Neuair airmaster

Package leaflet: Information for the patient

Neuair Airmaster, (50 micrograms + 100 micrograms)/dose, powder for inhalation,
divided
Neuair Airmaster, (50 micrograms + 250 micrograms)/dose, powder for inhalation,
divided
Salmeterolum + Fluticasoni propionas
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, 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. This makes it easier for air to flow into and out of the lungs. The 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.

To ensure proper asthma control, Neuair Airmaster must be used every day as directed by your doctor.
Neuair Airmaster prevents shortness of breath 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. The patient should always
have such a medicine available.

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 bronchodilators (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 used daily until your doctor advises otherwise. Do not take a higher dose than recommended. 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
Adults and adolescents aged 12 years and older

• Neuair Airmaster (50 micrograms + 100 micrograms/dose): one inhalation twice daily.
• Neuair Airmaster (50 micrograms + 250 micrograms/dose): one inhalation twice daily. If asthma symptoms are well controlled while taking 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.
There may be an increase in wheezing, more frequent chest tightness, or you may need to use a higher dose of a fast-acting inhaled medicine to help breathing. In any of these situations, continue using Neuair Airmaster, but do not increase the number of inhalations. 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 important to ensure you receive the correct dose. If you have not received this training, ask your doctor, nurse, or pharmacist to demonstrate how to use the inhaler correctly, especially before first use. They should also periodically check that you are using the inhaler correctly. Using Neuair Airmaster incorrectly may result in the medicine not providing 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 indicating how many doses of medicine remain in the device. The counter displays the number of doses down to 0. Numbers from 5 to 0 appear in red as a warning that only a few doses remain.

If the counter shows 0, the inhaler is empty.
Using the inhaler

1. To open the inhaler, hold the device in one hand parallel to the floor. Press the red button with your thumb (see Fig. 1) and rotate the light pink (for 50/100 micrograms) or pink (for 50/250 micrograms) mouthpiece cover away from you until it stops, and you hear a "click" (see Fig. 2). After performing 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 is ready for inhalation. For this reason, do not open the mouthpiece cover unless you intend to take the medicine, as the next blister will open and medicine will be lost.

2. Hold the inhaler at a distance from your mouth and breathe out calmly and deeply. Do not breathe out into the inhaler.
3. Place the mouthpiece in your mouth (see Fig. 3). Breathe in deeply 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 comfortable without causing discomfort. Breathe out calmly.

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 the medicine.

4. Close the inhaler to keep it clean by rotating the light pink (for 50/100 micrograms) or pink (for 50/250 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 use at the next scheduled dose.
5. After inhaling the medicine, rinse your mouth with water and spit out the water 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.
Using more than the recommended dose of Neuair Airmaster
It is important to use the inhaler as instructed. If you accidentally use more than the recommended 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.
Missing 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 taking Neuair Airmaster or reduce the dose, as symptoms may worsen.
Additionally, abruptly stopping or reducing the dose of Neuair Airmaster may (very rarely) cause adrenal gland dysfunction (adrenal insufficiency), which may sometimes lead to adverse effects.
These adverse effects may include any of the following:

• 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 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 will experience them.
To reduce the risk of adverse symptoms, your doctor will prescribe the lowest dose of this medicine that provides asthma control.
Allergic reactions: The patient may experience sudden breathing difficulties immediately after
using Neuair Airmaster. Wheezing, coughing, or shortness of breath may worsen, and itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or throat) may occur. There may also be a sensation of very rapid heartbeat, weakness, or dizziness (which may lead to falling or loss of consciousness). 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).

Very common adverse reactions (may occur in more than 1 in 10 people)

• Headache – this adverse reaction usually decreases over time with continued treatment.

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

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

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

• Increased blood sugar (glucose) levels (hyperglycaemia). In diabetic patients, more frequent monitoring of blood glucose levels and adjustment of current antidiabetic medication doses 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 tend to decrease with continued treatment.
• Chest pain.
• Restlessness (this reaction occurs mainly in children).
• Sleep disturbances.
• Allergic skin rash.

Rare adverse reactions (may occur in 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, especially when high doses are used for prolonged periods. These effects may include:
  • slowed growth in children and adolescents,
  • decreased bone mass,
  • glaucoma,
  • increased body weight,
  • facial rounding (moon face) (Cushing's syndrome). Your doctor will regularly monitor for such 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 (arrhythmia). Inform your doctor, but do not stop using Neuair Airmaster unless your doctor advises you to do so.
• Fungal infection of the oesophagus, which may cause difficulty swallowing.

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

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

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 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 provide more information on the safety of this medicine.

5. How to store Neuair Airmaster

• Keep the medicine out of 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 should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Neuair Airmaster contains
The active substances in the medicine are salmeterol and fluticasone propionate.
Neuair Airmaster, (50 micrograms + 100 micrograms)/dose
Each single inhalation delivers a dose (dose leaving the mouthpiece) of
47 micrograms of salmeterol (as salmeterol xinafoate) and 92 micrograms of fluticasone
propionate. This corresponds to a divided dose equivalent of 50 micrograms of salmeterol (as
salmeterol xinafoate) and 100 micrograms of fluticasone propionate.
Neuair Airmaster, (50 micrograms + 250 micrograms)/dose
Each single inhalation delivers a dose (dose leaving the mouthpiece) of
45 micrograms of salmeterol (as salmeterol xinafoate) and 229 micrograms of fluticasone
propionate. This corresponds to a divided dose equivalent of 50 micrograms of salmeterol (as
salmeterol xinafoate) and 250 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 white or off-white powder. The foil protects the inhalation powder from atmospheric conditions.
• Each dose is pre-measured.
• White plastic devices with a light pink (for strength 50/100 micrograms) or pink (for 50/250 micrograms) mouthpiece are packaged 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/100 microgram/ dose, inhalation powder, pre-dispensed
Brecur Airmaster 50 microgram/250 microgram/ dose, inhalation powder, pre-dispensed
Brecur Airmaster 50 microgrammes/100 microgrammes/dose, poudre pour inhalation en récipient unidose
Brecur Airmaster 50 microgrammes/250 microgrammes/dose, poudre pour inhalation en récipient unidose
Brecur Airmaster 50 Mikrogramm/100 Mikrogramm einzeldosiertes Pulver zur Inhalation
Brecur Airmaster 50 Mikrogramm/250 Mikrogramm einzeldosiertes Pulver zur Inhalation
Bulgaria Everio Airmaster 50 micrograms/100 micrograms/dose powder for inhalation, pre-dosed
Everio Airmaster 50 micrograms/250 micrograms/dose powder for inhalation, pre-dosed
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
Italy SALMETEROLO E FLUTICASONE DOCgen