Airiam

Leaflet accompanying the packaging: patient information

Airiam, (100 micrograms + 6 micrograms)/dose measured,

inhalation aerosol, solution
Beclometasone dipropionate + 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, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. 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 side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Airiam and what is it used for

Airiam is a solution in an inhalation aerosol, containing two active substances, which are inhaled through the mouth and go directly to the lungs.
The medicine contains two active substances:

• Beclometasone dipropionate, which belongs to a group of medicines called corticosteroids, which have an anti-inflammatory effect by reducing swelling and irritation of the lungs.
• Formoterol fumarate dihydrate, which belongs to a group of long-acting bronchodilator medicines, which relax the muscles in the airways and make breathing easier.

Together, these two active substances make breathing easier by relieving symptoms such as shortness of breath, wheezing, and coughing in patients with asthma or chronic obstructive pulmonary disease (COPD), and also help prevent asthma symptoms.
Asthma
Airiam is indicated for the regular treatment of asthma in adult patients, in whom:

• asthma symptoms are not adequately controlled with inhaled corticosteroids and a short-acting bronchodilator used as needed, or
• asthma symptoms have been adequately controlled with both inhaled corticosteroids and long-acting bronchodilators.

COPD
Airiam may also be used to treat symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a chronic respiratory disease in the lungs, mainly caused by smoking.

2. Important information before using Airiam

When not to use Airiam:

• if the patient is allergic or suspects they are allergic to one or both of the active substances of Airiam, or if they are allergic to other medicines or products used to treat asthma, or to any of the other ingredients of Airiam (listed in section 6, "Package contents and other information"), they should consult a doctor.

Warnings and precautions
Before starting to use Airiam, you should discuss it with your doctor, pharmacist, or
nurse:

• If the patient has heart disease, such as angina pectoris (chest pain), a recent heart attack (myocardial infarction), heart failure, coronary heart disease, heart valve defects, or any other heart disease, or a disease known as hypertrophic obstructive cardiomyopathy (HOCM), which is an abnormal heart muscle structure.
• If the patient has narrowing of the arteries (also known as atherosclerosis); if the patient has high blood pressure or a diagnosed aneurysm (abnormal dilation of a blood vessel wall).
• If the patient has heart rhythm disturbances, such as rapid or irregular heartbeat, rapid pulse, or palpitations, or if there is any information about an abnormal heart rhythm.
• If the patient has hyperthyroidism.
• If the patient has low potassium levels in the blood.
• If the patient has liver or kidney disease.
• If the patient has diabetes (inhalation of high doses of formoterol may increase blood glucose levels, so it may be necessary to perform additional blood tests to measure blood glucose levels before starting treatment and from time to time during treatment).
• If the patient has a pheochromocytoma (a tumor of the adrenal gland).
• If the patient is scheduled for general anesthesia. Depending on the type of anesthesia, it may be necessary to discontinue Airiam at least 12 hours before anesthesia.
• If the patient is being treated or has been treated for tuberculosis or if the patient has a viral or fungal infection in the chest.
• If the patient must avoid consuming alcohol for any reason.

Before using Airiam, you should always inform your doctor if any of the above warnings apply to you.

Before using the inhaler, you should consult a doctor, pharmacist, or nurse if you have any current or past health problems or allergies, or if you are unsure whether Airiam can be used.
Treatment with beta-agonists, such as formoterol in Airiam, may cause a sudden decrease in blood potassium levels (hypokalemia).
Particular caution is advised in patients with severe asthma.Low oxygen levels in the blood, as well as the use of other medicines with Airiam, such as heart disease or high blood pressure medicines, known as diuretics, or other asthma medicines, may increase the decrease in blood potassium levels. For this reason, your doctor may recommend checking your blood potassium levels from time to time.
If you are taking high doses of inhaled corticosteroids for a long time, you may be more likely to need corticosteroids during periods of stress. Stressful situations may include hospitalization after an accident, serious injury, or scheduled surgery. In such situations, your doctor will decide whether to increase the dose of corticosteroids or recommend other steroids in the form of tablets or injections.
If you need to be hospitalized, you should remember to take all your medicines and inhalers, including Airiam, as well as over-the-counter medicines, if possible, in their original packaging.

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

Airiam should not be used in children and adolescents under 18 years of age until more data are available.
Airiam and other medicines:
You should tell your doctor about all medicines you are currently taking or have recently taken, including those available without a prescription.
Some medicines may enhance the effect of Airiam, and your doctor may want to monitor your condition closely while taking such medicines (including certain HIV medicines: ritonavir, cobicistat).
Do not use beta-adrenergic blockers with Airiam. Beta-adrenergic blockers, such as atenolol, propranolol, and sotalol, are used to treat many diseases, including high blood pressure and heart disease, such as irregular heartbeat and heart failure; timolol is used to treat glaucoma. If beta-adrenergic blockers, including those in eye drops, are administered, the effect of formoterol may be reduced or formoterol may not work. On the other hand, the concurrent use of other beta-adrenergic medicines (medicines that work in the same way as formoterol) may enhance the effect of formoterol.

Concomitant use of Airiam with:

• medicines used to treat irregular heartbeat (quinidine, disopyramide, procainamide), medicines used to treat allergies (antihistamines), medicines used to treat symptoms of depression or mental disorders, such as monoamine oxidase inhibitors (e.g., phenelzine and isocarboxazid), tricyclic antidepressants (e.g., amitriptyline and imipramine), phenothiazines, may cause certain changes in the electrocardiogram (ECG, a record of heart activity). They may also increase the risk of heart rhythm disturbances (ventricular arrhythmias).
• medicines used to treat Parkinson's disease (L-dopa), hypothyroidism (L-thyroxine), medicines containing oxytocin (which induce uterine contractions), and alcohol, may reduce the heart's tolerance to beta-agonists, such as formoterol.
• monoamine oxidase inhibitors (MAOIs), including medicines with similar properties, such as furazolidone and procarbazine, used to treat mental disorders, may cause an increase in blood pressure.
• medicines used to treat heart disease (digoxin) may cause a decrease in blood potassium levels. This may increase the risk of heart rhythm disturbances.
• other medicines used to treat asthma (theophylline, aminophylline, or steroids) and diuretics (water pills), may cause a decrease in blood potassium levels.
• certain anesthetics, may increase the risk of heart rhythm disturbances.

Pregnancy, breastfeeding, and fertility
There are no clinical data on the use of Airiam during pregnancy.
Airiam should not be used if the patient is pregnant, suspects they are pregnant, or plans to have a child, or if the patient is breastfeeding, unless the doctor decides otherwise.
Driving and using machines
It is unlikely that Airiam will affect your ability to drive or use machines. However, if you experience side effects such as dizziness and/or tremors, they may affect your ability to drive or use machines.
Airiam contains alcohol
Airiam contains 7 mg of alcohol (ethanol) in each inhalation from the inhaler.
The amount of alcohol in a dose of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not have noticeable effects.

3. How to use Airiam

Airiam is intended for inhalation use. Airiam should be inhaled through the mouth into the lungs.

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist. The leaflet contains information on how many inhalations to take and how often to take them.
Dosage
Asthma
Your doctor will regularly check that you are taking the optimal dose of Airiam.
Your doctor will determine the smallest dose that provides the best control of asthma symptoms.
Your doctor may prescribe Airiam in one of two ways:
a) Airiam should be used daily to treat asthma, along with another inhaled "reliever" medicine in case of sudden worsening of asthma symptoms, such as an attack of shortness of breath, wheezing, and coughing

Adults and the elderly:

The recommended dose is one or two inhalations twice a day. The maximum daily dose is 4 inhalations.
Remember: You should always carry a quick-acting inhaled reliever medicine with you to treat worsening asthma symptoms or a sudden asthma attack.
b) Airiam should be used daily to treat asthma, as well as to relieve sudden worsening of asthma symptoms, such as an attack of shortness of breath, wheezing, and coughing

Adults and the elderly:

The recommended dose is one inhalation in the morning and one inhalation in the evening.
You should also use Airiam as an inhaled reliever medicine in case of sudden worsening of asthma symptoms. If symptoms occur, use one inhalation and wait a few minutes. If there is no improvement, use another inhalation.

Do not use more than 6 reliever inhalations of Airiam in 24 hours.

The maximum daily dose of Airiam is 8 inhalations.

If you need to take more inhalations to control your asthma symptoms, you should consult your doctor. A change in treatment may be necessary.

Use in children and adolescents under 18 years of age:

This medicine should NOT be used in children and adolescents under 18 years of age.

Chronic obstructive pulmonary disease (COPD)

Adults and the elderly:

The recommended dose is two inhalations in the morning and two inhalations in the evening.

Special patient groups:

There is no need to adjust the dosage in elderly patients. There is no information on the use of Airiam in patients with liver or kidney impairment.

The dose of beclometasone dipropionate in Airiam, which is effective in treating asthma, may be lower than the dose contained in other inhaled medicines containing beclometasone dipropionate. If you have previously used another inhaled medicine containing

beclometasone dipropionate, your doctor will recommend the appropriate dose of Airiam for asthma.

Do not increase the dose

If you feel that the effect of the medicine is insufficient, you should always consult your doctor before increasing the dose.

In case of worsening breathing difficulties:

If you experience worsening shortness of breath or wheezing(breathing with a noticeable whistling sound) immediately after inhaling the medicine, you should immediately STOP using Airiam and use a quick-acting inhaled bronchodilatorto relieve shortness of breath and wheezing. You should contact your doctor as soon as possible. Your doctor will assess your symptoms and, if necessary, recommend alternative treatment.
See also section 4, "Possible side effects".

In case of worsening asthma symptoms:

If your symptoms worsen or you have difficulty controlling them (e.g., if you need to use another inhaled reliever medicine or Airiam as a reliever medicine more often) or if the reliever medicine or Airiam does not relieve your symptoms, you should immediately inform your doctor. This may indicate a worsening of your asthma, and your doctor may decide to change the dosage of Airiam or use alternative treatment.
If you have any further questions about using this medicine, you should consult your doctor or pharmacist.

Method of administration:

Airiam is intended for inhalation use

This medicine is in a pressurized container, in a plastic housing with a mouthpiece. At the front of the inhaler, there is a dose counter that shows how many doses of medicine are left. Each time the inhaler is pressed, a dose of medicine is released. With each activation, the dose counter also emits a clicking sound, providing acoustic feedback indicating proper operation of the indicator. The inhaler is equipped with an integrated dose counter, which accurately counts each dose and displays every 20th dose. The dose counter window displays the approximate number of actuations (inhalations) left in the container in units of twenty (e.g., 120, 100, 80, etc.). When 20 actuations are left on the display, the number 20 appears on a half-red and half-white background, indicating that the container is near the end of its use. You should stop using the inhaler when the counter shows 0 on a red background, as the medicine left in the container may not be enough to deliver a full dose, and you should start using a new inhaler.

How to use the inhaler

If possible, you should stand or sit upright while inhaling.
Before inhaling, check the dose counter:
any number between "1" and "120" means that there are still doses left. If the dose counter shows "0", there are no more doses - you should discard the inhaler and buy a new one.

• 1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust or other contaminants.
• 2. Exhale slowly and deeply, as much as possible.
• 3. Hold the container upright, with the stem facing upwards, and then place the mouthpiece between your lips. Do not bite the mouthpiece. Inhale slowly and deeply through your mouth, and just after starting to inhale, press the top of the inhaler firmly to release one dose of medicine.
• 4. For people with a weak grip, it will be easier to hold the inhaler with both hands: you should then place both index fingers on the top of the inhaler and both thumbs on the bottom.
• 5. Hold your breath for as long as possible, and then remove the inhaler from your mouth and exhale slowly. Do not exhale into the inhaler.

If you need to take another dose of medicine, you should hold the inhaler upright for about half a minute, and then repeat the steps described in points 2 to 5.
Important:The actions described in points 2 to 5 should not be performed too quickly.
After use, you should replace the protective cap and check the dose counter.
To reduce the risk of fungal infection of the mouth and throat, you should rinse your mouth or gargle with water or brush your teeth after each use of the inhaler.

When to replace the inhaler

The inhaler should be replaced with a new one when the counter shows 20, and the color on the dose counter changes from white to half-red and half-white, indicating that the container is near the end of its use. You should stop using the inhaler when the counter shows 0 on a red background, as the medicine left in the container may not be enough to deliver a full dose, and you should start using a new inhaler.

If a "mist" appears over the top opening of the mouthpiece or from the side of the mouth, it means that Airiam will not reach the lungs as it should. You should take another dose, following the instructions, starting again from point 2.

If you feel that the effect of Airiam is too strong or too weak, you should consult your doctor or pharmacist.
If you have difficulty handling the inhaler during inhalation, you can use a spacer (AeroChamber Plus). You should ask your doctor, pharmacist, or nurse about this device. It is essential to carefully read the leaflet that comes with the AeroChamber Plus spacer and follow the instructions for use and cleaning recommendations.

Cleaning the inhaler

The inhaler should be cleaned once a week.
During cleaning, do not remove the container from the housing, and do not use water or other liquids to clean the inhaler.
Cleaning the inhaler:

• 1. Remove the protective cap from the mouthpiece by pulling it off the inhaler.
• 2. Wipe the mouthpiece and dose counter with a clean, dry cloth or tissue from the inside and outside.
• 3. Replace the protective cap.

Taking a higher dose of Airiam than recommended:

• using a higher dose of formoterol than recommended may cause the following symptoms: nausea, vomiting, rapid heartbeat, palpitations, heart rhythm disturbances, changes in the electrocardiogram (ECG, a record of heart activity), headache, tremors, drowsiness, excessive acidic products in the blood, decreased blood potassium levels, increased blood glucose levels. Your doctor may recommend a blood test to check your potassium and glucose levels.
• using too high a dose of beclometasone dipropionate may cause temporary disturbances in adrenal function. Improvement will occur within a few days, but your doctor may recommend a blood test to check your cortisol levels.

If you experience any of these symptoms, you should inform your doctor.

Missing a dose of Airiam:

You should take the missed dose as soon as possible. If it is almost time for the next dose, do not take the missed dose, just take the next dose at the usual planned time.
Do not take a double dose to make up for a missed dose.

Stopping Airiam:

You should not reduce the dose or stop using the medicine.
Even if you feel better, you should not stop using Airiam or reduce the dose without consulting your doctor. It is very important to use Airiam regularly, even when your symptoms have improved.
If you have any further questions about using this medicine, you should consult your doctor or pharmacist.

• 4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with other inhaled medicines, there is a risk of worsening shortness of breath and wheezing immediately after taking Airiam, known as paradoxical bronchospasm.You should immediately STOP using Airiam and use a quick-acting inhaled bronchodilatorto relieve shortness of breath and wheezing. You should contact your doctor as soon as possible.
You should immediately inform your doctorif you experience any allergic reactions, such as skin allergies, itching, rash, redness, swelling of the skin or mucous membranes, especially of the eyes, face, lips, and throat.
Other possible side effects are listed below, depending on their frequency.

• Fungal infections (of the mouth and throat)
• headache
• hoarseness
• sore throat
• pneumonia (lung infection) in patients with COPD: You should tell your doctor if any of the following symptoms occur while using Airiam, as they may be symptoms of a lung infection:
• fever or chills
• increased production of mucus or change in mucus color
• worsening cough or increased difficulty breathing

Uncommon(occurring in less than 1 in 100 people):

• abnormal rapid heartbeat and heart rhythm disturbances
• certain changes in the electrocardiogram (ECG)
• asthma attack
• tremors
• restlessness
• dizziness
• palpitations
• flu-like symptoms
• vaginal fungal infections
• sinusitis
• otitis (ear infection)
• throat irritation
• cough and cough with expectoration
• nausea
• abnormal or altered sense of taste
• lip burning
• dry mouth
• difficulty swallowing
• indigestion
• stomach upset
• diarrhea
• muscle pain and muscle cramps
• redness of the face
• increased sweating
• increased blood flow to some tissues in the body
• nasal sinus infection
• changes in some blood test results:
• decrease in white blood cell count
• increase in platelet count
• decrease in blood potassium levels
• increase in blood glucose levels
• increase in insulin, free fatty acids, and ketone bodies in the blood
• rash or hives

The following side effects have also been reported as "uncommon" in patients with chronic obstructive pulmonary disease:

• Decreased cortisol levels in the blood, which is caused by the effect of corticosteroids on the adrenal glands.
• Irregular heartbeat.

Rare(occurring in less than 1 in 1000 people):

• feeling of pressure in the chest
• heart rhythm disturbances (caused by premature contraction of the heart chambers)
• increased or decreased blood pressure
• kidney inflammation
• swelling of the skin and mucous membranes that lasts for several days

Very rare(occurring in less than 1 in 10,000 people):

• worsening of asthma
• shortness of breath
• decreased platelet count
• swelling of the hands and feet

The use of inhaled corticosteroids in high doses for a long time may rarely cause systemic side effects.

These include:

• adrenal function disorders (adrenal suppression)
• increased intraocular pressure (glaucoma)
• cataracts
• delayed growth in children and adolescents
• decreased bone density (osteoporosis)

Unknown (frequency cannot be estimated from available data):

• Sleep disturbances, depression, or feelings of sadness, restlessness, nervousness, overexcitement, or irritability. These side effects are more likely to occur in children.
• Blurred vision.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 or its representative in Poland.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Airiam

The medicine should be stored out of sight and reach of children.
The single pack contains 1 container of 120 doses.
The medicine should not be used after 3 months from the date of dispensing by the pharmacist and never after the expiry date stated on the carton and label after EXP. The expiry date refers to the last day of the month stated.
Before use: the inhaler should be stored upright in the refrigerator (at a temperature of 2-8°C) for a maximum of 18 months.
After first opening: the inhaler should not be stored at a temperature above 25°C.
Store for a maximum of 3 months.
If the inhaler has been cooled, before using the medicine, you should warm it in your hands for a few minutes. You should never use other methods to heat the container.
Warning:The container contains a pressurized liquid. Do not expose the container to temperatures above 50°C. Do not pierce the container.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Airiam contains

• The active substances of the medicine are: beclometasone dipropionate, formoterol fumarate dihydrate. Each measured dose from the inhaler contains 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose through the mouthpiece, containing 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.
• The other ingredients are: norflurane (HFC-134a), ethanol, maleic acid, and water for injection.

This medicine contains fluorinated greenhouse gases.
Each inhaler contains 8.12 g of norflurane (HFC-134a), which corresponds to 0.012 tons of CO2 equivalent (global warming potential, GWP = 1430).

What Airiam looks like and what the package contains

Airiam is an inhalation aerosol in the form of a solution, which is in an aluminum container coated with a fluoropolymer (FCP), closed with a metering valve, in a cardboard box. The container is equipped with a white plastic dose counter and a pink plastic protective cap. The dose counter is equipped with an integrated dose counter, which accurately counts each dose and displays every 20th dose.
Package size:
1 package (one container delivers 120 doses)

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Vivaire 100 micrograms/6 micrograms per actuation, pressurized inhalation solution
Bulgaria: Вивер 100 микрограма/6 микрограма/доза разтвор под налягане за инхалация
Czech Republic: Vivaire
Hungary: Vivaire 100 micrograms/6 micrograms pressurized inhalation solution
Poland: Airiam
Romania: VIVAIRE 100 micrograms/6 micrograms/dose, pressurized inhalation solution

Marketing authorization holder:

Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Importer:

Hormosan Pharma GmbH
Hanauer Landstrasse 139 - 143
60314 Frankfurt Am Main, Germany
Oy Medfiles Ltd
Volttikatu 5, Volttikatu 8
70700 Kuopio, Finland

To obtain more detailed information, you should contact the local representative of the marketing authorization holder:

Zentiva Poland Sp. z.o.o.
ul. Bonifraterska 17
00-203 Warsaw, Poland
tel.: +48 22 375 92 00
Date of last revision of the leaflet:March 2025