Airflusal

Leaflet accompanying the packaging: patient information

AirFluSal, (25 micrograms + 125 micrograms)/metered dose,

inhalation aerosol, suspension

AirFluSal, (25 micrograms + 250 micrograms)/metered dose, inhalation aerosol, suspension

Salmeterol + Fluticasone propionate

You should 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. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What AirFluSal is and what it is used for

AirFluSal contains two active substances, salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. It helps to keep the airways open, making it easier to breathe. This effect lasts for at least 12 hours.
• Fluticasone propionate is a corticosteroid, which reduces inflammation and swelling in the lungs.

AirFluSal is not recommended for use in children. Your doctor has prescribed this medicine to prevent breathing difficulties, which may be caused by asthma. To ensure proper control of asthma, AirFluSal should be used every day, as directed by your doctor. AirFluSal helps to prevent shortness of breath and wheezing, but it should not be used to relieve sudden attacks of shortness of breath or wheezing. In such cases, a fast-acting "rescue" inhaler, such as salbutamol, should be used. You should always carry a "rescue" inhaler with you.

2. Important information before using AirFluSal

When not to use AirFluSal

if you are allergic to salmeterol, fluticasone propionate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before using AirFluSal, you should discuss with your doctor if you have: heart disease, including irregular or rapid heartbeat, overactive thyroid gland, high blood pressure, diabetes (AirFluSal may increase blood sugar levels), low potassium levels in the blood, tuberculosis (currently or in the past) or other lung infections. If you start to feel dizzy or have other vision problems, you should tell your doctor.

AirFluSal and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take. This includes medicines for asthma or medicines available without a prescription. Using AirFluSal with other medicines may not be appropriate. Before using AirFluSal, you should tell your doctor about the use of the following medicines. Beta-blockers (such as atenolol, propranolol or sotalol). Beta-blockers are mainly used to treat high blood pressure or heart disease. Medicines used to treat infections, including some medicines used to treat HIV infection (such as ritonavir, cobicistat, ketoconazole, itraconazole and erythromycin). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in the body, which may increase the risk of side effects of AirFluSal (including irregular heart rhythms) or make them worse. Your doctor may carefully monitor your treatment if you are taking these medicines. Oral or injectable corticosteroids. In patients who have recently received them, the risk of adrenal insufficiency may increase. Diuretics used to treat high blood pressure. Other bronchodilators (such as salbutamol). Medicines containing xanthine derivatives (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 taking this medicine.

Driving and using machines

It is unlikely that AirFluSal will affect your ability to drive or use machines.

3. How to use AirFluSal

This medicine should always be used as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

• AirFluSal should be used every day, until your doctor advises you to stop. Do not exceed the recommended dose. If you are not sure, ask your doctor or pharmacist.
• Do not stop using AirFluSal or reduce the dose without first discussing it with your doctor.
• AirFluSal should be inhaled through the mouth into the lungs.

Recommended dose:

Adults

AirFluSal, (25 µg + 125 µg): 2 inhalations twice a day. AirFluSal, (25 µg + 250 µg): 2 inhalations twice a day. If asthma symptoms are controlled with AirFluSal used twice a day, your doctor may reduce the dose to once a day: once in the evening, if symptoms occur at night, or once in the morning, if symptoms occur during the day. It is very important to use the recommended number and frequency of inhalations. If you are using AirFluSal for asthma, your doctor will regularly check your symptoms.

If your asthma symptoms get worse or your breathing gets worse, you should see your doctor immediately.

You should continue to use your medicine, but do not increase the number of inhalations.Your symptoms may get worse and your condition may deteriorate. You should contact your doctor, as you may need additional treatment.

Use in children

AirFluSal is not recommended for use in children.

How to use the inhaler

• Your doctor or pharmacist should demonstrate how to use the inhaler and check your technique from time to time. Incorrect use or use in a way other than described in this leaflet may mean that the medicine does not produce the expected improvement in asthma symptoms.
• The medicine is contained in a pressurized canister, placed in a plastic casing with a mouthpiece.
• On the front of the inhaler, there is a dose counter, which shows how many doses of medicine are left. When using the inhaler, the dose counter moves every 5 to 7 inhalations to the next, smaller number of doses. The counter shows the approximate number of doses left in the inhaler.
• Be careful not to drop the inhaler, as this may cause the dose counter to decrease.

Checking the inhaler

• 1. Before first use, check that the inhaler is working properly. Remove the mouthpiece cover by squeezing the sides of the cover with your thumb and index finger.
• 2. To make sure it is working properly, shake the inhaler well with the mouthpiece pointing away from you, and then press the canister to release a dose into the air. The counter will show 120 - this is the number of doses of medicine in the inhaler. If the inhaler has not been used for at least a week, release two doses into the air.

Using the inhaler

It is important to start breathing in as slowly as possible before using the inhaler.

• 1. Stand or sit upright when inhaling.
• 2. Remove the mouthpiece cover (as described above in point 1 of the "Checking the inhaler" section). Check that the inside and outside of the mouthpiece are clean and free of any foreign bodies (Figure A).

• 3. Shake the inhaler 4 or 5 times to ensure that any foreign bodies are removed and the contents of the canister are well mixed (Figure B).

• 4. Hold the inhaler upright with your thumb on the base, below the mouthpiece. Take a slow, deep breath out (Figure C).

• 5. Put the mouthpiece in your mouth, between your teeth, and close your lips around it, without biting.

• 6. Start breathing in slowly and deeply and press the top of the inhaler to release a dose of medicine. Continue to breathe in slowly and deeply (Figure D).
• 7. Hold your breath, take the inhaler out of your mouth, and release your finger from the top of the inhaler. Hold your breath for a few seconds or as long as you comfortably can (Figure E).

• 8. To take a second inhalation, wait about half a minute and then repeat steps 3 to 7.
• 9. To prevent thrush and hoarseness, after each dose of medicine, rinse your mouth with water and spit it out and/or brush your teeth.
• 10. After use, replace the mouthpiece cover to protect the inhaler from dust. The correct replacement of the cover is indicated by a click. If you do not hear a click, turn the cover around its axis and try to replace it again. Do not use too much force.

Do not rush the steps described in points 4, 5, 6 and 7. It is important to start breathing in as slowly as possible before pressing the inhaler. You can practice the first few inhalations in front of a mirror. If you see a "mist" coming out of the end of the inhaler or the corners of your mouth, start the procedure again from step 3. If you have difficulty using the inhaler or if your doctor recommends it, you can use a spacer (such as Volumatic or AeroChamber Plus) (according to national guidelines). Your doctor, pharmacist or other healthcare professional should show you how to use the inhaler with a spacer and how to clean these devices and answer any questions you may have. It is important that once you start using the inhaler with a spacer, you do not stop using the spacer without first discussing it with your doctor. It is also important not to change the type of spacer used without consulting your doctor. If you stop using a spacer or change the type of spacer, your doctor may need to change the dose of medicine needed to control your asthma symptoms. Any change in asthma treatment should always be discussed with your doctor. If you have difficulty handling the inhaler with one hand, you can hold it with both hands. Place both index fingers on the top of the inhaler and both thumbs on the base, below the mouthpiece. You should consider replacing the inhaler when the counter shows 40 and changes from green to red. You should stop using the inhaler when the counter shows 0, as the remaining amount of suspension in the inhaler may not be sufficient to deliver a full dose. Never try to change the number on the counter or detach the counter from the metal canister. The counter cannot be reset and is permanently attached to the canister.

Cleaning the inhaler

To prevent the inhaler from clogging, it should be cleaned at least once a week. To clean the inhaler, you should: remove the mouthpiece cover; do not remove the metal canister from the plastic casing; wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth or tissue; replace the mouthpiece cover. The correct replacement of the cover is indicated by a click. If you do not hear a click, turn the cover around its axis and try to replace it again. Do not use too much force.

Do not put the metal canister in water.

Using a higher dose of AirFluSal than recommended

It is important to use the inhaler as directed. If you accidentally use a higher dose than recommended, you should consult your doctor or pharmacist. You may feel your heart beating faster than usual and feel shaky. You may also feel dizzy, weak and have muscle cramps. If you use higher doses for a long time, you should consult your doctor or pharmacist for advice, as higher doses of AirFluSal may cause a decrease in the production of steroid hormones by the adrenal glands.

Missing a dose of AirFluSal

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

Stopping use of AirFluSal

It is important to use AirFluSal every day, as directed by your doctor. Do not stop using AirFluSal or suddenly reduce the dose without your doctor's advice, as this may worsen breathing difficulties. Stopping use of AirFluSal or reducing the dose may very rarely cause adrenal insufficiency (adrenal gland disorder), which can cause side effects such as: abdominal pain, feeling tired and loss of appetite, nausea and vomiting, diarrhea, weight loss, headache or drowsiness, low blood sugar, low blood pressure and seizures. In stressful situations, such as fever, injury (e.g. car accident), infection or surgery, adrenal insufficiency may worsen and any of the above side effects may occur. If you experience any side effects, you should consult your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe additional corticosteroid tablets (e.g. prednisolone). If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, AirFluSal can cause side effects, although not everybody gets them. To minimize the risk of side effects, your doctor will prescribe the smallest dose of AirFluSal that will control your asthma.

Allergic reactions: you may experience sudden breathing difficulties immediately after using AirFluSal.

You may experience wheezing and coughing or shortness of breath, as well as itching, rash (hives) and swelling (usually of the face, lips, tongue or throat), and a sudden feeling of a fast heartbeat or fainting and dizziness (which can lead to falls or loss of consciousness). If you experience any of these symptoms or if they occur suddenly after using AirFluSal, you should stop using the medicine and inform your doctor immediately.Allergic reactions to AirFluSal are uncommon (they may occur less often than in 1 in 100 people). Other side effects: Very common (may occur more often than in 1 in 10 people): headache (usually goes away during treatment), increased number of colds in patients with chronic obstructive pulmonary disease (COPD). Common (may occur less often than in 1 in 10 people): thrush (painful, creamy-white patches) in the mouth and throat, as well as tongue pain, hoarseness and throat irritation. Rinsing your mouth with water and spitting it out and/or brushing your teeth immediately after each inhalation may help. Your doctor may prescribe an antifungal medicine to treat thrush. muscle pain, joint pain and swelling, muscle cramps. In patients with COPD, the following side effects have also been reported: pneumonia and bronchitis. You should tell your doctor if you experience any of the following symptoms: increased production of sputum, change in sputum color, fever, chills, worsening cough, worsening shortness of breath. bruising and fractures. sinusitis (feeling of pressure or fullness in the nose, cheeks and eyes, sometimes with a pulsating pain). low potassium levels in the blood (which can cause irregular heartbeat, weakness and muscle cramps). Uncommon (may occur less often than in 1 in 100 people): high blood sugar (hyperglycemia). In patients with diabetes, it may be necessary to monitor blood sugar levels more frequently and adjust the dose of diabetes medicine. cataracts (clouding of the lens in the eye). very fast heartbeat (tachycardia). feeling shaky (tremor) and fast or irregular heartbeat (palpitations). These are usually harmless symptoms that go away during treatment. chest pain. feeling sad (mainly in children). sleep disturbances. allergic rash. Rare (may occur less often than in 1 in 1,000 people): worsening shortness of breath or wheezing, which gets worse immediately after using AirFluSal. In this case, you should stop using AirFluSal. To make breathing easier, you should use a fast-acting "rescue" bronchodilator inhaler and see your doctor immediately. disorders of steroid hormone production in the body, especially if the medicine is used in high doses for a long time. Symptoms are: slowed growth in children and adolescents. thinning of bone tissue. glaucoma. weight gain. rounded ("moon-shaped") face (Cushing's syndrome). Your doctor will regularly check if you are experiencing any of these side effects and ensure that you are using the smallest possible dose of AirFluSal. changes in behavior, such as unusual excitement and irritability. These symptoms occur mainly in children. irregular heartbeat or extra heartbeats (arrhythmia). You should tell your doctor, but do not stop using AirFluSal without advice. fungal infection of the esophagus, which can cause difficulty swallowing. Frequency not known (cannot be estimated from the available data), but may also occur: depression or aggression. These symptoms occur mainly in children. blurred vision.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store AirFluSal

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. The batch number is stated on the packaging as "Lot". Store below 25°C. Keep the canister in the outer packaging to protect from light. The canister contains a pressurized suspension. Do not expose the canister to temperatures above 50°C. Do not pierce the canister. Do not puncture, damage or burn the canister, even if it is empty. Do not store in a refrigerator or freeze. As with most inhaled medicines in pressurized canisters, the effectiveness of this medicinal product may be less if the inhaler is cold. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What AirFluSal contains

The active substances are salmeterol (as salmeterol xinafoate) and fluticasone propionate. AirFluSal 25 µg + 125 µg: Each metered dose contains 25 micrograms of salmeterol (as salmeterol xinafoate) and 125 micrograms of fluticasone propionate. AirFluSal 25 µg + 250 µg: Each metered dose contains 25 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate. The other ingredient is norflurane (HFA 134a) - a propellant gas.

What AirFluSal looks like and contents of the pack

The inhaler consists of an aluminum canister (aluminum canister coated with FCP) with a suitable valve, a metering device made of polypropylene (PP) and a cap made of PP, with a dose counter, all in a cardboard box. The canister contains a white homogeneous suspension. Each canister contains 120 metered doses. Pack sizes: 1 inhaler containing 120 doses of medicine.

Marketing authorization holder and manufacturer

Marketing authorization holder: Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria. Manufacturer/Importer: Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany.

For more information about this medicine and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o., ul. Domaniewska 50C, 02-672 Warszawa, tel. +48 22 209 70 00. Date of last revision of the leaflet:08/2024. Sandoz logo