Bedufora

Leaflet accompanying the packaging: information for the user

Bedufora, (100 micrograms + 6 micrograms)/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 Bedufora and what is it 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 packaging and other information

1. What is Bedufora and what is it used for

Bedufora is a solution in an inhalation aerosol, containing two active substances that 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 have an anti-inflammatory effect by reducing swelling and irritation in the lungs.
Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators, which relax the muscles in the airways and make breathing easier.
Together, these two active substances make breathing easier by relieving symptoms such as:
shortness of breath, wheezing, and cough in patients with asthma or chronic obstructive pulmonary disease (COPD), and also help prevent asthma symptoms.
Asthma
Bedufora is indicated for the regular treatment of asthma in adult patients, in whom:

• asthma symptoms are not adequately 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.

COPD
Bedufora 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.

Bedufora should be used in adults.

2. Important information before using 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 treatment with Bedufora, you should discuss with your doctor, pharmacist, or nurse:

• if the patient has 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 called hypertrophic cardiomyopathy with outflow obstruction (characterized by abnormal heart muscle structure);
• if the patient has narrowing of the arteries (also known as atherosclerosis); if the patient has high blood pressure or an aneurysm (abnormal dilation of a blood vessel wall);
• if the patient has arrhythmias, such as: rapid or irregular heartbeat, rapid pulse, or palpitations, or any information about 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 (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 check blood glucose levels);
• if the patient has a pheochromocytoma (a tumor of the adrenal gland);
• if the patient is scheduled for general anesthesia. Depending on the type of anesthesia, it may be necessary to discontinue Bedufora for at least 12 hours before anesthesia;
• if the patient is being treated or has 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 Bedufora, you should always inform your doctor if any of the above warnings apply to you.

Before using an inhaler, you should consult a doctor, pharmacist, or nurse if you have any current or past health problems or allergies, or if you are unsure whether Bedufora can be used.
Treatment with beta-agonists, such as formoterol in Bedufora, may cause a sudden decrease in potassium levels in the blood (hypokalemia).
Particular caution is recommended for patients with severe asthma,as oxygen deficiency in the blood, as well as the use of other medicines with Bedufora, such as: medicines used to treat heart disease or high blood pressure, called diuretics, or other medicines used to treat asthma, may exacerbate the decrease in potassium levels in the blood. For this reason, your doctor may recommend checking potassium levels in the blood from time to time.
If you are taking high doses of inhaled corticosteroids for a long time, you may be more likely to need corticosteroids during periods of stress. Stressful situations may include: hospitalization after an accident, serious injury, or pending surgery. In such situations, your doctor will decide whether to increase the dose of corticosteroids or recommend other steroids in the form of tablets or injections.
If hospitalization is necessary, you should remember to bring all your medicines and inhalers, including Bedufora, 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

Bedufora should not be used in children and adolescents under 18 years of age until more data are available.
Bedufora and other medicines

• You should tell your doctor about all medicines you are currently taking or have recently taken, including over-the-counter medicines. This is because Bedufora may affect the way some other medicines work. Additionally, some medicines may affect the way Bedufora works.

In particular, you should inform your doctor, pharmacist, or nurse about the use of any of the following medicines:

• certain medicines may enhance the effect of Bedufora and your doctor may want to closely monitor your condition while taking such medicines (including certain HIV medicines: ritonavir, cobicistat);
• beta-blockers. Beta-blockers are medicines used to treat many diseases, including heart disease, high blood pressure, and glaucoma (increased pressure in the eye). If beta-blockers need to be administered (including eye drops), the effect of formoterol may be reduced or formoterol may not work at all;
• medicines that stimulate beta-adrenergic receptors (medicines that work in the same way as formoterol)
• may enhance the effect of formoterol;
• medicines used to treat irregular heart rhythms (quinidine, disopyramide, procainamide);
• medicines used to treat allergies (antihistamines);
• 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;
• medicines used to treat Parkinson's disease (L-dopa);
• medicines used to treat hypothyroidism (L-thyroxine);
• medicines containing oxytocin (which induce uterine contractions);
• medicines used to treat mental disorders, such as monoamine oxidase inhibitors (MAOIs) or medicines with similar properties, such as furazolidone and procarbazine;
• medicines used to treat heart disease (digoxin);
• other medicines used to treat asthma (theophylline, aminophylline, or steroids);
• diuretics.

You should also inform your doctor about planned general anesthesia for surgery or dental procedures.
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, thinks they may be pregnant, or plans to have a baby, or if the patient is breastfeeding, unless the doctor decides otherwise.
Driving and using machines
It is unlikely that Bedufora will affect the ability to drive or use machines.

Bedufora contains alcohol

Bedufora contains 7 mg of alcohol (ethanol) per actuation, which is equivalent to 0.20 mg/kg body weight per dose, when two actuations are used. The amount of alcohol in two actuations 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 is unlikely to have noticeable effects.

3. How to use Bedufora

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Asthma

Your doctor will regularly check that you are taking the optimal dose of Bedufora. Your doctor will determine the smallest dose that provides the best control of asthma symptoms.

Your doctor may prescribe Bedufora in two different ways:

a)
Bedufora should be used daily to treat asthma, along with another inhaled medicine that provides quick relief in case of sudden worsening of asthma symptoms, such as shortness of breath, wheezing, and cough.

Adults and the elderly:

The recommended dose is one or two actuations, twice daily. The maximum daily dose is 4 actuations.
Remember: You should always carry a quick-acting inhaled medicine with you to treat sudden worsening of asthma symptoms or a sudden asthma attack.
b)
Bedufora should be used daily to treat asthma, as well as to provide quick relief in case of sudden worsening of asthma symptoms, such as shortness of breath, wheezing, and cough.

Adults and the elderly:

The recommended dose is one actuation in the morning and one actuation in the evening.
You should also use Bedufora as a quick-acting inhaled medicine in case of sudden worsening of asthma symptoms.
If asthma symptoms occur, you should use one actuation and wait a few minutes.
If there is no improvement, you should use another actuation.

Do not use more than 6 quick-relief actuations of Bedufora in 24 hours.

The maximum daily dose of Bedufora as the only inhaler for asthma treatment is 8 actuations.

If you need to take more actuations to control your asthma symptoms, you should 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 the elderly:

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 no information on the use of Bedufora in patients with liver or kidney impairment.

The dose of beclometasone dipropionate in Bedufora, which is effective in treating asthma, may be lower than the dose contained in other inhaled medicines containing beclometasone dipropionate. If you have previously used another inhaled medicine containing beclometasone dipropionate, your doctor will recommend the appropriate dose of Bedufora to use for asthma treatment.

Do not increase the dose.

If you feel that the effect of the medicine is too weak, you should always consult your doctor before increasing the dose.
In case of worsening breathing difficulties:

If shortness of breath or wheezing worsens(breathing with a noticeable whistling sound) immediately after inhaling the medicine, you should stop using Bedufora immediatelyand use a quick-acting inhaled medicineright away. You should contact your doctor as soon as possible, who 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 if you have difficulty controlling them (e.g., if you need to use another inhaled medicine or Bedufora as a quick-relief medicine more often), or if a quick-relief medicine or Bedufora does not relieve your symptoms, you should contact your doctor right away. This may indicate that your asthma is worsening, and your doctor may decide to change your Bedufora dose or prescribe alternative treatment.

Method of administration:

Bedufora is intended for inhalation use.

This medicine is contained in a pressurized canister, in a plastic holder 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 informs you of the number of doses remaining.
In the case of a 120-dose packaging, each press of the canister releases a dose of the medicine, and the dose counter counts down by one. Be careful not to drop the inhaler, as this may cause the counter to count down.
In the case of a 180-dose packaging, the dose indicator will show an approximate number of uses (actuations) remaining in the canister. The dose indicator window displays the number of actuations remaining in the inhaler in units of twenty (e.g., 180, 120, 100, 80, etc.). When 20 doses remain, and the display shows 20, it means that the canister is approaching the end of its usage period.
When 180 doses have been used, the display will show 0.
The indicator will stop moving at "0".

Testing the inhaler:

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

• Remove the protective cap from the mouthpiece.
• Hold the canister in an upright position with the mouthpiece pointing downwards.
• Point the mouthpiece away from you and press the canister firmly to release one actuation.
• If the inhaler has not been used for 14 days or more, press the canister firmly to release one actuation.
• For a 120-dose packaging, check the dose counter. If the inhaler is being tested for the first time, the counter should show 120.
• For a 180-dose packaging, check the dose indicator. If the inhaler is being tested for the first time, the counter should show 180.

How to use the inhaler:

If possible, you should stand or sit upright while inhaling.
Before inhaling, check the dose counter or dose indicator, which shows how many doses are remaining. If the dose counter or dose indicator shows "0", there are no doses remaining - you should discard the inhaler and purchase a new one.

• 1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust or other contaminants (Figure 1).

• 2. Exhale slowly and as deeply as possible (Figure 2).
• 3. Hold the canister in an upright position, with the stem pointing upwards, and then place the mouthpiece between your lips. Do not bite the mouthpiece (Figure 3).
• 4. Take a deep and slow breath in through your mouth. Just after starting to breathe in, press the top of the inhaler firmlyto release one actuation of the medicine. If you have a weak grip, it will be easier to hold the inhaler with both hands: you should then place both index fingers on the top of the inhaler and both thumbs on the bottom (Figure 4).
• 5. Hold your breath for 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 you need to take another actuation, hold 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, replace the protective cap and check the dose counter for a 120-dose packaging and the dose indicator for a 180-dose packaging.
To reduce the risk of fungal infection of the mouth and throat, you should rinse your mouth or throat with water, or brush your teeth after each inhalation.

When to replace the inhaler

If the counter or dose indicator shows 20, you should have a new inhaler ready.
You should stop using the inhaler and start using a new inhaler when the counter shows 0, as the remaining medicine in the canister may not provide a full dose.

If a "mist" appears from the top of the inhaler or from the side of the mouth, it means that Bedufora is not reaching the lungs as it should. You should take another actuation, following the instructions, starting again from step 2.

If you feel that the effect of Bedufora is too strong or too weak, you should consult your doctor or pharmacist.
If you have difficulty using the inhaler during inhalation, you can use a spacer (AeroChamber Plus). You should ask your doctor, pharmacist, or nurse about this device.
It is essential to carefully read the leaflet accompanying the AeroChamber Plus spacer and follow the instructions for use and cleaning recommendations.

Cleaning

The inhaler should be cleaned once a week.

When cleaning, do not remove the canister from the plastic holder, and 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 dose counter from the inside and outside with a dry cloth or tissue.
• 3. Replace the protective cap.

Using more than the recommended dose of Bedufora:

• using more than the recommended dose of formoterol may cause the following symptoms: nausea, vomiting, rapid heartbeat, palpitations, arrhythmias, changes in the electrocardiogram (ECG), headache, tremors, drowsiness, too many acidic products in the blood, decreased potassium levels in the blood, increased glucose levels in the blood. Your 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 temporary adrenal gland problems. This condition will improve within a few days, but your doctor may recommend a blood test to check cortisol levels in the blood.

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

If you experience any of these symptoms, you should inform your doctor.

Missing a dose of Bedufora:

You should take the missed dose as soon as possible. If it is almost time for the next dose, do not take the missed dose, just take the next dose at the usual planned time. Do not take a double doseto make up for a missed dose.

Stopping treatment with Bedufora:

Even if you feel better, you should not stop using Bedufora or reduce the dose without consulting your doctor. It is very important to use the medicine regularly, even when your symptoms have disappeared.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Bedufora 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 Bedufora, known as paradoxical bronchospasm. You should stop using Bedufora immediatelyand use a quick-acting inhaled bronchodilator to relieve shortness of breath and wheezing. You should contact your doctor right away.
You should tell your doctor immediately if you experience any allergic reactions, such as: skin allergies, itching, skin rash, skin redness, swelling of the skin or mucous membranes, especially of the eyes, face, lips, and throat.
Other possible side effects are listed below by frequency of occurrence.
Common(may affect up to 1 in 10 people):

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

Pneumonia (lung infection) in patients with COPD:
You should tell your doctor if any of the following symptoms occur while using Bedufora; these may be symptoms of pneumonia:

• fever or chills
• increased production of sputum or change in sputum color
• worsening cough or increased difficulty breathing.

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

• palpitations, irregular heartbeat, and arrhythmias,
• changes in the electrocardiogram (ECG),
• flu-like symptoms,
• sinusitis,
• nasal congestion,
• ear infection,
• throat irritation,
• cough and cough with sputum production,
• asthma attack,
• vaginal fungal infection,
• nausea,
• taste disturbances,
• mouth burning,
• dry mouth,
• difficulty swallowing,
• indigestion,
• stomach upset,
• diarrhea,
• muscle pain and muscle cramps,
• redness of the face and throat,
• increased blood flow to some tissues,
• increased sweating,
• tremors,
• restlessness, especially movement-related,
• 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 levels, free fatty acids, and ketone bodies in the blood.

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

• decreased cortisol levels in the blood, which is caused by the effect of corticosteroids on the adrenal glands.
• irregular heartbeat.

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

• feeling of pressure in the chest,
• arrhythmias (caused by premature contraction of the heart),
• increased blood pressure,
• decreased blood pressure,
• kidney inflammation,
• swelling of the skin and mucous membranes, 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.

Using inhaled corticosteroids in high doses for a long time may

cause systemic effects in very rare cases. These include:

• adrenal gland problems (suppression of adrenal gland function),
• decreased bone density (thinning of the bones),
• delayed growth in children and adolescents,
• increased eye pressure (glaucoma),
• cataracts.

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

• sleep disturbances,
• depression or feeling depressed,
• nervousness,
• excessive excitement or irritability.

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

• blurred vision.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bedufora

The medicine should be stored out of sight and reach of children.
Single packaging containing one inhaler with 120 doses or 180 doses

For the pharmacist

Store in a refrigerator (2°C – 8°C) for a maximum of 18 months.
Write the dispensing date on the label sticker on the packaging and attach the sticker to the inhaler.
Make sure that the period between the dispensing date and the expiry date printed on the packaging is at least 3 months.

For the patient

Do not store the inhaler at a temperature above 25°C.
Do not use Bedufora for more than 3 months from the date you received the inhaler from the pharmacist and never use it after the expiry date stated on the carton and label after "EXP". The expiry date refers to the last day of the month stated.
Double or triple packaging containing two or three inhalers with 120 or 180 doses
Before first use: store the inhalers in a refrigerator (2°C – 8°C) for a maximum of 18 months.
After first use: do not store the inhalers at a temperature above 25°C. Store for a maximum of 3 months.
Each time you start using an inhaler, write the date of first use on one of the label stickers and attach the sticker to the inhaler. Do not use this medicine after the expiry date stated on the carton and label after "EXP". The expiry date refers to the last day of the month stated.
Do not freeze.
If the inhaler has been exposed to very low temperatures, you should warm it in your hands for a few minutes before use. Never use other methods to warm the canister.
Caution: The canister contains a pressurized liquid. Do not expose to temperatures above 50°C. Do not pierce the canister.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Bedufora contains:

The active substances of the medicine are: beclometasone dipropionate and formoterol fumarate dihydrate.
Each actuation/dose of 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 5.0 micrograms of formoterol fumarate dihydrate.
The other ingredients are: anhydrous ethanol, hydrochloric acid, and norflurane (HFA-134a).
This medicine contains fluorinated greenhouse gases.
Each inhaler containing 120 doses contains 8.15 g of HFA-134a, which corresponds to 0.012 tons of CO2 equivalent (global warming potential GWP = 1,430).
Each inhaler containing 180 doses contains 11.2 g of HFA-134a, which corresponds to 0.016 tons of CO2 equivalent (global warming potential GWP = 1,430).

What Bedufora looks like and contents of the packaging:

Bedufora is available as a solution for inhalation, contained in a pressurized aluminum canister, with a dose counter and a mouthpiece, and a pink protective plastic cap.
Each packaging 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 authorization holder:

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer:

Genetic S.p.A.
Contrada Canfora
84084 Fisciano
Italy
To obtain further information, you should contact the local representative of the marketing authorization holder:
Stada Pharm Sp. z o.o.
Krakowiaków Street 44
02-255 Warsaw
Phone: +48 22 737 79 20

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria
Beclometason/Formoterol STADA 100 Mikrogramm /6 Mikrogramm pro Sprühstoß, Druckgasinhalation, Lösung
Belgium
Beclometasone/Formoterol EG 100/6 microgram/dosis aërosol, oplossing
Croatia
Laberon 100/6 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

Date of last revision of the leaflet: