Airbufo forspiro

Patient Information Leaflet

Airbufo Forspiro, (160 micrograms + 4.5 micrograms)/inhalation dose,
inhalation powder, pre-dispensed
Budesonide + Formoterol fumarate dihydrate
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet Contents:

1. What Airbufo Forspiro is and what it is used for
2. What you need to know before using Airbufo Forspiro
3. How to use Airbufo Forspiro
4. Possible side effects
5. How to store Airbufo Forspiro
6. Contents of the pack and other information

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

Airbufo Forspiro is a medicine delivered via an inhaler, used for the treatment of:
Asthma in adults and adolescents aged 12 to 17 years, and
Symptoms of chronic obstructive pulmonary disease (COPD) in adults aged 18 years and older.
Airbufo Forspiro contains two active substances: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called corticosteroids. It works by reducing and preventing inflammation and swelling in the lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called long-acting beta-2 adrenergic agonists or bronchodilators. It works by relaxing the muscles in the airways, making breathing easier.

Asthma
Airbufo Forspiro may be prescribed for asthma treatment in two different ways:
a) Some patients are prescribed two inhaler medicines for asthma: Airbufo Forspiro and a separate reliever inhaler.

• Airbufo Forspiro is taken daily. It helps prevent asthma symptoms from occurring.
• The reliever inhaler is used when asthma symptoms occur, to help ease breathing.

b) Some patients are prescribed Airbufo Forspiro as the only inhaler medicine for asthma.

• Airbufo Forspiro is taken daily. It helps prevent asthma symptoms.
• Airbufo Forspiro is also used when additional doses are needed to relieve asthma symptoms and ease breathing. These patients do not require a separate reliever inhaler.

Chronic Obstructive Pulmonary Disease (COPD)
Airbufo Forspiro may also be used in adults to treat symptoms of COPD. COPD is a chronic condition characterised by persistent breathing difficulties caused by narrowed airways in the lungs, often accompanied by cough and sputum production. COPD is frequently caused by smoking.

2. Important information before using Airbufo Forspiro

When not to use Airbufo Forspiro:

• if the patient is allergic to budesonide, formoterol, or to any other component of this medicine – lactose (which contains small amounts of milk proteins).

Warnings and precautions
Before starting treatment with Airbufo Forspiro, discuss with your doctor or pharmacist if the patient:

• has diabetes,
• has a lung infection,
• has high blood pressure or has ever had heart disease (including heart rhythm disorders, very fast heartbeat, narrowed arteries, or heart failure),
• has thyroid or adrenal gland disease,
• has low blood potassium levels,
• has severe liver impairment.

If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Airbufo 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 take.
Especially inform your doctor or pharmacist if the patient is taking any of the following medicines:

• beta-blockers (such as atenolol or propranolol used to treat high blood pressure), including eye drops (such as timolol used in the treatment of glaucoma);
• medicines used to treat fast or irregular heartbeat (such as quinidine, disopyramide, procainamide);
• antihistamines (medicines used to treat allergies, e.g. terfenadine);
• oxytocin (a medicine used to induce labour);
• procarbazine (a medicine used to treat cancer);
• medicines such as digoxin, commonly used in the treatment of heart failure;
• diuretics (such as furosemide) used to treat high blood pressure;
• corticosteroids (such as prednisolone) used to treat inflammatory conditions or to prevent rejection of transplanted organs;
• xanthine derivatives (such as theophylline or aminophylline) commonly used in the treatment of asthma;
• other medicines used to dilate the airways (such as salbutamol);
• medicines used to treat depression, tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone;
• medicines used to treat psychiatric disorders, nausea or vomiting, phenothiazine-type medicines (such as chlorpromazine and prochlorperazine);
• medicines used to treat fungal infections (such as ketoconazole, itraconazole, voriconazole, posaconazole) and bacterial infections (such as clarithromycin, telithromycin, furazolidone);
• medicines used to treat Parkinson's disease (such as levodopa);
• medicines used to treat thyroid disorders (such as levothyroxine);
• ritonavir, cobicistat (medicines used in the treatment of 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 if the patient is unsure whether they are taking any of the listed medicines, they should consult their doctor or pharmacist before using Airbufo Forspiro.
Also inform your doctor or pharmacist if general anaesthesia is planned due to surgery or a dental procedure.
Pregnancy and breastfeeding

• If the patient is pregnant or planning to become pregnant, she should consult her doctor before using Airbufo Forspiro. Airbufo Forspiro should not be used during pregnancy unless advised by a doctor.
• If the patient becomes pregnant while being treated with Airbufo Forspiro, she should not stop taking the medicine but should contact her doctor immediately.
• If the patient is breastfeeding, she should consult her doctor before using Airbufo Forspiro.

Driving and using machines
Airbufo Forspiro has no effect or has a negligible effect on the ability to drive or operate tools or machinery.
Airbufo Forspiro contains lactose
Airbufo Forspiro contains lactose, a type of sugar. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine. The amount of lactose in this medicine should not usually cause problems for people with lactose intolerance.
Lactose, an excipient in this medicine, contains small amounts of milk proteins, which may cause allergic reactions.

3. How to use Airbufo Forspiro

• This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
• It is important to use Airbufo Forspiro every day, even if you do not have asthma or COPD symptoms at the time.
• If you are using Airbufo Forspiro for asthma treatment, your doctor will regularly monitor your symptoms.

If you are taking tablets containing corticosteroids for asthma or COPD, your doctor may reduce their number after starting Airbufo Forspiro. If you have been taking oral corticosteroids for a long time, your doctor may occasionally recommend blood tests. After reducing the dose of oral corticosteroids, you may feel unwell, even if your breathing symptoms improve. Symptoms may include nasal congestion or runny nose, weakness, muscle or joint pain, or rash (skin eruption). If any of these symptoms concern you, or if you experience headache, fatigue, nausea, or vomiting, contact your doctor immediately. If symptoms of allergy or joint inflammation occur, additional medicines may be necessary. If you have any doubts about continuing to use Airbufo Forspiro, consult your doctor.
During periods of stress (e.g., chest infection or prior to surgery), your doctor may consider adding corticosteroid tablets to your usual treatment.

Important information about asthma or COPD symptoms
If you experience shortness of breath or wheezing while using Airbufo Forspiro, continue using the medicine and contact your doctor as soon as possible, as additional treatment may be needed.
Contact your doctor immediately if:

• your breathing problems worsen or asthma symptoms frequently wake you at night;
• you begin to feel chest tightness in the morning or chest tightness lasts longer than usual.
  These symptoms may indicate inadequate control of asthma or COPD and may require immediate additional or alternative treatment.

Asthma
For asthma treatment, your doctor may prescribe Airbufo Forspiro in one of two ways.
The dose and timing of Airbufo Forspiro depend on the prescribed method of use.
a) If your doctor has prescribed Airbufo Forspiro and a separate reliever inhaler, read the instructions below under section “a) Using Airbufo Forspiro and a separate reliever inhaler”.
b) If your doctor has prescribed Airbufo Forspiro as the only inhaled medicine, read the instructions below under section “b) Using Airbufo Forspiro as the only inhaler for asthma treatment”.

a) Using Airbufo Forspiro and a separate reliever inhaler
Airbufo Forspiro should be used daily. This helps prevent asthma symptoms.

Adults (aged 18 years and older)
The usual dose is 1 or 2 inhalations twice daily.
Your doctor may increase this dose to 4 inhalations twice daily.
Once symptoms are controlled, your doctor may recommend using the medicine once daily.

Adolescents (aged 12 to 17 years)
The usual dose is 1 or 2 inhalations twice daily.
Once symptoms are controlled, your doctor may recommend using the medicine once daily.
Airbufo Forspiro is not recommended for children under 12 years of age.
Your doctor will help you properly control asthma symptoms and determine the lowest effective dose. Do not change the dose without discussing it with your doctor first.

For treating asthma symptoms, use a separate “reliever inhaler”.
Always carry this inhaler with you so you can use it when needed. Do not use Airbufo Forspiro to treat asthma symptoms – use the separate reliever inhaler for this purpose.

b) Using Airbufo Forspiro as the only inhaler for asthma treatment
Airbufo Forspiro should be used only as directed by your doctor and only in individuals aged 12 years and older.
Airbufo Forspiro should be used daily. This helps prevent asthma symptoms. You may use:

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

Your doctor may increase the dose to 2 inhalations twice daily.
Airbufo Forspiro should also be used as a “reliever inhaler” to treat asthma symptoms.

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

Always carry the Airbufo Forspiro inhaler so you can use it when needed.
Usually, a total daily dose greater than 8 inhalations is not required. However, your doctor may allow up to 12 inhalations per day for a limited period.
If you regularly need 8 or more inhalations per day, contact your doctor or nurse, as your treatment may need to be adjusted.
Do not use more than 12 inhalations per day.
If asthma symptoms occur during physical exertion, use Airbufo Forspiro as described above. However, do not use this medicine before exercise to prevent asthma symptoms.

Chronic obstructive pulmonary disease (COPD)

• This medicine should be used only in adults (aged 18 years and older).
• The usual dose is 2 inhalations twice daily.

For COPD treatment, your doctor may also prescribe other bronchodilator medicines, such as tiotropium and ipratropium bromide.

Instructions for use
Your doctor, nurse, or pharmacist should demonstrate how to use the inhaler and regularly check that you are using it correctly.
The inhaler contains 60 doses of medicine on a coiled foil strip. It has a dose counter indicating the number of doses remaining (from 60 to 0). The last 10 doses are indicated on a red background.
The inhaler is not designed to be refilled. Once used, it should be discarded and replaced with a new one.

Before using the inhaler
Open the transparent side chamber cover.
Carefully peel 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 side chamber cover and dispose of the detached foil strip.
Note:
As the inhaler is used, the side chamber gradually fills with used foil strips. Foil strips with black bars 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 detach the foil strip (as shown above) and dispose of it safely.

Using the inhaler
Hold the inhaler in your hands as shown in the pictures.
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: Use the white lever only when you are ready to take a dose. Unnecessary use wastes doses.

Opening: Pull the white lever fully until you hear a click, which loads the dose and displays its number in the dose counter.

Closing: Close the white lever completely 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.
Hold the inhaler with the protective cap pointing downward.
Seal your lips tightly around the mouthpiece.
Breathe in as deeply and forcefully as possible through your mouth (not your nose).

Remove the inhaler from your mouth and hold your breath for 5–10 seconds, or as long as comfortable without discomfort.
Then breathe out slowly, not toward the inhaler.
Close the protective cap over the mouthpiece.
Rinse your mouth with water (spit out the water) to help prevent oral fungal infection and hoarseness.

Cleaning
If necessary, wipe the outside of the mouthpiece with a clean, dry cloth.
Do not disassemble the inhaler for cleaning or any other purpose.
Do not clean any parts with water or wet wipes, as moisture may alter the dose.
Never insert needles or other sharp objects into the mouthpiece or any other part of the inhaler, as this may damage it.

Overdose of Airbufo Forspiro
It is important to use this medicine exactly as prescribed by your doctor. Do not increase the prescribed dose without consulting your doctor.
The most common symptoms after taking more than the recommended dose of Airbufo Forspiro are: tremors, headache, rapid or irregular heartbeat.

Missed dose of Airbufo Forspiro

• If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the symptoms listed below occur, stop using Airbufo Forspiro immediately and contact a doctor:

• Swelling of the face, particularly around the mouth (swelling of the tongue and/or throat and/or difficulty swallowing), or hives with breathing difficulties (angioedema) and/or sudden feeling of fainting. These symptoms may indicate a rare allergic reaction (may occur in fewer than 1 in 1,000 people).
• Sudden onset of wheezing or breathlessness immediately after inhalation. If any of these symptoms occur, stop using Airbufo Forspiro immediately and use a rescue inhaler without delay. Contact a doctor immediately, as a change in treatment may be necessary. This situation is very rare (may occur in fewer than 1 in 10,000 people).

Other possible adverse reactions:
Common (may occur in fewer than 1 in 10 people)
palpitations (awareness of heartbeat), muscle twitching, tremor (usually mild and decreasing during continued use of Airbufo Forspiro)
oral candidiasis (fungal infection in the mouth) – risk of development is reduced if the patient rinses the mouth with water after inhalation
mild sore throat, cough, hoarseness
headache
pneumonia (lung infection) in patients with COPD
If any of the following symptoms occur during treatment with Airbufo Forspiro, consult a doctor – these may be signs of lung infection:
fever or chills
increased production of bronchial secretions, change in their colour
worsening cough or increased difficulty breathing

Uncommon (may occur in fewer than 1 in 100 people)
feeling of restlessness, nervousness or agitation
sleep disturbances
dizziness
blurred vision
nausea
increased heart rate
skin bruising
muscle cramps
aggression
anxiety

Rare (may occur in fewer than 1 in 1,000 people)
rash, itching
bronchospasm (constriction of muscles in the airways causing wheezing). If sudden wheezing occurs immediately after inhalation, discontinue use of Airbufo Forspiro and contact a doctor immediately.
low blood potassium levels
irregular heartbeat

Very rare (may occur in fewer than 1 in 10,000 people)
depression
behavioural changes, particularly in children
chest pain or tightness (angina pectoris)
increased blood glucose (sugar) levels
taste disturbances, such as unpleasant taste in the mouth
blood pressure changes
weight gain, moon-shaped face, weakness, abdominal obesity (Cushing's syndrome).
Inhaled corticosteroids, especially when used long-term at high doses, may affect the body's normal production of steroid hormones. Symptoms include:

• changes in bone mineral density (thinning of bones)
• cataract (clouding of the lens in the eye)
• glaucoma (increased pressure in the eye)
• slowed growth rate in children and adolescents
• effects on the adrenal glands (small glands located near the kidneys)
• cushingoid features
• increased susceptibility to infections and reduced ability to cope with stressful situations.

The likelihood of these symptoms occurring is significantly lower with inhaled corticosteroids than with oral corticosteroid tablets.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 4921 301,
fax: +48 22 4921 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Airbufo Forspiro

Keep this medicine out of sight and reach of children.
Do not store at temperatures above 30°C.
Do not use this medicine after the expiry date stated on the packaging or on the inhaler label following EXP. 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 package and other information

What Airbufo Forspiro contains

• The active substances are budesonide and formoterol fumarate dihydrate. Each delivered dose (metered dose) contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate. Each metered dose (dose of drug in the blister prior to 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 contents of the pack
Airbufo Forspiro is a red-and-white plastic inhaler containing the medicine, in a cardboard box.
Each inhaler contains a foil OPA/Aluminium/PVC/Aluminium blister with 60 divided doses of powder for inhalation. The powder for inhalation is uniform, white, off-white or light yellow.
The pack contains 1 or 2 inhalers (each with 60 divided doses).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturers:
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

For further 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
tel. 22 209 70 00
(logo of the marketing authorisation holder)