Leaflet: information for the user

Beclometasona/Formoterol Cipla 200 micrograms/6 micrograms/pulsation, solution for inhalation in a pressurized container.

dipropionato de beclometasona/fumarato de formoterol dihidrato

Read this 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, consult your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Beclometasona/Formoterol Cipla is a pressurized inhalation solution that contains two active ingredients that are inhaled through the mouth and released directly into the lungs.

The two active ingredients are beclometasone dipropionate and formoterol fumarate dihydrate. Beclometasone dipropionate belongs to a group of medicines called corticosteroids that 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 that relax the muscles of the airways, making it easier to breathe.

The combination of these two active ingredients facilitates breathing by providing relief from symptoms such as difficulty breathing, wheezing, and coughing in patients with asthma.

This medicine is used to treat asthma in adults.

If you have been prescribed this medicine, it is likely that:

• Your asthma is not well controlled using inhaled corticosteroids and short-acting bronchodilators administered "as needed".

or

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

No use Beclometasona/Formoterol Cipla:

or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Beclometasona/Formoterol Cipla if you:

• have heart problems, such as angina (chest pain, heart pain), heart failure, narrowing of the arteries, heart valve disease, or any other known heart abnormality
• have high blood pressure or if you know you have an aneurysm (an abnormal bulging of the blood vessel wall)
• have heart rhythm disorders, such as increased heart rate or irregular heart rate, rapid pulse, or palpitations, or if you have been told you have electrocardiographic abnormalities
• have an overactive thyroid gland
• have low potassium levels in the blood
• have any liver or kidney disease
• have diabetes (inhalation of high doses of formoterol may cause an increase in blood glucose levels and, therefore, you should undergo additional blood tests to control blood sugar levels when starting to use the inhaler and occasionally during treatment)
• have a tumor of the adrenal glands (called pheochromocytoma)
• if you are to receive anesthesia. Depending on the type of anesthetic, you may need to stop using this medicine for at least 12 hours before anesthesia
• if you have been or are being treated for tuberculosis (TB) or if you have any known viral or fungal infection in the lungs
• if you must avoid taking alcoholfor any reason

If any of the above conditions apply to you, inform your doctor before using Beclometasona/Formoterol Cipla.

If you have or have had 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.

Your doctor may want to measure your potassium levels in the blood 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 (hypokalemia). This is due to a lack of oxygen in the blood combined with other treatments you may be taking with this medicine that can worsen the decrease in potassium levels.

If high doses of inhaled corticosteroids are administered for prolonged periods, you may need more corticosteroids in situations of stress. Such situations include hospital admission after an accident, the existence of a serious injury, or before a surgical procedure. In this case, your treating doctor will decide whether to increase the dose of corticosteroids and may prescribe tablets or injections of steroids.

In case you need to go to the hospital,remember to bring with you all your medicines and inhalers, including this medicine and any other medicines or tablets you have purchased without a prescription, 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 further data is available.

Other medicines and Beclometasona/Formoterol Cipla

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medicines, including those purchased without a prescription. This is because this medicine may affect the way some medicines work.

Particularly, inform your doctor or pharmacist or nurse if you are using any of the following medicines:

• Some medicines may increase the effects of this medicine, so your doctor may want to perform close monitoring if you are taking these medicines (including some for HIV: 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 cancelled out.
• Beta-adrenergic medicines (medicines with the same action as formoterol) may increase the effects of formoterol.
• Medicines to treat heart rhythm disorders (quinidine, disopyramide, procainamide)
• Medicines to treat allergic reactions (antihistamines)
• Medicines to treat depression or psychiatric disorders such as monoamine oxidase inhibitors (e.g. phenelzine, isocarboxazid) or tricyclic antidepressants (e.g. amitriptyline and imipramine), or phenothiazines
• Medicines to treat Parkinson's disease (levodopa)
• Medicines to treat hypothyroidism (levothyroxine)
• Medicines containing oxytocin (which causes uterine contraction)
• Medicines used to treat psychiatric disorders such as monoamine oxidase inhibitors (MAO), including similar substances, such as furazolidone and procarbazine
• Medicines to treat heart disease (digoxin)
• Other medicines used to treat asthma (theophylline, aminophylline, or steroids)
• Diuretics

Inform your doctor also if you are to receive general anesthesia for a surgical or dental procedure.

Pregnancy, breastfeeding, and fertility

No clinical data is available on the use of Beclometasona/Formoterol Cipla during pregnancy.

Do not use Beclometasona/Formoterol Cipla if you are pregnant or think you may be pregnant, if you intend to become pregnant, or if you are breastfeeding, unless your doctor tells you otherwise.

Driving and operating machines

It is unlikely that Beclometasona/Formoterol Cipla will affect your ability to drive and operate machines.

Beclometasona/Formoterol Cipla contains alcohol

This medicine contains 9 mg of alcohol (ethanol) in each puff. The amount of alcohol in a puff in this medicine is equivalent to less than 1 ml of beer or wine. The small amount of alcohol in this medicine has no perceptible effect.

Beclometasona/Formoterol Cipla is for inhalation use. This medication should be inhaled through the mouth into the lungs.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will conduct regular check-ups to ensure that you are administering the optimal dose of this medication. Your doctor will adjust the treatment to the minimum dose that best controls your symptoms.

Dose:

Adults and elderly patients:

The recommended dose is two puffs twice a day.

The maximum daily dose is 4 puffs.

Remember: you should always carry with you the rescue inhaler with rapid action to treat a worsening of asthma symptoms or a sudden asthma attack.

Patients at risk:

No dose adjustment is necessary in elderly patients. There is no information available on the use of this medication in patients with liver or kidney problems.

Use in children and adolescents under 18 years:

Children and adolescents under 18 years of age should not take this medication.

Beclometasona/Formoterol Cipla is effective for the treatment of asthma at a beclometasone dipropionate dose 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 medication that you should take for asthma.

Do not increase the dose.

If you think the medication is not very effective, always consult your doctor before increasing the dose.

If asthma worsens

If symptoms worsen or it is difficult to control them (for example, if the frequency of use of the rescue inhaler with rapid action increases), or if the rescue inhaler does not improve symptoms, see your doctor immediately. Your asthma may be worsening, and your doctor may need to modify the dose of this medication or prescribe an alternative treatment.

Administration form

Beclometasona/Formoterol Cipla is for inhalation use

This medication is contained in a pressurized cartridge within a plastic cover with a mouthpiece. There is a counter on the back of the inhaler that indicates how many doses are left. Each time you press the cartridge, a puff of medication is released, and the counter is decremented. Be careful not to drop the inhaler, as this could cause the counter to be decremented.

Checking the 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 correctly.

1. Remove the protective cap from the mouthpiece.

2. Hold the inhaler in a vertical position with the mouthpiece at the bottom.

3. Direct the mouthpiece away from you and press the cartridge firmly to release a puff.

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

How to use your inhaler

When possible, stand or sit upright to perform the inhalation.

Before starting the inhalation, check the dose counter: any number between "1" and "120" shows that doses are available. If the dose counter shows "0", there are no doses available - discard the inhaler and acquire a new one.

1. Remove the protective cap from the mouthpiece and check that it is clean and free of dust, dirt, or other foreign particles.
2. Breathe in as slowly and deeply as possible.
3. Hold the cartridge in a vertical position with the body upwards and place the mouthpiece between your lips. Do not bite the mouthpiece.
4. Breathe in slowly and deeply through the mouth and, just as you start to breathe in, press the top of the inhaler firmly to release a puff. If you have weakness in your hands, it may be easier to hold the inhaler with both hands: hold the top of the inhaler with both index fingers and the bottom with both thumbs.
5. Hold your breath as long as possible and, finally, remove the inhaler from your mouth and breathe out slowly. Do not expel air through the inhaler.

If you need to inhale another puff, hold the inhaler in a vertical position for approximately half a minute and then repeat steps 2 to 5.

Important: Do not perform steps 2 to 5 too quickly.

After administration, close the protective cap and check the dose counter.

You should replace the inhaler when the counter shows 20. Stop using the inhaler when the counter marks 0, as the remaining puffs in the device may not be sufficient to take the full dose.

If you see a "mist" escaping from the top of the inhaler or from the corner of your lips, this means that the medication 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 think the effect of this medication is too strong or insufficient, consult your doctor or pharmacist.

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

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

Cleaning

You should clean the inhaler once a week.

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

To clean the inhaler:

1. Remove the protective cap from the mouthpiece, separating it from the inhaler.
2. Pass a clean, dry cloth or paper towel through the interior and exterior of the mouthpiece and actuator.
3. Replace the protective cap on the mouthpiece.

If you use more Beclometasona/Formoterol Cipla than you should

Consult your doctor if you experience any of these symptoms.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Beclometasona/Formoterol Cipla

Do not take a double dose to compensate for a missed dose. Take it as soon as you remember. If it is almost time for the next dose, do not take the dose you missed, limit yourself to taking the next dose at the correct time.

If you interrupt treatment with Beclometasona/Formoterol Cipla

Do not decrease the dose or stop using the medication. Although you may feel better, do not stop using this medication or decrease the dose. If you want to do so, consult your doctor. It is very important to use this medication regularly, even if you do not have symptoms.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Like with other treatments using inhalers, there is a risk of worsening difficulty breathing and immediate sibilant sounds after using beclometasona/formoterol, known asparadoxical bronchospasm. If this happens,STOP using Beclometasona/Formoterol Cipla and use your quick-acting inhaler right away to treat breathing difficulty and sibilant symptoms. Contact your doctor immediately.

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

Other side effects are listed below according to their frequency.

Frequent(may affect fewer than 1 in 10 people):

• oral and throat fungal infections
• headache
• hoarseness
• sore throat

Less frequent(may affect 1 in 100 people):

• palpitations,
• exceptionally fast heart rate and heart rhythm disorders
• certain electrocardiogram (ECG) alterations
• increased blood pressure
• flu-like symptoms
• sinusitis
• rhinitis
• ear inflammation
• throat irritation
• cough and productive cough
• asthma attack
• vaginal fungal infections
• nausea
• alteration or decrease in sense of taste
• lip burning
• dry mouth
• difficulty swallowing
• indigestion
• stomach discomfort
• diarrhea
• muscle pain and cramps
• face and throat redness
• increased blood flow to certain tissues in the body
• excessive sweating
• tremors
• restlessness
• dizziness
• eruption or rash
• alterations in certain blood components:

• decrease in white blood cell count
• increase in platelet count
• decrease in blood potassium concentration
• increase in blood sugar
• increase in blood insulin, free fatty acids, and ketone bodies

The following side effects have also been reported as “less frequent” in patients with chronic obstructive pulmonary disease:

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

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

• chest tightness
• sensation of missed heartbeats
• decreased blood pressure
• kidney inflammation
• persistent skin and mucous membrane swelling for several days

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

• asthma worsening
• breathing difficulty
• decrease in platelet count
• swelling of hands and feet

The inhalation of corticosteroids in high doses for a prolonged period may cause, in very rare cases, systemic effects,including:

• problems with adrenal gland function (suppressed adrenal function)
• increased intraocular pressure (glaucoma)
• cataracts
• growth retardation (delayed growth in children and adolescents)
• bone density decrease (bone weakening)

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

• sleep problems
• depression or anxiety
• nervousness
• excitement or irritability

These effects may occur more frequently in children.

• blurred vision

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Usehttps://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Before dispensation: store the inhaler in the refrigerator (between 2 °C and 8 °C)
• After dispensation (medication dispensed by your pharmacist):

• Do not use this medication after 3 months from the date it was dispensed by your pharmacist and never use it after the expiration date shown on the box and label after CAD. The expiration date is the last day of the month indicated.
• Do not store the inhaler at a temperature above 25 °C
• If the inhaler has been exposed to intense cold, warm it up with your hands for a few minutes before using. Do not heat it up artificially.

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

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Beclometasona/Formoterol Cipla

The other components are: anhydrous ethanol and hydrochloric acid.

Appearance of Beclometasona/Formoterol Cipla and contents of the package

Beclometasona/Formoterol Cipla is packaged in a 19 mL aluminum pressurized cartridge sealed with a dosing valve and inserted into a propylene plastic actuator with a dose counter that incorporates a mouthpiece and provided with a plastic protective cap.

Package sizes:

1 pressurized container providing 120 actuations or

2 pressurized containers providing 120 actuations each

Only some package sizes may be commercially available.

Marketing Authorization Holder:

Cipla Europe NV

De Keyserlei, 60C, Bus-1301,

2018, Antwerp,

Belgium.

Responsible for manufacturing:

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. plant),

Czech Republic

For more information about this medication, please contact the local representative of the marketing authorization holder:

Cipla Europe NV subsidiary in Spain

C/Guzmán el Bueno 133, Edificio Britannia

28003, Madrid

Spain

This medication is authorized in the member states of the European Economic Area with 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: Beclometasona/Formoterol Cipla 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

Last review date of this leaflet:January 2025

Further detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.