Bedufora

Patient Information Leaflet

Bedufora, (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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

1. What 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 containing two active substances, which are inhaled through the mouth and delivered directly to the lungs.
The medicine contains two active ingredients: beclometasone dipropionate and formoterol fumarate dihydrate.
Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which have anti-inflammatory action by reducing swelling and irritation in the lungs.
Formoterol fumarate dihydrate belongs to a group of long-acting bronchodilator medicines that relax the muscles in the airways and make breathing easier.
Together, these two active substances help breathing by relieving symptoms such as breathlessness, wheezing, and cough in patients with asthma, and also help prevent asthma symptoms.
Bedufora is intended for the treatment of asthma in adults.
Bedufora is used in patients who:

• do not have their asthma symptoms sufficiently controlled with inhaled corticosteroids and a short-acting reliever bronchodilator

or

• have achieved adequate control of asthma symptoms with both inhaled corticosteroids and long-acting bronchodilators.

2. Important information before using Bedufora

When not to use Bedufora:

• if the patient is allergic to beclometasone dipropionate or formoterol fumarate dihydrate, or to 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 diseases, such as angina (chest pain), heart failure, coronary artery narrowing, heart valve disorders, or any other heart conditions
• if the patient has high blood pressure or a diagnosed aneurysm (an abnormal widening of the blood vessel wall)
• if the patient has heart rhythm disorders, such as rapid or irregular heartbeat, increased heart rate, or palpitations, or if there is any history of abnormal heart rhythm
• if the patient has hyperthyroidism
• if the patient has low blood potassium levels
• if the patient has liver or kidney disease
• if the patient has diabetes (inhalation of 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)
• if the patient has a pheochromocytoma (an adrenal gland chromaffin tumor)
• if the patient is scheduled for general anesthesia. Depending on the type of anesthesia, treatment with Bedufora may need to be discontinued at least 12 hours before anesthesia
• if the patient is currently 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 before using Bedufora.
Before using this medicine, consult your doctor, pharmacist or nurse if you currently have or have had any medical problems or allergies, or if you have any doubts about whether Bedufora can be used.
Your doctor may periodically order blood tests to check potassium levels, especially in patients with severe asthma. Like other bronchodilators, Bedufora may cause a sudden decrease in serum potassium (hypokalemia). This is associated with low oxygen levels in the blood caused by concomitant use of other medications with Bedufora, which may worsen the reduction in blood potassium levels.
If the patient is taking high doses of inhaled corticosteroids for a prolonged period, they may require additional corticosteroid treatment during periods of stress. Stress situations may include hospital admission following an accident, serious injury, or prior to surgery. In such cases, the treating physician will decide whether to increase the corticosteroid dose or recommend alternative steroid treatment in tablet form or by injection.
If hospital treatment is required, the patient should remember to bring all their medicines and inhalers, including Bedufora, as well as any over-the-counter medications, preferably in their original packaging.
If the patient experiences blurred vision or any other visual disturbances, contact a doctor immediately.

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

Bedufora and other medicines

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

In particular, inform your doctor, pharmacist or nurse if the patient is using the following medicines:

• certain medicines may enhance the effects of Bedufora, and the doctor may wish to closely monitor the patient taking such medicines (including some HIV medications: ritonavir, cobicistat);
• beta-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 (including eye drops) must be used, the effect of formoterol may be reduced or formoterol may not work at all;
• beta-adrenergic agonists (medicines that act similarly to formoterol) – may intensify the effects of formoterol;
• medicines used to treat abnormal heart rhythms (quinidine, disopyramide, procainamide);
• medicines used to treat allergies (antihistamines);
• medicines used to treat depression or psychiatric disorders, such as monoamine oxidase inhibitors (e.g. phenelzine, isocarboxazid), tricyclic antidepressants (e.g. amitriptyline, 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 the patient is scheduled to receive general anesthesia for surgery or a dental procedure.

Pregnancy, breastfeeding and fertility

There are no clinical data on the use of Bedufora during pregnancy.
Bedufora 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 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 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 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 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 Bedufora.
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 4 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 dosage in elderly patients. There is insufficient information regarding the use of Bedufora 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 Bedufora 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 the appropriate dose of Bedufora to use for asthma treatment.
Do not increase the dose.
If you feel the medicine is not effective enough, always consult your doctor before increasing the dose.
In case of worsening asthma symptoms:
If your symptoms worsen or become difficult to control (e.g., if you need to use your reliever inhaler more frequently), or if your reliever inhaler does not relieve symptoms, contact your doctor immediately. This may indicate worsening asthma, and your doctor may decide to change the dose of Bedufora or initiate alternative treatment.
Method of administration:
Bedufora 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, 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 an approximate number of remaining uses (sprays) in the canister. The dose indicator window displays the number of remaining sprays in increments of twenty (e.g., 180, 120, 100, 80, etc.). When 20 doses remain and the display shows "20", this indicates the canister is nearing the end of its use. After 180 doses have been delivered, 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 spray.
• If the inhaler has not been used for 14 days or longer, press the canister firmly to release one spray.
• If using the inhaler for the first time, press the canister firmly once to release a spray.
• For the 120-dose pack, check the dose counter. If testing for the first time, the counter should display 120.
• For the 180-dose pack, check the dose indicator. If testing for the first time, the indicator should display 180.

How to use the inhaler:
If possible, stand or sit upright during inhalation.
Before starting inhalation, check the dose counter or dose indicator to see how many doses remain. If the counter or indicator shows "0", no doses remain—discard the inhaler and obtain a new one.

1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust or other debris (Figure 1).
2. Breathe out as deeply and slowly as possible (Figure 2).
3. Hold the canister upright with the mouthpiece at the top, 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 as you begin to inhale, press firmly on the top of the inhaler to release one spray of medicine. For patients with weak grip, it may be easier to hold the inhaler with both hands: place both index fingers on the top of the inhaler and both thumbs on the base (Figure 4).
5. Hold your breath as long as possible, then remove the inhaler from your mouth and breathe out slowly. Do not exhale into the inhaler (Figure 5).

If a second dose is required, 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 fungal infection in the mouth or throat, rinse your mouth or throat with water immediately after each inhalation, or brush your teeth.
When to replace the inhaler
When the counter or dose indicator shows "20", have a new inhaler ready.
Stop using the inhaler when the indicator 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 spray as instructed, 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 or pharmacist about this device.
It is important to carefully read the leaflet provided with the AeroChamber Plus spacer and follow the instructions for use and cleaning recommendations.
Cleaning
Clean the inhaler once a week.
Do not remove the canister from the plastic casing. Do not use water or other liquids to clean the inhaler.
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:

• Overdosing on formoterol may cause the following symptoms: nausea, vomiting, faster heartbeat, palpitations, heart rhythm disturbances, changes in electrocardiogram (ECG), headache, tremor, drowsiness, excess acidic metabolic products in the blood, low blood potassium levels, and increased blood glucose levels. Your doctor may recommend a blood test to check potassium and glucose levels.
• Overdosing on beclometasone dipropionate may cause temporary impairment of adrenal function. 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 immediately.
Missed dose of Bedufora
Take the missed dose as soon as possible. If it is almost time for your next dose, do not take the missed dose—take only 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 Bedufora 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 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, inhalation of Bedufora must be STOPPED IMMEDIATELY, and a fast-acting inhaled bronchodilator should be used to relieve symptoms of breathlessness and wheezing. Immediate contact with your doctor is required.
You must inform your doctor immediately if any hypersensitivity reactions occur, such as: skin allergies, skin itching, skin rash, skin redness, or swelling of the skin or mucous membranes, particularly of the eyes, face, lips, or throat.

Other possible adverse reactions 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.

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

• palpitations, abnormally rapid heartbeat, and heart rhythm disturbances,
• 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:
  o decreased white blood cell count,
  o increased platelet count,
  o decreased blood potassium concentration,
  o increased blood glucose concentration,
  o increased blood insulin, free fatty acids, and ketone bodies concentrations.

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

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

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

• chest tightness,
• heart rhythm disturbances (caused by premature ventricular contractions),
• low 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, high-dose use of inhaled corticosteroids may, in very rare cases, lead to systemic effects, including:

• adrenal suppression (impaired adrenal function),
• decreased bone mineral density (osteoporosis),
• growth retardation in children and adolescents,
• increased intraocular pressure (glaucoma),
• cataract.

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

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

These adverse reactions are more likely to occur in children, but their frequency is unknown.

• blurred vision.

Reporting of adverse reactions
If any adverse reactions occur, including any 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 to provide more information on the safety of this 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 supply to the patient on the self-adhesive label on the packaging and affix the label to the inhaler.
Ensure that the period between the date of supply 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 it after the expiry date stated on the carton and label after "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 a maximum of 3 months. Each time a new inhaler is started, enter the date of first use on one of the self-adhesive labels and affix it 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 stated month.
Do not freeze.
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 pressurised liquid. Do not expose to temperatures above 50°C. Do not pierce the container.
Medicines should not be disposed of via the sewage system 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 Bedufora contains:
The active substances in this medicine are: beclometasone dipropionate and formoterol fumarate dihydrate.
Each 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.
The other ingredients are: norflurane (HFA-134a), anhydrous ethanol, concentrated hydrochloric acid.
This medicine contains fluorinated greenhouse gases.
Each inhaler containing 120 doses contains 10.35 g of HFA-134a, equivalent to 0.015 tonnes of CO₂e (global warming potential GWP = 1,430).
Each inhaler containing 180 doses contains 14.24 g of HFA-134a, equivalent to 0.020 tonnes of CO₂e (global warming potential GWP = 1,430).

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

• 1 pressurized container containing 120 doses, or
• 2 pressurized containers, each containing 120 doses, or
• 3 pressurized containers, each containing 120 doses, or
• 1 pressurized container containing 180 doses, or
• 3 pressurized containers, 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 detailed information, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
Tel. +48 22 737 79 20

This medicinal product is authorised in the European Economic Area countries under the following names:

Austria  Beclometason/Formoterol STADA 200 Mikrogramm /6 Mikrogramm pro Sprühstoß, Druckgasinhalation, Lösung
Belgium  Beclometasone/Formoterol EG 200 microgram/dosis aërosol, oplossing
Croatia  Laberon 200/6 mikrograma po potisku, stlačeni inhalat, otopina
Czech Republic  Oreto
Denmark  Laberon
Estonia  Bedufora
Greece  Beclometasone+Formoterol / STADA
Finland  Oparta 200 mikrog / 6 mikrog/annos inhalaatiosumute, liuos
France  BECLOMETASONE / FORMOTEROL EG 200 / 6 microgrammes/dose, solution pour inhalation en flacon pressurisé
Iceland  Laberon
Lithuania  Bedufora 200 mikrogramų/6 mikrogramai/spūsnyje suslėgtasis įkvepiamasis tirpalas
Latvia  Bedufora 200 mikrogrami/6 mikrogrami izsmidzinājumā aerosols inhalācijām, zem spiediena, šķīdums
Norway  Laberon
Germany  Beclometason/Formoterol AL 200 Mikrogramm/6 Mikrogramm pro Inhalation Druckgasinhalation, Lösung
Netherlands  Beclometason/Formoterol CF 200/6 microgram/dosis, aërosol, oplossing
Poland  Bedufora
Romania  Beclometazonă /Formoterol Stada, 200/6 micrograme pe doză, soluţie de inhalat presurizată
Sweden  Oparta 200 mikrogram/6 mikrogram per dos inhalationsspray, lösning
Slovakia  Beklometazón/Formoterol STADA 200/6 mikrogramov/dávka
Italy  BECLOMETASONE E FORMOTEROLO EG