Airflusal forspiro

Package leaflet: Information for the patient

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

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are identical.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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 to treat:

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

The medicine contains two active substances:

• salmeterol: a long-acting substance that dilates the airways
• 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 your 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
• 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 is important to remember that the medicine does not work when breathlessness or wheezing has already started.
In case of a breathlessness attack, a fast-acting medicine (such as salbutamol) that quickly dilates the airways should be used.
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 necessary.
Children and adolescents
AirFluSal Forspiro must not be used in children and adolescents under 18 years of age.
AirFluSal Forspiro and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use, including over-the-counter medicines.
AirFluSal Forspiro and the following medicines may interact with each other:

• 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 certain medicines used to treat 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 to prevent transplant rejection
• diuretics used to treat high blood pressure
• other bronchodilators (such as salbutamol)
• medicines containing xanthine derivatives (often used in asthma treatment).

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. The doctor will assess whether use of AirFluSal Forspiro during pregnancy is appropriate.
Driving and operating machinery
It is unlikely that AirFluSal Forspiro will affect the ability to drive or operate machinery.
AirFluSal Forspiro contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, consult the doctor before using this medicine.
The amount of lactose contained in the medicine usually does not cause problems in individuals with lactose intolerance.

3. How to use AirFluSal Forspiro

This medicine should always be used exactly as your doctor has told you. 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.

Method of administration
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). The numbers indicating the last 10 doses are displayed on a red background.
The inhaler is not refillable – once empty, it must be replaced with a new device.

Before using the inhaler

• Open the transparent cover of the side chamber.
• Carefully tear off the entire length of the strip using the serrated edge (as shown in the picture). 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 marks do not contain medicine. At the end, numbered segments of the strip will appear in the chamber.
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 remove 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 medicine doses.

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

• Close: Fully close 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 of medicine.
• 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 possible without discomfort.
• Then breathe out slowly, not towards 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 tissue.
• Do not disassemble the inhaler for cleaning or for any other reason!
• Do not clean any parts of the inhaler with water or wet wipes, as moisture may alter the dose of medicine!
• Never insert a needle or any other sharp object into the mouthpiece or any other part of the inhaler, as this may damage the device.

Taking 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 increased doses of AirFluSal Forspiro may reduce the adrenal glands’ production of steroid hormones.
It is important to use the medicine exactly as prescribed. Do not increase or decrease the dose without your doctor’s approval.

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

Stopping AirFluSal Forspiro treatment
Do not stop treatment 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 occur very rarely during infection or in situations of severe stress (e.g. due to fever, injury, serious accident, or surgical procedure). 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 everyone will experience them.
Allergic reactions: the patient may experience sudden breathing difficulties immediately after
using AirFluSal Forspiro. Wheezing, coughing, or shortness of breath may occur, as well as itching, rash (urticaria), and swelling (usually of the face, lips, tongue, or throat), along with 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 (may affect fewer than 1 in 100 people).

Other possible 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 throat fungal infections (white, creamy patches), pain in the tongue, hoarseness, and throat irritation. Rinsing the mouth with water and spitting it out immediately and/or brushing teeth after each inhalation may help. Your doctor may prescribe an antifungal medicine to treat the fungal infection.
• 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 while using 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)
• trembling sensation and rapid or irregular heartbeat (palpitations). These are usually harmless symptoms that resolve during treatment.
• feeling of sadness (mainly in children)
• increased blood sugar levels. In diabetic patients, more frequent monitoring of blood glucose levels may be necessary, and the dose of antidiabetic medication may need adjustment
• sleep disturbances
• chest pain
• clouding of the lens (cataract)
• allergic rash.

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

• breathing difficulties or wheezing that worsens immediately after using AirFluSal Forspiro. Stop using AirFluSal Forspiro and contact your doctor immediately. To help ease breathing, use a fast-acting inhaled bronchodilator.

• abnormal production of certain 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, increased eye pressure (glaucoma), weight gain, and a rounded ("moon-shaped") face (Cushing's syndrome).
  Your doctor will regularly check whether any of these adverse effects occur and ensure that you are using the lowest possible dose of the medicine.

• behavioural changes such as unusual excitability and irritability. These effects occur mainly 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 effects 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 or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Reporting adverse effects helps 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℃.
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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 the 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, each containing 60 doses.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in the Czech Republic, country of export: 14/412/14-C
Parallel import authorisation number: 199/25