Befoair

Leaflet accompanying the packaging: information for the user

Befoair, (100 micrograms + 6 micrograms)/metered dose, inhalation aerosol, solution

Beclometasone dipropionate + Formoterol fumarate dihydrate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Befoair and what is it used for

Befoair is a solution in an inhalation aerosol, containing two active substances, which are inhaled directly into the lungs through the mouthpiece of the inhaler.
The medicine contains two active substances:
Beclometasone dipropionate, belonging to a group of medicines called corticosteroids, which have an anti-inflammatory effect by reducing swelling and irritation of the lungs.
Formoterol fumarate dihydrate, belonging to a group of long-acting bronchodilators, which relax the muscles in the airways and make breathing easier.
Together, these two active substances make breathing easier. They relieve 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
Befoair is intended for regular treatment of asthma in adults who:

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

COPD
Befoair may also be used to treat symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a chronic respiratory disease in the lungs, mainly caused by smoking.

2. Important information before using Befoair

When not to use Befoair:

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

Warnings and precautions

Before starting treatment with Befoair, the patient should discuss with their doctor, pharmacist, or nurse if they have any of the following conditions:

• heart disease, such as angina pectoris (chest pain), recent myocardial infarction (heart attack), heart failure, coronary artery disease, heart valve defects, or any other heart disease, or a disease known as hypertrophic obstructive cardiomyopathy (HOCM), which is an abnormal structure of the heart muscle)
• arterial narrowing (also known as atherosclerosis), if the patient has high blood pressure or an aneurysm (abnormal dilation of a blood vessel wall)
• heart rhythm disorders (rapid or irregular heartbeat), rapid heart rate, or palpitations, or any information about abnormal heart rhythm
• hyperthyroidism
• low potassium levels in the blood
• any liver or kidney disease
• diabetes (inhalation of high doses of formoterol may increase blood glucose levels, so before starting treatment with this medicine, and from time to time during treatment, additional blood tests may be necessary to determine blood sugar levels).
• adrenal gland tumor (pheochromocytoma)
• the patient is scheduled for general anesthesia. Depending on the type of anesthesia, it may be necessary to discontinue Befoair for at least 12 hours before anesthesia.
• if the patient is being treated or has ever been treated for tuberculosis or if the patient has a viral or fungal infection in the chest
• if the patient must avoid consuming alcohol for any reason.

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

Before using this medicine, the patient should consult a doctor, nurse, or pharmacist if they have any current or past health problems or allergies, or if they are unsure whether Befoair can be used.

The doctor may occasionally order a blood test to check potassium levels, especially

in patients with severe asthma.Like other bronchodilators, Befoair may cause a sudden decrease in serum potassium levels (hypokalemia). This is related to oxygen deficiency in the blood caused by taking other medicines simultaneously with Befoair, which may exacerbate the decrease in potassium levels in the blood.
If the patient is taking high doses of inhaled corticosteroids for a long time, they may be more likely to require corticosteroid administration in stressful situations. Stressful situations may include hospitalization after an accident, serious injury, or waiting for surgery. In such situations, the doctor will decide on a possible increase in corticosteroid dose or may prescribe other steroids in tablet or injection form.
If hospitalization is necessary, the patient should remember to bring all their medicines and inhalers, including Befoair, as well as over-the-counter medicines, if possible, in their original packaging.

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

Children and adolescents

Befoair should not be used in children and adolescents under 18 years of age.

Befoair and other medicines

The patient should tell their doctor, pharmacist, or nurse about all the medicines they are currently taking or have recently taken, including those available without a prescription. This is necessary because Befoair may affect the action of some other medicines. Similarly, some medicines may affect the action of Befoair.
Concomitant use of Befoair with:

• HIV medicines ritonavir and cobicistat, and some other medicines, may enhance the effect of Befoair, and the doctor may want to closely monitor the patient's condition when taking such medicines
• beta-blocker medicines, including eye drops, may reduce the effect of formoterol or formoterol may not work at all. Beta-blocker medicines are used to treat many diseases, including heart disease, high blood pressure, and glaucoma (increased eye pressure).
• beta-agonist medicines (medicines that work in the same way as formoterol) - may enhance the effect of formoterol
• medicines used to treat irregular heart rhythm (quinidine, disopyramide, procainamide), medicines used to treat allergies (antihistamines), or medicines used to treat symptoms of depression or mental disorders, such as monoamine oxidase inhibitors (e.g., phenelzine and isocarboxazid), tricyclic antidepressants (e.g., amitriptyline and imipramine), phenothiazines, may cause certain changes in the electrocardiogram (ECG, a record of heart activity). They may also increase the risk of heart rhythm disorders (ventricular arrhythmias).
• medicines used to treat Parkinson's disease (L-dopa), medicines used to treat hypothyroidism (L-thyroxine), medicines containing oxytocin (which cause uterine contractions), or alcohol may reduce the heart's tolerance to beta-agonists, such as formoterol
• medicines used to treat mental disorders, such as monoamine oxidase inhibitors (MAOIs) or medicines with similar properties, such as furazolidone and procarbazine, may cause an increase in blood pressure
• medicines used to treat heart disease (digoxin) may cause a decrease in potassium levels in the blood. This may increase the risk of heart rhythm disorders
• other medicines used to treat asthma (theophylline, aminophylline, or steroids) and diuretic medicines (diuretic tablets) may cause a decrease in potassium levels in the blood.
• certain general anesthetics containing halogenated hydrocarbons (used during operations and dental procedures) may increase the risk of heart rhythm disorders

Pregnancy, breastfeeding, and fertility

There are no clinical data on the use of Befoair during pregnancy.
Befoair should not be used if the patient is pregnant, thinks they may be pregnant, or plans to have a child, or if the patient is breastfeeding, unless the doctor decides otherwise.

Driving and using machines

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

Befoair contains alcohol

Befoair contains 7 mg of alcohol (ethanol) in each puff, which is equivalent to 0.2 mg/kg body weight per dose, when two puffs are used. The amount of alcohol in two puffs of this medicine is equivalent to less than 1 mL of beer or wine. The small amount of alcohol in this medicine will not have noticeable effects.

3. How to use Befoair

This medicine should always be used as directed by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Asthma
The doctor will regularly check if the patient is taking the optimal dose of Befoair.
The doctor will determine the smallest dose that provides the best control of asthma symptoms.
The doctor may prescribe Befoair in two different ways:
a)
Befoair should be used daily to treat asthma, along with another inhaled medicine that provides relief in case of sudden worsening of asthma symptoms
such as shortness of breath, wheezing, and cough,
b)
Befoair should be used daily to treat asthma, and also in case of sudden worsening of asthma symptoms
such as shortness of breath, wheezing, and cough.
a)

Using Befoair with another inhaled medicine that provides relief.

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

Remember: Always carry a quick-acting inhaled medicine that provides relief to treat worsening of asthma symptoms or sudden asthma attacks.

b)

Using Befoair as the only inhaled medicine for asthma.

Adults and elderly:
The usual recommended dose is one puff in the morning and one puff in the evening.
Befoair should also be used as an inhaled medicine that provides relief in case of sudden worsening of asthma symptoms.
If asthma symptoms occur, one puff should be used and the patient should wait a few minutes.
If there is no improvement, another puff should be used.
No more than 6 relief puffs should be used within 24 hours.
The maximum daily dose of Befoair is 8 puffs.
If the patient needs to take more puffs to control asthma symptoms, they should consult their doctor. A change in treatment may be necessary.
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:

There is no need to adjust the dosage in elderly patients. There is no information on the use of Befoair in patients with liver or kidney function disorders.

Using Befoair 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 in Befoair, which is effective in treating asthma, may be lower than the dose contained in other inhaled medicines containing beclometasone dipropionate. If the patient has previously used another inhaled medicine containing beclometasone dipropionate, the doctor will recommend the appropriate dose of Befoair.

Do not increase the dose

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

In case of worsening breathing difficulties:

If the patient experiences worsening shortness of breath or wheezing (breathing with a noticeable whistling sound) immediately after inhaling the medicine, they should stop using Befoair immediately and use a quick-acting inhaled medicine that provides relief. The patient should contact their doctor as soon as possible. The doctor will assess the symptoms and, if necessary, prescribe other treatment. See also section 4, "Possible side effects".

In case of worsening asthma symptoms:

If the patient's symptoms worsen or become difficult to control (e.g., when the patient needs to use another inhaled medicine or Befoair as a relief medicine more frequently), or if the inhaled medicine that provides relief does not relieve symptoms, the patient should immediately inform their doctor.
This may indicate a worsening of asthma, and the doctor may decide to change the dose of Befoair or prescribe other treatment.

Method of administration:

Befoair is intended for inhalation use

This medicine is in a pressurized container, in a plastic casing with a mouthpiece. At the back of the inhaler, there is a dose counter that shows how many doses of medicine are left. After each press of the inhaler, a dose of medicine is released, and the dose counter decreases by one. The patient should be careful not to drop the inhaler, as this may cause the dose counter to decrease.

Testing the inhaler

Before first use, or if the inhaler has not been used for 14 days or more, the patient should perform an inhaler test to ensure it is working properly.

• 1. Remove the protective cap from the mouthpiece.
• 2. Hold the container upright with the mouthpiece pointing downwards.
• 3. Point the mouthpiece "away from you" and firmly press the top of the container to release one puff.
• 4. Check the dose counter. If the inhaler is being tested for the first time, the dose counter should show 120.

How to use the inhaler

If possible, the patient should stand or sit upright while inhaling.
Before inhaling, the patient should check the dose counter: any value between "1" and "120" indicates that there are still doses of medicine left in the container. If the dose counter shows "0", it means that there are no more doses of medicine left, and the old inhaler should be discarded and a new one purchased.

• 1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free of dust or other contaminants.
• 2. Exhale slowly and deeply.
• 3. Hold the container upright, with the stem pointing upwards, and then place the mouthpiece between the lips. Do not bite the mouthpiece.
• 4. Inhale slowly and deeply through the mouth. Immediately after starting to inhale, press the top of the inhaler firmly to release one puff of medicine.
• 5. Hold the breath for as long as possible, then remove the inhaler from the mouth and exhale slowly. Do not exhale into the inhaler. To take another dose of medicine, the patient should keep the inhaler upright for about half a minute, then repeat the steps from 2 to 5. Important:The steps from 2 to 5 should not be performed too quickly.

After use, the patient should replace the protective cap and check the dose counter. To reduce the risk of fungal infection of the mouth and throat, the patient should rinse their mouth or throat with water, or brush their teeth, immediately after each inhalation.

If the dose counter shows 20, the patient should have a new inhaler ready.

The patient should stop using the inhaler if the dose counter shows 0, as the medicine left in the container may not provide a full dose.

If a "mist" appears over the top opening of the mouthpiece or to the side of the mouth, it means that Befoair is not reaching the lungs as it should. The patient should take another dose, following the instructions, starting again from step 2.
Patients with a weak grip will find it easier to hold the inhaler with both hands: they should then place both index fingers on the top of the inhaler and both thumbs on the bottom.
If the patient feels that the effect of Befoair is too strong or too weak, they should consult their doctor or pharmacist.
If the patient has difficulty using the inhaler during inhalation, they can use a spacer (Aerochamber Plus). The patient should ask their doctor or pharmacist about this device.
It is essential to read the leaflet accompanying the Aerochamber Plus spacer and follow the instructions for use and cleaning recommendations.

Cleaning the inhaler:

The inhaler should be cleaned once a week.

When cleaning, the container should not be removed from the plastic casing, and water or other liquids should not be used to clean the inhaler.

Cleaning the inhaler:

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

Using a higher than recommended dose of Befoair

• using a higher than recommended dose of formoterol may cause the following symptoms: nausea, vomiting, rapid heartbeat, palpitations, heart rhythm disorders, changes in the electrocardiogram (ECG, a record of heart activity), headache, tremors, drowsiness, excessive acid production in the blood, decreased potassium levels in the blood, increased glucose levels in the blood. The doctor may recommend a blood test to check potassium and glucose levels in the blood.
• using too high a dose of beclometasone dipropionate may cause short-term adrenal gland disorders, which resolve on their own within a few days. The doctor may recommend a blood test to check cortisol levels in the blood. If any of these symptoms occur, the patient should inform their doctor.

Missing a dose of Befoair

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

Stopping treatment with Befoair

Even if the patient's condition improves, they should not stop using Befoair or reduce the dose without consulting their doctor. It is essential to regularly use Befoair, even when symptoms of the disease have resolved.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Befoair can cause side effects, although not everybody gets them.
As with other inhaled medicines, there is a risk of worsening shortness of breath and wheezing immediately after using Befoair, known as paradoxical bronchospasm.The patient should stop using Befoair immediatelyand use a quick-acting inhaled bronchodilator to relieve shortness of breath and wheezing. The patient should contact their doctor immediately.
The patient should immediately inform their doctorif they experience any allergic reactions, such as skin allergies, itching, rash, redness, swelling of the skin or mucous membranes, especially of the eyes, face, lips, and throat.
Other possible side effects are listed below, depending on their frequency.

• thrush (infection of the mouth and throat)
• headache
• hoarseness
• sore throat. Less common ( may affect up to 1 in 100 people):
• palpitations, abnormal rapid heartbeat, and heart rhythm disorders
• changes in the electrocardiogram (ECG)
• increased blood pressure
• flu-like symptoms
• sinusitis
• nasal congestion
• otitis (ear infection)
• throat irritation
• cough and cough with sputum production
• asthma attack
• vaginal thrush
• nausea
• taste disturbances
• lip burning
• dry mouth
• difficulty swallowing
• indigestion
• upset stomach
• diarrhea
• muscle pain and muscle cramps
• redness of the face and throat
• increased blood flow to some tissues
• increased sweating
• tremors
• restlessness, especially motor restlessness
• dizziness
• hives
• changes in some blood test results:
• decreased white blood cell count
• increased platelet count
• decreased potassium levels in the blood
• increased glucose levels in the blood
• increased insulin, free fatty acids, and ketone bodies in the blood.

Rare ( may affect up to 1 in 1,000 people):

• feeling of chest tightness
• heart rhythm disorders (caused by premature contraction of the heart chambers)
• decreased blood pressure
• kidney inflammation
• skin and mucous membrane swelling, lasting for several days. Very rare ( may affect up to 1 in 10,000 people):
• shortness of breath
• worsening of asthma
• decreased platelet count
• swelling of the hands and feet.

Unknown ( frequency cannot be estimated from the available data):

• blurred vision These side effects are more likely to occur in children:
• sleep disturbances
• depression or feeling of sadness
• nervousness
• excessive excitement or irritability.

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

• pneumonia (common): the patient should inform their doctor if they experience any of the following symptoms: increased production of sputum, change in sputum color, fever, increased cough, increased breathing difficulties
• decreased cortisol levels in the blood (uncommon), which is caused by the effect of corticosteroids on the adrenal glands
• irregular heartbeat (uncommon). The use of inhaled corticosteroids in high doses for a long time may rarely cause systemic effects, including:
• adrenal gland disorders (suppression of adrenal gland function)
• decreased bone density (osteoporosis)
• delayed growth in children and adolescents
• increased eye pressure (glaucoma)
• cataract.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw,
phone: (22) 49 21 301, fax: (22) 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Befoair

The medicine should be stored out of sight and reach of children.
Information for the pharmacist:
Store in a refrigerator (2°C to 8°C) for a maximum of 18 months.
Information for the patient:
Do not use the medicine after 3 months from the date of issue from the pharmacy and never use this medicine after the expiry date stated on the carton and label after: "Expiry date (EXP)".
The expiry date refers to the last day of the stated month.
Store at a temperature below 25°C, for a maximum of 3 months.
If the inhaler has been exposed to very low temperatures, it should be warmed in the hands for a few minutes before use. The container should never be heated in any other way.
Warning: The container contains a pressurized liquid. Do not expose to temperatures above 50°C. Do not pierce the container.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Befoair contains

• The active substances of Befoair 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 a delivered dose through the mouthpiece, containing 84.6 micrograms of beclometasone dipropionate and 5 micrograms of formoterol fumarate dihydrate.
• This medicine contains fluorinated greenhouse gases. Each inhaler contains 8.15 g of HFA-134a, which corresponds to 0.012 tons of CO2 equivalent (GWP = 1430).
• The other ingredients are norflurane (HFA 134a), anhydrous ethanol, and concentrated hydrochloric acid (to adjust pH).

What Befoair looks like and contents of the pack

Befoair is available as a solution for inhalation, in an aluminum container with a dose counter, placed in a plastic casing with a mouthpiece and a plastic protective cap.
Each cardboard box contains:
1 container (which delivers 120 doses).

Marketing authorization holder

Orion Corporation
Orionintie 1
02200 Espoo
Finland

Importer

Orion Corporation Orion Pharma
Orionintie 1
02200 Espoo
Finland
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]
Date of last revision of the leaflet:2024-12