Aerox

Package leaflet: Information for the patient

Aerox, (100 micrograms + 6 micrograms)/dose, inhalation aerosol, solution
Beclometasone dipropionate + Formoterol fumarate dihydrate
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Aerox and what is it used for

Aerox is an inhalation aerosol solution containing two active substances that are delivered directly to the lungs when inhaled through the inhaler mouthpiece.
The medicine contains two active substances: beclometasone dipropionate and formoterol fumarate dihydrate.
Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which work by reducing inflammation, swelling, and irritation in the lungs.
Formoterol fumarate dihydrate belongs to a group of long-acting bronchodilators, which relax the muscles in the airways and make breathing easier.
Together, these two active substances help improve breathing by relieving symptoms such as:
shortness of breath, wheezing, and cough in patients with asthma or chronic obstructive pulmonary disease (COPD), and also help prevent asthma symptoms.

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

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

COPD
Aerox may also be used in the treatment of symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a chronic lung disease of the airways, primarily caused by cigarette smoking.
Aerox is intended for use in adults.

2. Important information before using Aerox

When not to use Aerox:

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

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

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

Always inform your doctor if any of the above warnings apply to the patient.
Before using an inhaled medicine, consult your doctor or pharmacist if you currently have or have ever had any health problems or allergies, or if you have any doubts about whether Aerox can be used.

Treatment with beta-2 agonists such as formoterol contained in Aerox may cause a sudden decrease in serum potassium levels (hypokalaemia).
Special caution is required in patients with severe asthma, as oxygen deficiency in the blood, as well as concomitant use of other medicines with Aerox—such as medicines used to treat heart conditions or high blood pressure called diuretics, or other medicines used to treat asthma—may worsen the decrease in blood potassium levels. For this reason, your 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: hospital admission following an accident, serious injury, or prior to surgery. In such cases, the treating doctor will decide whether the corticosteroid dose should be increased or whether other steroids in tablet form or injections should be prescribed.

If hospitalization is required, the patient should remember to bring all their medicines and inhalers, including Aerox, as well as any over-the-counter medicines, preferably in their original packaging.

If the patient experiences blurred vision or any other visual disturbances, they should contact their doctor.

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

Aerox and other medicines:

• Inform your doctor about all medicines currently used, recently used, or planned for use, including over-the-counter medicines. This is necessary because Aerox may affect the action of certain other medicines. Similarly, some medicines may affect the action of Aerox.

In particular, inform your doctor, pharmacist, or nurse if the patient is taking any of the following medicines:

• Some medicines may enhance the effect of Aerox, and the doctor may wish to closely monitor the patient taking such medicines (including certain antiviral drugs used in HIV infection: ritonavir, cobicistat).
• Beta-blockers (beta-adrenergic receptor blockers). Beta-blockers are used in the treatment of various conditions, including heart diseases, high blood pressure, and glaucoma (increased pressure within the eye). If beta-blockers must be used (including eye drops), the effect of formoterol may be reduced or formoterol may not work at all.
• Beta-adrenergic receptor agonists (medicines that work similarly to formoterol) may enhance the effect of formoterol.
• Medicines used to treat abnormal heart rhythms (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, isocarboxazid), tricyclic antidepressants (e.g. amitriptyline, 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) or 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.

You should also inform your doctor if you are scheduled to receive general anaesthesia for surgery or a dental procedure.

Pregnancy, breastfeeding, and fertility

There are no clinical data on the use of Aerox during pregnancy.
Aerox must 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 Aerox will affect the ability to drive or operate machinery.

Aerox contains alcohol
Aerox contains 7 mg of alcohol (ethanol) per spray, equivalent to 0.20 mg/kg body weight per dose when two sprays are used. The amount of alcohol in two sprays of this medicine is less than that in 1 ml of beer or wine. The small amount of alcohol in this medicine will not cause noticeable effects.

3. How to use Aerox

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Asthma
Your doctor will regularly check whether you are taking the optimal dose of Aerox.
Your doctor will determine the lowest dose that provides the best control of asthma symptoms.
Your doctor may prescribe Aerox in two different ways:
a) Aerox should be taken daily to treat asthma, together with another inhaled medicine that provides
rapid relief during sudden worsening of asthma symptoms, such as an attack of breathlessness,
wheezing and coughing
Adults and elderly patients:
The recommended dose is one or two sprays twice daily. The maximum daily dose is 4 sprays.
Important: Always carry a fast-acting inhaled reliever medicine to treat worsening asthma symptoms or sudden asthma attacks.
b) Aerox should be taken daily to treat asthma, and also used as a reliever in case of sudden
worsening of asthma symptoms, such as breathlessness, wheezing and coughing
Adults and elderly patients:
The recommended dose is one spray in the morning and one spray in the evening.
Aerox should also be used as a reliever medicine when asthma symptoms occur suddenly.
When asthma symptoms occur, take one spray and wait a few minutes.
If there is no improvement, take another spray.
Do not use more than 6 reliever sprays in 24 hours.
The maximum daily dose of Aerox, when used as the only inhaled medicine for asthma treatment,
is 8 sprays.
If you need to use more sprays to control your asthma symptoms, 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 elderly patients:
The recommended dose is two sprays in the morning and two sprays in the evening.
Special patient groups:
Dose adjustment is not required in elderly patients. There is no information available on the use of Aerox in patients with hepatic or renal impairment.
The dose of beclometasone dipropionate contained in Aerox that is effective in treating asthma may
be lower than the dose contained in other inhaled medicines containing beclometasone dipropionate.
If you previously used another inhaled medicine containing beclometasone dipropionate, your
doctor will advise you on the appropriate dose of Aerox.
Do not increase the dose.
If you feel the effect of the medicine is too weak, always consult your doctor before increasing the dose.
In case of increased breathing difficulties:
If breathing difficulties or wheezing worsen immediately after inhalation of Aerox, stop using the medicine immediately and use a fast-acting inhaled reliever medicine without delay. Contact your doctor as soon as possible. Your doctor will assess your symptoms and, if necessary, recommend a change in treatment.
See also section 4. "Possible side effects".
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 or Aerox more frequently), or if your reliever inhaler or Aerox does not relieve your symptoms, inform your doctor immediately. This may indicate worsening asthma, and your doctor may decide to change the dose of Aerox or switch to another treatment.
Method of administration:
Aerox is intended for inhalation use only.
This medicine is contained in a pressurized canister housed in a plastic casing with a mouthpiece. At the back of the inhaler, there is a dose counter for the 120-dose pack and a dose indicator for the 180-dose pack, showing the number of doses remaining.
For the 120-dose pack, each time the inhaler is pressed, one dose is released and the counter decreases by one. Be careful not to drop the inhaler, as this may cause an unintended dose to be counted.
For the 180-dose pack, the indicator shows the approximate number of sprays remaining in the canister. The dose indicator window displays the number of sprays remaining in increments of twenty (e.g. 180, 120, 100, 80, etc.). When 20 doses remain and the display shows "20", this indicates that the inhaler is nearing the end of its use.
After 180 sprays have been used, the display will show "0".
The indicator will stop moving at "0".
Inhaler test
Before first use, or if the inhaler has not been used for 14 days or more, perform an inhaler test to ensure it is working properly.

• Remove the protective cap from the mouthpiece.
• Hold the canister upright with the mouthpiece pointing downwards.
• Point the mouthpiece away from yourself and firmly press the canister to release one spray.
• If the inhaler has not been used for 14 days or more, firmly press the canister once to release a spray.
• For the 120-dose pack, check the dose counter. If this is the first time testing the inhaler, the counter should display 120.
• For the 180-dose pack, check the dose indicator. If this is the first time testing the inhaler, the indicator should display 180.

How to use the inhaler
If possible, stand or sit upright during inhalation.
Before starting inhalation, check the dose counter or indicator to see how many doses remain. If the counter or indicator shows "0", no doses remain – discard the inhaler and get 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 (Figure 1).
2. Breathe out as deeply and slowly as possible (Figure 2).
3. Hold the canister upright with the stem pointing upwards, then place the mouthpiece between your lips. Do not bite down on it (Figure 3).
4. Breathe in deeply and slowly through your mouth. Just after starting to inhale, firmly (forcefully) press the top of the inhaler to release one spray of medicine. For patients 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 (Figure 4).
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 (Figure 5).

If another dose is to be taken, keep 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 (for 120-dose pack) or dose indicator (for 180-dose pack).
To reduce the risk of developing a fungal infection in the mouth or throat, rinse your mouth or throat with water or brush your teeth immediately after each inhalation.
When to replace the inhaler
When the dose counter or indicator shows 20, have a new inhaler ready. Stop using the inhaler when the counter or indicator shows 0, as the remaining medicine in the canister may not deliver a full dose.
If a mist appears above the top of the mouthpiece or from the side of the mouth, this means Aerox is not reaching your lungs as it should. Take another dose according to the instructions, starting again from step 2.
If you feel that the effect of Aerox 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
Clean the inhaler once a week.
Do not remove the canister from the plastic casing. Do not use water or other liquids to clean the inhaler.
How to clean the inhaler:

1. Remove the protective cap by pulling it off the inhaler.
2. Wipe the mouthpiece and actuator inside and outside with a dry cloth or tissue.
3. Replace the protective cap.

Use of more than the recommended dose of Aerox:

• Taking more than the recommended dose of formoterol may cause the following symptoms: nausea, vomiting, faster heartbeat, palpitations, heart rhythm disturbances, changes in electrocardiogram (ECG), headache, tremor, drowsiness, excess acid metabolites in the blood, low blood potassium levels, increased blood glucose levels. Your doctor may recommend a blood test to check potassium and glucose levels.
• Taking too high a dose of beclometasone dipropionate may cause temporary adrenal gland function disturbances, which resolve spontaneously within a few days. Your doctor may recommend a blood test to check serum cortisol levels.

If any of these symptoms occur, inform your doctor.
Missed dose of Aerox:
Take the missed dose as soon as possible. If it is almost time for your 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 Aerox:
Even if you feel better, do not stop using Aerox or reduce the dose without consulting your doctor. It is very important to take the medicine regularly, even when symptoms have subsided.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
As with other inhaled medicines, there is a risk of worsening breathlessness and
wheezing immediately after taking Aerox, known as paradoxical bronchospasm.
In such a case, Aerox must be stopped IMMEDIATELY, and a fast-acting inhaled bronchodilator should be used to relieve symptoms of breathlessness and wheezing.
Medical advice must be sought immediately.
You must inform your doctor immediately if any hypersensitivity reactions occur, such as:
skin allergies, skin itching, skin rash, skin redness, swelling of the skin or mucous membranes, especially of the eyes, face, lips, or throat.

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

Common (occur less frequently than in 1 out of 10 patients):

• fungal infections (of the mouth and throat),
• headache,
• hoarseness,
• sore throat.

Pneumonia in COPD patients: Inform your doctor if any of the following symptoms occur during treatment with Aerox; these may be signs of lung infection:

• fever or chills,
• increased mucus production, change in mucus colour,
• worsening cough or increased breathing difficulties.

Uncommon (occur less frequently than in 1 out of 100 patients):

• palpitations, unusual rapid heartbeat, and cardiac arrhythmias,
• changes in electrocardiogram (EKG),
• influenza-like symptoms,
• sinusitis,
• rhinitis,
• otitis,
• throat irritation,
• cough and cough with sputum,
• asthma attack,
• vaginal fungal infections,
• nausea,
• taste disturbances,
• burning lips,
• dryness of the oral mucosa,
• difficulty swallowing,
• indigestion,
• stomach discomfort,
• diarrhoea,
• muscle pain and muscle cramps,
• redness of face and throat,
• increased blood flow to certain tissues,
• increased sweating,
• tremor,
• restlessness, especially motor restlessness,
• dizziness,
• urticaria,
• changes in certain blood parameters:
  o decrease in white blood cell count,
  o increase in platelet count,
  o decrease in blood potassium concentration,
  o increase in blood glucose concentration,
  o increase in blood insulin, free fatty acids, and ketone bodies.

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

• decreased blood cortisol concentration, caused by corticosteroid effects on the adrenal glands,
• irregular heartbeat.

Rare (occur less frequently than in 1 out of 1000 patients):

• feeling of chest tightness,
• cardiac arrhythmias (caused by premature ventricular contractions),
• low blood pressure,
• high blood pressure,
• kidney inflammation,
• skin and mucous membrane swelling lasting for several days.

Very rare (occur less frequently than in 1 out of 10,000 patients):

• breathlessness,
• worsening of asthma,
• 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 gland dysfunction (suppression of adrenal function),
• decreased bone mineral density (osteoporosis),
• growth retardation in children and adolescents,
• increased intraocular pressure (glaucoma),
• cataract.

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

• sleep disturbances,
• depression or depressed mood,
• nervousness,
• excessive excitability or irritability.

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

• Blurred vision,

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Aerox

Keep this medicine out of the sight and reach of children.

Single pack containing one container with 120 or 180 doses

For the pharmacist:
Store the inhaler in a refrigerator (2°C – 8°C) for up to 18 months.
Enter the date of dispensing on the self-adhesive label on the packaging and attach the label to the inhaler. Ensure that the period between the date of dispensing and the expiry date stated on the packaging is at least 3 months.

For the patient:
Do not store the inhaler at temperatures above 25°C.
Do not use Aerox after 3 months from the first use or after the expiry date stated on the box or label. The expiry date refers to the last day of the stated month.

Double or triple packs containing two or three containers with 120 doses each

Before first use: store inhalers in a refrigerator (2°C – 8°C).
After first use: do not store inhalers at temperatures above 25°C. Store for a maximum of 3 months.
Each time a new inhaler is started, enter the date of first use on the self-adhesive label on the packaging and attach the label to the inhaler. Do not use this medicine after 3 months from the first use or after the expiry date stated on the box or label. The expiry date refers to the last day of the stated month.

Do not freeze.
If the inhaler becomes cold, warm it in your hands for several minutes before use. Never use other methods to heat the container.

Important: The container contains pressurised liquid. Do not expose 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Aerox contains:
The active substances in this medicine are: beclometasone dipropionate and formoterol fumarate dihydrate.
One 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.
The other ingredients are: anhydrous ethanol, concentrated hydrochloric acid, norflurane (HFA 134a).
This medicine contains fluorinated greenhouse gases.
Each 120-dose inhaler contains 8.15 g of HFA 134a, equivalent to 0.012 tonnes of CO(_2)
(global warming potential GWP = 1,430).
Each 180-dose inhaler contains 11.2 g of HFA 134a, equivalent to 0.016 tonnes of CO(_2)
(global warming potential GWP = 1,430).

What Aerox looks like and contents of the pack:
Aerox is available as a solution for inhalation, contained in an aluminium pressurised canister fitted with a metering valve, assembled in a white plastic actuator which includes a dose counter (120 doses) or a dose indicator (180 doses), and a pink plastic protective mouthpiece cap.
Each pack contains:
1 pressurised canister delivering 120 doses (sprays), or
2 pressurised canisters delivering 120 doses each, or
3 pressurised canisters delivering 120 doses each, or
1 pressurised canister delivering 180 doses.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel: +48 22 732 77 00

Manufacturer
Genetic S.p.A.
Contrada Canfora
84084 Fisciano
Italy

This medicine is authorised in the European Economic Area countries under the following names: