Bibecfo 100 micrograms/6 micrograms/puff solution for inhalation in pressurized container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bibecfo 100 micrograms/6 micrograms per actuation, pressurised inhalation solution.

beclometasone dipropionate/formoterol fumarate dihydrate

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Bibecfo is and what it is used for

Bibecfo is a pressurized metered-dose inhalation solution containing two active substances that are inhaled through the mouth and delivered directly into the lungs.

The two active substances are beclometasone dipropionate and formoterol fumarate dihydrate. Beclometasone dipropionate belongs to a group of medicines called corticosteroids, which have an anti-inflammatory action that reduces inflammation and irritation in your lungs.

Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators that relax the muscles in the airways, helping you to breathe more easily.

The combination of these two active substances helps to improve breathing by providing relief from symptoms such as breathlessness, wheezing, and coughing in patients with asthma or chronic obstructive pulmonary disease (COPD). It also helps prevent asthma symptoms.

Asthma

This medicine is indicated for the regular treatment of asthma in adult patients in whom:

• Asthma is not adequately controlled with inhaled corticosteroids and short-acting bronchodilators taken "as needed".

or:

• Asthma is well controlled with a combination therapy of corticosteroids and long-acting bronchodilators.

COPD

This medicine may also be used to treat symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a chronic lung airway disease primarily caused by cigarette smoking.

2. What you need to know before using Bibecfo

Do not use Bibecfo:

• If you are 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

Talk to your doctor, pharmacist, or nurse before starting to use Bibecfo:

• If you have heart problems, such as angina (chest pain, heart pain), a recent heart attack (myocardial infarction), heart failure, narrowing of the arteries around the heart (coronary heart disease), heart valve disease, or any other known heart condition, or if you have a condition called obstructive hypertrophic cardiomyopathy (also known as HCM, in which the heart muscle is enlarged).

• If you have narrowing of the arteries (also called atherosclerosis), if you have high blood pressure, or if you know you have an aneurysm (an abnormal bulging of a blood vessel wall).

• If you have heart rhythm disorders, such as increased heart rate or irregular heartbeat, a fast pulse, palpitations, or if you have been told you have electrocardiographic abnormalities.

• If your thyroid gland is overactive.

• If your blood potassium levels are low.

• If you have any liver or kidney disease.

• If you are diabetic (inhaling high doses of formoterol may increase blood glucose levels, so you may need additional blood tests to monitor your blood sugar when you start using the inhaler and occasionally during treatment).

• If you have a tumour of the adrenal glands (called a phaeochromocytoma).

• If you are due to receive anaesthesia. Depending on the anaesthetic agent used, you may need to stop using this medicine at least 12 hours before anaesthesia.

• If you are being treated or have previously been treated for tuberculosis (TB), or if you have a known viral or fungal lung infection.

• If you cannot take alcohol for any reason.

If any of the above apply to you, always inform your doctor before using beclometasone/formoterol.

If you have or have had any medical problems or allergies, or if you are unsure whether you can use this medicine, consult your doctor, nurse, or pharmacist before using this medicine.

Treatment with a β2 agonist such as formoterol contained in this medicine may cause a sudden drop in serum potassium levels (hypokalaemia).

Take special care if you have severe asthma. This is because low oxygen levels in the blood and other treatments you may be receiving alongside beclometasone/formoterol, such as medicines for heart conditions or high blood pressure (known as diuretics) or other medicines used to treat asthma, may worsen the drop in potassium levels. Therefore, your doctor may want to check your blood potassium levels from time to time.

If you take higher doses of inhaled corticosteroids for prolonged periods, you may require corticosteroids during times of stress. Such situations include hospital admission following an accident, a serious injury, or before surgery. In such cases, your treating doctor will decide whether corticosteroid doses need to be increased and may prescribe steroid tablets or injections.

If you go to hospital, remember to bring all your medicines and inhalers with you, including beclometasone/formoterol and any other medicines or over-the-counter tablets, preferably in their original packaging.

Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age until more data are available.

Other medicines and Bibecfo

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines for asthma and COPD, or other medicines obtained without a prescription.

Some medicines may increase the effects of beclometasone/formoterol, so your doctor will monitor you closely if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).

Do not use beta-blockers with this medicine

Beta-blockers such as atenolol, propranolol, and sotalol are used to treat various conditions, including high blood pressure and heart conditions such as abnormal heart rhythms and heart failure; timolol is used to treat glaucoma. If you need to use beta-blockers, including eye drops, the effect of formoterol may be reduced or even blocked. Conversely, the use of other beta-adrenergic drugs (drugs that work similarly to formoterol) may enhance the effects of formoterol.

The combined use of Bibecfo with:

• Medicines used to treat heart rhythm disorders (quinidine, disopyramide, procainamide), medicines used to treat allergic reactions (antihistamines), medicines used to treat symptoms of depression or psychiatric disorders, such as monoamine oxidase inhibitors (e.g. phenelzine and isocarboxazide), tricyclic antidepressants (e.g. amitriptyline and imipramine), and phenothiazines, may lead to electrocardiographic abnormalities (ECG). They may also increase the risk of heart rhythm disorders (ventricular arrhythmias).

• Medicines used to treat Parkinson’s disease (L-dopa) or an underactive thyroid gland (L-thyroxine), medicines containing oxytocin (which causes uterine contractions), and alcohol, may reduce cardiac tolerance to β2 agonists such as formoterol.

• Monoamine oxidase inhibitors (MAOIs), including drugs with similar properties such as furazolidone and procarbazine, used to treat psychiatric disorders, may cause an increase in blood pressure.

• Medicines used to treat heart conditions (digoxin), may cause a drop in serum potassium levels. This may increase the likelihood of heart rhythm disorders.

• Other medicines used to treat asthma (theophylline, aminophylline, or steroids) and diuretics, may cause a drop in serum potassium levels.

• Some anaesthetics may increase the risk of heart rhythm disorders.

Pregnancy, breastfeeding, and fertility

There are no clinical data on the use of beclometasone/formoterol during pregnancy.

Do not use beclometasone/formoterol if you are pregnant or think you may be pregnant, if you are planning to become pregnant, or if you are breastfeeding, unless your doctor tells you otherwise.

Driving and using machines

It is unlikely that beclometasone/formoterol will affect your ability to drive or operate machinery. However, if you experience side effects such as dizziness and/or tremors, your ability to drive or operate machinery may be impaired.

Bibecfo contains alcohol

This medicine contains 7 mg of alcohol (ethanol) in each actuation. The amount of alcohol in one actuation of this medicine is equivalent to less than 1 ml of beer or wine. The small amount of alcohol contained in this medicine does not produce any noticeable effect.

3. How to use Bibecfo

Bibecfo is for inhalation use. This medicine must be inhaled through the mouth into the lungs.

Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Asthma

Your doctor will periodically review you to ensure you are taking the optimal dose of beclometasone/formoterol. Your doctor will always adjust the treatment to the lowest dose that adequately controls your symptoms.

This medicine may be prescribed by your doctor in two different ways:

1. Use beclometasone/formoterol daily to treat your asthma, together with a separate "rescue" inhaler to treat sudden worsening of asthma symptoms, such as difficulty breathing, wheezing, and cough.

2. Use beclometasone/formoterol daily to treat your asthma and also use beclometasone/formoterol as needed to treat sudden worsening of asthma symptoms, such as difficulty breathing, wheezing, and cough.

3. Use of Bibecfo together with a separate "rescue" inhaler:

Adults and elderly patients:

The recommended dose of this medicine is one to two inhalations twice daily. The maximum daily dose is four inhalations.

Remember: You should always carry a fast-acting "rescue" inhaler to treat worsening asthma symptoms or a sudden asthma attack.

2. Use of Bibecfo as the sole asthma inhaler:

Adults and elderly patients:

The recommended dose of this medicine is one inhalation in the morning and one inhalation at night.

You should also use beclometasone/formoterol as a "rescue" inhaler to treat sudden asthma symptoms.

If you experience asthma symptoms, inhale one dose and wait a few minutes. If you do not feel better, inhale another dose.

Do not inhale more than 6 rescue puffs of beclometasone/formoterol per day.

The maximum daily dose of beclometasone/formoterol is 8 puffs.

If you feel you need more puffs per day to control your asthma symptoms, contact your doctor for advice. You may need to change your treatment.

Use in children and adolescents under 18 years of age:

Children and adolescents under 18 years of age MUST NOT take this medicine.

Chronic obstructive pulmonary disease (COPD)

Adults and elderly patients:

The recommended dose is two puffs in the morning and two puffs at night.

At-risk patients:

Elderly patients do not require dose adjustment. There is no information available on the use of this medicine in patients with hepatic or renal impairment.

Bibecfo is effective for the treatment of asthma at a dose of beclometasone dipropionate that may be lower than that of other inhalers containing the same component. If you have previously been using another inhaler containing beclometasone dipropionate, your doctor will advise you on the exact dose of this medicine you should take for asthma.

Do not increase the dose.

If you think the medicine is not working well, always consult your doctor before increasing the dose.

Method of administration

Bibecfo is for inhalation use only

This medicine is contained in a pressurized cartridge inside a plastic casing with a mouthpiece. There is a dose counter on the back of the inhaler indicating how many doses remain. Each time you press the cartridge, one puff of medicine is released and the counter decreases by one dose. Be careful not to drop the inhaler, as this could cause the counter to decrement.

Checking your inhaler

Before using the inhaler for the first time, or if you have not used it for 14 days or more, you must check your inhaler to ensure it is working properly.

1. Remove the protective cap from the mouthpiece.
2. Hold the inhaler upright with the mouthpiece at the bottom.
3. Point the mouthpiece away from you and firmly press down on the cartridge to release one puff.
4. Check the dose counter. If checking the inhaler for the first time, the counter should display 120.

How to use your inhaler

Whenever possible, stand or sit upright when inhaling.

Before beginning to inhale, check the dose counter: any number between "1" and "120" indicates that doses remain. If the dose counter shows "0", no doses remain: discard your inhaler and obtain a new one.

1. Remove the protective cap from the mouthpiece and check that it is clean and free from dust, dirt, or other foreign particles.
2. Breathe out slowly and as completely as possible.
3. Hold the cartridge upright with the body facing upwards and place the mouthpiece between your lips. Do not bite the mouthpiece.
4. Breathe in slowly and deeply through your mouth, and just as you begin to inhale, firmly press down on the top of the inhaler to release one puff. If you have weak hands, it may be easier to hold the inhaler with both hands: place both index fingers on top of the inhaler and both thumbs underneath the base.
5. Hold your breath for as long as you can, then remove the inhaler from your mouth and breathe out slowly. Do not exhale into the inhaler.

If you need to inhale a second puff, 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 administration, replace the protective cap and check the dose counter.

You should replace the inhaler when the counter shows the number 20. Stop using the inhaler when the counter reads 0, as the remaining puffs in the device may not provide a full dose.

If you see a "mist" escaping from the top of the inhaler or from the corners of your lips, this means the medicine is not reaching your lungs as it should. Take another puff, following the instructions starting again from step 2.

To reduce the risk of fungal infection in the mouth and throat, rinse your mouth or gargle with water, or brush your teeth each time you use the inhaler.

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

If you find it difficult to press the inhaler while starting to breathe in, you may use the AeroChamber Plus™ spacer device. Consult your doctor, pharmacist, or nurse about using this device.

It is important that you read the leaflet provided with the AeroChamber Plus™ spacer device and carefully follow the instructions on how to use and clean the AeroChamber Plus™ spacer device.

Cleaning

You should clean the inhaler once a week.

When cleaning, do not remove the cartridge from the actuator and do not use water or other liquids to clean the inhaler.

To clean the inhaler:

1. Remove the mouthpiece cap by separating it from the inhaler.
2. Wipe the inside and outside of the mouthpiece and actuator with a clean, dry cloth or paper towel.
3. Replace the mouthpiece cap.

If you use more Bibecfo than you should

• If you use more formoterol than you should, you may experience the following adverse effects: nausea, vomiting, rapid pulse, palpitations, cardiac rhythm disturbances, certain electrocardiographic changes (heart signal), headache, tremors, drowsiness, excess acid in the blood, low blood potassium levels, and high blood glucose levels. Your doctor may request blood tests to check your potassium and glucose levels.
• Taking too much beclometasone dipropionate may cause short-term disturbances in adrenal gland function. This condition will resolve within a few days. However, your doctor may check your serum cortisol concentration.

Consult your doctor if you experience any of these symptoms.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount ingested.

If you forget to use Bibecfo

Do not take a double dose to make up for a missed dose. Take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at the regular time.

If you stop using Bibecfo

Do not reduce the dose or stop using the medicine. Even if you feel better, do not stop using this medicine or reduce the dose. If you wish to do so, consult your doctor. It is very important to use this medicine regularly even if you do not have symptoms.

If asthma worsens

If symptoms worsen or become difficult to control (for example, if you are using your separate rapid-acting inhaler or beclometasone/formoterol as a rescue inhaler more frequently), or if the rapid-acting inhaler or beclometasone/formoterol does not help improve symptoms, see your doctor immediately. Your asthma may be worsening, and your doctor may need to increase the dose of beclometasone/formoterol or prescribe an alternative treatment.

If you have any further questions about the use of this medicine, ask 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 treatments using inhalers, there is a risk of worsening breathing difficulty and wheezing immediately after using beclometasone/formoterol, a condition known as paradoxical bronchospasm. If this occurs, STOP using beclometasone/formoterol and use your fast-acting inhaler immediately to treat symptoms of breathing difficulty and wheezing. Contact your doctor immediately.

Inform your doctor immediately if you experience hypersensitivity reactions, such as skin allergies, itching, rash, skin redness, or swelling of the skin or mucous membranes, especially in the eyes, face, lips, and throat.

Other adverse effects are listed below according to their frequency.

Frequent (affects less than 1 in 10 people):

• Fungal infections (of the mouth and throat)
• Headache
• Hoarseness
• Sore throat

Pneumonia in patients with COPD: inform your doctor if you experience any of the following symptoms while inhaling this medicine, as they could be signs of a lung infection:

• Fever or chills
• Increased mucus production, change in mucus color
• Increased cough or increased breathing difficulty

Uncommon (affects less than 1 in 100 people):

• Exceptionally rapid heartbeat and disturbances in heart rhythm
• Certain electrocardiographic (ECG) abnormalities
• Asthma attacks
• Tremors
• Restlessness
• Dizziness
• Palpitations
• Flu-like symptoms
• Fungal infections of the vagina
• Sinus inflammation
• Ear inflammation
• Throat irritation
• Cough and productive cough
• Nausea
• Taste disturbances or reduced sense of taste
• Burning sensation of the lips
• Dry mouth
• Difficulty swallowing
• Indigestion
• Gastric discomfort
• Diarrhea
• Muscle pain and cramps
• Facial redness
• Excessive sweating
• Increased blood flow in certain body tissues
• Rhinitis

Alterations in certain blood components:

• Decreased number of leukocytes
• Increased number of platelets
• Decreased concentration of potassium in blood
• Increased concentration of glucose in blood
• Increased concentration of insulin, free fatty acids, and ketones in blood
• Rash or hives

The following adverse effects have also been reported as "uncommon" in patients with Chronic Obstructive Pulmonary Disease (COPD):

• Reduced blood cortisol levels; this is caused by the effect of corticosteroids on your adrenal gland
• Irregular heartbeats

Rare (affects less than 1 in 1,000 people):

• Sensation of chest tightness
• Sensation of missed heartbeats
• Increase or decrease in blood pressure
• Kidney inflammation
• Persistent swelling of the skin and mucous membranes lasting several days

Very rare (affects less than 1 in 10,000 people):

• Worsening of asthma
• Difficulty breathing
• Decreased number of platelets
• Swelling of the hands and feet

Inhaled corticosteroids at high doses over a prolonged period may very rarely cause systemic effects. These include:

• Adrenal gland function problems (adrenal suppression)
• Increased intraocular pressure (glaucoma)
• Cataracts
• Growth retardation (slowed growth in children and adolescents)
• Decreased bone mineral density (weakened bones)

Not known (frequency cannot be estimated from available data):

• Sleep disorders
• Depression or feeling anxious
• Restlessness
• Nervousness
• Over-excitability or irritability

These effects may occur especially in children.

• Blurred vision

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bibecfo

• Keep this medicine out of the sight and reach of children.

• Before dispensing: store in the refrigerator (between 2 °C and 8 °C).

• After dispensing (medicine dispensed by your pharmacist):

• Do not use this medicine after 3 months from the date it was dispensed by your 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 indicated.

• Do not store the inhaler at temperatures above 25 °C.

• If the inhaler has been exposed to extreme cold, warm it with your hands for a few minutes before use. Never heat it by artificial means.

Warning: The cartridge contains pressurized liquid. Do not expose the cartridge to temperatures above 50 °C. Do not pierce the cartridge.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This helps protect the environment.

6. Contents of the pack and other information

Composition of Bibecfo

• The active substances are: beclometasone dipropionate and formoterol fumarate dihydrate. Each actuation/measured dose of the inhaler contains 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose from the mouthpiece of 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate.
• This medicine contains fluorinated greenhouse gases.
• Each inhaler contains 8.15 g of HFC-134a (Norflurane), equivalent to 0.012 tonnes of CO2 (global warming potential GWP = 1430).
• The other components are: anhydrous ethanol and hydrochloric acid.

Appearance of Bibecfo and contents of the pack

Bibecfo is packaged in a 19 mL pressurized aluminium cartridge sealed with a metering valve, inserted into a polypropylene plastic actuator with a dose counter incorporating a mouthpiece, and provided with a plastic protective cap.

Pack sizes:

1 pressurized container delivering 120 actuations or

2 pressurized containers delivering 120 actuations each

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Cipla Europe NV

De Keyserlei 60C, Bus-1301,

2018 Antwerp

Belgium

Manufacturer

Cipla Europe NV

De Keyserlei 60C, Bus-1301,

2018 Antwerp

Belgium

S&D Pharma CZ, spol. s.r.o.

Theodor 28, 273 08,

Pchery (facility of Pharmos a.s.),

Czech Republic

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Cipla Europe NV, Spanish branch

C/Guzmán el Bueno 133, Edificio Britannia

28003, Madrid

Spain

This medicine is authorized in the European Economic Area member states under the following names:

Austria: Beclometason/ Formoterol Cipla 100 Mikrogramm/6 Mikrogramm pro Sprühstoß Druckgasinhalation, Lösung

Bulgaria: BIBECFO 100/6 micrograms per actuation pressurised inhalation solution

Czech Republic: Beklometason/Formoterol Cipla

Germany: Beclometason/ Formoterol Cipla 100 Mikrogramm/6 Mikrogramm pro Sprühstoß Druckgasinhalation, Lösung

Spain: Bibecfo 100 micrograms/6 micrograms/actuation solution for pressurized inhalation

France: BÉCLOMÉTASONE/FORMOTÉROL CIPLA 100/6 microgrammes/dose, solution pour inhalation en flacon pressurisé

Italy: Beclometasone e Formoterolo Cipla

Norway: Beklometasondipropionat/Formoterol Cipla

Romania: Beclometazona/Formoterol Cipla 100/6 micrograme pe doza solutie de inhalat presurizata

Sweden: Brofobec

Slovakia: BIBECFO 100/6 mikrogramov na inhaláciu inhalacný roztok v tlakovom obale

Date of the most recent review of this leaflet: January 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.