Bibecfo 200 micrograms/6 micrograms/puff inhalation solution in pressurised container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bibecfo 200 micrograms/6 micrograms/dose, inhalation solution in pressurised container.

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 effects, consult your doctor or pharmacist or nurse, even if they are adverse effects 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 inhalation solution that contains two active substances which are inhaled through the mouth and released 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 the lungs.

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

The combination of these two active substances helps breathing by providing relief from symptoms such as shortness of breath, wheezing, and coughing in patients with asthma.

This medicine is used to treat asthma in adults.

If this medicine has been prescribed for you, it is likely because:

• Your asthma is not adequately controlled by inhaled corticosteroids and short-acting bronchodilators taken "as needed".

or

• Your asthma responds well to a combination treatment of corticosteroids and long-acting bronchodilators.

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 using Bibecfo if you:

• have heart problems, such as angina (chest pain), heart failure, narrowed arteries, heart valve disease, or any other known heart abnormality
• have high blood pressure or if you know you have an aneurysm (an abnormal bulge in a blood vessel wall)
• have heart rhythm disorders, such as increased heart rate, irregular heartbeat, rapid pulse, or palpitations, or if you have been informed of electrocardiographic abnormalities
• have an overactive thyroid gland
• have low potassium levels in the blood
• have any liver or kidney disease
• have diabetes (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)
• have a tumor of the adrenal glands (called a pheochromocytoma)
• are due to receive anesthesia. Depending on the type of anesthetic, you may need to stop using this medicine at least 12 hours before anesthesia
• are being or have been treated for tuberculosis (TB) or if you have a known viral or fungal lung infection
• should avoid alcohol for any reason

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

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

Your doctor may want to check your blood potassium levels from time to time, especially if you have severe asthma. Like many other bronchodilators, this medicine may cause a sudden drop in serum potassium levels (hypokalaemia). This is because lack of oxygen in the blood, combined with other treatments you may be taking alongside this medicine, can worsen the decrease in potassium levels.

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

If you need to go to hospital, remember to bring all your medicines and inhalers with you, including this medicine and any other medicines or over-the-counter products you are using, 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 or 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 those obtained without a prescription. This is because this medicine may affect how some medicines work.

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

• Some medicines may increase the effects of this medicine, so your doctor may monitor you closely if you are taking these (including some HIV medicines: ritonavir, cobicistat).
• Beta-blockers. Beta-blockers are medicines used to treat various conditions such as heart problems, high blood pressure, or glaucoma (increased intraocular pressure). If you need to use beta-blockers (including eye drops), the effect of formoterol may be reduced or even blocked.
• Beta-adrenergic medicines (medicines with the same action as formoterol) may increase the effects of formoterol.
• Medicines used to treat heart rhythm disorders (quinidine, disopyramide, procainamide).
• Medicines used to treat allergic reactions (antihistamines).
• Medicines used to treat depression or psychiatric disorders such as monoamine oxidase inhibitors (e.g. phenelzine, isocarboxazid) or tricyclic antidepressants (e.g. amitriptyline, imipramine), or phenothiazines.
• Medicines used to treat Parkinson’s disease (levodopa).
• Medicines used to treat hypothyroidism (levothyroxine).
• Medicines containing oxytocin (which causes uterine contractions).
• Medicines used to treat psychiatric disorders such as monoamine oxidase inhibitors (MAOIs), including drugs 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.

Also inform your doctor if you are due to receive general anesthesia for surgery or dental procedures.

Pregnancy, breastfeeding, and fertility

There are no clinical data on the use of Bibecfo during pregnancy.

Do not use Bibecfo if you are pregnant or think you may be pregnant, if you plan to become pregnant, or if you are breastfeeding, unless your doctor has instructed you otherwise.

Driving and using machines

It is unlikely that Bibecfo will affect your ability to drive or operate machinery.

Bibecfo contains alcohol

This medicine contains 9 mg of alcohol (ethanol) per 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 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 administration instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will periodically review you to ensure you are receiving the optimal dose of this medicine. Your doctor will adjust your treatment to the lowest dose that best controls your symptoms.

Dosage:

Adults and elderly patients:

The recommended dose is two actuations twice daily.

The maximum daily dose is 4 actuations.

Remember: you should always carry your fast-acting “rescue” inhaler to treat worsening asthma symptoms or a sudden asthma attack.

At-risk patients:

Dosage adjustment is not necessary in elderly patients. There is no information available on the use of this medicine in patients with liver or kidney problems.

Use in children and adolescents under 18 years of age:

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

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 used 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 very effective, always consult your doctor before increasing the dose.

If asthma worsens

If symptoms worsen or become difficult to control (for example, if you increase the frequency of use of your fast-acting “rescue” inhaler), or if the “rescue” inhaler does not improve symptoms, contact your doctor immediately. Your asthma may be worsening, and your doctor may need to adjust the dose of this medicine or prescribe an alternative treatment.

Method of administration

Bibecfo is for inhalation use

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 actuation 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 decrease.

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 actuation.
4. Check the dose counter. If you are checking your inhaler for the first time, the counter should display 120.

How to use your inhaler

Whenever possible, stand or sit upright when inhaling.

Before starting 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 the 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 as slowly and deeply 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. Inhale 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 actuation. If you have weak hands, 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 bottom.
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 actuation, 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 displays the number 20. Stop using the inhaler when the counter reads 0, as any remaining actuations in the device may not be sufficient for a complete 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 actuation, 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 must clean the inhaler once a week.

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

To clean the inhaler:

1. Remove the mouthpiece cap by detaching 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, heart 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 telephone number 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, do not take the missed dose; simply take the next dose at the correct time.

If you stop treatment with 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 have no symptoms.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

As with other treatments using inhalers, there is a risk of worsening breathing difficulty and wheezing immediately after using beclometasone/formoterol, known as paradoxical bronchospasm. If this occurs, STOP using Bibecfo and immediately use your fast-acting inhaler to treat symptoms of breathing difficulty and wheezing. Contact your doctor immediately.

Immediately inform your doctor if you experience hypersensitivity reactions, such as skin allergies, itching, rash, skin redness, 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 (may affect less than 1 in 10 people):

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

Uncommon (may affect 1 in 100 people):

• palpitations

• unusually fast heartbeat and heart rhythm disorders

• certain electrocardiographic (ECG) abnormalities

• increased blood pressure

• flu-like symptoms

• sinusitis

• rhinitis

• ear inflammation

• throat irritation

• cough and productive cough

• asthma attack

• fungal infections of the vagina

• nausea

• altered or reduced sense of taste

• burning sensation of the lips

• dry mouth

• difficulty swallowing

• indigestion

• stomach discomfort

• diarrhea

• muscle pain and cramps

• redness of the face and throat

• increased blood circulation in certain body tissues

• excessive sweating

• tremors

• restlessness

• dizziness

• rash or hives

• changes in certain blood components:

• decreased number of white blood cells

• increased number of platelets

• decreased concentration of potassium in the blood

• increased blood sugar

• increased concentration of insulin, free fatty acids, and ketone bodies in the blood

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

• pneumonia; inform your doctor if you experience any of the following symptoms: increased sputum production, changes in sputum color, fever, worsening cough, increased breathing problems
• reduced levels of cortisol in the blood; caused by the effect of corticosteroids on the adrenal gland
• irregular heartbeat

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

• chest tightness
• sensation of missed heartbeats
• decreased blood pressure
• kidney inflammation
• persistent swelling of the skin and mucous membranes lasting several days

Very rare (may affect 1 in 10,000 people):

• worsening of asthma
• difficulty breathing
• decreased number of platelets
• swelling of hands and feet

Long-term, high-dose inhaled corticosteroids may very rarely cause systemic effects, including:

• adrenal gland function problems (adrenal suppression)
• increased intraocular pressure (glaucoma)
• cataracts
• growth retardation (slowed growth in children and adolescents)
• decreased bone mineral density (weakening of bones)

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

• sleep disorders
• depression or anxiety
• nervousness
• overexcitement or irritability

These effects may occur more frequently 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 may 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 the inhaler 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 following 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 containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help 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 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose from the mouthpiece of 169.2 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate.
• This medicine contains fluorinated greenhouse gases.
• Each inhaler contains 10.24 g of HFC-134a (Norflurane), equivalent to 0.015 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 supplied in a 19 mL pressurized aluminium canister 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 canister delivering 120 actuations, or

2 pressurized canisters delivering 120 actuations each.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 (Pharmos a.s. facility),
Czech Republic

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

Cipla Europe NV, Spanish branch
C/Guzmán el Bueno 133, Edificio Britannia
28003, Madrid
Spain

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

Austria: Beclometason/ Formoterol Cipla 200 Mikrogramm/6 Mikrogramm pro Sprühstoß Druckgasinhalation, Lösung
Bulgaria: BIBECFO 200/6 micrograms per actuation pressurised inhalation solution
Czech Republic: Beklometason/Formoterol Cipla
Germany: Beclometason/ Formoterol Cipla 200 Mikrogramm/6 Mikrogramm pro Sprühstoß Druckgasinhalation, Lösung
Spain: Bibecfo 200 microgramos/6 microgramos/pulsación solución para inhalación en envase a presión
France: BÉCLOMÉTASONE/FORMOTÉROL CIPLA 200/6 microgrammes/dose, solution pour inhalation en flacon pressurisé
Italy: BIBECFO
Norway: Beklometasondipropionat/Formoterol Cipla
Romania: Beclometazona/Formoterol Cipla 200/6 micrograme pe doza solutie de inhalat presurizata
Sweden: Brofobec
Slovakia: BIBECFO 200/6 mikrogramov na inhaláciu inhalacný roztok v tlakovom obale

Date of the most recent review of this Patient Information Leaflet: January 2025

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