Befoair

Patient Information Leaflet

Befoair, (200 micrograms + 6 micrograms)/metered dose, inhalation aerosol, solution
Beclometasoni dipropionas + Formoteroli fumaras dihydricus
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. 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.

Table of Contents

1. What Befoair is and what it is 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 pack and other information

1. What Befoair is and what it is used for

Befoair is an inhalation aerosol solution containing two active substances which, when inhaled through the inhaler mouthpiece, are delivered directly to the lungs.
The medicine contains two active substances:
Beclometasone dipropionate, belonging to a group of medicines called corticosteroids, which work anti-inflammatory by reducing swelling and irritation in the lungs.
Formoterol fumarate dihydrate, belonging to a group of long-acting bronchodilator medicines, which relax the muscles in the airways and make breathing easier.
Together, these two active substances help you breathe more easily. They also help prevent asthma symptoms such as breathlessness, wheezing, and coughing.

Asthma
Befoair is intended for regular treatment of asthma in adults 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.

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, discuss with your doctor, pharmacist or nurse if the patient has any of the following conditions:

• 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 disease, or a condition known as hypertrophic obstructive cardiomyopathy (HOCM), characterized by abnormal structure of the heart muscle
• arterial narrowing (also known as arteriosclerosis), if the patient has high blood pressure or a diagnosed aneurysm (abnormal widening of a blood vessel wall)
• heart rhythm disorders (accelerated or irregular heartbeat), rapid heartbeat or palpitations, or any history of abnormal heart rhythm
• hyperthyroidism
• low blood potassium levels
• any liver or kidney disease
• 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 therapy)
• adrenal medulla tumour (pheochromocytoma)
• if the patient is scheduled for general anaesthesia. Depending on the type of anaesthesia, it may be necessary to discontinue Befoair at least 12 hours before the procedure.
• if the patient is currently being treated or has previously 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 if any of the above warnings apply to the patient.

Consult your doctor, nurse or pharmacist if you currently have or have previously had any health problems or allergies, or if you have any doubts about whether Befoair can be used.
Your doctor may periodically order blood tests to check potassium levels, especially in patients with severe asthma. Like other bronchodilator medicines, Befoair may cause a sudden decrease in serum potassium levels (hypokalaemia). This is associated with low oxygen levels in the blood and may be worsened by concomitant use of other medicines, further reducing blood potassium levels.
If the patient is taking high doses of inhaled corticosteroids over a long period, they may require additional corticosteroid treatment during periods of stress. Stress situations include hospital admission following an accident, serious injury, or prior to surgery. In such cases, the treating doctor will decide whether to increase the corticosteroid dose or prescribe alternative steroids in tablet form or by injection.
If hospital treatment is required, the patient should remember to bring all their medicines and inhalers, including Befoair, as well as any over-the-counter medicines, preferably in their original packaging.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.

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

Befoair and other medicines
Inform your doctor, pharmacist or nurse about all medicines currently taken or recently used, including those obtained without a prescription. This is necessary because Befoair may affect the action of certain other medicines. Similarly, some medicines may affect the action of Befoair.

Concomitant use of Befoair with:

• HIV medications ritonavir and cobicistat, and certain other medicines, may enhance the effect of Befoair, and the doctor may wish to closely monitor the patient taking these medicines
• beta-blockers, including eye drops, may reduce or completely block the effect of formoterol. Beta-blockers are medicines used in the treatment of various conditions, including heart diseases, high blood pressure and glaucoma (increased intraocular pressure)
• beta-adrenergic agonists (medicines acting similarly to formoterol) – may enhance the effect of formoterol
• medicines used to treat abnormal heart rhythm (quinidine, disopyramide, procainamide), antihistamines used for 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). They may also increase the risk of cardiac arrhythmias (ventricular rhythm disturbances)
• medicines used in the treatment of Parkinson's disease (L-dopa), medicines used for hypothyroidism (L-thyroxine), medicines containing oxytocin (which induce uterine contractions), or alcohol may reduce cardiac tolerance to beta-agonists such as formoterol
• medicines used in the treatment of psychiatric disorders such as monoamine oxidase inhibitors (MAOIs) or medicines with similar properties, such as furazolidone and procarbazine, may cause increased blood pressure
• medicines used in the treatment of heart disease (digoxin) may reduce blood potassium levels, increasing susceptibility to cardiac arrhythmias
• other medicines used to treat asthma (theophylline, aminophylline or steroids) and diuretics (water tablets) may reduce blood potassium levels
• certain anaesthetic agents containing halogenated hydrocarbons (used during surgery and dental procedures) may increase the risk of cardiac arrhythmias

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

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

Befoair contains alcohol
Befoair contains 9 mg of alcohol (ethanol) per 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 1 mL of beer or wine. The small amount of alcohol in this medicine will not cause noticeable effects.

3. How to use Befoair

This medicine should always be used exactly as prescribed 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 Befoair.
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:
There is no need to adjust the dose in elderly patients. There is insufficient information regarding the use of Befoair in patients with hepatic or renal impairment.

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 Befoair 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 Befoair.

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

In case of worsening breathing difficulties:
If you experience increased shortness of breath or wheezing (whistling sound during breathing) immediately after inhalation, stop using Befoair immediately and use your fast-acting reliever inhaled medicine without delay. Contact your doctor as soon as possible. Your doctor will assess your symptoms and, if necessary, recommend alternative 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 inhaled medicine more frequently), or if your reliever medicine fails to relieve symptoms, contact your doctor immediately. This may indicate worsening asthma, and your doctor may decide to adjust the dose of Befoair or initiate alternative treatment.

Method of administration:
Befoair 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 is a dose counter indicating how many doses remain. Each time the inhaler is pressed, a dose is released and the counter decreases by one. Be careful not to drop the inhaler, as this may cause the counter to advance unintentionally.

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.

1. Remove the protective cap from the mouthpiece.
2. Hold the canister upright with the mouthpiece pointing downwards.
3. Point the mouthpiece away from you and firmly press the top of the medicine canister to release one spray.
4. Check the dose counter. If this is the first time testing the inhaler, the counter should display 120.

How to use the inhaler
If possible, stand or sit upright during inhalation.
Before inhaling, check the dose counter: any value between "1" and "120" indicates that medicine doses remain. If the dose counter shows "0", no doses remain, and you should discard the old inhaler and obtain a new one.

1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust or other debris.
2. Breathe out as deeply and slowly as possible.
3. Hold the canister upright with the stem pointing upwards, then place the mouthpiece between your lips. Do not bite down on it.
4. Breathe in deeply and slowly through your mouth. Just after starting to inhale, firmly press the top of the inhaler to release one spray.
5. Hold your breath as long as possible, then remove the inhaler from your mouth and breathe out slowly. Do not exhale into the inhaler. To take a second dose, 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. 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 the dose counter shows 20, you should have a new inhaler ready.
Stop using the inhaler when the counter shows 0, as the remaining medicine may not deliver a full dose.

If you see a "mist" above the top opening of the mouthpiece or around the side of your mouth, this means Befoair is not reaching your lungs as intended. Take another dose according to instructions, starting again from step 2.

Patients with weak grip may find it easier to hold the inhaler with both hands: place both index fingers on the top of the inhaler and both thumbs on the base.

If you feel the effect of Befoair is too strong or too weak, consult your doctor or pharmacist.

If you have difficulty using the inhaler during inhalation, you may use an Aerochamber Plus spacer device. Ask your doctor or pharmacist about this device.
It is important to carefully read the instructions leaflet 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 plastic casing. Do not use water or other liquids to clean the inhaler.

Cleaning the inhaler:

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

Accidental overdose of Befoair

• 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 metabolites in the blood, decreased blood potassium levels, increased blood glucose levels. Your doctor may recommend a blood test to check potassium and glucose levels.
• Taking too much 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 immediately.

Missed dose of Befoair
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 your next dose at the usual scheduled time. Do not take a double dose to make up for a missed dose.

Stopping treatment with Befoair
Even if you feel better, do not stop using Befoair or reduce the dose without consulting your doctor. It is very important to use Befoair 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
As with other inhaled medicines, there is a risk of worsening breathlessness and wheezing immediately after taking Befoair, known as paradoxical bronchospasm. In such cases, Befoair administration must be STOPPED IMMEDIATELY, and a fast-acting inhaled bronchodilator should be used to relieve breathlessness and wheezing symptoms. Immediate contact with the treating physician is required.
Immediately inform the doctor if any hypersensitivity reactions occur, such as skin allergies, skin itching, skin rash, skin redness, swelling of the skin or mucous membranes, particularly eyes, face, lips, and throat.

Other possible adverse reactions are listed below by frequency of occurrence.

Common (may occur in up to 1 in 10 people):

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

Uncommon (may occur in up to 1 in 100 people):

• palpitations, unusual rapid heartbeat, and heart rhythm disorders
• changes in electrocardiogram (ECG)
• increased blood pressure
• influenza-like symptoms
• sinusitis
• rhinitis
• otitis
• throat irritation
• cough and productive cough
• asthma attack
• vaginal fungal infections
• nausea
• taste disturbances
• burning sensation of the lips
• dryness of the oral mucosa
• difficulty swallowing
• indigestion
• stomach discomfort
• diarrhoea
• muscle pain and muscle cramps
• facial and throat redness
• increased blood flow to certain tissues
• increased sweating
• tremor
• restlessness, particularly 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 concentrations

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

• feeling of chest tightness
• heart rhythm disorders (caused by premature ventricular contractions)
• low blood pressure
• kidney inflammation
• skin and mucous membrane swelling lasting several days

Very rare (may occur in up to 1 in 10,000 people):

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

Unknown frequency (cannot be estimated from available data):

• blurred vision

The following adverse reactions are more likely in children:

• sleep disorders
• depression or feeling depressed
• nervousness
• excessive excitability or irritability

The following adverse reactions have also been reported in patients with chronic obstructive pulmonary disease (COPD):

• pneumonia (common): inform the 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 (uncommon), caused by the effect of corticosteroids on the adrenal glands
• irregular heartbeat (uncommon)

Prolonged use of inhaled corticosteroids at high doses may, in very rare cases, lead to systemic effects, including:

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

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

5. How to store Befoair

Keep this medicine out of the sight and reach of children.
Information for the pharmacist:
Store in a refrigerator (2°C to 8°C) for up to 18 months.
Information for the patient:
Do not use this medicine more than 3 months after the date it was dispensed 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 below 25°C for up to 3 months.
If the inhaler has been exposed to very low temperatures, 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 to temperatures above 50°C. Do not pierce the container.
Medicines must not be disposed of via wastewater 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 Befoair contains

• The active substances 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 delivered dose via mouthpiece, containing 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate dihydrate.
• This medicine contains fluorinated greenhouse gases. Each inhaler contains 10.24 g of HFA-134a, equivalent to 0.015 tonnes of CO₂ (global warming potential GWP = 1430).
• Other ingredients: norflurane (HFA 134a), anhydrous ethanol, hydrochloric acid concentrated (for pH adjustment).

What Befoair looks like and contents of the pack
Befoair is available as a solution for inhalation contained in an aluminium container with a metering valve, fitted in a plastic housing equipped with a dose counter and a plastic protective cap.
Each carton contains:
1 container (delivering 120 doses).
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
02200 Espoo
Finland
Importer
Orion Corporation Orion Pharma
Orionintie 1
02200 Espoo
Finland
For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]