AIRBUFO 160 mcg + 4.5 mcg Powder

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Airbufo Forspiro, (160 micrograms + 4.5 micrograms)/inhalation dose,
   1. You should carefully 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 Airbufo Forspiro and what is it used for
   1. Asthma
   2. Chronic Obstructive Pulmonary Disease (COPD)
4. Important information before using Airbufo Forspiro
   1. When not to use Airbufo Forspiro:
   2. Warnings and precautions
   3. Airbufo Forspiro and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Airbufo Forspiro contains lactose
5. How to use Airbufo Forspiro
   1. Important information about asthma or COPD symptoms
   2. Asthma
   3. In the treatment of asthma symptoms, a separate "emergency inhaler" should be used.
   4. Airbufo Forspiro should also be used as an "emergency inhaler" to treat
   5. Chronic Obstructive Pulmonary Disease (COPD)
   6. Instructions for use
   7. Before using the inhaler
   8. Warning:
   9. Using the inhaler
6. Opening
7. Preparing the dose
8. Inhaling the dose
   1. Cleaning
   2. Using a higher than recommended dose of Airbufo Forspiro
   3. Missing a dose of Airbufo Forspiro
9. Possible side effects
   1. If any of the following symptoms occur, the patient should stop using Airbufo Forspiro and consult their doctor immediately:
   2. Other possible side effects:
   3. Reporting side effects
10. How to store Airbufo Forspiro
11. Package contents and other information
    1. What Airbufo Forspiro contains
    2. What Airbufo Forspiro looks like and what the package contains
    3. Marketing authorization holder and manufacturer
    4. To obtain more detailed information about the medicine and its names in the Member States of the European Economic Area, please contact:

Leaflet attached to the packaging: patient information

Airbufo Forspiro, (160 micrograms + 4.5 micrograms)/inhalation dose,

inhalation powder, divided
Budesonide + Formoterol fumarate dihydrate

You should carefully 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.
• If you have 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 tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Airbufo Forspiro and what is it used for
• 2. Important information before using Airbufo Forspiro
• 3. How to use Airbufo Forspiro
• 4. Possible side effects
• 5. How to store Airbufo Forspiro
• 6. Package contents and other information

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

Airbufo Forspiro is a medicine used in an inhaler for the treatment of:
asthma in adults and adolescents from 12 to 17 years old.
symptoms of chronic obstructive pulmonary disease (COPD) in adultsaged 18 and over.
Airbufo Forspiro contains two medicines: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called corticosteroids. It works by reducing and preventing swelling and inflammation in the lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called long-acting beta-2-adrenergic receptor agonists or bronchodilators. Its action is to relax the muscles in the airways. The medicine makes breathing easier.

Asthma

Airbufo Forspiro may be prescribed for the treatment of asthma in two different ways:
a) Some people are prescribed two medicines in inhalers by their doctor: Airbufo Forspiro and a separate medicine for emergency use.

• Airbufo Forspiro is used daily. The medicine helps prevent the onset of asthma symptoms.
• The emergency inhaler is used when asthma symptoms occur, to facilitate breathing.

b) Some people are prescribed Airbufo Forspiro as the only inhaler medicine for the treatment of asthma.

• Airbufo Forspiro is used daily. The medicine helps prevent the onset of asthma symptoms.
• Airbufo Forspiro is also used in situations where additional doses are needed to relieve asthma symptoms and facilitate breathing. These people do not need a separate emergency inhaler.

They do not need a separate emergency inhaler.

Chronic Obstructive Pulmonary Disease (COPD)

Airbufo Forspiro can also be used in adults to treat symptoms of COPD. COPD is a chronic disease characterized by persistent difficulty breathing due to narrowing of the airways in the lungs, often with coughing and expectoration of phlegm. COPD is often caused by smoking.

2. Important information before using Airbufo Forspiro

When not to use Airbufo Forspiro:

Warnings and precautions

Before starting to use Airbufo Forspiro, the patient should discuss it with their doctor or pharmacist if they:

• have diabetes,
• have a lung infection,
• have high blood pressure or have ever had heart disease (including arrhythmias, very fast heart rate, narrowing of the arteries, or heart failure),
• have thyroid or adrenal gland disease,
• have low potassium levels in the blood,
• have severe liver function disorders.

If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Airbufo 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.
They should especially tell their doctor or pharmacist if they are taking any of the following medicines:

• beta-adrenergic blockers (such as atenolol or propranolol used to treat high blood pressure), also in eye drops (such as timolol used to treat glaucoma);
• medicines used to treat rapid or irregular heart rhythm (such as quinidine, disopyramide, procainamide);
• medicines used to treat allergies, so-called antihistamines (e.g., terfenadine);
• oxytocin (a medicine used to accelerate childbirth);
• procarbazine (a medicine used to treat cancer);
• medicines such as digoxin, often used to treat heart failure;
• diuretics (such as furosemide) used to treat high blood pressure;
• corticosteroids (such as prednisolone) used to treat inflammation or prevent rejection of a transplanted organ;
• xanthine derivatives (such as theophylline or aminophylline) often used to treat asthma;
• other medicines used to dilate the airways (such as salbutamol);
• medicines used to treat depression, so-called tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone;
• medicines used to treat mental illnesses, nausea, or vomiting, so-called phenothiazine medicines (such as chlorpromazine and prochlorperazine);
• medicines used to treat fungal (such as ketoconazole, itraconazole, voriconazole, posaconazole) and bacterial (such as clarithromycin, telithromycin, furazolidone) infections;
• medicines used to treat Parkinson's disease (such as levodopa);
• medicines used to treat thyroid diseases (such as levothyroxine);
• ritonavir, cobicistat (medicines used to treat HIV infection). The effect of Airbufo Forspiro may be enhanced, and the doctor may need to closely monitor the patient's condition.

If any of these situations apply to the patient or the patient is unsure if they are taking any of the listed medicines, they should consult their doctor or pharmacist before using Airbufo Forspiro.
They should also tell their doctor or pharmacist if they are planning to undergo general anesthesia due to surgery or a dental procedure.

Pregnancy and breastfeeding

• If the patient is pregnant or plans to have a child, they should consult their doctor before using Airbufo Forspiro. Airbufo Forspiro should not be used during pregnancy unless prescribed by a doctor.
• If the patient becomes pregnant while being treated with Airbufo Forspiro, they should not stop using it, but should contact their doctor immediately.
• If the patient is breastfeeding, they should consult their doctor before using Airbufo Forspiro.

Driving and using machines

Airbufo Forspiro has no or negligible influence on the ability to drive and use machines.

Airbufo Forspiro contains lactose

Airbufo Forspiro contains lactose, a type of sugar. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine. The amount of lactose in this medicine should not normally be a problem for people with lactose intolerance.
The lactose, an excipient of the medicine, contains small amounts of milk proteins, which may cause allergic reactions.

3. How to use Airbufo Forspiro

• This medicine should always be used as directed by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
• It is essential to use Airbufo Forspiro daily, even if the patient does not have symptoms of asthma or COPD at that time.
• If the patient is using Airbufo Forspiro to treat asthma, the doctor will regularly monitor the disease symptoms.

If the patient is taking tablets containing corticosteroids to treat asthma or COPD, the doctor may reduce their number after starting to use Airbufo Forspiro. If the patient has been taking oral corticosteroids for a long time, the doctor may occasionally recommend blood tests. After reducing the dose of oral corticosteroids, the patient's condition may worsen, even if the respiratory symptoms improve. Symptoms such as a feeling of nasal congestion or runny nose, weakness, or muscle or joint pain and rash (rash) may occur. If any of these symptoms concern the patient or occur, they should contact their doctor immediately. If symptoms of allergy or arthritis occur, it may be necessary to use other medicines. If the patient is unsure whether to continue using Airbufo Forspiro, they should consult their doctor.
In periods of stress (e.g., associated with chest infection or before surgery), the doctor may consider adding tablets containing corticosteroids to the usual treatment.

Important information about asthma or COPD symptoms

If the patient experiences shortness of breath or wheezing while using Airbufo Forspiro, they should continue to use Airbufo Forspiro and consult their doctor as soon as possible, as additional treatment may be necessary.
The patient should contact their doctor immediately if:
breathing difficulties worsen or asthma symptoms wake them up often at night;
the patient experiences chest tightness in the morning or chest tightness that lasts longer than usual.
These symptoms may indicate inadequate control of asthma or COPD, and it may be necessary to use other or additional treatment immediately.

Asthma

In the treatment of asthma, the doctor may prescribe Airbufo Forspiro in two different ways.
The dose and duration of Airbufo Forspiro depend on the prescribed method of use.
a) If the doctor has prescribed Airbufo Forspiro and a separate emergency inhaler, the patient should read the instructions below in the section "a) Using Airbufo Forspiro and an additional emergency inhaler".
b) If the doctor has prescribed Airbufo Forspiro as the only inhaled medicine, the patient should read the instructions below in the section "b) Using Airbufo Forspiro as the only inhaler in the treatment of asthma".
a) Using Airbufo Forspiro and an additional emergency inhaler
Airbufo Forspiro should be used daily.This helps prevent the onset of asthma symptoms.
Adults (aged 18 and over)
The usual dose is 1 or 2 inhalations twice a day.
The doctor may increase this dose to 4 inhalations twice a day.
After achieving symptom control, the doctor may recommend using the medicine once a day.
Adolescents (aged 12 to 17)
The usual dose is 1 or 2 inhalations twice a day.
After achieving symptom control, the doctor may recommend using the medicine once a day.
Airbufo Forspiro should not be used in children under 12 years of age.
The doctor will help the patient properly control their asthma symptoms and determine the smallest dose that will control the disease symptoms. The patient should not change the dose of the medicine without first discussing it with their doctor.

In the treatment of asthma symptoms, a separate "emergency inhaler" should be used.

This inhaler should always be carried with the patient so that it can be used if needed. Airbufo Forspiro should not be used to treat asthma symptoms - this is what the additional emergency inhaler is for.
b) Using Airbufo Forspiro as the only inhaler in the treatment of asthma
Airbufo Forspiro should be used only as directed by the doctor and only in people aged 12 and over.
Airbufo Forspiro should be used daily.This helps prevent the onset of asthma symptoms. The patient can use:

• 1 inhalation in the morning and 1 inhalation in the evening or
• 2 inhalations in the morning or
• 2 inhalations in the evening.

The doctor may increase this dose to 2 inhalations twice a day.

Airbufo Forspiro should also be used as an "emergency inhaler" to treat

asthma symptoms.

• If asthma symptoms occur, the patient should take 1 inhalation and wait a few minutes.
• If there is no improvement, the patient should take another inhalation.
• The patient should not use more than 6 inhalations at a time.

The Airbufo Forspiro inhaler should always be carried with the patient so that it can be used if needed.
Normally, the total daily dose should not exceed 8 inhalations. However, the doctor may allow the use of up to 12 inhalations per day for a certain period.
If the patient regularly needs to use 8 or more inhalations per day, they should contact their doctor or nurse. The treatment may need to be changed.
The patient should not use more than 12 inhalations per day.
If asthma symptoms occur during physical exertion, the patient should use Airbufo Forspiro as described above. However, the patient should not use this medicine before exertion to prevent asthma symptoms.

Chronic Obstructive Pulmonary Disease (COPD)

• The medicine should only be used in adults (aged 18 and over).
• The usual dose is 2 inhalations twice a day.

In the treatment of COPD, the doctor may also prescribe other bronchodilators, such as tiotropium and ipratropium bromide.

Instructions for use

The doctor, nurse, or pharmacist should demonstrate to the patient how to use the inhaler and regularly check that it is being used correctly.
The inhaler contains 60 doses of the medicine in a rolled-up foil strip. The inhaler has a dose counter that shows how many doses are left (from 60 to 0). The last 10 doses are marked on a red background.
The inhaler is not intended for multiple refilling. The used inhaler should be disposed of and replaced with a new one.

Before using the inhaler

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

Close the side chamber cover and discard the torn strip of foil.

Warning:

As the inhaler is used, the side chamber will gradually fill with used foil strips. The foil strips with black lines do not contain medicine. At the end, numbered sections of the strip will appear in the chamber.
The side chamber should not contain more than 2 strips, as this may cause the inhaler to clog. The foil strip should be gently torn off (as shown above) and safely disposed of.

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

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 will result in loss of doses.

Opening: pull the white lever all the way(until a clickis heard), which will load the dose of the medicine and show its number in the dose counter.

Closing:the white lever should be closed carefullyso that a clickis heard. The inhaler is ready for immediate use.

3. Inhaling the dose

Hold the inhaler in the hands as shown in the pictures.

Exhale as far as possible away from the mouthpiece. Never exhale directly into the inhaler, as this may change the size of the dose.
Hold the inhaler with the protective cap facing downwards.
Put the mouthpiece to the lips and close the mouth tightly around it.
Take a deepand forceful inhalationthrough the mouth (not the nose), as deeply as possible.

Remove the inhaler from the mouth and hold the breath for 5-10 secondsor as long as it is comfortable.
Then breathe out slowly away from 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 a fungal infection in the mouth and the occurrence of hoarseness.

Cleaning

If necessary, wipe the outer part of the mouthpiece with a clean, dry cloth.
The inhaler should not be disassembled or cleaned with water or wet cloths, as moisture may change the size of the dose.
Never insert a needle or other sharp objects into the mouthpiece or other parts of the inhaler, as this may damage it!

Using a higher than recommended dose of Airbufo Forspiro

It is essential to use the medicine as directed by the doctor. The patient should not increase the prescribed dose without consulting their doctor.
The most common symptoms that may occur after taking a higher than recommended dose of Airbufo Forspiro are: tremors, headache, rapid or irregular heartbeat.

Missing a dose of Airbufo Forspiro

• If a dose is missed, it should be taken as soon as possible after remembering. However, if it is almost time for the next dose, the missed dose should be skipped.
• The patient should not take a double dose to make up for the missed dose.

If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following symptoms occur, the patient should stop using Airbufo Forspiro and consult their doctor immediately:

• Swelling of the face, especially around the mouth (swelling of the tongue and/or throat and/or difficulty swallowing) or hives with difficulty breathing (angioedema) and/or a sudden feeling of fainting. These symptoms may indicate a rare allergic reaction (may occur less often than in 1 in 1000 people).
• Sudden onset of wheezing or shortness of breath immediately after inhalation. If any of these symptoms occur, the patient should stop using Airbufo Forspiro and use their emergency inhaler immediately. They should contact their doctor immediately, as a change in treatment may be necessary.This situation occurs very rarely (may occur less often than in 1 in 10,000 people).

Other possible side effects:

Common(may occur less often than in 1 in 10 people)
palpitations (feeling of heartbeat), muscle tremors, tremors (usually mild and disappearing during continued use of Airbufo Forspiro)
thrush (fungal infection) in the mouth (the risk of its development is lower if the patient rinses their mouth with water after inhalation)
mild sore throat, cough, and hoarseness
headache
pneumonia (lung infection) in patients with COPD
If any of the following symptoms occur while using Airbufo Forspiro, the patient should consult their doctor - these may be symptoms of a lung infection:
fever or chills
increased production of sputum, change in its color
worsening cough or increased breathing difficulties
Uncommon(may occur less often than in 1 in 100 people)
feeling of restlessness, nervousness, or agitation
sleep disturbances
dizziness
blurred vision
nausea
rapid heartbeat
presence of bruises on the skin
muscle cramps
aggression
anxiety
Rare(may occur less often than in 1 in 1000 people)
rash, itching
bronchospasm (constriction of the airway muscles causing wheezing). If wheezing occurs suddenly after inhalation, the patient should stop using Airbufo Forspiro and consult their doctor immediately.
low potassium levels in the blood
irregular heartbeat
Very rare(may occur less often than in 1 in 10,000 people)
depression
changes in behavior, especially in children
chest pain or tightness (angina pectoris)
increased blood sugar levels
changes in taste, such as unpleasant taste in the mouth
changes in blood pressure
weight gain, moon face, weakness, central obesity (Cushing's syndrome).
Inhaled corticosteroids, especially when used for a long time in high doses, may affect the normal production of steroid hormones in the body. Symptoms include:

• changes in bone density (thinning of bones)
• cataract (clouding of the lens in the eye)
• glaucoma (increased pressure in the eye)
• slowing of growth rate in children and adolescents
• effects on the adrenal glands (small glands located near the kidneys)
• Cushing's syndrome
• increased susceptibility to infections and reduced ability to adapt to stressful situations.

The likelihood of these symptoms is much lower when using inhaled corticosteroids than when taking corticosteroid tablets.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. 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,
phone: +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 gather more information on the safety of the medicine.

5. How to store Airbufo Forspiro

The medicine should be stored out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging or inhaler label after EXP. 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 needed. This will help protect the environment.

6. Package contents and other information

What Airbufo Forspiro contains

• The active substances are budesonide and formoterol fumarate dihydrate. Each delivered dose (inhalation dose) contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate. Each measured dose (dose of medicine in the blister before administration) contains 194.7 micrograms of budesonide and 6.1 micrograms of formoterol fumarate dihydrate.
• The other ingredient is lactose monohydrate (contains milk proteins).

What Airbufo Forspiro looks like and what the package contains

Airbufo Forspiro is a red and white plastic inhaler containing the medicine, in a cardboard box.
Each inhaler contains a blister of OPA/Aluminum/PVC/Aluminum foil with 60 divided doses of inhalation powder. The inhalation powder is uniform, white, off-white, or light yellow.
The package contains 1 or 2 inhalers (each with 60 divided doses).

Marketing authorization holder and manufacturer

Marketing authorization holder:
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer:
AEROPHARM GmbH
François-Mitterrand-Allee 1
07407 Rudolstadt, Germany
Lek Pharmaceuticals d.d
Verovškova ulica 57
1526 Ljubljana, Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany

To obtain more detailed information about the medicine and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
phone: 22 209 70 00
Date of last revision of the leaflet:10/2021
(logo of the marketing authorization holder)