Bedufora

Package leaflet: Information for the user

Bedufora, (100 micrograms + 6 micrograms)/metered dose, inhalation aerosol,
solution
Beclometasone dipropionate + Formoterol fumarate dihydrate
Please read all of this leaflet carefully before you start using this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Bedufora is and what it is used for

Bedufora is an inhalation aerosol solution. It contains two active substances which are inhaled through the mouth and 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 by reducing inflammation, 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 coughing in patients with asthma or chronic obstructive pulmonary disease (COPD), and also help prevent asthma symptoms.

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

• asthma symptoms are not adequately controlled by inhaled corticosteroids and a short-acting, as-needed bronchodilator

or

• good asthma control has been achieved with both inhaled corticosteroids and long-acting bronchodilators.

COPD
Bedufora 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 affecting the airways, primarily caused by cigarette smoking.
Bedufora should be used in adults only.

2. Important information before using the medicine Bedufora

When not to use Bedufora:

• 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 to use Bedufora, discuss this with your doctor, pharmacist, or
nurse:

• if the patient has heart conditions such as angina (chest pain), recent heart attack (myocardial infarction), heart failure, narrowed heart arteries (coronary heart disease), heart valve disorders, or any other heart diseases, or a condition known as obstructive hypertrophic cardiomyopathy (abnormal heart muscle structure);
• if 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);
• if the patient has heart rhythm disorders, such as rapid or irregular heartbeat, increased pulse rate, or palpitations, or if there is any history of abnormal heart rhythm;
• if the patient has hyperthyroidism;
• if the patient has low potassium levels in the blood;
• if the patient has liver or kidney disease;
• if 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);
• if the patient has a tumour of the adrenal gland (pheochromocytoma);
• if general anaesthesia is planned. Depending on the type of anaesthesia, it may be necessary to discontinue Bedufora at least 12 hours before anaesthesia;
• if the patient has been treated or is currently being treated for tuberculosis of the lungs, 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 Bedufora if any of the
above warnings apply to you.
Before using the inhaled medicine, consult your doctor, pharmacist, or nurse if you currently have or have had in the past any health problems or allergies, or if you have any doubts whether Bedufora can be used.
Treatment with beta-agonists such as formoterol contained in Bedufora may cause a sudden decrease in serum potassium levels (hypokalaemia).
Special caution is required in patients with severe asthma, as hypoxia (lack of oxygen in the blood), and concomitant use of other medicines with Bedufora such as drugs used to treat heart conditions or high blood pressure called diuretics, or other asthma medications, may worsen the reduction in blood potassium levels. For this reason, your doctor may periodically recommend blood potassium level testing.
If the patient is taking high doses of inhaled corticosteroids for a prolonged period, they may require additional corticosteroid treatment during periods of stress. Stress situations may include hospitalization after an accident, serious injury, or prior to surgery. In such cases, the treating doctor will decide whether to increase the corticosteroid dose or may recommend other steroids in tablet form or by injection.
If hospitalization is required, the patient should remember to bring all their medicines and inhalers, including Bedufora, 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
Bedufora should not be used in children and adolescents under 18 years of age until further data are available.

Bedufora and other medicines

• Inform your doctor about all medicines currently used or recently used, including those obtained without a prescription. This is because Bedufora may affect how some other medicines work. Additionally, some medicines may affect how Bedufora works.

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

• certain medicines may enhance the effect of Bedufora, and your doctor may wish to closely monitor your condition when taking such medicines (including some HIV medicines: ritonavir, cobicistat);
• beta-adrenergic receptor blockers. Beta-blockers are medicines used to treat various conditions including heart diseases, high blood pressure, and glaucoma (increased pressure within the eye). If beta-blockers must be administered (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 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 conditions (digoxin);
• other medicines used to treat asthma (theophylline, aminophylline, or steroids);
• diuretics.

Also inform your doctor if general anaesthesia is planned for surgery or a dental procedure.

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

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

Bedufora contains alcohol
Bedufora 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 equivalent to less than 1 mL of beer or 1 mL of wine. The small amount of alcohol in this medicine will not cause noticeable effects.

3. How to use Bedufora

This medicine should always be used as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Asthma
Your doctor will regularly check whether you are taking the optimal dose of Bedufora. The doctor will
determine the lowest dose that provides the best control of asthma symptoms.
Your doctor may prescribe Bedufora in two different ways:
a) Bedufora should be used daily for asthma treatment, together with another inhaled medicine that provides relief during sudden worsening of asthma symptoms, such as an asthma attack, wheezing, and cough.
Adults and elderly patients:
The recommended dose is one or two actuations twice daily. The maximum daily dose is 4 actuations.
Important: Always carry a fast-acting inhaled reliever medicine to treat sudden worsening of asthma symptoms or an acute asthma attack.
b) Bedufora should be used daily for asthma treatment and also as needed during sudden worsening of asthma symptoms, such as an asthma attack, wheezing, and cough.
Adults and elderly patients:
The recommended dose is one actuation in the morning and one actuation in the evening.
You should also use Bedufora as an inhaled reliever medicine when asthma symptoms occur suddenly.
When asthma symptoms occur, take one actuation and wait a few minutes.
If there is no improvement, take another actuation.
Do not use more than 6 reliever actuations of Bedufora per day.
The maximum daily dose of Bedufora when used as the only inhaler for asthma treatment is 8 actuations.
If you need to use more actuations to control 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 actuations in the morning and two actuations in the evening.
Special patient groups:
There is no need to adjust the dose in elderly patients. There is insufficient information regarding the use of Bedufora in patients with hepatic or renal impairment.
The dose of beclometasone dipropionate contained in Bedufora that is effective in asthma treatment 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 the appropriate dose of Bedufora to use for asthma treatment.
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 breathing difficulties:
If breathing becomes more difficult or wheezing (audible whistling during breathing) occurs immediately after inhalation, stop using Bedufora immediately and use a fast-acting inhaled reliever medicine without delay. Contact your doctor as soon as possible. The 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 asthma symptoms worsen or become difficult to control (e.g., if you need to use another inhaled reliever medicine or Bedufora as a reliever more frequently), or if the reliever medicine or Bedufora does not relieve symptoms, contact your doctor immediately. This may indicate worsening asthma, and your doctor may decide to change the dose of Bedufora or initiate alternative treatment.
Method of administration:
Bedufora is intended for inhalation use.
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 120 doses and a dose indicator for 180 doses, which shows the number of remaining doses.
For the 120-dose pack, each press of the canister releases one dose of medicine, and the counter decreases by one. Be careful not to drop the inhaler, as this may cause the counter to decrement.
For the 180-dose pack, the dose indicator shows the approximate number of remaining uses (actuations). The dose indicator window displays the number of remaining actuations 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.
When 180 actuations 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 press the canister firmly to release one actuation.
• If the inhaler has not been used for 14 days or longer, press the canister firmly to release one actuation.
• 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 dose indicator to see how many doses remain. If the dose 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 of 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 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, press firmly on the top of the inhaler to release one actuation of medicine. 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 (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 actuation is planned, 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 of the mouth or throat, rinse your mouth or throat with water or brush your teeth immediately after each inhalation.
When to replace the inhaler
If the counter or dose indicator shows "20", have a new inhaler ready.
Stop using the current inhaler and start using a new one when the counter shows "0", as the remaining medicine in the canister may not deliver a full dose.
If you see a "mist" coming from the top of the inhaler or from the sides of your mouth,
this means Bedufora is not reaching your lungs as it should. Take another actuation according to the instructions, starting again from step 2.
If you feel the effect of Bedufora 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 included 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 Bedufora:

• Using more than the recommended dose of formoterol may cause the following symptoms: nausea, vomiting, faster heartbeat, palpitations, heart rhythm disturbances, changes in the electrocardiogram (heart tracing), headache, tremor, drowsiness, excess acid metabolites in the blood, low blood potassium levels, and high blood glucose levels. Your doctor may recommend a blood test to check potassium and glucose levels.

• Using too high a dose of beclometasone dipropionate may cause temporary adrenal gland function disturbances. This condition will resolve within a few days, but your doctor may recommend a blood test to check serum cortisol levels.

If any of these symptoms occur, inform your doctor.
Missed dose of Bedufora:
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 use of Bedufora:
Even if you feel better, do not stop using Bedufora 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 Bedufora, known as paradoxical bronchospasm.
In such a case, immediately DISCONTINUE administration of Bedufora and use
a fast-acting inhaled bronchodilator to relieve symptoms of breathlessness and
wheezing. Contact your doctor immediately.
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, categorized 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.

Pneumonia (lung infection) in patients with COPD:
Tell your doctor if any of the following symptoms occur while taking Bedufora; these may be signs of a lung infection:

• fever or chills,
• increased mucus production, change in mucus color,
• worsening cough or increased difficulty breathing.

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

• palpitations, unusually rapid heartbeat, and heart rhythm disturbances,
• changes in electrocardiogram (ECG),
• influenza-like symptoms,
• sinusitis,
• nasal mucositis,
• ear infection,
• throat irritation,
• cough and cough with sputum,
• asthma attack,
• fungal vaginal infection,
• nausea,
• taste disturbances,
• burning 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, especially motor restlessness,
• dizziness,
• urticaria,
• changes in values of 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 the effect of corticosteroids on the adrenal glands,
• irregular heartbeat.

Rare (may occur in up to 1 in 1000 people):

• feeling of chest tightness,
• heart rhythm disturbances (caused by premature ventricular contractions),
• increased blood pressure,
• decreased blood pressure,
• kidney inflammation,
• skin and mucous membrane swelling lasting for 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.

Long-term use of inhaled corticosteroids at high doses may very rarely lead to systemic adverse effects, including:

• adrenal gland function disorders (suppression of adrenal function),
• decreased bone mineral density (bone thinning),
• growth retardation in children and adolescents,
• increased intraocular pressure (glaucoma),
• cataract.

Frequency not known (frequency cannot be estimated from available data):

• sleep disorders,
• depression or feeling of low mood,
• nervousness,
• excessive excitation or irritability.

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

• blurred vision.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 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 Bedufora

Keep this medicine out of sight and reach of children.
Single pack containing one inhaler with 120 doses or 180 doses
For the pharmacist
Store 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 affix the label to the inhaler.
Ensure that the period between the date of dispensing and the expiry date printed on the packaging is at least 3 months.
For the patient
Do not store the inhaler at temperatures above 25°C.
Do not use Bedufora for longer than 3 months from the date of receiving the inhaler from the pharmacist, and never use after the expiry date stated on the box and label following "EXP". The expiry date refers to the last day of the stated month.
Double or triple pack containing two or three inhalers with 120 or 180 doses each
Before first use: store inhalers in a refrigerator (2°C – 8°C) for up to 18 months.
After first use: do not store inhalers at temperatures above 25°C. Store for no longer than 3 months.
Each time a new inhaler is started, enter the date of first use on one of the self-adhesive labels and attach this label to the inhaler. Do not use this medicine after the expiry date printed on the box and label after "EXP". The expiry date refers to the last day of the stated month.
Do not freeze.
If the inhaler has been exposed to very low temperatures, warm it in the hands for several minutes before use. Never use other methods to warm the container.
Warning: The container contains pressurised 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Bedufora contains:
The active substances are: beclometasone dipropionate and formoterol fumarate dihydrate.
Each activation/dose dispensed from the inhaler contains 100 micrograms of beclometasone
dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to the delivered
dose via mouthpiece, containing 84.6 micrograms of beclometasone dipropionate and 5.0
micrograms of formoterol fumarate dihydrate.
Other ingredients: anhydrous ethanol, concentrated hydrochloric acid, and norflurane (HFA-134a).
This medicine contains fluorinated greenhouse gases.
Each inhaler containing 120 doses contains 8.15 g of HFA-134a, equivalent to 0.012 tonnes of CO(_2)
equivalent (global warming potential GWP = 1,430).
Each inhaler containing 180 doses contains 11.2 g of HFA-134a, equivalent to 0.016 tonnes of CO(_2)
equivalent (global warming potential GWP = 1,430).

What Bedufora looks like and contents of the pack:
Bedufora is available as a solution for inhalation contained in a pressurized aluminium canister
with a metering valve, fitted with a polypropylene dosing device incorporating a dose counter
(pack of 120 doses) or a dose indicator (pack of 180 doses), a mouthpiece, and a pink protective
plastic cap.
Each pack contains:

• 1 pressurized canister containing 120 doses, or
• 2 pressurized canisters, each containing 120 doses, or
• 3 pressurized canisters, each containing 120 doses, or
• 1 pressurized canister containing 180 doses, or
• 3 pressurized canisters, each containing 180 doses.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

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

For further information, contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:

Austria: Beclometason/Formoterol STADA 100 Mikrogramm /6 Mikrogramm pro Sprühstoß, Druckgasinhalation, Lösung
Belgium: Beclometasone/Formoterol EG 100 microgram/dosis aërosol, oplossing
Croatia: Laberon 100 mikrograma po potisku, stlačeni inhalat, otopina
Czech Republic: Oreto
Denmark: Laberon
Estonia: Bedufora
Greece: Beclometasone+Formoterol / STADA
Finland: Oparta 100 mikrog / 6 mikrog/annos inhalaatiosumute, liuos
France: BECLOMETASONE / FORMOTEROL EG 100 / 6 microgrammes/dose, solution pour inhalation en flacon pressurisé
Iceland: Laberon
Lithuania: Bedufora 100 mikrogramų/6 mikrogramai/spūsnyje suslėgtasis įkvepiamasis tirpalas
Latvia: Bedufora 100 mikrogrami/6 mikrogrami izsmidzinājumā aerosols inhalācijām, zem spiediena, šķīdums
Norway: Laberon
Germany: Beclometason/Formoterol AL 100 Mikrogramm/6 Mikrogramm pro Inhalation Druckgasinhalation, Lösung
Netherlands: Beclometason/Formoterol CF 100/6 microgram/dosis, aërosol, oplossing
Poland: Bedufora
Romania: Beclometazonă /Formoterol Stada, 100/6 micrograme pe doză, soluţie de inhalat presurizată
Sweden: Oparta 100 mikrogram/6 mikrogram per dos inhalationsspray, lösning
Slovakia: Beklometazón/Formoterol STADA 100/6 mikrogramov/dávka
Italy: BECLOMETASONE E FORMOTEROLO EG