AIRFLUSAL

Package leaflet: Information for the patient

AirFluSal, (25 micrograms + 125 micrograms)/metered dose,
inhalation aerosol, suspension
AirFluSal, (25 micrograms + 250 micrograms)/metered dose,
inhalation aerosol, suspension
Salmeterol + Fluticasone propionate
Read the entire leaflet before using the medicine, as it contains important information
for the patient.
Keep this leaflet for possible future reference.
If in doubt, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual only. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.
Leaflet contents:

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 keep the airways open, making it easier for air to flow into and out of the lungs. This effect lasts for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and irritation in the lungs.

Use of AirFluSal is not recommended in children.
Your doctor has prescribed this medicine to prevent breathing difficulties caused by asthma.
To ensure proper asthma control, AirFluSal must be used every day as directed by your doctor.
AirFluSal helps prevent episodes of breathlessness and wheezing, but it should not be used to relieve sudden asthma attacks or acute wheezing.
In such cases, a fast-acting "reliever" inhaler medicine, such as salbutamol, must be used. Always carry a fast-acting "reliever" inhaler with you.

2. Important information before using AirFluSal

When not to use AirFluSal
if the patient is allergic to salmeterol, fluticasone propionate, or to any of the excipients
listed in section 6.

Warnings and precautions
Before using AirFluSal, consult a doctor if the patient has:

• heart disease, including irregular or rapid heartbeat
• hyperthyroidism
• high blood pressure
• diabetes (AirFluSal may increase blood sugar levels)
• low blood potassium levels
• tuberculosis (current or past) or other lung infections

If the patient experiences blurred vision or other visual disturbances, inform the doctor immediately.

AirFluSal and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines planned for future use. This includes all asthma treatments and any over-the-counter medications. Using AirFluSal together with certain other medicines may not be appropriate.

Before using AirFluSal, inform the doctor if the patient is taking any of the following medicines:

Beta-blockers (such as atenolol, propranolol, or sotalol). Beta-blockers are mainly used to treat high blood pressure or heart conditions.

Medicines used to treat infections, including some drugs used in HIV treatment (such as ritonavir, cobicistat, ketoconazole, itraconazole, and erythromycin). Some of these drugs may increase levels of fluticasone propionate or salmeterol in the body, thereby increasing the risk or severity of adverse effects of AirFluSal (including heart rhythm disturbances). The doctor may closely monitor treatment in patients taking these medicines.

Oral or injectable corticosteroids. In patients who have recently received these, there may be an increased risk of adrenal dysfunction.

Diuretics used in the treatment of high blood pressure.

Other bronchodilators (such as salbutamol).

Medicines containing xanthine derivatives (commonly used in asthma treatment).

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
It is unlikely that AirFluSal will affect the ability to drive or operate machinery.

3. How to use AirFluSal

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

• AirFluSal should be taken daily until your doctor advises stopping treatment. Do not exceed the recommended dose. If in doubt, consult your doctor or pharmacist.
• Do not stop using AirFluSal or reduce its 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 daily
AirFluSal (25 µg + 250 µg): 2 inhalations twice daily
If asthma symptoms are well controlled with AirFluSal taken twice daily, your doctor may reduce
the dose to once daily:
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 number and frequency of inhalations as prescribed by your doctor.
If you are using AirFluSal for asthma, your doctor will regularly monitor your symptoms.
If asthma symptoms worsen or breathing deteriorates, seek medical advice immediately.
This may include increased wheezing, more frequent chest tightness, or the need to use a higher dose
of a fast-acting, inhaled "rescue" medicine. In such cases, continue using the medicine 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.

Use in children
AirFluSal is not recommended for use in children.

Instructions for use

• Your doctor or pharmacist should demonstrate how to use the inhaler and should periodically check your technique. Incorrect use or use in a manner different from that described in this leaflet may result in the medicine not providing the expected improvement in asthma symptoms.
• The medicine is contained in a pressurized canister placed in a plastic housing with a mouthpiece.
• On the front of the inhaler there is a dose indicator showing how many doses of medicine remain. As the inhaler is used, the dose counter moves every 5 to 7 inhalations to the next lower number of doses. The indicator shows an approximate number of doses remaining in the inhaler.
• Be careful not to drop the inhaler, as this may cause the displayed number of doses to decrease.

Checking the inhaler

1. Before first use, check that the inhaler works properly. Remove the mouthpiece cap by gently squeezing its sides with your thumb and index finger.
2. To ensure proper function, shake the inhaler well with the mouthpiece pointing away from you, then press the canister to release four puffs of medicine into the air. The indicator will show 120 – this is the number of doses contained in the inhaler. If the inhaler has not been used for at least one week, release two puffs into the air.

Using the inhaler
It is important to begin breathing in as slowly as possible just before using the inhaler.

1. Use the inhaler while standing or sitting.
2. Remove the mouthpiece cap (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 foreign objects (Figure A).

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

4. Hold the inhaler upright with your thumb placed at the base, below the mouthpiece. Breathe out as deeply as possible (Figure C).

5. Place the mouthpiece in your mouth between your teeth and close your lips around it without biting (Figure D).

6. Begin a slow and deep inhalation and immediately press the top of the inhaler to release a dose of medicine, then continue a steady, deep inhalation (Figure D).
7. Remove the inhaler from your mouth and take your finger off the top of the device while holding your breath. 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, then repeat steps 3 to 7.
9. To prevent the occurrence of oral thrush and hoarseness, rinse your mouth with water after each dose, spit it out, and (or) brush your teeth.
10. After use, immediately replace the protective cap on the mouthpiece to protect it from dust. Proper placement of the cap is indicated by an audible click. If no click is heard, rotate the cap around its axis and try again to place it on the mouthpiece. Do not use excessive force.

Do not rush through steps 4, 5, 6, and 7. It is important to begin a slow inhalation just before pressing
the inhaler. The first few inhalations may be practiced in front of a mirror. If the patient sees a "mist"
escaping from the end of the inhaler or from the corners of the mouth, the procedure should be
restarted from step 3.
If the patient has difficulty using the inhaler or if recommended by a doctor or other healthcare
professional, a spacer device (e.g., Volumatic or AeroChamber Plus) may be used (in accordance
with national guidelines). Your doctor, pharmacist, or other healthcare professional should show you
how to use the inhaler with a spacer, how to clean these devices, and answer any questions. It is
important not to stop using the spacer once you have started using it with the inhaler without first
discussing it with your doctor. It is also important not to change the type of spacer used without
consulting your doctor. If the patient stops using a spacer or changes the type, the doctor may need
to adjust the dose of medicine required to control asthma symptoms.
Any change in asthma treatment must always be discussed with your doctor.
If the patient has difficulty handling the inhaler with one hand, it may be held with both hands.
Place both index fingers on the top of the inhaler and both thumbs at its base below the mouthpiece.
Consider replacing the inhaler when the indicator shows 40 and changes color from green to red.
Stop using the inhaler when the indicator shows 0, as the remaining residue in the inhaler may not
be sufficient to deliver a full dose. Never attempt to alter the number on the indicator or detach the
indicator from the metal canister. The indicator cannot be reset and is permanently attached to the
canister.

Cleaning the inhaler
To prevent blockage, clean the inhaler at least once a week.
To clean the inhaler:

• Remove the mouthpiece cap;
• Do not remove the metal canister from the plastic housing;
• Wipe the inside and outside of the mouthpiece and the plastic housing with a dry cloth or tissue;
• Replace the mouthpiece cap. Proper placement is indicated by an audible click.
  If no click is heard, rotate the cap around its axis and try again to place it on the mouthpiece. Do not use excessive force.
  Do not place the metal canister in water.

Use of a higher than recommended dose of AirFluSal
It is important to use the inhaler as instructed. If the patient accidentally uses a higher dose than
recommended, consult a doctor or pharmacist. The patient may experience a faster than usual
heartbeat and tremors. In addition, dizziness, muscle weakness, and joint pain may occur.
If higher doses are used for a prolonged period, consult a doctor or pharmacist for advice, as higher
doses of AirFluSal may reduce the production of steroid hormones by the adrenal glands.

Missed dose of AirFluSal
Do not use a double dose to make up for a missed dose. Take the next dose at the usual time.

Stopping use of AirFluSal
It is important to use AirFluSal daily as directed. The medicine should be used until your doctor
advises stopping it. Do not stop using AirFluSal or suddenly reduce its dose without your doctor's
approval, as this may worsen breathing problems.
Additionally, abruptly stopping AirFluSal or reducing its dose may very rarely cause adrenal
insufficiency, which may sometimes lead to the following adverse effects:

• abdominal pain
• feeling of fatigue and loss of appetite, nausea
• vomiting and diarrhea
• weight loss
• headache or drowsiness
• low blood sugar
• low blood pressure and seizures.
  During periods of stress, such as fever, injury (e.g., car accident), infection, or surgery, symptoms of
  adrenal insufficiency may worsen and any of the above adverse effects may occur. If any adverse
  effects occur, consult your doctor or pharmacist. To prevent these symptoms, your doctor may
  prescribe additional corticosteroid tablets (e.g., prednisolone).
  If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
To minimise the risk of adverse effects in the patient, the doctor will prescribe the lowest dose of AirFluSal that provides asthma control.

Allergic reactions: the patient may experience sudden breathing difficulties immediately after
administration of AirFluSal. Wheezing, coughing or shortness of breath may occur, as well as itching, rash (urticaria) and swelling (usually of the face, lips, tongue or throat), and also sudden sensations of very rapid heartbeat or fainting and dizziness (which may lead to falling or loss of consciousness). If any of these symptoms occur, or if they occur suddenly after using AirFluSal, the use of the medicine must be stopped immediately and the doctor should be informed without delay. Allergic reactions to AirFluSal occur uncommonly (may affect fewer than 1 in 100 people).

Other adverse effects:

Very common (may affect more than 1 in 10 people)
headache (usually resolves during treatment)
increased number of colds in patients with chronic obstructive pulmonary disease (COPD)

Common (may affect fewer than 1 in 10 people)
oral and pharyngeal candidiasis (painful creamy-yellow lesions), as well as tongue pain, hoarseness, and throat irritation.
Rinsing the mouth with water and spitting it out immediately and/or brushing teeth immediately after each inhalation may be helpful. The doctor may prescribe an antifungal medicine to treat candidiasis.
joint pain, joint swelling and muscle pain
muscle cramps

In patients with chronic obstructive pulmonary disease (COPD), the following adverse effects have also been reported:
pneumonia and bronchitis

Patients should inform the doctor if any of the following symptoms occur:
increased sputum production, change in sputum colour, fever, chills, worsening cough, or increased breathing difficulties.

bruising and traumatic fractures
sinusitis (feeling of pressure or fullness in the nose, cheeks and eyes, sometimes with pulsating pain)
decreased blood potassium levels (which may cause irregular heartbeat, weakness and muscle cramps)

Uncommon (may affect fewer than 1 in 100 people)
increased blood sugar (glucose) levels (hyperglycaemia)
In patients with diabetes, more frequent monitoring of blood glucose levels may be necessary and the dose of antidiabetic medicine may need to be adjusted.
cataract (clouding of the lens in the eye)
very rapid heart rate (tachycardia)
sensation of tremor (shakiness) and rapid or irregular heartbeat (palpitations)
These are usually harmless symptoms that resolve during treatment.
chest pain
feeling of sadness (mainly in children)
sleep disturbances
allergic rash

Rare (may affect fewer than 1 in 1000 people)
breathing difficulties or wheezing that worsen immediately after using AirFluSal
In such a case, the use of AirFluSal must be stopped. To help breathing, a fast-acting "rescue" bronchodilator should be used by inhalation, and medical advice must be sought immediately.
disturbances in the body's production of steroid hormones, especially if the medicine is used in high doses for a long time
Symptoms include:

• slowed growth in children and adolescents
• thinning of bone tissue
• glaucoma
• weight gain
• rounded ("moon-shaped") face (Cushing's syndrome). The doctor will systematically check whether any of these adverse effects occur and ensure that the patient is using the lowest possible dose of AirFluSal. behavioural changes such as unusual excitability and irritability. These symptoms occur mainly in children. irregular heartbeat or extra heartbeats (arrhythmia). Patients should inform the doctor, but should not stop using AirFluSal without medical advice. fungal infection of the oesophagus, which may cause difficulty in swallowing

Frequency not known (cannot be estimated from available data), but may also occur:
depression or aggression. These symptoms occur mainly in children.
blurred vision

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects 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.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to 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 stated on the label and carton after EXP. The expiry date refers to the last day of the specified month.
The batch number on the packaging is indicated by "Lot".
Store below 25°C.
Keep the container in the outer carton to protect it from light.
The container holds a pressurised suspension.
Do not expose the container to temperatures above 50°C.
Do not pierce the container.
Do not puncture, damage, or burn the container, even when it is empty.
Do not store in a refrigerator or freeze.
As with most inhaled medicines in pressurised containers, the effectiveness of this medicinal product may be reduced if the inhaler is cold.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What AirFluSal contains
The active substances in the medicine 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) – propellant gas.

What AirFluSal looks like and contents of the pack
The inhaler consists of an aluminium container (an aerosol container coated with FCP plasma) with a suitable metering valve, a dosing device made of polypropylene (PP), a PP cap, and a dose counter, all contained in a cardboard box.
The container holds a white, homogeneous suspension.
Each container contains 120 metered doses.

Pack sizes
1 inhaler with 120 doses of medicine.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer/Importer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany

For further information about the medicine and its names in the countries 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