Airiam

Patient Information Leaflet

Airiam, (200 micrograms + 6 micrograms)/metered dose,
inhalation aerosol, solution
Beclometasone dipropionate + Formoterol fumarate dihydrate
Please read all of this leaflet carefully before you start using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not share it with 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, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Airiam is and what it is used for

Airiam is an inhalation aerosol solution containing two active substances which, when inhaled through the mouth, act directly in the lungs.
The two active substances are:

• Beclometasone dipropionate, a corticosteroid medicine that works by reducing inflammation, swelling, and irritation in the lungs.
• Formoterol fumarate dihydrate, a long-acting beta2-adrenergic agonist bronchodilator that relaxes the muscles in the airways and makes breathing easier. Together, these two active substances help you breathe more easily and help prevent asthma symptoms such as breathlessness, wheezing, and coughing.

Airiam is used in the treatment of asthma in adult patients.
If you have been prescribed Airiam, it is likely because:

• your asthma symptoms are not adequately controlled with inhaled corticosteroids and a short-acting reliever medicine taken as needed, or
• you have achieved good control of your asthma symptoms 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, discuss with your doctor, pharmacist, or nurse if the patient has any of the following conditions:

• heart problems, such as angina (chest pain), heart failure, narrowed heart arteries (coronary heart disease), heart valve disorders, or any other heart conditions.
• high blood pressure or diagnosed aneurysm (an abnormal widening of a blood vessel wall).
• heart rhythm disorders, such as rapid or irregular heartbeat, increased pulse, or palpitations, or if there is any history of abnormal heart rhythm.
• hyperthyroidism.
• low blood potassium levels.
• liver or kidney disease.
• diabetes (inhaling high doses of formoterol may increase blood glucose levels. Additional blood tests to monitor blood sugar levels may be necessary after starting treatment and periodically during therapy).
• adrenal gland tumour (phaeochromocytoma).
• if the patient is scheduled for general anaesthesia. Depending on the type of anaesthesia, it may be necessary to stop taking Airiam at least 12 hours before anaesthesia.
• if the patient is currently being treated or has previously been treated for tuberculosis of the lungs, or if the patient has a viral or fungal infection in the chest area.
• if the patient must avoid alcohol consumption for any reason.

Always inform your doctor before using Airiam if any of the above warnings apply to the patient.
Before using any inhaled medicine, consult your doctor, nurse, or pharmacist if you currently have or have had any medical problems or allergies, or if you have any doubts about whether Airiam can be used.
Your doctor may recommend checking blood potassium levels, especially if asthma is severe.
Like many other bronchodilator medicines, Airiam may cause a rapid decrease in serum potassium levels (hypokalaemia). This may occur because lack of oxygen in the blood, combined with other medicines taken concurrently with this medicine, may worsen the reduction in blood potassium levels.
If the patient has been taking high doses of inhaled corticosteroids for a long time, they may require additional corticosteroid treatment during periods of stress. Stress situations may include hospital admission following an accident, serious injury, or prior to surgery. In such cases, the treating doctor will decide whether to increase the corticosteroid dose or may recommend other steroid treatment in the form of tablets or injections.
If hospitalisation is required, the patient should remember to bring all their medicines and inhalers, including Airiam, as well as any over-the-counter medicines, preferably in their original packaging.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Children and adolescents
Airiam must not be used in children and adolescents under 18 years of age.

Airiam and other medicines:
Tell your doctor, pharmacist, or nurse about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription. This is because this medicine may affect the action of certain other medicines. In addition, some medicines may affect the action of Airiam.
In particular, inform your doctor, nurse, or pharmacist if the patient is taking any of the following medicines:

• Some medicines may enhance the effect of this medicine, and the doctor may wish to closely monitor the patient taking these medicines (including certain medicines used to treat HIV: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are used to treat many conditions, including heart diseases, high blood pressure, and glaucoma (increased eye pressure). If beta-blockers are required, including eye drops, the effect of formoterol may be weakened or formoterol may not work at all.
• Beta-adrenergic medicinal products (medicines that work in the same way as formoterol) may intensify the effect of formoterol.
• Medicines used to treat abnormal heart rhythm (quinidine, disopyramide, procainamide).
• Medicines used to treat allergies (antihistamines).
• Medicines used to treat symptoms of depression or psychiatric 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 psychiatric disorders, such as monoamine oxidase inhibitors (MAOIs), including medicines with similar properties, such as furazolidone and procarbazine.
• Medicines used to treat heart conditions (digoxin).
• Other medicines used to treat asthma (theophylline, aminophylline, or steroids).
• Diuretics (water tablets).

You should also inform your doctor if you plan to undergo general anaesthesia before surgery
or a dental procedure.

Pregnancy, breastfeeding, and fertility
There are no clinical data on the use of Airiam during pregnancy.
Airiam must not be used if the patient is pregnant, suspects she may be pregnant, plans to become pregnant, or is breastfeeding, unless otherwise decided by a doctor.

Driving and using machines
It is unlikely that Airiam will affect the ability to drive or operate machinery.

Airiam contains alcohol
This medicine contains 9 mg of alcohol (ethanol) in each spray from the inhaler, equivalent to 0.25 mg/kg for a dose consisting of two puffs. The amount of alcohol in two doses of this medicine corresponds to less than 1 ml of wine or beer.
The small amount of alcohol in this medicine will not cause noticeable effects.

3. How to use Airiam

Airiam is intended for inhalation use. Airiam should be inhaled through the mouth into the lungs.
Always use this medicine exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Your doctor will carry out regular check-ups to ensure you are receiving the appropriate dose of Airiam. The treatment will be adjusted to the lowest dose that best controls your symptoms.

Dosage:
Adults and elderly patients:
The recommended dose is one or two actuations twice daily.
The maximum daily dose is 4 actuations.

Important: Always carry a fast-acting reliever inhaler to treat worsening asthma symptoms or sudden asthma attacks.

Special patient groups:
There is no need to adjust the dose in elderly patients. There is insufficient information regarding the use of this medicine in patients with impaired liver or kidney function.

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.

The dose of beclometasone dipropionate contained in Airiam that is effective in treating asthma may be lower than the dose contained in other inhaled medicines containing this substance. If you have previously used another inhaled medicine containing beclometasone dipropionate, your doctor will advise on the appropriate dose of Airiam for asthma treatment.

Do not increase the dose
If you feel the medicine is not effective enough, always consult your doctor before increasing the dose.

In case of worsening asthma symptoms:
If your symptoms worsen or become difficult to control (e.g. if you need to use your reliever inhaler more often), or if your reliever inhaler does not relieve your symptoms, contact your doctor immediately. This may indicate worsening asthma, and your doctor may decide to change the dose of Airiam or initiate alternative treatment.

Method of administration:
Airiam is intended for inhalation use.
This medicine is contained in a pressurized canister housed in a plastic casing with a mouthpiece. At the front of the inhaler is a dose counter indicating how many doses remain. Each time the inhaler is pressed, a dose of medicine is released. With each actuation, the dose counter also emits a clicking sound, providing audible feedback confirming correct operation of the indicator. The dispenser is equipped with an integrated dose counter that accurately counts each dose and displays every 20th dose. The dose counter shows the approximate number of actuations (sprays) remaining in the canister. The counter window displays the number of sprays remaining in the inhaler in units of twenty (e.g. 120, 100, 80, etc.). When 20 actuations (sprays) remain, the display will show the number 20 on a half-red, half-white background, indicating that the canister is nearing the end of its use.
After 120 actuations, the display will show the number 0 on a red background. The dose counter will stop moving at "0" and will no longer emit the clicking sound after "0" is displayed.

Checking the inhaler
Before first use, or if the inhaler has not been used for 14 days or longer, perform a test to ensure it is working properly.

1. Remove the protective cap from the mouthpiece.
2. Hold the canister upright with the mouthpiece pointing downwards.
3. Point the mouthpiece away from yourself.
   4.a. If the inhaler is being used for the first time, press the canister firmly three times, releasing a dose with each press.
   4.b. If the inhaler has not been used for 14 days or longer, press the canister firmly once to release one dose.
4. Check the dose counter. If testing the inhaler for the first time, the dose counter should display 120.

How to use the inhaler
If possible, stand or sit upright during inhalation.
Before starting inhalation, check the dose counter: any number between "1" and "120" means doses remain. If the dose counter shows "0", no doses remain – discard the inhaler and obtain a new one.

1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust or other debris.
2. Breathe out slowly and as deeply as possible.
3. Hold the canister upright with the stem pointing upwards, then place the mouthpiece between your lips. Do not bite down on it.
4. Begin to breathe in slowly and deeply through your mouth, and just after starting inhalation, press firmly on the top of the inhaler to release one spray of medicine. For people with weak grip, it may be easier to hold the inhaler with both hands: place both index fingers on the top of the inhaler and both thumbs on the base.
5. Hold your breath for as long as possible, then remove the inhaler from your mouth and breathe out slowly. Do not breathe out into the inhaler.

If a second dose is required, hold the inhaler upright for about half a minute, then repeat steps 2 to 5.
Important: Do not perform steps 2 to 5 too quickly.
After use, replace the protective cap and check the dose counter.
To reduce the risk of developing a fungal infection of the mouth or throat, rinse your mouth or throat with water or brush your teeth each time after using the inhaler.

When to replace the inhaler
Replace the inhaler with a new one when the counter shows 20 and the color on the dose counter changes from white to half-red, half-white, indicating the canister is nearing the end of its use. Stop using the inhaler when the counter shows 0 on a red background, as the remaining medicine in the canister may not deliver a full dose. Begin using a new inhaler.

If a "mist" appears above the top opening of the mouthpiece or from the side of the mouth, this means Airiam has not reached your lungs as it should. Take another dose according to the instructions, starting again from step 2.

If you feel the effect of Airiam is too strong or too weak, consult your doctor or pharmacist.
If you have difficulty using the inhaler during inhalation, you may use a spacer device (AeroChamber Plus). Ask your doctor, pharmacist, or nurse about this device. It is important to carefully read the leaflet provided with the AeroChamber Plus spacer and follow the instructions for use and cleaning recommendations.

Cleaning the inhaler
Clean the inhaler once a week.
Do not remove the canister 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 actuator inside and outside with a clean, dry cloth or tissue.
3. Replace the protective cap.

Accidental overdose of Airiam:

• An overdose of formoterol may cause the following symptoms: nausea, vomiting, faster heartbeat, palpitations, heart rhythm disturbances, changes in electrocardiogram (ECG), headache, tremor, drowsiness, excess acid in the blood (acidosis), low blood potassium levels, high blood glucose levels. Your doctor may recommend a blood test to check potassium and glucose levels.
• An overdose of beclometasone dipropionate may cause temporary adrenal suppression. Recovery occurs within a few days, but your doctor may recommend a blood test to check serum cortisol levels.

If any of these symptoms occur, inform your doctor immediately.

Missed dose of Airiam:
Take the missed dose as soon as possible. If it is almost time for the next dose, do not take the missed dose; instead, take the next dose at the usual scheduled time. Do not take a double dose to make up for a missed dose.

Stopping Airiam treatment:
Even if you feel better, do not stop using Airiam or reduce the dose without consulting your doctor. It is very important to use Airiam regularly, even when symptoms have subsided.
If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Airiam can cause side effects, although not everyone will experience them.
As with other inhaled medicines, there is a risk of worsening breathlessness and wheezing immediately after taking Airiam, known as paradoxical bronchospasm. If this occurs, stop using Airiam immediately and use a fast-acting bronchodilator inhaler to relieve breathlessness and wheezing. Contact your doctor immediately.

Inform your doctor immediately if you experience any hypersensitivity reactions, such as skin allergy, skin itching, skin rash, skin redness, or swelling of the skin or mucous membranes, especially of the eyes, face, lips, or throat.

Other possible side effects are listed below by frequency of occurrence.

Common (affects less than 1 in 10 people):

• Fungal infections (of the mouth and throat)
• Headache
• Hoarseness
• Sore throat

Uncommon (affects less than 1 in 100 people):

• Unusually fast heartbeat and heart rhythm disturbances
• Certain changes in electrocardiogram (EKG)
• Increased blood pressure
• Flu-like symptoms
• Sinusitis
• Sinusitis
• Ear infection
• Throat irritation
• Cough and cough with sputum
• Asthma attack
• Vaginal fungal infection
• Nausea
• Altered or impaired sense of taste
• Burning lips
• Dry mouth
• Difficulty swallowing
• Indigestion
• Stomach upset
• Diarrhea
• Muscle pain and muscle cramps
• Redness of face and throat
• Increased blood flow to certain tissues in the body
• Increased sweating
• Tremor
• Restlessness
• Dizziness
• Rash or hives
• Changes in certain blood parameters:
  • Decreased white blood cell count
  • Increased platelet count
  • Decreased blood potassium levels
  • Increased blood glucose levels
  • Increased blood insulin, free fatty acids, and ketone bodies

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

• Pneumonia; inform your doctor if you experience any of the following: increased sputum production, change in sputum color, fever, worsening cough, or worsening breathing problems
• Decreased blood cortisol levels, caused by corticosteroid effects on the adrenal glands
• Irregular heartbeat

Rare (affects less than 1 in 1,000 people):

• Feeling of chest tightness
• Heart rhythm disturbances (caused by premature ventricular contractions)
• Low blood pressure
• Kidney inflammation
• Skin and mucous membrane swelling lasting several days

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

• Breathlessness
• Worsening of asthma
• Decreased platelet count
• Swelling of hands and feet

Long-term use of high-dose inhaled corticosteroids may, in very rare cases, lead to systemic effects.
These include:

• Adrenal suppression (impaired adrenal function)
• Decreased bone mineral density (bone thinning)
• Growth retardation (in children and adolescents)
• Increased intraocular pressure (glaucoma)
• Cataract

Not known (frequency cannot be estimated from available data):

• Sleep disturbances
• Depression or depressed mood (feeling low)
• Nervousness
• Excessive excitement or irritability

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

• Blurred vision.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309, 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 helps to provide more information on the safety of the medicine.

5. How to store Airiam

Keep this medicine out of sight and reach of children.
The single pack contains 1 container with 120 doses.
Do not use this medicine after 3 months from the date it was dispensed from the pharmacy by the pharmacist, and never use the medicine 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 first use: store the inhaler upright in the refrigerator (at 2–8°C) for up to 18 months.
After first opening: do not store the inhaler at temperatures above 25°C.
Store for a maximum of three months.
If the inhaler has become cold, warm it in your hands for several minutes before use. Never artificially heat the container.
Warning: The container contains pressurised 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack 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 the delivered dose via the mouthpiece, containing 177.7 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.
• Other ingredients: norflurane (HFC-134a), ethanol, malic acid and water for injections.

This medicine contains fluorinated greenhouse gases.
Each inhaler contains 10.29 g of norflurane (HFC-134a), equivalent to 0.015 tonnes of CO(_2)
(global warming potential GWP = 1430).

What Airiam looks like and contents of the pack
Airiam is a pressurized inhalation solution, a yellowish liquid contained in an aluminum canister
polymer-coated with fluorinated polymer (FCP), fitted with a metering valve, and packed in a cardboard
box. The canister is equipped with a white plastic actuator and a green plastic protective cap. The actuator
incorporates an integrated dose counter that accurately counts each dose and counts down every 20th dose.

Pack size:
1 pack (one canister delivers 120 doses).

This medicine is authorized in the European Economic Area countries under the following names:
Bulgaria: Вивер 200 микрограма/6 микрограма/доза разтвор под налягане за инхалация
Germany: Vivaire 200 Mikrogramm/6 Mikrogramm pro Sprühstoß Druckgasinhalation, Lösung
Poland: Airiam
Czech Republic: Vivaire
Romania: VIVAIRE 200 micrograme/6 micrograme/doză, soluţie de inhalat presurizată
Slovakia: Vivaire 200 mikrogramov/6 mikrogramov/dávka
Hungary: Vivaire 200 mikrogramm/6 mikrogramm túlnyomásos inhalációs oldat

Marketing Authorisation 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
Eurofins BioPharma Product Testing Finland Oy
Volttikatu 5 and 8
70700 Kuopio, Finland

For more detailed information, contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw, Poland
tel.: +48 22 375 92 00