Airflusal forspiro

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
AirFluSal Forspiro (Airflusan Forspiro)
(50 micrograms + 250 micrograms)/dose, powder for inhalation, divided
Salmeterolum + Fluticasoni propionas
AirFluSal Forspiro and Airflusan Forspiro are different brand names of the same medicine.
Please read the leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please 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 other people, even if their symptoms are the same.
• If you experience any adverse effects, including any 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 in the treatment of bronchial asthma.
The medicine contains two active substances:

• salmeterol (as salmeterol xinafoate): a long-acting bronchodilator
• fluticasone propionate: 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
• tuberculosis (current or past) or other lung infections.

If the patient develops blurred vision or other visual disturbances, inform the doctor immediately.
AirFluSal Forspiro helps prevent breathlessness and wheezing. It is important to remember that this medicine does not work during an acute episode of breathlessness or wheezing.
In case of an asthma attack, a fast-acting medicine (such as salbutamol) must be used to quickly open the airways.
If asthma symptoms or breathing difficulties worsen, contact a doctor immediately. This may include:

• wheezing
• more frequent 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, potentially leading to severe illness. Contact a 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 the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including over-the-counter medicines, as well as any medicines the patient plans to use.
AirFluSal Forspiro and the following medicines may interact with each other:

• medicines used to treat high blood pressure, heart conditions, or other diseases containing active substances ending in "olol" (beta-blockers), such as atenolol, propranolol, and sotalol
• antiviral medicines, including certain drugs used to treat HIV infection, such as ritonavir or cobicistat. The doctor may wish to closely monitor the patient when 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 to treat high blood pressure
• other bronchodilators (such as salbutamol)
• medicines containing xanthine derivatives (often used in the treatment of asthma).

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine. The doctor will assess whether use of AirFluSal Forspiro is appropriate during pregnancy.
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, consult a doctor before using this medicine.
The amount of monohydrate 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 directed by your doctor.
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.
If asthma 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 the mouth with water.
Incorrect or non-compliant use of AirFluSal Forspiro may worsen respiratory symptoms. To achieve optimal effectiveness, the medicine should be used daily, even if symptoms are not present.

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 powder for inhalation 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 should be replaced with a new device.

Before using the inhaler

• Open the transparent cover of the side chamber.
• Carefully tear off the full 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 bars do not contain medicine. At the end, numbered segments 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 remove it safely.

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 through the dose counter window how many doses of medicine remain.

2. Preparing a dose of medicine

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

• Open: Pull the white lever fully to the stop (a click will be heard), which will load the dose and display its number in the dose counter.

• Closing: Fully close the white lever until a click is heard. The inhaler is now ready for immediate use.

3. Inhaling the dose of medicine

• 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 lips tightly around the mouthpiece.
• Breathe in slowly and deeply through the mouth (not through the nose).

• Remove the inhaler from the mouth and hold your breath for 5–10 seconds, or as long as comfortably possible without discomfort.
• After this time, breathe out slowly, not towards the inhaler.
• Close the protective cap over the mouthpiece.
• Rinse the 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 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.

Use of more than the recommended dose of AirFluSal Forspiro
Contact your doctor or pharmacist.
Symptoms of overdose 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 for advice, as higher doses of AirFluSal Forspiro may lead to reduced production of steroid hormones by the adrenal glands.
It is important to use the medicine exactly as prescribed by your doctor. 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 the usual time.

Stopping treatment with AirFluSal Forspiro
Do not stop using or suddenly reduce the dose of AirFluSal Forspiro without your doctor’s approval, 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 diarrhea
• 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Allergic reactions: patients 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 side 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 throat candidiasis (painful, creamy-yellow lesions), tongue pain, hoarseness, and throat irritation. Rinsing the mouth with water and spitting it out immediately and/or brushing teeth right after each inhalation may help. A doctor may prescribe an antifungal medication to treat candidiasis.
• Joint pain, joint swelling, and muscle pain
• Muscle cramps

In patients with chronic obstructive pulmonary disease (COPD), the following side effects have been reported:

• Pneumonia (lung infection). Inform your doctor if any of the following symptoms occur while using AirFluSal Forspiro; they may indicate a lung infection:
  • Increased mucus production
  • Change in mucus color
  • Fever
  • Chills
  • Worsening cough
  • Increased breathing difficulty
• 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 occurs in children)
• Increased blood sugar levels. In patients with diabetes, more frequent monitoring of blood glucose levels may be required, and adjustment of antidiabetic medication dose may be necessary.
• Sleep disturbances
• Chest pain
• Lens opacity (cataract)
• Allergic rash

Rare (may affect fewer than 1 in 1000 people)

• Breathing difficulties or wheezing that worsen immediately after using AirFluSal Forspiro. Discontinue use of AirFluSal Forspiro and contact a doctor immediately. To ease breathing, use a fast-acting bronchodilator by inhalation.
• 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), weight gain, and a rounded ("moon-shaped") face (Cushing's syndrome). The doctor will regularly check whether any of these adverse effects occur and ensure the patient is using the lowest possible dose of the medicine.
• Behavioral 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 side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 side effects helps provide more information on the safety of this medicine.

5. How to store AirFluSal Forspiro

Keep this medicine out of the 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 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 in this medicine are salmeterol and fluticasone propionate. Each metered dose contains 50 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate. This corresponds to the delivered dose containing 45 micrograms of salmeterol (as salmeterol xinafoate) and 233 micrograms of fluticasone propionate.
• The other ingredient is lactose monohydrate.

What AirFluSal Forspiro looks like and contents of the pack
AirFluSal Forspiro is a purple, plastic inhalation device with a foil blister containing 60 doses of inhalation powder.
Pack sizes: 1 or 2 inhalation devices, each containing 60 doses.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, the 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
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in the Czech Republic, the country of export: 14/411/14-C
Parallel Import Licence Number: 54/21