Airiam

Leaflet accompanying the packaging: patient information

Airiam, (200 micrograms + 6 micrograms)/metered dose,

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. Contents of the packaging and other information

1. What is Airiam and what is it used for

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

• Beclometasone dipropionate, which belongs to a group of medicines called corticosteroids, has an anti-inflammatory effect by reducing swelling and irritation of the lungs.
• Formoterol fumarate dihydrate, which belongs to a group of long-acting bronchodilators, relaxes the muscles in the airways and makes breathing easier. Together, these two active substances make breathing easier and also help prevent asthma symptoms such as shortness of breath, wheezing, and coughing.

Airiam is used to treat asthma in adult patients.
If a patient has been prescribed Airiam, it is likely that:

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

2. Important information before using Airiam

When not to use Airiam:

if the patient is allergic to beclometasone dipropionate or formoterol fumarate dihydrate or
to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions Before starting treatment with Airiam, the patient should discuss with their doctor, pharmacist, ornurse if they have any of the following conditions:

• heart disease, such as angina (chest pain), heart failure, coronary artery disease, heart valve defects, or any other heart disease.
• high blood pressure or an aneurysm (abnormal dilation of a blood vessel wall).
• arrhythmias, such as rapid or irregular heartbeat, rapid pulse, or palpitations, or if there is any information about an abnormal heart rhythm,
• hyperthyroidism.
• low potassium levels in the blood.
• liver or kidney disease
• diabetes (inhalation of high doses of formoterol may increase blood glucose levels. After starting treatment with this medicine, and from time to time during treatment, additional blood tests may be necessary to determine blood sugar levels).
• pheochromocytoma (a tumor of the adrenal gland).
for any reason.

Before using Airiam, the patient should always inform their doctor if any of the above warnings apply to them.

Before using an inhaled medicine, the patient should consult a doctor, nurse, or pharmacist
if they currently have or have had any health problems or allergies, or if they are unsure whether Airiam can be used.
The doctor may recommend a blood test to check potassium levels, especially if asthma is severe.
Like many other bronchodilators, Airiam may cause a sudden
decrease in blood potassium levels (hypokalemia). This happens because the lack of oxygen in the blood
in combination with other medicines used at the same time with this medicine may exacerbate the decrease
in blood potassium levels.
If the patient is taking high doses of inhaled corticosteroids for a long time, they
may be more likely to need corticosteroids during periods of stress. Stressful situations
may include: hospitalization after an accident, serious injury, or waiting for surgery. In such situations, the doctor will decide whether to increase the dose of corticosteroids or recommend other steroids in the form of tablets or injections.
If hospitalization is necessary, the patient should remember to bring all their 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.

Airiam and other medicines:

The patient should tell their doctor, pharmacist, or nurse about all the medicines they are currently taking or have recently taken, including those available without a prescription. This is because this medicine
may affect the action of some other medicines. Additionally, some medicines may affect the action of Airiam.
In particular, the patient should tell their doctor, nurse, or pharmacist if they are taking any of the following medicines:

• Some medicines may enhance the effect of this medicine, and the doctor may want to closely monitor the patient's condition when taking these medicines (including some HIV medicines: ritonavir, cobicistat).
• Beta-adrenergic blockers. Beta-blockers are used to treat many conditions, including heart disease, high blood pressure, and glaucoma (increased eye pressure). If beta-blockers need to be used, including eye drops, the effect of formoterol may be weakened or formoterol may not work at all.
• Beta-adrenergic medicines (medicines that work in the same way as formoterol) may enhance the effect of formoterol.
• 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.
• Medicines used to treat Parkinson's disease (L-dopa).
• Medicines used to treat hypothyroidism (L-thyroxine).
• Medicines containing oxytocin (which cause uterine contractions).
• Medicines used to treat mental disorders, such as monoamine oxidase inhibitors (MAOIs), including medicines with similar properties, such as furazolidone and procarbazine.
• Medicines used to treat heart disease (digoxin).
• Other medicines used to treat asthma (theophylline, aminophylline, or steroids).
• Diuretics (water pills).

The patient should also tell their doctor if they plan to undergo general anesthesia before surgery
or dental procedures.

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, thinks they may be pregnant, or plans to have a baby, or if the patient is breastfeeding, unless the doctor decides otherwise.

Driving and using machines

It is unlikely that Airiam will affect the ability to drive or use machines.

Airiam contains alcohol

This medicine contains 9 mg of alcohol (ethanol) in each inhalation from the inhaler, which corresponds to 0.25 mg/kg per dose consisting of two inhalations. The amount of alcohol in two inhalations of this medicine is equivalent to less than 1 ml of wine or beer.
The small amount of alcohol in this medicine is unlikely to 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 the doctor or pharmacist. If the patient has any doubts,
they should consult their doctor or pharmacist.
The doctor will perform regular check-ups to ensure that the patient is taking the correct dose of Airiam. The doctor will adjust the treatment to the lowest dose that best relieves the symptoms.

Dosage:

Adults and the elderly:

The recommended dose is one or two inhalations twice a day.
The maximum daily dose is 4 inhalations.

Remember: Always carry a fast-acting inhaled reliever medicine to treat asthma symptoms or a sudden asthma attack.

Special patient groups:

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

Use in children and adolescents under 18 years of age:

This medicine should NOTbe used in children and adolescents under 18 years of age.

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 this substance. If the patient has previously used another inhaled medicine containing beclometasone

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

Do not increase the dose

If the patient feels that the effect of the medicine is insufficient, they should always consult their doctor before increasing the dose.

If asthma symptoms worsen:

If the patient's asthma symptoms worsen or if they have difficulty controlling them (e.g., if they need to use another inhaled reliever medicine more often) or if the inhaled reliever medicine does not relieve the symptoms,
they should immediately inform their doctor. This may indicate that the asthma is worsening, and the doctor may decide to change the dose of Airiam or use another treatment.

Method of administration:

Airiam is intended for inhalation use

This medicine is in a pressurized container, in a plastic case 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 of the inhaler, the dose counter also makes 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 number of inhalations left in the inhaler in units of twenty (e.g., 120, 100, 80, etc.). When 20 inhalations 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. The patient 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 they should start using a new inhaler.

How to use the inhaler

If possible, the patient should stand or sit upright while inhaling.
Before inhaling, the patient should 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 -
the inhaler should be discarded and a new one purchased.

• 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.
• 3. Hold the container upright with the mouthpiece facing upwards and then place the mouthpiece between the lips. Do not bite the mouthpiece.
• 4. Inhale slowly and deeply through the mouth, and immediately after starting inhalation, press the top of the inhaler firmly to release one inhalation of the medicine. Patients with weak grip will find it easier to hold the inhaler with both hands: they should then place both index fingers on the top of the inhaler and both thumbs on the bottom.
• 5. Hold the breath for as long as possible, and then remove the inhaler from the mouth and exhale slowly. Do not exhale into the inhaler.

If an additional dose is required, the inhaler should be held upright for about half a minute, and then the steps described in points 2 to 5 should be repeated.
Important:The actions described in points 2 to 5 should not be performed too quickly.
After use, the protective cap should be replaced, and the dose counter should be checked.
To reduce the risk of fungal infection of the mouth and throat, the patient should rinse their mouth or throat with water or brush their 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. The patient 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 they should start using a new inhaler.

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

If the patient feels that the effect of Airiam is too strong or too weak, they should consult their doctor or pharmacist.
If the patient has difficulty using the inhaler during inhalation, they can use a spacer (AeroChamber Plus). The patient should ask their 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.

Cleaning the inhaler

The inhaler should be cleaned once a week.
During cleaning, the container should not be removed from the case, and water or other liquids should not be used 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 inhaler 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:

• taking a higher dose of formoterol than recommended may cause the following symptoms: nausea, vomiting, rapid heartbeat, palpitations, arrhythmias, changes in the electrocardiogram (ECG), headache, tremors, drowsiness, excessive acid production in the blood, low potassium levels in the blood, high blood sugar levels. The doctor may recommend a blood test to check potassium and blood sugar levels.
• taking a higher dose of beclometasone dipropionate than recommended may cause short-term adrenal gland problems. Improvement will occur within a few days, but the doctor may recommend a blood test to check cortisol levels in the blood.

If any of these symptoms occur, the patient should inform their doctor.

Missing a dose of Airiam:

The patient should take the missed dose as soon as possible. If it is almost time for the next dose, they should not take the missed dose, but only the next scheduled dose.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Airiam:

Even if the patient feels better, they should not stop using Airiam or reduce the dose without consulting their doctor. It is essential to regularly use Airiam, even when asthma symptoms have disappeared.
If the patient has any further questions about using this medicine, they should consult their doctor or pharmacist.

• 4.

Possible side effects

Like all medicines, Airiam can cause side effects, although not everyone 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.If this happens, the patient should immediately STOP using Airiam and use a
fast-acting inhaled bronchodilatorto relieve shortness of breath and wheezing. The patient should immediately contact their doctor.
The patient should immediately inform their doctorif they 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 effectsare listed below, depending on their frequency:

• Frequent(occurring in less than 1 in 10 people):
• fungal infections (of the mouth and throat)
• headache
• hoarseness
• sore throat

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

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

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

• pneumonia; the patient should tell their doctor if they experience any of the following symptoms: increased production of sputum, change in sputum color, fever, worsening cough, worsening breathing difficulties
• 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,
• arrhythmias (caused by premature contraction of the heart chambers)
• decreased blood pressure
• kidney inflammation
• skin and mucous membrane swelling that lasts for several days Very rare(occurring in less than 1 in 10,000 people):
• shortness of breath
• worsening of asthma
• decreased platelet count
• swelling of the hands and feet

Long-term use of inhaled corticosteroids in high doses may rarely cause systemic side effects.

These include:

• adrenal gland problems (adrenal gland suppression)
• decreased bone density (osteoporosis)
• growth retardation (in children and adolescents)
• increased eye pressure (glaucoma)
• cataracts

Unknown(frequency cannot be determined from available data) :

• sleep disturbances
• depression or feeling depressed (anxiety)
• irritability
• excessive stimulation or agitation.

These side effects are more likely to occur in children, but the frequency is unknown.

• blurred vision.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 or its representative in Poland.
Reporting side effects will help 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 with 120 doses.
The medicine should not be used after 3 months from the date of dispensing by the pharmacist and should never be used after the expiry date stated on the carton and label after EXP. The expiry date refers to the last day of the stated month.
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 temperatures above 25°C.
Store for a maximum of 3 months.
If the inhaler becomes cold, before using the medicine, it should be warmed in the hands for a few minutes. The container should never be heated artificially.
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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Airiam contains

• The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate. Each metered dose from the inhaler contains 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose through the mouthpiece, containing 177.7 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 injections.

This medicine contains fluorinated greenhouse gases.
Each inhaler contains 10.29 g of norflurane (HFC-134a), which corresponds to 0.015 tons of CO2 equivalent (global warming potential GWP = 1430).

What Airiam looks like and what the pack contains

Airiam is an inhalation aerosol in the form of a yellowish 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 metering device and a green plastic protective cap. The metering device is equipped with an integrated dose counter, which accurately counts each dose and displays every 20th dose.
Pack size:
1 pack (one container delivers 120 doses).

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

Bulgaria: Вивер 100 микрограма/6 микрограма/доза разтвор под налягане за инхалация
Germany: Vivaire 100 Mikrogramm/6 Mikrogramm pro Sprühstoß Druckgasinhalation, Lösung
Poland: Airiam Republic of Czech: Vivaire
Romania: VIVAIRE 100 micrograme/6 micrograme/doză, soluţie de inhalat presurizată
Slovakia: Vivaire 100/6 mikrogramov/dávka
Hungary: Vivaire 100 mikrogramm/6 mikrogramm túlnyomásos inhalációs oldat

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, the patient should contact the local representative of the marketing authorization holder:

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