Airiam

Package leaflet: Information for the patient

Airiam, (100 micrograms + 6 micrograms)/metered dose,
inhalation aerosol, solution
Beclometasoni dipropionas + Formoteroli fumaras dihydricus
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

1. What Airiam is and what it is 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 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, reach directly into the lungs.
The medicine contains two active substances:

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

Together, these two active substances help breathing by relieving symptoms such as breathlessness, wheezing and coughing in patients with asthma or chronic obstructive pulmonary disease (COPD), and also help prevent asthma symptoms.

Asthma
Airiam is indicated for regular treatment of asthma in adult patients in whom:

• asthma symptoms are not sufficiently controlled with inhaled corticosteroids and a short-acting bronchodilator used as needed, or
• adequate control of asthma symptoms has been achieved 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 lung disease affecting the airways, primarily caused by cigarette smoking.

2. Information before using Airiam

When not to use Airiam:

• If the patient has an allergy or suspects an allergy to either of the active substances in Airiam, or if they are allergic to other medicines or inhalation products used in the treatment of asthma, or to any of the other ingredients of Airiam (listed in section 6, "Contents of the pack and other information"), they should consult a doctor.

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

• If the patient has heart conditions such as: angina (chest pain), recent heart attack (myocardial infarction), heart failure, coronary artery narrowing (coronary heart disease), heart valve disorders, or any other heart disease, or a condition known as hypertrophic obstructive cardiomyopathy (HOCM), characterized by abnormal structure of the heart muscle.
• If the patient has narrowed arteries (also known as arteriosclerosis); if the patient has high blood pressure or a diagnosed aneurysm (an abnormal widening of a blood vessel wall).
• If the patient has heart rhythm disorders, such as rapid or irregular heartbeat, increased heart rate, or palpitations, or if there is any history of abnormal heart rhythm.
• If the patient has hyperthyroidism.
• If the patient has low blood potassium levels.
• If the patient has liver or kidney disease.
• If the patient has diabetes (inhaled high doses of formoterol may increase blood glucose levels, so additional blood tests to monitor blood sugar levels may be necessary before starting treatment and periodically during treatment).
• If the patient has a tumour of the adrenal gland (pheochromocytoma).
• If general anaesthesia is planned. Depending on the type of anaesthesia, it may be necessary to discontinue Airiam at least 12 hours before the procedure.
• If the patient is currently being treated or has ever been treated for pulmonary tuberculosis, or if the patient has a viral or fungal infection within the chest.
• If the patient must avoid alcohol for any reason.

Always inform the doctor before using Airiam if any of the above warnings apply to the patient.
Before using an inhaled medicine, consult a doctor, pharmacist, or nurse if the patient currently has or has ever had any health problems or allergies, or if they are unsure whether Airiam can be used.
Treatment with beta-agonists such as formoterol contained in Airiam may cause a sudden decrease in serum potassium levels (hypokalaemia).
Particular caution is required in patients with severe asthma. Low oxygen levels in the blood, as well as concomitant use of other medicines with Airiam—such as medicines used to treat heart conditions or high blood pressure called diuretics, or other asthma medicines—may worsen the reduction in blood potassium levels. For this reason, the doctor may periodically recommend checking blood potassium levels.
If the patient is taking high doses of inhaled corticosteroids for a prolonged period, they may require additional corticosteroid treatment during periods of stress. Stress situations may include hospitalization after 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 steroids in tablet form or by injection.
If hospitalization 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, they should contact their doctor.

Children and adolescents
Airiam should not be used in children and adolescents under 18 years of age until further data are available.

Airiam with other medicines:
Tell the doctor about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription.
Some medicines may intensify the effect of Airiam, and the doctor may wish to closely monitor the patient taking such medicines (including certain HIV medications: ritonavir, cobicistat).
Beta-blockers should not be used with Airiam. Beta-adrenergic receptor blocking agents, such as atenolol, propranolol, and sotalol, are used in the treatment of various conditions, including high blood pressure and heart diseases such as irregular heart rhythm and heart failure; timolol is used in the treatment of glaucoma. If beta-blockers, including beta-blocking eye drops, must be used, the effect of formoterol may be reduced or formoterol may not work at all. On the other hand, concurrent use of other beta-adrenergic drugs (medicines acting similarly to formoterol) may enhance the effect of formoterol.

Concurrent use of Airiam with:

• Medicines used to treat irregular heart rhythm (quinidine, disopyramide, procainamide), antihistamines (used to treat allergies), or 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, may cause certain changes in the electrocardiogram (ECG, heart tracing). 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 cardiac tolerance to beta-agonists such as formoterol.
• Monoamine oxidase inhibitors (MAOIs), including drugs with similar properties such as furazolidone and procarbazine, used in the treatment of psychiatric disorders, may cause increased blood pressure.
• Medicines used to treat heart disease (digoxin) may cause decreased blood potassium levels. This may increase susceptibility to heart rhythm disturbances.
• Other medicines used to treat asthma (theophylline, aminophylline, or steroids) and diuretics (water tablets) may cause decreased blood potassium levels.
• Certain anaesthetic agents, which may increase the risk of heart rhythm disturbances.

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

Driving and operating machinery
It is unlikely that Airiam will affect the ability to drive or operate machinery. However, if the patient experiences side effects such as dizziness and/or tremor, these may impair the ability to drive or operate machinery.

Airiam contains alcohol
Airiam contains 7 mg of alcohol (ethanol) in each spray from the inhaler.
The amount of alcohol in a dose of this medicine corresponds to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not produce 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 a doctor or pharmacist. If in doubt, consult a doctor or pharmacist. The package leaflet contains information on how many puffs to take and how often they should be taken.

Dosage
Asthma
The treating physician will regularly check whether the patient is receiving the optimal dose of Airiam. The doctor will determine the lowest dose providing the best control of asthma symptoms.
The doctor may prescribe Airiam to be used in two different ways:

a) Airiam should be used daily for asthma treatment, together with another inhaled "reliever" medicine for sudden worsening of asthma symptoms, such as asthma attack, wheezing and coughing

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

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

b) Airiam should be used daily for asthma treatment and also as a reliever in case of sudden worsening of asthma symptoms, such as asthma attack, wheezing and coughing

Adults and elderly:
The recommended dose is one puff in the morning and one puff in the evening.
Airiam should also be used as an inhaled reliever medicine in case of sudden asthma symptoms.
If asthma symptoms occur, take one puff and wait a few minutes. If there is no improvement, take another puff.

Do not use more than 6 reliever puffs of Airiam per day.
The maximum daily dose of Airiam is 8 puffs.
If a patient needs to use more puffs to control asthma symptoms, they should consult a doctor. A change in treatment may be necessary.

Use in children and adolescents under 18 years of age:
This medicine must NOT be used in children and adolescents under 18 years of age.

Chronic obstructive pulmonary disease (COPD)
Adults and elderly:
The recommended dose is two puffs in the morning and two puffs in the evening.

Special patient groups:
No dose adjustment is necessary in elderly patients. There is no information available regarding the use of Airiam in patients with hepatic or renal impairment.

The dose of beclometasone dipropionate contained in Airiam that is effective in asthma treatment may be lower than the dose contained in other inhaled medicines containing beclometasone dipropionate. If a patient 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 medicine seems ineffective, always consult a doctor before increasing the dose.

In case of worsening breathing difficulties:
If breathing becomes more difficult or wheezing (audible whistling during breathing) occurs immediately after inhalation of Airiam, stop using Airiam immediately and use a fast-acting inhaled reliever medicine without delay. Contact the treating doctor as soon as possible. The doctor will assess symptoms and, if necessary, recommend alternative treatment.
See also section 4. "Possible side effects".

In case of worsening asthma symptoms:
If asthma symptoms worsen or become difficult to control (e.g. if the patient needs to use another inhaled reliever medicine or Airiam as a reliever more frequently), or if the reliever medicine or Airiam does not relieve symptoms, inform the treating doctor immediately. This may indicate worsening asthma, and the doctor may decide to change the dosage of Airiam or initiate alternative treatment.

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

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. On the front of the inhaler is a dose counter showing the number of doses remaining. Each time the inhaler is pressed, a dose of medicine is released. Each actuation also produces an audible click, providing acoustic 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 an approximate number of actuations (puffs) remaining in the canister. The counter window displays the number of puffs remaining in the inhaler in increments of twenty (e.g. 120, 100, 80, etc.). When 20 actuations (puffs) 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 "0" on a red background. The counter will stop moving at "0" and will no longer produce a 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 downward.
3. Point the mouthpiece away from yourself.
   4.a. If the inhaler is being used for the first time, press the canister firmly down 3 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 down once to release one dose.
4. Check the dose counter. If the inhaler is being tested 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" indicates that 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 contamination.
2. Breathe out as slowly and deeply as possible.
3. Hold the canister upright with the body pointing upward, then place the mouthpiece between your lips. Do not bite down on it. Begin to inhale slowly and deeply through your mouth, and just after starting inhalation, press firmly on the top of the inhaler to release one dose of medicine.
4. For individuals 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 as long as possible, then remove the inhaler from your mouth and breathe out slowly. Do not breathe out into the inhaler.

If another 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 fungal infection of the mouth and 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 background color changes from white to half-red and half-white, indicating that 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 be sufficient to deliver a full dose, and start using a new inhaler.

If a "mist" appears above the upper opening of the mouthpiece or from the side of the mouth, this means that Airiam is not reaching the lungs as it should. Take another dose according to the instructions, restarting from step 2.

If you feel that 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 read carefully the instructions provided with the AeroChamber Plus spacer and follow the usage and cleaning recommendations.

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

Accidental overdose of Airiam:

• Taking more formoterol than recommended 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, decreased blood potassium levels, increased blood glucose levels. The doctor may recommend a blood test to check potassium and glucose levels.
• Taking too high a dose of beclometasone dipropionate may cause temporary adrenal suppression. Improvement occurs within a few days, but the doctor may recommend a blood test to check serum cortisol levels.

If any of these symptoms occur, inform your doctor.

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:
Do not reduce the dose or stop using Airiam.
Even if symptoms improve, 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, this medicine can cause side effects, although not everybody gets them.
As with other inhaled medicines, there is a risk of worsening breathlessness and wheezing immediately after taking Airiam, known as paradoxical bronchospasm. In this case, stop using Airiam IMMEDIATELY and use a fast-acting inhaled bronchodilator to relieve breathlessness and wheezing. Contact your doctor immediately.

Inform your doctor immediately if any signs of hypersensitivity occur, such as skin allergies, skin itching, skin rash, skin redness, or swelling of the skin or mucous membranes, especially eyes, face, lips, and throat.

Other possible side effects are listed below according to frequency of occurrence.

Common (occurs in fewer than 1 in 10 people):

• Fungal infections (mouth and throat)
• Headache
• Hoarseness
• Sore throat
• Pneumonia (lung infection) in patients with COPD: Inform your doctor if any of the following symptoms occur during treatment with Airiam, as they may indicate lung infection:
  • Fever or chills
  • Increased mucus production, change in mucus color
  • Worsening cough or increased difficulty breathing

Uncommon (occurs in fewer than 1 in 100 people):

• Unusual rapid heartbeat and heart rhythm disturbances
• Certain changes in electrocardiogram (ECG)
• Asthma attack
• Tremor
• Restlessness
• Dizziness
• Palpitations
• Influenza-like symptoms
• Fungal infection of the vagina
• Sinusitis
• Ear infection
• Throat irritation
• Cough and cough with sputum
• Nausea
• Altered or impaired sense of taste
• Burning sensation of the lips
• Dry mouth
• Difficulty swallowing
• Indigestion
• Stomach discomfort
• Diarrhea
• Muscle pain and muscle cramps
• Facial flushing
• Increased sweating
• Increased blood flow to certain tissues in the body
• Nasal mucosal inflammation
• 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
  • Rash or urticaria

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

• Decreased blood cortisol levels, caused by corticosteroid effects on the adrenal glands.
• Irregular heartbeat.

Rare (occurs in fewer than 1 in 1,000 people):

• Chest tightness
• Heart rhythm disturbances (caused by premature ventricular contractions)
• Increased or decreased blood pressure
• Kidney inflammation
• Skin and mucous membrane swelling lasting several days

Very rare (occurs in fewer than 1 in 10,000 people):

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

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

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

Unknown (frequency cannot be estimated from available data):

• Sleep disorders, depression or depressed mood, anxiety, nervousness, excessive excitement or irritability. These side effects are more likely in children.
• Blurred vision.

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, Office for 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 helps provide more information on the safety of this 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 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 use other methods to warm the container.
Warning: The container contains a pressurised liquid. Do not expose the container to temperatures above 50°C. Do not pierce the container.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Airiam contains

• The active substances in this medicinal product are: beclometasone dipropionate, formoterol fumarate dihydrate. Each metered dose from the inhaler contains 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to the delivered dose via mouthpiece containing 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.
• Other components are: norflurane (HFC-134a), ethanol, malic acid and water for injections.

This medicine contains fluorinated greenhouse gases.
Each inhaler contains 8.12 g of norflurane (HFC-134a), equivalent to 0.012 tonnes of CO
(global warming potential GWP = 1430).
What Airiam looks like and contents of the pack
Airiam is a pressurised solution for inhalation. It is contained in a polymer-coated aluminium canister (FCP) fitted with a metering valve, and supplied in a cardboard carton. The canister is fitted with a white plastic actuator and a pink plastic protective cap. The actuator incorporates an integrated dose counter which accurately counts down each dose and displays every 20th dose remaining.
Pack size:
1 pack (one canister provides 120 doses)
This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Vivaire 100 Mikrogramm/6 Mikrogramm pro Sprühstoß Druckgasinhalation, Lösung
Bulgaria: Вивер 100 микрограма/6 микрограма/доза разтвор под налягане за инхалация
Czech Republic: Vivaire
Hungary: Vivaire 100 mikrogramm/6 mikrogramm túlnyomásos inhalációs oldat
Poland: Airiam
Romania: VIVAIRE 100 micrograme/6 micrograme/doză, soluţie de inhalat presurizată
Slovakia: Vivaire 100/6 mikrogramov/dávka
Marketing Authorisation Holder:
Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
Importers:
Hormosan Pharma GmbH
Hanauer Landstrasse 139 - 143
60314 Frankfurt Am Main, Germany
Eurofins BioPharma Product Testing Finland Oy
Volttikatu 5 ja 8
70700 Kuopio, Finland
For further information, please 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