Aerox

Package leaflet: Information for the patient

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

• Keep this leaflet, as you may need to read it again.
• 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. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

1. What Aerox is and what it is 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 Aerox is and what it is used for

Aerox is an inhalation aerosol solution containing two active substances which, when inhaled through the mouthpiece of the inhaler, are delivered directly to the lungs.
The medicine contains two active substances: beclometasone dipropionate and formoterol fumarate dihydrate.
Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which work as anti-inflammatory agents by reducing swelling and irritation in the lungs.
Formoterol fumarate dihydrate belongs to a group of long-acting bronchodilator medicines 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 cough in patients with asthma, and also help prevent asthma symptoms.
Aerox is intended for the treatment of asthma in adults.
Aerox is used in patients:

• whose asthma symptoms are not adequately controlled with inhaled corticosteroids and an as-needed short-acting bronchodilator, or
• who have achieved adequate asthma symptom control with both inhaled corticosteroids and long-acting bronchodilators.

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, pharmacist, or
nurse:

• If the patient has heart diseases, such as: angina pectoris (chest pain, pain in the chest), heart failure, arterial stenosis, heart valve disorders, or any other heart conditions.
• If the patient has high blood pressure or a diagnosed aneurysm (abnormal dilation of a blood vessel wall).
• If the patient has heart rhythm disorders, such as rapid or irregular heartbeat, tachycardia, or palpitations, or if there is any history of abnormal heart rhythm.
• If the patient has overactive thyroid gland.
• If the patient has low potassium levels in the blood.
• If the patient has liver or kidney disease.
• If the patient has diabetes (inhaling high doses of formoterol may increase blood glucose levels. Before starting treatment with this medicine, and periodically during treatment, additional blood tests to monitor blood sugar levels may be necessary).
• If the patient has a tumour of the adrenal gland (pheochromocytoma).
• If 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.
• If the patient is 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 consumption for any reason.

Always inform your doctor before using Aerox if any of the above warnings apply to the patient.
Before using an inhaled medicine, consult your doctor, pharmacist, or nurse if you currently have or have had any health problems or allergies, or if you have any doubts about whether Aerox can be used.
Your doctor may periodically order blood tests to check potassium levels, especially in patients with severe asthma. Like other bronchodilator medicines, Aerox may cause a sudden decrease in serum potassium (hypokalaemia). This is associated with low oxygen levels in the blood and may be worsened by concomitant use of other medicines with Aerox, which may exacerbate the reduction in 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 doctor will decide whether to increase the corticosteroid dose or may recommend other steroids in tablet form or by injection.
If hospital treatment is required, the patient should remember to bring all their medicines and inhalers, including Aerox, as well as over-the-counter medicines, if possible in their original packaging.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Children and adolescents
Aerox must not be used in children and adolescents under 18 years of age.
Aerox and other medicines:

• Inform your doctor about all medicines currently used, recently used, or planned for use, including those obtained without a prescription. 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 the following medicines:

• Certain medicines may enhance the effect of Aerox, and the doctor may wish to closely monitor the patient taking such medicines (including some antiviral drugs used in HIV infection: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are medicines used to treat many 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 agonists (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) or medicines with similar properties, such as furazolidone and procarbazine.
• Medicines used to treat heart diseases (digoxin).
• Other medicines used to treat asthma (theophylline, aminophylline, or steroids).
• Diuretics.

Also inform your doctor if the patient is scheduled for 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 decided by a doctor.
Driving and operating machinery
It is unlikely that Aerox affects the ability to drive or operate machinery.
Aerox contains alcohol
Aerox contains 9 mg of alcohol (ethanol) in each spray, equivalent to 0.25 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.
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.
Dosage:
Adults and elderly patients:
The recommended dose is two sprays twice daily.
The maximum daily dose is four sprays.
Important: Always carry a fast-acting inhaled medicine for relief
to treat worsening asthma symptoms or sudden asthma attacks.
Special patient groups:
No dosage adjustment is necessary for elderly patients. There is no information available
regarding the use of Aerox in patients with impaired liver or kidney function.
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.
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 this
substance. If the patient has previously used another inhaled medicine containing beclometasone
dipropionate, the doctor will recommend the appropriate dose of Aerox.
Do not increase the dose.
If you feel the medicine is not working adequately, always consult your doctor before increasing the dose.
In case of worsening asthma symptoms:
If asthma symptoms worsen or become difficult to control (e.g. if you need to use your reliever inhaler more frequently), or if your fast-acting reliever inhaler does not relieve symptoms, contact your doctor immediately. This may indicate worsening asthma, and your doctor may decide to change the dose of Aerox or initiate alternative 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, a dose counter is provided 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 the counter to advance unnecessarily.
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 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 longer, 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 downward.
• Point the mouthpiece away from yourself and firmly press the canister to release a 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 testing for the first time, the counter should display "120".
• For the 180-dose pack, check the dose indicator. If testing for the first time, 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 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 (Figure 1).
2. Breathe out as deeply and slowly as possible (Figure 2).
3. Hold the canister upright with the mouthpiece upward, 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 in an upright position 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 the 120-dose pack) or dose indicator (for the 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 counter or indicator shows "20", have a new inhaler ready. Stop using the inhaler when the counter shows "0", as the remaining medicine may not deliver a full dose, and begin using a new inhaler.
If a mist appears above the top opening of the mouthpiece or at the side of the mouth,
this means Aerox is not reaching the lungs as it should. Take another dose according to the instructions, restarting from step 2.
If you feel 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.
Cleaning 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.

Accidental overdose of Aerox:

• 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, increased levels of acidic metabolic products in the blood, low blood potassium levels, and 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 dysfunction, which resolves 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 immediately.
Missed dose of Aerox:
Take the missed dose as soon as possible. If it is almost time for the next dose, do not take the missed dose—take the next dose at the usual scheduled time. Do not take a double dose
to make up for a missed dose.
Stopping Aerox treatment:
Even if you feel better, do not stop using Aerox or reduce the dose without consulting your doctor. It is very important to use 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 breathlessness and wheezing.
Contact a doctor immediately.
Inform your doctor immediately if any hypersensitivity reactions occur, such as:
skin allergies, skin itching, skin rash, redness of the skin, swelling of the skin or mucous membranes, especially of the eyes, face, lips, and throat.

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

Common (occur in fewer than 1 in 10 patients):

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

Uncommon (occur in fewer than 1 in 100 patients):

• palpitations, unusual rapid heartbeat, and heart rhythm disturbances,
• changes in electrocardiogram (EKG),
• increased blood pressure,
• influenza-like symptoms,
• sinusitis,
• rhinitis,
• otitis,
• throat irritation,
• cough and cough with sputum,
• asthma attack,
• fungal vaginal infections,
• nausea,
• taste disturbances,
• lip burning,
• 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:
  • decreased white blood cell count,
  • increased platelet count,
  • decreased blood potassium concentration,
  • increased blood glucose concentration,
  • increased 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):

• pneumonia: inform your doctor if any of the following symptoms occur: increased sputum production, change in sputum colour, fever, worsening cough, increased breathing difficulties,
• decreased blood cortisol concentration, due to corticosteroid effects on the adrenal glands,
• irregular heartbeat.

Rare (occur in fewer than 1 in 1,000 patients):

• feeling of chest tightness,
• heart rhythm disturbances (due to premature ventricular contractions),
• low blood pressure,
• kidney inflammation,
• swelling of the skin and mucous membranes lasting for several days.

Very rare (occur in fewer than 1 in 10,000 patients):

• breathlessness,
• worsening of asthma,
• decreased platelet count,
• swelling of hands and feet.

Long-term, high-dose inhaled corticosteroid therapy may very rarely 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.

Unknown frequency (cannot be estimated from available data):

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

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

• Blurred vision.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this 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.
Write 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 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, write 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 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 a few 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 required. These measures help protect the environment.

6. Contents of the package and other information

What Aerox contains:
The active substances in this medicinal product are: beclometasone dipropionate and formoterol fumarate dihydrate.
One metered dose from the inhaler contains 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to the dose delivered via the mouthpiece, containing 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate dihydrate.
The other ingredients are: norflurane (HFA 134a), anhydrous ethanol, concentrated hydrochloric acid.
This medicinal product contains fluorinated greenhouse gases.
Each 120-dose inhaler contains 10.35 g of HFA 134a, equivalent to 0.015 tonnes of CO₂ equivalent (global warming potential GWP = 1,430).
Each 180-dose inhaler contains 14.24 g of HFA 134a, equivalent to 0.020 tonnes of CO₂ equivalent (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 green plastic protective 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 medicinal product is authorised in the Member States of the European Economic Area under the following names: