Airflusal forspiro

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
AirFluSal Forspiro (Airflusan Forspiro)
(50 micrograms + 500 micrograms)/dose, inhalation powder, pre-dispensed
Salmeterolum + Fluticasoni propionas
AirFluSal Forspiro and Airflusan Forspiro are different brand names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, 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 AirFluSal Forspiro is and what it is used for
2. Important information before using AirFluSal Forspiro
3. How to use AirFluSal Forspiro
4. Possible side effects
5. How to store AirFluSal Forspiro
6. Contents of the pack and other information

1. What AirFluSal Forspiro is and what it is used for

AirFluSal Forspiro is used in the treatment of:

• bronchial asthma
• chronic obstructive pulmonary disease (COPD). This disease is characterized by persistent breathing difficulties due to narrowing of the airways, often accompanied by cough and mucus retention. The medicine reduces the frequency of COPD exacerbations.

The medicine contains two active substances:

• salmeterol: a long-acting bronchodilator
• fluticasone: a corticosteroid that reduces swelling and inflammation in the lungs.

2. Important information before using AirFluSal Forspiro

When not to use AirFluSal Forspiro

• if the patient is allergic to salmeterol, fluticasone, or to any of the excipients of the medicine (listed in section 6).

Warnings and precautions
Before using AirFluSal Forspiro, discuss with a doctor or pharmacist if the patient has:

• heart disease, including irregular or rapid heartbeat
• hyperthyroidism
• high blood pressure
• diabetes (AirFluSal Forspiro may increase blood sugar levels)
• low potassium levels in the blood

Page 1 of 9

• tuberculosis (current or past) or other lung infections.

If the patient develops blurred vision or other visual disturbances, inform the doctor.
AirFluSal Forspiro helps prevent breathlessness and wheezing. It should be noted that this medicine does not work when breathlessness or wheezing has already started.
In case of a breathlessness attack, it is necessary to use a fast-acting medicine (such as salbutamol) that quickly dilates the airways.
If asthma symptoms or breathing difficulties worsen, contact the doctor immediately. This may be
indicated by:

• wheezing
• more frequent feeling of chest tightness
• increased need for a fast-acting bronchodilator compared to usual.

In such cases, continue using AirFluSal Forspiro, but do not increase the number of inhalations, as the patient's condition may deteriorate, leading to a serious illness. Contact the doctor, as additional treatment may be required.

Children and adolescents
AirFluSal Forspiro should not be used in children and adolescents under 18 years of age.

AirFluSal Forspiro and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for use, including those available without a prescription.
AirFluSal Forspiro and the following medicines may affect each other’s action:

• medicines used to treat high blood pressure, heart diseases or other conditions containing an active substance with a name ending in “olol” (beta-blockers), such as atenolol, propranolol, and sotalol
• antiviral medicines, including some used in the treatment of HIV infection, such as ritonavir or cobicistat. The doctor may wish to closely monitor the patient taking such medicines;
• medicines used to treat infections, such as ketoconazole, itraconazole, and erythromycin
• corticosteroids taken orally or by injection: medicines used to treat inflammation or prevent transplant rejection
• diuretics used in the treatment of high blood pressure
• other bronchodilators (such as salbutamol)
• medicines containing xanthine derivatives (commonly used in asthma treatment).

Pregnancy, breastfeeding, and fertility
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. The doctor will assess whether use of AirFluSal Forspiro during pregnancy is advisable.

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

AirFluSal Forspiro contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, contact the doctor before using this medicine.
The amount of lactose contained in the medicine usually does not cause problems in individuals with lactose intolerance.
Page 2 of 9

3. How to use AirFluSal Forspiro

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

• Asthma
  The recommended dose for adults is: one inhalation twice daily.

Your doctor will regularly monitor your asthma symptoms.

• COPD
  The recommended dose for adults is: one inhalation twice daily.

If your symptoms are well controlled with AirFluSal Forspiro 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.

How to use
AirFluSal Forspiro should be used every day as directed by your doctor, preferably just before a meal, in the morning and/or evening.
After inhalation, rinse your mouth with water.
Improper or inconsistent use of AirFluSal Forspiro may worsen respiratory symptoms. To achieve optimal effectiveness, the medicine should be used daily, even if you do not have symptoms.

Instructions for use
Your doctor, nurse, or pharmacist should show you how to use the inhaler and should regularly check that you are using it correctly.
The inhaler contains 60 doses of inhalation powder in a coiled foil strip (blister strip). It is equipped with a dose counter indicating the number of doses remaining (from 60 to 0). Numbers indicating the last 10 doses are displayed on a red background.
The inhaler is not refillable – once empty, it should be replaced with a new device.

Page 3 of 9
Before using the inhaler

• Open the transparent side chamber cover.
• Carefully tear off the entire length of the strip using the serrated edge (as shown in the illustration). Do not pull or jerk the strip.

• Close the chamber cover and dispose of the used foil strip.

Note:
As the inhaler is used, the side chamber gradually fills with the used foil strip. Foil strips with black lines do not contain medicine. At the end, numbered sections of the strip will appear.
Do not allow more than 2 strips to accumulate in the side chamber, as this may block the inhaler. Gently tear off the foil strip (as shown above) and safely dispose of it.

Using the inhaler
Hold the inhaler in your hands as shown in the illustrations.

1. Opening

• Uncover the mouthpiece by pulling down the protective cap.
• Check the dose counter window to see how many doses remain.

2. Preparing the dose

• Lift the edge of the white lever. Ensure the side chamber is closed. Note: The white lever should only be used when you are ready to take your dose. Unnecessary use will result in loss of doses.

Page 4 of 9

• Open: Pull the white lever fully upwards (you will hear a click), which will load the dose and display its number in the dose counter.

• Close: Carefully push down the white lever until you hear a click. The inhaler is now ready for immediate use.

3. Inhaling the dose

• Breathe out as deeply as possible away from the mouthpiece. Never breathe out directly into the inhaler, as this may alter the dose.

• Hold the inhaler with the protective cap pointing downwards.

• Close your lips tightly around the mouthpiece.

• Breathe in slowly and deeply through your mouth (not through your nose).

• Remove the inhaler from your mouth and hold your breath for 5–10 seconds, or as long as comfortably possible.
• After this time, breathe out slowly away from the inhaler.
• Close the protective cap over the mouthpiece.
• Rinse your mouth with water (spit the water out), to help prevent the development of oral fungal infection and hoarseness.

Cleaning

• If necessary, wipe the outer part of the mouthpiece with a clean, dry cloth.
• Do not disassemble the inhaler for cleaning or any other purpose!
• Do not clean any parts of the inhaler with water or wet wipes, as moisture may alter the dose size!

Page 5 of 9

• Never insert a needle or any other sharp object into the mouthpiece or any other part of the inhaler, as this may damage it.

Using more than the recommended dose of AirFluSal Forspiro
Contact your doctor or pharmacist immediately.
Symptoms of overdose may include:

• dizziness
• headache
• rapid heartbeat
• muscle weakness
• joint pain
• trembling sensation.

If higher doses have been used for a prolonged period, consult your doctor or pharmacist, as excessive use of AirFluSal Forspiro may reduce steroid hormone production by the adrenal glands.
It is important to use this medicine exactly as prescribed. Do not increase or decrease the dose without your doctor’s approval.

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

Stopping treatment with AirFluSal Forspiro
Do not stop using or suddenly reduce the dose of AirFluSal Forspiro without consulting your doctor, as this may worsen breathing problems and, very rarely, cause adverse effects such as:

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

Similar adverse effects may also very rarely occur during infections or in situations of severe stress (e.g. due to fever, injury, serious accident, or surgery). To prevent these symptoms, your doctor may prescribe additional corticosteroids (e.g. prednisolone).

If you have any further questions about 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 everybody will experience them.
Allergic reactions: the patient may experience sudden breathing difficulties immediately after
using AirFluSal Forspiro. Wheezing and 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 a sensation 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 Forspiro, contact a doctor immediately. Allergic reactions to AirFluSal Forspiro occur uncommonly (they may affect fewer than 1 in 100 people).
Page 6 of 9
Other possible adverse effects:
Very common (may affect more than 1 in 10 people)

• headache (usually resolves during treatment)
• increased incidence 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 immediately spitting it out 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 been reported:

• pneumonia (lung infection). Inform your doctor if any of the following symptoms occur during treatment with AirFluSal Forspiro; these may be signs of lung infection:
• increased mucus production
• change in mucus colour
• fever
• chills
• worsening cough
• increased breathing difficulties
• bruising and traumatic fractures
• sinusitis
• low blood potassium levels (which may cause irregular heartbeat, weakness, and (or) muscle cramps).

Uncommon (may affect fewer than 1 in 100 people)

• very fast heartbeat (tachycardia)
• tremor and rapid or irregular heartbeat (palpitations). These are usually harmless symptoms that resolve during treatment.
• feeling of sadness (mainly in children)
• increased blood glucose levels. In patients with diabetes, more frequent monitoring of blood glucose levels may be necessary and adjustment of antidiabetic medication may be required.
• sleep disturbances
• chest pain
• lens opacity (cataract)
• allergic rash.

Rare (may affect fewer than 1 in 1,000 people)

• breathing difficulties or wheezing that worsen immediately after using AirFluSal Forspiro. Discontinue use of AirFluSal Forspiro and contact a doctor immediately. To help breathing, use a fast-acting inhaled bronchodilator.
• impaired production of certain hormones, especially if the medicine is used at high doses for a prolonged period. Symptoms include:
• slowed growth in children and adolescents
• osteoporosis
• increased intraocular pressure (glaucoma)

Page 7 of 9

• weight gain
• rounded (‘moon-shaped’) face (Cushing's syndrome). The doctor will regularly check whether any of these adverse effects occur and ensure that the patient is using the lowest possible dose of the medicine.
• behavioural changes such as unusual excitability and irritability. These symptoms mainly occur in children;
• irregular heartbeat or extra heartbeats. Inform your doctor, but do not stop using AirFluSal Forspiro without medical advice;
• fungal infection of the oesophagus, which may cause difficulty swallowing.

Frequency not known, but may also occur:

• depression or aggression. These symptoms mainly occur in children;
• blurred vision.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions 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
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store AirFluSal Forspiro

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use AirFluSal Forspiro after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines should 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 Forspiro contains

• The active substances are salmeterol and fluticasone propionate. Each metered dose contains 50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of fluticasone propionate. This corresponds to a delivered dose containing 45 micrograms of salmeterol (as salmeterol xinafoate) and 465 micrograms of fluticasone propionate.
• The other ingredient is lactose monohydrate.

What AirFluSal Forspiro looks like and contents of the pack
An inhaler with a foil blister containing 60 doses of inhalation powder.
Pack sizes: 1 or 2 inhalers containing 60 doses each.
Page 8 of 9
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in the Czech Republic, country of export:
Sandoz s.r.o., Na Pankráci 1724/129, 140 00 Prague 4 - Nusle, Czech Republic
Manufacturer:
Aeropharm GmbH, Francois-Mitterand-Allee 1, Wohngebiet Rudolspark, 07407 Rudolstadt, Thuringia, Germany
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Czech Republic, country of export, marketing authorisation number: 14/412/14-C
Parallel import authorisation number: 43/26
Page 9 of 9