NEUAIR 50 mcg + 250 mcg Powder

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Neuair Airmaster, (50 micrograms + 100 micrograms)/dose, powder for inhalation,
   1. Neuair Airmaster, (50 micrograms + 250 micrograms)/dose, powder for inhalation, divided
   2. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   3. Table of contents of the leaflet
3. What is Neuair Airmaster and what is it used for
   1. Neuair Airmaster is used to treat adults and adolescents aged 12 years and older.
   2. Neuair Airmaster prevents shortness of breath and wheezing in the airways. However, it should not be used to relieve sudden attacks of shortness of breath or wheezing in the airways. If such an attack occurs, it is necessary to use a fast-acting bronchodilator, such as salbutamol, immediately. The patient should always have such a medicine with them.2. Important information before using Neuair AirmasterWhen not to use Neuair Airmaster
   3. Warnings and precautions
   4. Children
   5. Neuair Airmaster and other medicines
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Neuair Airmaster contains lactose
4. How to use Neuair Airmaster
   1. Adults and adolescents aged 12 years and older
   2. In case of worsening asthma symptoms or breathing difficulties, the patient should immediately
   3. Instructions for use
   4. This training is important to ensure that the patient receives the required dose. If the patient has not received this training, they should ask their doctor, nurse, or pharmacist to show them how to use the inhaler correctly, especially before the first
   5. Cleaning the inhaler
   6. Using a higher dose of Neuair Airmaster than recommended
   7. Missing a dose of Neuair Airmaster
   8. Stopping the use of Neuair Airmaster
5. Possible side effects
   1. Allergic reactions: The patient may experience sudden breathing difficulties immediately after
   2. Very common side effects (may occur more often than in 1 in 10 people)
   3. Common side effects (may occur less often than in 1 in 10 people)
   4. Uncommon side effects (may occur less often than in 1 in 100 people)
   5. Rare side effects (may occur less often than in 1 in 1000 people)
   6. Side effects with unknown frequency (frequency cannot be estimated from the available data)
   7. Reporting side effects
6. How to store Neuair Airmaster
7. Contents of the packaging and other information
   1. What Neuair Airmaster contains
   2. What Neuair Airmaster looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: 2021/11

Leaflet accompanying the packaging: patient information

Neuair Airmaster, (50 micrograms + 100 micrograms)/dose, powder for inhalation,

divided

Neuair Airmaster, (50 micrograms + 250 micrograms)/dose, powder for inhalation, divided

Salmeterol + Fluticasone propionate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Neuair Airmaster and what is it 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 packaging and other information

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

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

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

Neuair Airmaster is used to treat adults and adolescents aged 12 years and older.

The doctor has prescribed this medicine to the patient to prevent breathing problems that occur in:

• asthma,

In order to ensure proper control of asthma, Neuair Airmaster must be used every day according to the doctor's recommendation.

Neuair Airmaster prevents shortness of breath and wheezing in the airways. However, it should not be used to relieve sudden attacks of shortness of breath or wheezing in the airways. If such an attack occurs, it is necessary to use a fast-acting bronchodilator, such as salbutamol, immediately. The patient should always have such a medicine with them.

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 to use Neuair Airmaster, the patient should talk to their doctor, pharmacist, or nurse if they have:

• heart disease, including irregular or rapid heartbeat,
• hyperthyroidism,
• high blood pressure,
• diabetes (Neuair Airmaster may increase blood glucose levels),
• low potassium levels in the blood,
• tuberculosis currently being treated or a history of tuberculosis or other lung infections.

If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Children

This medicine should not be used in children under 12 years of age.

Neuair Airmaster and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Neuair Airmaster should not be used with certain medicines. Before starting to use Neuair Airmaster, the patient should inform their doctor about the use of the following medicines:

• Beta-adrenergic blockers (e.g., atenolol, propranolol, and sotalol). Beta-adrenergic blockers are most commonly used to treat high blood pressure or other heart diseases, such as angina pectoris.
• Medicines used to treat infections (e.g., ketoconazole, itraconazole, and erythromycin), including some medicines used to treat HIV (e.g., ritonavir, cobicistat-containing products). Some of these medicines may increase the levels of fluticasone propionate or salmeterol in the body. This may increase the risk of side effects of Neuair Airmaster, including irregular heartbeat, or may worsen existing side effects. The doctor may want to closely monitor the patient's condition while taking such medicines.
• Corticosteroids (orally or by injection). If the patient has recently taken such medicines, it may increase the risk of adrenal gland problems with Neuair Airmaster.
• Diuretics used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Medicines containing xanthine derivatives, such as aminophylline and theophylline, often used to treat asthma.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.

Driving and using machines

It is unlikely that Neuair Airmaster will affect the ability to drive or use machines.

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 for 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 according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.

• Neuair Airmaster should be used daily until the doctor recommends otherwise. The patient should not take a higher dose than recommended. In case of doubts, the patient should consult their doctor or pharmacist.
• The patient should not stop using Neuair Airmaster or reduce the dose without consulting their doctor.
• Neuair Airmaster should be inhaled into the lungs through the mouth.

Recommended dose

Adults and adolescents aged 12 years and older

• Neuair Airmaster, (50 micrograms + 100 micrograms)/dose: one inhalation twice a day.
• Neuair Airmaster, (50 micrograms + 250 micrograms)/dose: one inhalation twice a day.

If the patient's asthma symptoms are well-controlled while using Neuair Airmaster twice a day, the doctor may recommend reducing the frequency of use to once a day. The dose can be given:

• once a day, in the evening, if the patient's symptoms occur at night,
• once a day, in the morning, if the patient's symptoms occur during the day. It is very important that the doctor instructs the patient on how many inhalations and how often to use.

If the patient is using Neuair Airmaster for asthma, the doctor will regularly check the patient's symptoms.

In case of worsening asthma symptoms or breathing difficulties, the patient should immediately

contact their doctor.There may be an increase in wheezing, more frequent chest tightness, or a need for a higher dose of a fast-acting inhalation medicine. In any of these situations, the patient should continue to use Neuair Airmaster, but should not increase the number of inhalations. The patient's symptoms may worsen, and their condition may deteriorate. The patient should contact their doctor, as they may need additional treatment.

Instructions for use

• Neuair Airmaster may be different from inhalers used by the patient in the past, so it is very important to use it correctly. The doctor, nurse, or pharmacist should instruct the patient on how to use the inhaler properly.

This training is important to ensure that the patient receives the required dose. If the patient has not received this training, they should ask their doctor, nurse, or pharmacist to show them how to use the inhaler correctly, especially before the first

use.
The doctor, nurse, or pharmacist should also periodically check that the patient is using the inhaler correctly. Using Neuair Airmaster not according to the doctor's recommendation may cause the medicine not to produce the expected improvement in asthma.

• The inhaler contains blisters with salmeterol and fluticasone propionate in powder form.
• The inhaler is equipped with a dose counter, which indicates how many doses of the medicine are left in the inhaler. The counter shows the dose number down to 0. The numbers from 5 to 0 appear in red to warn that there are only a few doses of the medicine left in the inhaler. If the counter shows 0, it means that the inhaler is empty.

The inhaler delivers a dose of the medicine in the form of a very fine powder. The patient may, but does not have to, feel the powder. The patient should not take an additional dose from the inhaler if they do not feel the taste of the medicine.

• 4. To close the inhaler, the patient should turn the light pink (for 50/100 micrograms) or pink (for 50/250 micrograms) mouthpiece cover back to its original position - until it clicks (see Figure 4). The mouthpiece cover is now back in its original position. The inhaler is now ready for use at the next scheduled dose.
• 5. After inhaling the medicine, the patient should rinse their mouth with water and spit it out and/or brush their teeth. This may help prevent hoarseness and thrush.

Figure 1
Figure 2
Note: Each time the mouthpiece cover is opened after the "click", a blister opens inside and the next dose of powder is ready for inhalation. Therefore, the patient should not open the mouthpiece cover unless they need to take the medicine, as the next blister will open and the medicine will be wasted.

• 2. The patient should hold the inhaler at a distance from their mouth and exhale slowly and deeply. The patient should not exhale into the inhaler.
• 3. The patient should put the mouthpiece into their mouth (see Figure 3). The patient should take a deep breath in from the inhaler through their mouth, not through their nose. The patient should remove the inhaler from their mouth. The patient should hold their breath for about 10 seconds or as long as it is comfortable. The patient should exhale slowly.

Figure 3
The inhaler delivers a dose of the medicine in the form of a very fine powder. The patient may, but does not have to, feel the powder. The patient should not take an additional dose from the inhaler if they do not feel the taste of the medicine.

• 1. To open the inhaler, the patient should hold the inhaler with one hand in a horizontal position. The patient should press the red button with their thumb (see Figure 1) and turn the light pink (for 50/100 micrograms) or pink (for 50/250 micrograms) mouthpiece cover away from them - until it clicks (see Figure 2). After doing this, a small hole appears in the mouthpiece and a dose of the medicine is placed in the mouthpiece.

Figure 4

Cleaning the inhaler

The inhaler should be kept dry and clean.
In case of need, the mouthpiece of the inhaler can be wiped with a dry cloth or tissue.

Using a higher dose of Neuair Airmaster than recommended

It is important to use the inhaler according to the instructions. In case of accidental use of a higher dose than recommended, the patient should tell their doctor or pharmacist. The following may occur: faster than normal heartbeat, tremors, dizziness, headache, weakness, and joint pain.
In case of using higher doses for a long time, the patient should contact their doctor or pharmacist for advice, as high doses of Neuair Airmaster may cause a decrease in the production of steroid hormones by the adrenal glands.

Missing a dose of Neuair Airmaster

The patient should not take a double dose of the medicine to make up for a missed dose. The patient should take the next dose at the scheduled time.

Stopping the use of Neuair Airmaster

It is very important to take Neuair Airmaster every day according to the doctor's recommendations. The patient should take the medicine until the doctor recommends stopping it. The patient should not suddenly stop taking Neuair Airmaster or reduce the dose, as the symptoms of the disease may worsen.
Additionally, sudden stopping or reducing the dose of Neuair Airmaster may (very rarely) cause adrenal gland problems (adrenal insufficiency), which can sometimes cause side effects. These side effects may include:

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

When the body is under stress, such as from fever, injury (such as a car accident), infection, or surgery, adrenal insufficiency may worsen and any of the above side effects may occur.
If the patient experiences any of these side effects, they should tell their doctor or pharmacist. To prevent these symptoms, the doctor may prescribe additional corticosteroids in tablet form (e.g., prednisolone).
In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Neuair Airmaster can cause side effects, although not everybody gets them.
To minimize the risk of side effects, the doctor will recommend the smallest dose of this medicine that will control the asthma.

Allergic reactions: The patient may experience sudden breathing difficulties immediately after

using Neuair Airmaster. There may be an increase in wheezing, coughing, or shortness of breath, as well as itching, rash (hives), and swelling (usually of the face, lips, tongue, or throat). There may also be a feeling of a very fast heartbeat, weakness, dizziness (which can lead to falls or loss of consciousness). In case of any of these symptoms, including if they occur suddenly after using Neuair Airmaster, the patient should stop using Neuair Airmaster and contact their doctor immediately.Allergic reactions to Neuair Airmaster are uncommon (they may occur less often than in 1 in 100 people).

Very common side effects (may occur more often than in 1 in 10 people)

• Headache - this side effect usually decreases over time while continuing treatment.

Common side effects (may occur less often than in 1 in 10 people)

• Thrush (painful, creamy-white patches) in the mouth and throat, as well as sore tongue, hoarseness, and throat irritation. Rinsing the mouth with water and spitting it out and/or brushing the teeth after each inhalation may help. The doctor may recommend an antifungal medicine to treat thrush.
• Pain, swelling of the joints, and muscle pain.
• Muscle spasms.

Uncommon side effects (may occur less often than in 1 in 100 people)

• Increased blood sugar (glucose) levels (hyperglycemia). In patients with diabetes, it may be necessary to monitor blood sugar levels more frequently and adjust the dose of antidiabetic medicines.
• Cataract (clouding of the lens of the eye).
• Very fast heartbeat (tachycardia).
• Feeling of trembling and fast or irregular heartbeat (palpitations) - these symptoms usually are not serious and decrease over time while continuing treatment.
• Chest pain.
• Restlessness (this side effect occurs mainly in children).
• Sleep disturbances.
• Allergic skin rash.

Rare side effects (may occur less often than in 1 in 1000 people)

• Breathing difficulties or wheezing worsening immediately after taking Neuair Airmaster. In case of such symptoms, the patient should stop using Neuair Airmaster, use a fast-acting inhalation medicine, and contact their doctor immediately.
• Neuair Airmaster may disrupt the normal production of steroid hormones by the body, especially when taking high doses of the medicine for a long time. These symptoms include:
• slowed growth in children and adolescents,
• decreased bone density,
• glaucoma,
• weight gain,
• rounding of the face (Cushing's syndrome). The doctor will regularly check if the patient is experiencing these side effects and ensure that the patient is using the smallest dose of this medicine that will control the asthma.
• Changes in behavior, such as excessive excitement and irritability (these symptoms occur mainly in children).
• Irregular heartbeat or extra heartbeats (arrhythmia). The patient should inform their doctor, but should not stop using Neuair Airmaster unless the doctor recommends it.
• Fungal infection of the esophagus, which can cause difficulty swallowing.

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• Depression or aggression (these side effects are more likely to occur in children).
• Blurred vision.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Neuair Airmaster

• The medicine should be stored out of sight and reach of children.
• The medicine should not be used after the expiry date stated on the carton and inhaler label after: EXP. The expiry date (EXP) means the last day of the stated month.
• The medicine should not be stored above 30°C.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Neuair Airmaster contains

The active substances of the medicine are salmeterol and fluticasone propionate.
Neuair Airmaster, (50 micrograms + 100 micrograms)/dose
Each single inhalation provides a delivered dose (dose leaving the mouthpiece) of 47 micrograms of salmeterol (as salmeterol xinafoate) and 92 micrograms of fluticasone propionate. This is equivalent to a metered dose of 50 micrograms of salmeterol (as salmeterol xinafoate) and 100 micrograms of fluticasone propionate.
Neuair Airmaster, (50 micrograms + 250 micrograms)/dose
Each single inhalation provides a delivered dose (dose leaving the mouthpiece) of 45 micrograms of salmeterol (as salmeterol xinafoate) and 229 micrograms of fluticasone propionate. This is equivalent to a metered dose of 50 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate.
The other ingredient is lactose monohydrate (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 with blisters filled with white or off-white powder. The foil protects the powder for inhalation from the environment.
• Each dose is divided.
• The white plastic parts with a light pink (for 50/100 micrograms) or pink (for 50/250 micrograms) mouthpiece are packaged in cardboard boxes, which contain: 1, 2, 3, or 10 inhalers, each containing 60 doses of powder.

Not all pack sizes may be marketed.

Marketing authorization holder

Neutec Inhaler Ireland Limited
22 Northumberland Road,
Ballsbridge,
Dublin 4,
Ireland

Manufacturer/Importer

Oy Medfiles, Ltd.
Volttikatu 5, Volttikatu 8
Kuopio, 70700
Finland

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

Sweden
Neuair Airmaster
Austria
Neuair Airmaster
Belgium
Brecur Airmaster 50 microgram/100 microgram/dose, inhalation powder, pre-dispensed
Brecur Airmaster 50 microgram/250 microgram/dose, inhalation powder, pre-dispensed
Brecur Airmaster 50 micrograms/100 micrograms/dose, powder for inhalation, single-dose container
Brecur Airmaster 50 micrograms/250 micrograms/dose, powder for inhalation, single-dose container
Brecur Airmaster 50 Mikrogramm/100 Mikrogramm einzeldosiertes Pulver zur Inhalation
Brecur Airmaster 50 Mikrogramm/250 Mikrogramm einzeldosiertes Pulver zur Inhalation
Bulgaria
Еверио Еърмастър 50 микрограма/100 микрограма/доза прах за инхалация, предварително дозиран
Еверио Еърмастър 50 микрограма/250 микрограма/доза прах за инхалация, предварително дозиран
Czech Republic
Everio Airmaster
Estonia
Everio Airmaster
France
PROPIONATE DE FLUTICASONE/SALMETEROL ZENTIVA 100 microgrammes/50 microgrammes/dose, poudre pour inhalation en récipient unidose
PROPIONATE DE FLUTICASONE/SALMETEROL ZENTIVA 250 microgrammes/50 microgrammes/dose, poudre pour inhalation en récipient unidose
Spain
Salmeterol/Fluticasona Zentiva 50 microgramos/100 microgramos/inhalación, polvo para inhalación (unidosis)
Salmeterol/Fluticasona Zentiva 50 microgramos/250 microgramos/inhalación, polvo para inhalación (unidosis)
Ireland
Bronx Airmaster
Lithuania
Everio Airmaster 50/100 mikrogramų/dozėje dozuoti įkvepiamieji milteliai
Everio Airmaster 50/250 mikrogramų/dozėje dozuoti įkvepiamieji milteliai.
Latvia
Everio Airmaster 50/100 mikrogrami/devā inhalācijas pulveris, dozēts
Everio Airmaster 50/250 mikrogrami/devā inhalācijas pulveris, dozēts
Poland
Neuair Airmaster
Romania
Everio Airmaster 50 micrograme /100 micrograme pulbere de inhalat unidoza
Everio Airmaster 50 micrograme /250 micrograme pulbere de inhalat unidoza
Slovakia
Everio Airmaster 50 mikrogramov/100 mikrogramov
Everio Airmaster 50 mikrogramov/250 mikrogramov
Hungary
Fluzalto Airmaster 50 mikrogramm/100 mikrogramm/adag adagolt inhalációs por
Fluzalto Airmaster 50 mikrogramm/250 mikrogramm/adag adagolt inhalációs por

Date of last revision of the leaflet: 2021/11