Airflusal Forspiro

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

AirFluSal Forspiro

(50 micrograms + 250 micrograms)/dose, inhalation powder, divided
Salmeterol + Fluticasone propionate

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

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 asthma.
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 any of the excipients 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
• have hyperthyroidism
• have high blood pressure
• have diabetes (AirFluSal Forspiro may increase blood sugar levels)
• have low potassium levels in the blood
• have tuberculosis (currently or in the past) or other lung infections.

If the patient starts to see blurred vision or has other vision problems, they should inform their doctor.
AirFluSal Forspiro prevents the onset of shortness of breath and wheezing. It should be remembered that the medicine does not work when shortness of breath or wheezing has already occurred.
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In case of a shortness of breath attack, it is necessary to use a medicine (such as salbutamol) that quickly expands the airways.

If the symptoms of asthma or breathing difficulties worsen, the patient should immediately inform their doctor. This may be indicated by:

• wheezing
• more frequent feeling of chest tightness
• greater than usual need for a quick-acting bronchodilator.

In such a case, the patient should continue using AirFluSal Forspiro, but not increase the number of inhalations, as this may worsen the patient's condition, leading to severe illness. 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-blockers), such as atenolol, propranolol, and sotalol
• medicines used to treat viral infections, including some medicines used to treat HIV, such as ritonavir or cobicistat. The doctor may want to closely monitor the patient's condition 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 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 monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult 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:
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one inhalation twice a day.
The doctor will regularly check the patient for asthma symptoms.
If the asthma 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 symptoms occur at night
• once in the morning, if the symptoms occur during the day.

Method of use

AirFluSal Forspiro should be used daily, as directed by the doctor, preferably immediately before 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 worsen respiratory symptoms. To achieve optimal effectiveness, 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 regularly check the correctness of its use.
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 on a red background.
The inhaler is not intended to be refilled – 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 serrated edge (as shown in the diagram). The strip should not be pulled or jerked.

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

Warning:

As the inhaler is used, the side chamber will gradually fill with the used strip. The strips with black marks do not contain 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 (as shown above) and dispose of it safely.

Using the inhaler

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

1. Opening

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

2. Preparing the dose of medicine

• Raisingthe 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 medicine. Unnecessary use of the lever will result in loss of medicine doses.

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• Opening: pull the white lever to the stop(hear a click), which will load the dose of medicine and show its number on the dose counter.

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

3. Inhaling the dose of medicine

• Exhaling as deeply as possible away from the mouthpiece. Never exhale directly into the inhaler, as this may change the size of the medicine dose.
• Holding the inhaler with the protective cap facing downwards.
• Tightly closing the lips around the mouthpiece.
• Taking a calm, deep breaththrough the mouth (not the nose).

• Removing the inhaler from the mouth and holding the breath for 5-10 secondsor as long as possible without discomfort.
• Then, slowly exhaling not towards the inhaler.
• Closing the protective cap over the mouthpiece.
• Rinsing the mouth with water (spitting 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 should not be disassembled for cleaning or any other purpose!
• The inhaler parts should not be cleaned with water or wet cloths, as moisture may change the size of the medicine dose!

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• Never insert a needle or other sharp objects into the mouthpiece or any 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 shaking

In case of using higher doses for a long time, the patient should consult their doctor or pharmacist for advice, as higher doses of AirFluSal Forspiro may lead to a decrease in the production of steroid hormones by the adrenal glands.
It is essential to use the medicine as directed by the doctor. The dose should not be increased or decreased 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 AirFluSal Forspiro or suddenly reduce the dose without consulting their doctor, 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
• low blood pressure and seizures.

Similar side effects may also occur very rarely during infection or in a situation of severe 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 using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, AirFluSal Forspiro 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), and a feeling of a very rapid heartbeat or fainting and dizziness (which may lead to a fall 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 resolving 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 immediately spitting it out may be helpful, and (or) brushing teeth immediately after each inhalation. 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 production of mucus
• change in the color of mucus
• fever
• chills
• worsening cough
• worsening breathing difficulties
• bruising and fractures
• sinusitis
• 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 shaking 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 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 difficulties or wheezingthat worsenimmediately after using AirFluSal Forspiro The use of AirFluSal Forspiro should be stoppedand the doctor informed immediately. To facilitate breathing, a quick-acting bronchodilator should be used
• 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)

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• weight gain
• rounded ("moon-shaped") face (Cushing's syndrome). The doctor will regularly check if the patient has 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. Such symptoms occur mainly in children
• irregular heartbeat or extra heartbeats The patient should inform 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. Such symptoms occur mainly in children
• blurred vision.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store AirFluSal Forspiro

The medicine should be stored out of sight and reach of children.
Store in a temperature 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 specified 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 used. 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 dose contains 50 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate. This corresponds to a 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 what the packaging contains

An inhalation device with a blister pack of foil containing 60 doses of inhalation powder.
Pack sizes: 1 or 2 inhalation devices, each containing 60 doses.
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For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Latvia, the country of export:

Sandoz d.d., Verovškova 57, SI-1000 Ljubljana, Slovenia

Manufacturer:

Aeropharm GmbH, Francois-Mitterrand-Allee 1, 07407 Rudolstadt, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Latvia, the country of export: 14-0224

Parallel import authorization number: 224/25

Date of leaflet approval: 01.07.2025

[Information about the trademark]
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