Airbufo forspiro

Package leaflet: Information for the user

Airbufo Forspiro, (320 micrograms + 9 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 as 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 them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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 in an inhaler used to treat asthma in adults and adolescents aged 12 to 17 years. It is also used to treat symptoms of chronic obstructive pulmonary disease (COPD) in adults aged 18 years and older.
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 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. This makes breathing easier.

Asthma
For the treatment of asthma, your doctor will prescribe two inhaler medicines: Airbufo Forspiro and a separate reliever medicine.

• Airbufo Forspiro is taken daily. It helps prevent asthma symptoms from occurring.
• A reliever inhaler is used when asthma symptoms occur, to help ease breathing. Do not use Airbufo Forspiro, (320 micrograms + 9 micrograms)/inhalation dose, as a reliever inhaler.

Chronic obstructive pulmonary disease (COPD)
Airbufo Forspiro may also be used in adults to treat symptoms of COPD. COPD is a chronic lung disease affecting the airways in the lungs, often 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 ingredient of this medicine

(listed in section 6).
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 function impairment.

If the patient experiences blurred vision or other visual disturbances, they should 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 use.
Especially inform your doctor or pharmacist if the patient is using any of the following medicines:

• beta-blocking agents (such as atenolol or propranolol used to treat high blood pressure), including eye drops (such as timolol used in glaucoma treatment);
• medicines used to treat rapid or irregular heartbeat (such as quinidine, disopyramide, procainamide);
• antihistamines (e.g. terfenadine);
• oxytocin (a medicine used to induce labour);
• procarbazine (a medicine used to treat cancer);
• medicines such as digoxin, commonly used in heart failure treatment;
• 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 asthma treatment;
• 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, known as phenothiazines (such as chlorpromazine and prochlorperazine);
• medicines used to treat fungal infections (such as ketoconazole, itraconazole, voriconazole, posaconazole) and bacterial infections (such as clarithromycin, telithromycin and furazolidone);
• medicines used to treat Parkinson's disease (such as levodopa);
• medicines used to treat thyroid disorders (such as levothyroxine);
• medicines known as HIV protease inhibitors (such as ritonavir, cobicistat), used in the treatment of HIV infection. The effect of Airbufo Forspiro may be enhanced and the doctor may closely monitor the patient's condition.

If any of these situations apply 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 operating machinery
Airbufo Forspiro has no effect or 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 contact their doctor before taking this medicine. The amount of lactose in this medicine should not usually be a problem for people with lactose intolerance. Lactose, an excipient of 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 as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
• It is important to use Airbufo Forspiro every day, even if the patient does not currently have symptoms of asthma or COPD.
• If the patient is using Airbufo Forspiro for the treatment of asthma, the doctor will regularly monitor the disease symptoms.

If the patient is taking steroid tablets for the treatment of asthma or COPD, the doctor may
reduce their number after starting Airbufo Forspiro. If the patient has been taking oral steroids
for a prolonged period, the doctor may occasionally recommend blood tests. After reducing
the dose of oral steroids, the patient may feel unwell, even if respiratory symptoms improve.
Symptoms may include nasal congestion or nasal discharge, weakness or muscle or joint
pain, and rash (eruption). If any of these symptoms concern the patient or if symptoms such
as headache, fatigue, nausea or vomiting occur, the patient should contact the doctor
immediately. If allergic symptoms or joint inflammation occur, additional medicines may be
necessary. If the patient has any doubts about continuing to use Airbufo Forspiro, they should
consult their doctor.
During periods of stress (e.g. chest infection or prior to surgery), the doctor may consider
adding steroid tablets to the usual treatment regimen.
Important information about asthma or COPD symptoms
If the patient experiences shortness of breath or wheezing while using Airbufo Forspiro, they
should continue using Airbufo Forspiro and contact their doctor as soon as possible, as
additional treatment may be required.
Contact the doctor immediately if:
breathing difficulties worsen or asthma symptoms frequently wake the patient at night;
the patient begins to experience chest tightness in the morning or chest tightness persists
longer than usual.
These symptoms may indicate inadequate control of asthma or COPD and may require
immediate initiation of different or additional treatment.
Asthma
Airbufo Forspiro should be used daily. This helps prevent asthma symptoms.
Adults (aged at least 18 years)
The usual dose is 1 inhalation twice daily.
The doctor may increase this dose to 2 inhalations twice daily.
Once symptoms are under control, the doctor may recommend using the medicine once daily.
Adolescents (aged 12 to 17 years)
The usual dose is 1 inhalation twice daily.
Once symptoms are under control, the doctor may recommend using the medicine once daily.
Airbufo Forspiro is not recommended for children under 12 years of age.
The doctor will help the patient properly control asthma symptoms and determine the lowest
dose that maintains symptom control. Do not change the dose without first discussing it with
the doctor.
For treating asthma symptoms as they occur, a separate “reliever inhaler” should be used.
This inhaler should always be carried to allow immediate use if needed. Do not use Airbufo
Forspiro (320 micrograms + 9 micrograms)/inhalation dose to treat asthma symptoms – a
separate reliever inhaler is intended for this purpose.
Chronic obstructive pulmonary disease (COPD)

• This medicine should only be used in adults (aged 18 years and older).
• The usual dose is 1 inhalation twice daily.

For the treatment of COPD, the doctor may also prescribe other bronchodilator medicines,
e.g. anticholinergics (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 medicine on a coiled foil strip. The inhaler has a dose counter
indicating how many doses remain (from 60 to 0). The last 10 doses are indicated on a red
background.
The inhaler is not designed to be refilled. Once used up, the inhaler 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
figure). 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. The 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 foil 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 the hands as shown in the figures.
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: The white lever should only be used when the patient is ready to take the dose.
Unnecessary use will result in loss of doses.

Opening: pull the white lever fully until a click is heard, which will load the dose and display
its number in the dose counter.

Closing: firmly close the white lever until a click is heard. 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 size.
Hold the inhaler with the protective cap pointing downwards.
Tightly close lips around the mouthpiece.
Take as deep and forceful a breath in through the mouth (not the nose) as possible.

Remove the inhaler from the mouth and hold breath for 5–10 seconds, or as long as possible
without discomfort.
After this time, breathe out slowly away from the inhaler.
Close the protective cap over the mouthpiece.
Rinse the mouth with water (spit the water out) to help prevent development of oral fungal
infection and hoarseness.
Cleaning
If necessary, wipe the outer part of the mouthpiece with a clean, dry tissue.
Do not disassemble the inhaler for cleaning or for any other purpose!
Do not clean any parts of the inhaler with water or wet wipes, as moisture may alter the dose
size!
Never insert a needle or other sharp objects into the mouthpiece or any other part of the
inhaler, as this may damage it!
Using more than the recommended dose of Airbufo Forspiro
It is important that the patient uses the medicine as directed by the doctor. Do not increase the
prescribed dose without consulting the doctor.
The most common symptoms that may occur after taking more than the recommended dose
of Airbufo Forspiro are: tremor, headache or rapid heartbeat.
Missing a dose of Airbufo Forspiro

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

If there are any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
If any of the following symptoms 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 reliever inhaler straight away. Contact a doctor without delay, as your treatment may need to be changed. This situation is very rare (may occur in fewer than 1 in 10,000 people).

Other possible side effects:
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 thrush (fungal infection in the mouth) – the risk of developing this is reduced if the patient rinses their mouth with water after each inhalation
mild sore throat, cough, hoarseness
headache
pneumonia (lung infection) in patients with COPD
If any of the following symptoms occur while using Airbufo Forspiro, consult a doctor – these may be signs of lung infection:
fever or chills
increased production of bronchial mucus, change in its colour
worsening cough or increased breathing difficulties

Uncommon (may occur in fewer than 1 in 100 people)
aggression
anxiety
feeling restless, nervousness, or agitation
sleep disturbances
dizziness
nausea
rapid heartbeat
skin bruising
muscle cramps
blurred vision

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, stop using 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, especially in children
chest pain or tightness (angina)
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 the bones)
• cataracts (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, including weight gain, development of a moon-shaped face, poor wound healing, and thinning of the skin
• increased susceptibility to infections and reduced ability to respond to stressful situations.

The likelihood of these effects is considerably lower with inhaled corticosteroids than with oral corticosteroid tablets.

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 Adverse Drug Reactions at 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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Airbufo Forspiro

Keep the medicine out of the 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 on the inhaler label after 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 will help protect the environment.

6. Contents of the pack and other information

What Airbufo Forspiro contains

• The active substances are budesonide and formoterol fumarate dihydrate. Each delivered dose (inhalation dose) contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate. Each metered dose (dose of medicine in the blister prior to administration) contains 346.3 micrograms of budesonide and 10.8 micrograms of formoterol fumarate dihydrate.
• The other ingredient is monohydrate lactose (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. Each inhaler contains a foil OPA/Aluminium/PVC/Aluminium blister with 60 divided doses of inhalation powder.
The inhalation powder is uniform, white, off-white or light yellow.
The pack contains 1 inhaler with 60 doses.

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

Manufacturers:
Aeropharm GmbH
Francois-Mitterrand-Allee 1
07407 Rudolstadt, Germany
LEK farmacevtska družba d.d.
Verovškova ulica 57
1526 Ljubljana, Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Saxony-Anhalt, Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Sweden Bofunir 320 microg/9 microg/dose, inhalation powder, pre-dispensed
Austria AirBuFo Forspiro 320 micrograms/9 micrograms - single-dose powder for inhalation
Bulgaria ErBuFo Forspiro 320 micrograms + 9 micrograms/dose inhalation powder, pre-dosed
AirBuFo® Forspiro® 320 micrograms + 9 micrograms/dose powder for inhalation, pre-dosed
Czech Republic Airbufo Forspiro
Germany Airbufo Forspiro 320 micrograms/9 micrograms single-dose powder for inhalation
Estonia Airbufo Forspiro
Greece AirBuFo Forspiro, 320 μg/9 μg/inhalation, inhalation powder in pre-dispensed doses
Croatia AirBuFo Forspiro 320/9 micrograms per dose, inhalation powder, pre-dosed
Lithuania AirBuFo Forspiro 320/9 micrograms per dose, inhalation powder
Latvia Airbufo Forspiro 320 micrograms/9 micrograms/inhalation, inhalation powder, pre-dosed
Netherlands AirBuFo Forspiro 320/9 microgram/dose, inhalation powder, pre-dispensed
Poland Airbufo Forspiro
Romania Airbufo Forspiro 320 micrograms/9 micrograms inhalation powder, single dose
Slovenia Airbufo Forspiro 320 micrograms/9 micrograms per dose, powder for inhalation, pre-measured
Slovakia Airbufo Forspiro 320 micrograms/9 micrograms/dose

For more detailed information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00