Airflusal

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 see blurred vision 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 that can be bought 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 heart rhythm disturbances) 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 taken them, the risk of adrenal gland problems 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 using 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 unsure, ask your doctor or pharmacist.

• AirFluSal should be used daily for as long as your doctor recommends. Do not exceed the recommended dose. If you are unsure, 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 well 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 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 should not be used in children.

How to use the inhaler

• Your doctor or pharmacist should show you how to use the inhaler and check how you use it 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, which is placed in a plastic casing with a mouthpiece.
• On the front of the inhaler, there is a dose counter that shows how many doses of medicine are left. As you use the inhaler, the dose counter moves down by one dose every 5 to 7 inhalations. 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.

• 3. Shake the inhaler 4 or 5 times to ensure that any foreign bodies are removed and the contents of the canister are evenly 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. Place the mouthpiece in your mouth between your teeth and seal it with your lips without biting (Figure D).

• 6. Start a slow, deep inhalation and press the inhaler immediately to release a dose of medicine, then continue with a slow, deep inhalation (Figure D).
• 7. Hold your breath and remove the inhaler from your mouth. Hold your breath for a few seconds or as long as possible (Figure E).

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

Do not rush the actions described in points 4, 5, 6, and 7. It is important to start a slow inhalation immediately 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, you should start the procedure again from point 3. If you have difficulty using the inhaler or if it is recommended by your doctor or other healthcare professional, you can use a spacer (such as Volumatic or AeroChamber Plus, according to local 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 the spacer or change its type, 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 think about replacing the inhaler when the counter shows 40 and changes color from green to red. You should stop using the inhaler when the counter shows 0, as the remaining suspension in the inhaler may not be enough 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, you should clean it at least once a week. To clean the inhaler, you should: remove the mouthpiece cap; 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 cap. Proper replacement of the cap is indicated by a click. If you do not hear a click, turn the cap around its axis and try to replace it again on the mouthpiece. 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 contact your doctor or pharmacist. You may experience a faster than normal heartbeat and tremors. Additionally, you may experience dizziness, weakness, and joint pain. If you use higher doses for a long time, you should contact 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 use a double dose of medicine to make up for a missed dose. Take the next dose of medicine at the usual time.

Stopping the use of AirFluSal

It is important to use AirFluSal daily, as recommended. The medicine should be used until your doctor recommends stopping it. Do not stop using AirFluSal or suddenly reduce the dose without your doctor's advice, as this may worsen breathing difficulties. Additionally, sudden stopping of AirFluSal or reducing the dose may very rarely cause adrenal gland problems (adrenal insufficiency), which can sometimes cause side effects such as: abdominal pain, feeling tired and loss of appetite, nausea, vomiting, and 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, it is possible that the symptoms of adrenal insufficiency may worsen, and any of the above side effects may occur. If you experience any side effects, you should contact 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.

This may be accompanied by wheezing, 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 may lead to falling 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 contact your doctor immediately.Allergic reactions to AirFluSal are uncommon (may occur in less than 1 in 100 people). Other side effects: Very common (may occur in more than 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 in less than 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. joint pain, muscle pain, and 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 mucus, change in mucus 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 may cause irregular heartbeat, weakness, and muscle cramps). Uncommon (may occur in less than 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. cataract (clouding of the lens in the eye). very fast heartbeat (tachycardia). feeling of trembling (shaking) and fast or irregular heartbeat (palpitations). These are usually harmless symptoms that go away during treatment. chest pain. feeling of sadness (mainly in children). sleep disturbances. allergic rash. Rare (may occur in less than 1 in 1,000 people): breathing difficulties or wheezing that worsen 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 contact your doctor immediately. adrenal gland problems, especially if the medicine is used in high doses for a long time. The 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 about this, 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 those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported 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. Side effects can also be reported 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 indicated 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 throw away or burn the canister, even if it is empty. Do not store in a refrigerator or freeze. As with most inhalers 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 packaging 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 (aerosol 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 with 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 Warsaw tel. +48 22 209 70 00 Date of last revision of the leaflet:08/2024 Sandoz logo