AIRFLUSAL 50 mcg + 500 mcg Powder

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. AirFluSal Forspiro
   1. You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is AirFluSal Forspiro and what is it used for
4. Important information before using AirFluSal Forspiro
   1. When not to use AirFluSal Forspiro
   2. Warnings and precautions
   3. If asthma symptoms or breathing difficulties worsen, the patient should immediately inform their doctor.
   4. Children and adolescents
   5. AirFluSal Forspiro and other medicines
   6. Pregnancy, breastfeeding and fertility
   7. Driving and using machines
   8. AirFluSal Forspiro contains lactose
5. How to use AirFluSal Forspiro
   1. Asthma
   2. COPD
   3. Method of use
   4. Instructions for use
   5. Before using the inhaler
   6. Note:
   7. Using the inhaler
6. Opening
7. Preparing the dose of medicine
8. Inhaling the dose of medicine
   1. Cleaning
   2. Using a higher dose of AirFluSal Forspiro than recommended
   3. Missing a dose of AirFluSal Forspiro
   4. Stopping the use of AirFluSal Forspiro
9. Possible side effects
   1. Allergic reactions: the patient may experience sudden breathing difficulties immediately after
   2. Other possible side effects:
10. How to store AirFluSal Forspiro
11. Contents of the packaging and other information
    1. What AirFluSal Forspiro contains
    2. What AirFluSal Forspiro looks like and contents of the pack
    3. Marketing authorization holder and manufacturer

Leaflet accompanying the packaging: patient information

AirFluSal Forspiro

(50 micrograms + 500 micrograms)/inhalation dose, inhalation powder, divided
Salmeterol + Fluticasone propionate

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

You should keep this leaflet so that you can read it again if you need to.
In case of any doubts, you should consult a doctor or pharmacist.
This medicine has been prescribed to a specific person. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is AirFluSal Forspiro and what is it 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 packaging and other information

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

AirFluSal Forspiro is used to treat:
bronchial asthma
chronic obstructive pulmonary disease (COPD)
This disease is characterized by persistent breathing difficulties due to narrowed airways, often with coughing and excess mucus. The medicine reduces the frequency of COPD symptom 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 allergicto salmeterol, fluticasone or to any of the other ingredients of the medicine (listed in section 6).

Warnings and precautions

Before using AirFluSal Forspiro, the patient should discuss it with their doctor or pharmacist if they have:
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 starts to experience blurred vision or other vision disturbances, they should tell their doctor.
AirFluSal Forspiro prevents the onset of shortness of breath and wheezing. Remember that the medicine does not work when shortness of breath or wheezing has already occurred.
In case of an asthma attack, it is necessary to use a medicine (such as salbutamol) that quickly expands the airways.

If asthma symptoms or breathing difficulties worsen, the patient should immediately inform their doctor.

This may be manifested by:
wheezing
more frequent feeling of chest tightness
greater than usual need for a quick-acting bronchodilator.
In such cases, the patient should continue using AirFluSal Forspiro, but not increase the number of inhalations, as this may worsen the patient's condition. The patient should contact their doctor, as additional treatment may be necessary.

Children and adolescents

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

AirFluSal Forspiro and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
AirFluSal Forspiro and the following medicines may interact with each other:
medicines used to treat high blood pressure, heart disease or other conditions, containing an active substance ending in "-olol" (beta-adrenolytics), such as atenolol, propranolol and sotalol
antiviral medicines, including some medicines used to treat HIV infection, such as ritonavir or cobicistat
The doctor may want to closely monitor the patient's condition when taking such medicines.
antibiotics, such as ketoconazole, itraconazole and erythromycin
oral or injectable corticosteroids: 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 to treat asthma).

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before using this medicine. The doctor will assess whether it is advisable to use AirFluSal Forspiro during pregnancy.

Driving and using machines

It is unlikely that AirFluSal Forspiro will affect the ability to drive or use machines.

AirFluSal Forspiro contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before using the medicine.
The amount of lactose in the medicine usually does not cause any problems in people with lactose intolerance.

3. How to use AirFluSal Forspiro

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

Asthma

The recommended dose for adultsis:
one inhalation twice a day.
The doctor will regularly examine the patient for asthma symptoms.

COPD

The recommended dose for adultsis:
one inhalation twice a day.
If the symptoms have been controlled with AirFluSal Forspiro used twice a day, the doctor may reduce the dose to once a day:
once in the evening, if the patient experiences symptoms at night
once in the morning, if the patient experiences symptoms during the day.

Method of use

AirFluSal Forspiro should be used daily, as directed by the doctor, preferably immediatelybefore a mealin the morning and (or) evening.
After inhalation, the patient should rinse their mouth with water.
Incorrect or non-compliant use of AirFluSal Forspiro may cause worsening of respiratory symptoms. To achieve optimal efficacy, the medicine should be used daily, even if symptoms do not occur.

Instructions for use

The doctor, nurse or pharmacist should show the patient how to use the inhaler and check its correct use regularly.
The inhaler contains 60 doses of inhalation powder in a rolled blister pack (strip) with foil. It is equipped with a dose counter that indicates how many doses are left (from 60 to 0). The numbers indicating the last 10 doses are displayed on a red background.
The inhaler is not intended for refilling – after emptying, it should be replaced with a new device.

Before using the inhaler

Open the transparent side chamber cover.
Carefully tear off the entire length of the strip, using the notched edge (as shown in the picture). The strip should not be pulled or jerked.

Close the side chamber cover and discard the used strip.

Note:

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

Using the inhaler

The inhaler should be held in the hands as shown in the pictures.

1. Opening

Exposing the mouthpiece by pulling down the protective cap.
Check the dose counter window to see how many doses of the medicine are left.

2. Preparing the dose of medicine

Liftthe edge of the white lever. Make sure the side chamber is closed.
Warning: the white lever should only be used when the patient is ready to take a dose of the medicine.
Unnecessary use of the lever causes loss of doses of the medicine.

Opening: pull the white lever to the stop(audible click), which will load the dose of the medicine and display its number in the dose counter.

Closing:carefully close the white leverso that an audible clickis heard. The inhaler is ready for immediate use.

3. Inhaling the dose of medicine

From a distance from the mouthpiece, the patient should perform a possible deep exhalation. Never exhale airdirectly intothe inhaler, as this may change the size of the dose of the medicine.
Hold the inhaler with the protective cap pointing downwards.
With the lips, tightly enclose the mouthpiece.
Perform a calm, deep inhalationthrough the mouth (not the nose).

Remove the inhaler from the mouth and hold the breath for 5-10 secondsor for as long as possible without feeling discomfort.
Then, perform a slow exhalation not in the direction of the inhaler.
Close the protective cap of the mouthpiece.
Rinse the mouth with water (spit out the water), which will help prevent the development of fungal infections in the mouth and throat irritation.

Cleaning

If necessary, the outer part of the mouthpiece can be wiped with a clean, dry cloth.
The inhaler must not be disassembled for cleaning or any other purpose!
Parts of the inhaler must not be cleaned with water or wet cloths, as moisture may change the size of the dose of the medicine!
Never insert a needle or other sharp objects into the mouthpiece or other part of the inhaler, as this may damage it!

Using a higher dose of AirFluSal Forspiro than recommended

The patient should contact their doctor or pharmacist.
Symptoms of overdose are:
dizziness
headache
rapid heartbeat
muscle weakness
joint pain
feeling of shakiness
If higher doses are used for a long time, the patient should consult their doctor or pharmacist for advice, as higher doses of AirFluSal Forspiro may cause a decrease in the production of steroid hormones by the adrenal glands.
It is important to use the medicine as directed by the doctor. Do not increase or decrease the dose without the doctor's consent.

Missing a dose of AirFluSal Forspiro

The patient should not take a double dose of the medicine to make up for a missed dose. The next dose of the medicine should be taken at the usual time.

Stopping the use of AirFluSal Forspiro

The patient should not stop using the medicine or suddenly reduce the dose of AirFluSal Forspiro without the doctor's consent, as this may worsen breathing difficulties and very rarely cause side 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 side effects may also occur very rarely during infection or in situations of extreme stress (e.g. due to fever, injury, serious accident or surgery). To prevent these symptoms, the doctor may prescribe additional corticosteroids (e.g. prednisolone) to the patient.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 (hives) and swelling (usually of the face, lips, tongue or throat), also a feeling of a very fast heartbeat or fainting and dizziness (which may lead to falls or loss of consciousness). If any of these symptoms occur or if they occur suddenly after using AirFluSal Forspiro, the patient should immediately inform their doctor.Allergic reactions to AirFluSal Forspiro are uncommon (may occur less often than in 1 in 100 people).

Other possible side effects:

Very common(may occur more often than in 1 in 10 people)
headache (usually subsiding during treatment)
increased number of colds in patients with chronic obstructive pulmonary disease (COPD)
Common(may occur less often than in 1 in 10 people)
thrush (painful, creamy-white patches) in the mouth and throat, as well as tongue pain, hoarseness and throat irritation.
Rinsing the mouth with water and spitting it out immediately after each inhalation may be helpful. The doctor may prescribe an antifungal medicine to treat thrush.
pain, swelling of the joints and muscle pain
muscle cramps
In patients with chronic obstructive pulmonary disease (COPD), the following side effects have been reported:
pneumonia (lung infection)
The patient should tell their doctor if any of the following symptoms occur while using AirFluSal Forspiro; these may be symptoms of a lung infection:

• increased mucus production
• change in mucus color
• fever
• chills
• worsening cough
• increased breathing difficulties
• bruising and fractures
• low potassium levels in the blood (which may cause irregular heartbeat, weakness and/or muscle cramps)

Uncommon(may occur less often than in 1 in 100 people)
very rapid heartbeat (tachycardia)
feeling of shakiness and rapid or irregular heartbeat (palpitations)
These are usually harmless symptoms that subside during treatment.
feeling of sadness (occurs mainly in children)
increased blood sugar levels
In patients with diabetes, it may be necessary to monitor blood sugar levels more frequently and adjust the dose of the antidiabetic medicine.
sleep disturbances
chest pain
cataract (clouding of the lens)
allergic rash
Rare(may occur less often than in 1 in 1000 people)
breathing difficultiesor wheezingthat worsensimmediately after using AirFluSal Forspiro
Stop usingAirFluSal Forspiro and immediately inform the doctor.
To facilitate breathing, a quick-acting bronchodilator should be used in an inhaler.
abnormal production of certain hormones, especially if the medicine is used in high doses for a long time
Symptoms are:

• slowed growth in children and adolescents
• thinning of bone tissue
• increased eye pressure (glaucoma)
• weight gain
• rounded ("moon-shaped") face (Cushing's syndrome). The doctor will regularly check if the patient is experiencing any of these side effects and ensure that the patient is using the smallest possible dose of the medicine. changes in behavior, such as unusual excitement and irritability These symptoms occur mainly in children. irregular heartbeat or extra heartbeats The patient should tell their doctor about this, but not stop using AirFluSal Forspiro without advice. Fungal infection of the esophagus, which may cause difficulty swallowing

Frequency not known, but may also occur:
depression or aggression
These symptoms occur mainly in children.
blurred vision
Reporting side effects
If side effects occur, including any not listed in this leaflet, the patient should tell their 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store AirFluSal Forspiro

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use AirFluSal Forspiro after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What AirFluSal Forspiro contains

The active substances of the medicine are salmeterol and fluticasone propionate. Each measured 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

Purple, plastic inhaler with a blister pack of foil containing 60 doses of inhalation powder.
Pack sizes: 1 or 2 inhalers containing 60 doses each.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Aeropharm GmbH
Francois-Mitterrand-Allee 1
07407 Rudolstadt, Germany