonary disease (COPD)
(common adverse reaction)
Tell your doctor if any of the following symptoms occur during treatment with Neuair Airmaster – these may be signs of a lung infection:

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

Other adverse reactions:
Very common adverse reactions (may affect more than 1 in 10 people)

• Headache – this adverse reaction usually decreases with continued treatment.
• Increased incidence of colds has been reported in patients with chronic obstructive pulmonary disease (COPD).

Common adverse reactions (may affect fewer than 1 in 10 people)

• Oral or pharyngeal candidiasis (painful, creamy-white lesions), as well as tongue pain, hoarseness, and throat irritation. Rinsing the mouth with water and spitting it out and/or brushing teeth immediately after each inhalation may be helpful. Your doctor may prescribe an antifungal medicine to treat candidiasis.
• Joint pain, joint swelling, and muscle pain.
• Muscle cramps.

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

• Easy bruising and fractures.
• Sinusitis (feeling of pressure and fullness in the nose, cheeks, and behind the eyes, sometimes with pulsating pain).
• Decreased blood potassium levels (the patient may experience irregular heartbeat, muscle weakness, cramps).

Uncommon adverse reactions (may affect fewer than 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycemia). In patients with diabetes, more frequent monitoring of blood glucose levels and adjustment of the dose of currently used antidiabetic medicines may be necessary.
• Cataract (clouding of the eye lens).
• Very rapid heartbeat (tachycardia).
• Tremor and rapid or irregular heartbeat (palpitations) – these symptoms are usually not serious and decrease with continued treatment.
• Chest pain.
• Restlessness (this reaction occurs mainly in children).
• Sleep disturbances.
• Allergic skin rash.

Rare adverse reactions (may affect fewer than 1 in 1000 people)

• Breathing difficulties or worsening wheezing occurring immediately after taking Neuair Airmaster. If such symptoms occur, stop using Neuair Airmaster , use a fast-acting inhaled medicine to relieve breathing, and contact your doctor immediately.
• Neuair Airmaster may interfere with the body's normal production of steroid hormones, particularly when high doses are used for a prolonged period. These effects include:
  • slowed growth in children and adolescents,
  • decreased bone mass,
  • glaucoma,
  • increased body weight,
  • rounded (moon-shaped) face (Cushing's syndrome). Your doctor will regularly check for these adverse effects and ensure that you are using the lowest effective dose of this medicine to control asthma.
• Behavioral changes such as excessive excitability and irritability (these effects occur mainly in children).
• Irregular, uneven heartbeat or extra beats (arrhythmias). Inform your doctor, but do not stop using Neuair Airmaster unless instructed by your doctor.
• Fungal infection of the esophagus, which may cause difficulty swallowing.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data)

• Depression or aggression (these reactions are more likely in children).
• Blurred vision.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store the medicine Neuair Airmaster

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and inhaler label following: EXP. The expiry date (EXP) refers to the last day of the specified month.
• Do not store above 30°C.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Doing so helps protect the environment.

6. Contents of the pack and other information

What Neuair Airmaster contains
The active substances in this medicine are salmeterol and fluticasone propionate.
Each single inhalation delivers a dose (leaving dose) of
43 micrograms of salmeterol (as salmeterol xinafoate) and 432 micrograms of fluticasone
propionate. This corresponds to a divided dose of 50 micrograms of salmeterol (as
salmeterol xinafoate) and 500 micrograms of fluticasone propionate.
The other ingredient is monohydrate lactose (see section 2 under "Neuair Airmaster contains lactose")
(which contains milk proteins).

What Neuair Airmaster looks like and contents of the pack

• Neuair Airmaster contains a strip of foil blisters filled with a white or whitish powder. The foil protects the inhalation powder from atmospheric conditions.
• Each dose is pre-measured.
• White plastic devices with a violet (for 50/500 micrograms) mouthpiece are packed in cardboard boxes containing: 1, 2, 3 or 10 inhalers, each containing 60 doses of powder.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Neutec Inhaler Ireland Limited
22 Northumberland Road,
Ballsbridge,
Dublin 4,
Ireland

Manufacturer/Importer
Oy Medfiles, Ltd.
Volttikatu 5, Volttikatu 8
Kuopio, 70700
Finland
PharmaTan Kft.
Kenderfoldek Utcaja 3
6640 Csongrad
Hungary

This medicinal product is authorised in the European Economic Area countries under the following names:

Sweden – Neuair Airmaster
Austria – Neuair Airmaster
Belgium – Brecur Airmaster 50 microgram/500 microgram/dose, inhalation powder, pre-dispensed
        Brecur Airmaster 50 microgrammes/500 microgrammes/dose, poudre pour inhalation en récipient unidose
        Brecur Airmaster 50 Mikrogramm/500 Mikrogramm einzeldosiertes Pulver zur Inhalation
Bulgaria – Everio Airmaster 50 micrograms/500 micrograms/dose inhalation powder, pre-dosed
Czech Republic – Everio Airmaster
Estonia – Everio Airmaster
France – PROPIONATE DE FLUTICASONE/SALMETEROL ZENTIVA 500 microgrammes/50 microgrammes/dose, poudre pour inhalation en récipient unidose
Spain – Salmeterol/Fluticasona Zentiva 50 microgramos/500 microgramos/inhalación, polvo para inhalación (unidosis)
Ireland – Bronx Airmaster
Lithuania – Everio Airmaster 50/500 mikrogramų/dozėje dozuoti įkvepiamieji milteliai
Latvia – Everio Airmaster 50/500 mikrogrami/devā inhalācijas pulveris, dozēts
Poland – Neuair Airmaster
Romania – Everio Airmaster 50 micrograme /500 micrograme pulbere de inhalat unidoza
Slovakia – Everio Airmaster 50 mikrogramov/500 mikrogramov
Hungary – Fluzalto Airmaster 50 mikrogramm/500 mikrogramm/adag adagolt inhalációs por
Italy – SALMETEROLO E FLUTICASONE DOCgen