Leaflet: information for the user

Beclometasona/Formoterol Cipla 100 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 medications called corticosteroids that have an anti-inflammatory action that reduces inflammation and irritation in the lungs.

Formoterol fumarate dihydrate belongs to a group of medications 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 or COPD, and also helps to prevent asthma symptoms.

Asthma

This medication is indicated for the routine treatment of asthma in adult patients in whom:

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

or:

• Asthma is responding well to a combination treatment of corticosteroids and long-acting bronchodilators.

COPD

This medication may also be used to treat the symptoms of severe chronic obstructive pulmonary disease (COPD) in adult patients. COPD is a chronic disease of the pulmonary airways caused mainly by smoking cigarettes.

Do not use Beclometasona/Formoterol Cipla:

• If you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate or to any of the other ingredients of this medication (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), a recent heart attack (myocardial infarction), heart failure, coronary artery disease, heart valve disease, or any other known heart abnormality, or if you have a condition called hypertrophic obstructive cardiomyopathy (also known as CMH, in which the heart muscle is enlarged).

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

• If you have heart rhythm disorders, such as increased heart rate or irregular heart rate, have a rapid pulse or experience palpitations, or have been informed that you have electrocardiographic abnormalities.

• If your thyroid gland is overactive.

• If your blood potassium level is low.

• If you have any liver or kidney disease.

• If you are diabetic (inhalation of high doses of formoterol may cause an increase in blood glucose levels and, therefore, you will need to undergo additional blood tests to control blood sugar levels when starting to use the inhaler and occasionally during treatment).

• If you have a tumor of the adrenal glands (called pheochromocytoma).

• If you are to receive anesthesia. Depending on the anesthetic agent, you may need to stop using this medication for at least 12 hours before anesthesia.

• If you are to be treated or have already been treated for tuberculosis (TB) or if you have a known viral or fungal lung infection.

• If you cannot take alcoholfor any reason.

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

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

The treatment with a β2agonist such as formoterol contained in this medication may cause abrusque fall in serum potassium concentration (hypokalemia).

Be particularly careful if you have severe asthma.The reason is that a lack of oxygenin the blood and other treatments you may be receiving in addition to beclometasona/formoterol, such as medications for heart disease or high blood pressure (known as diuretics) or other medications used to treat asthma, may worsen the fall in potassium concentrations. Therefore, your doctor will want to check your potassium blood concentration from time to time.

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

In case of hospital admission, remember to bring with you all your medications and inhalers, including beclometasona/formoterol and other medications or tablets purchased without a prescription, if possible, in their original packaging.

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

Children and adolescents

This medication should not be used in children or adolescents under 18 years of age, until more data is available.

Other medications and Beclometasona/Formoterol Cipla

Inform your doctor or pharmacist if you are using, have used recently or may need to use other medications, including medications for asthma and COPD, or other medications purchased without a prescription.

Some medications may increase the effects of beclometasona/formoterol, so your doctor will make meticulous controls if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Do not use beta blockers with this medication

Beta blockers such as atenolol, propranolol and sotalol are used to treat a range of 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, it is likely that the effect of formoterol will be reduced or even nullified. On the other hand, the use of other beta-adrenergic drugs (drugs that work in the same way as formoterol) may potentiate the effects of formoterol.

The combined use of Beclometasona/Formoterol Cipla with:

• Medications to treat heart rhythm disorders (quinidine, disopyramide, procainamide), medications to treat allergic reactions (antihistamines), medications to treat symptoms of depression or mental disorders, such as monoamine oxidase inhibitors (for example, phenelzine and isocarboxazid), tricyclic antidepressants (for example, amitriptyline and imipramine) and phenothiazines, may cause electrocardiographic abnormalities (ECG, electrocardiogram). They may also increase the risk of heart rhythm disorders (ventricular arrhythmias).

• Medications to treat Parkinson's disease (L-dopa) or to treat an underactive thyroid gland (L-thyroxine), medications that contain oxytocin (which causes uterine contraction) andalcohol, may reduce cardiac tolerance to β2agonists, such as formoterol.

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

• Medications to treat heart disease (digoxin), may cause a fall in serum potassium concentration. This may increase the risk of heart rhythm disorders.

• Other medications used to treat asthma (theophylline, aminophylline or steroids) and diuretics, may produce a fall in serum potassium concentration.

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

Pregnancy, breastfeeding and fertility

No clinical data is available on the use of beclometasona/formoterol during pregnancy.

Do not use beclometasona/formoterol 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 machinery

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

Beclometasona/Formoterol Cipla contains alcohol

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

Beclometasone/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.

Asthma

Your doctor will conduct regular check-ups to ensure you are taking the optimal dose of beclometasone/formoterol. Your doctor will always adjust the treatment to the minimum dose that best controls your symptoms.

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

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

1. Use of Beclometasone/Formoterol Cipla along with a separate "rescue" inhaler:

Adults and elderly patients:

The recommended dose of this medication is one to two puffs twice a day. The maximum daily dose is four puffs.

Remember:Always carry a "rescue" inhaler with you to treat a worsening of asthma symptoms or a sudden asthma attack.

1. Use of Beclometasone/Formoterol Cipla as a single inhaler for asthma:

Adults and elderly patients:

The recommended dose of this medication is one puff in the morning and one puff at night.

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

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

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

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

If you consider that 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:

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

Chronic obstructive pulmonary disease (COPD)

Adults and elderly patients:

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

High-risk patients:

Elderly patients do not need dose adjustment. There is no information available on the use of this medication in patients with liver or kidney problems.

Beclometasone/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 to 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.

Administration form

Beclometasone/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 firmly on the cartridge 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 to inhale, check the dose counter: any number between "1" and "120" shows that there are doses left. If the dose counter shows "0", there are no doses left: discard your inhaler and get a new one.

1. Remove the protective cap from the mouthpiece and check that it is clean and free of dust and other 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 firmly on the top of the inhaler to release a puff. If you have weak 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 the air through the inhaler.

If you need to inhale another puff, hold the inhaler in a vertical position for about 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 shows 0 as the remaining doses in the device may not be enough to take the full dose.

If you see a "mist" escaping from the top of the inhaler or from the corner of your lips, it 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 you clean it, 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 protective cap from the mouthpiece by separating it from the inhaler.
2. Pass a clean and dry cloth or paper through the interior and exterior of the mouthpiece and actuator.
3. Replace the protective cap on the mouthpiece.

If you use more Beclometasone/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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Beclometasone/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 your next dose, do not take the missed dose, just take the next dose at the correct time.

If you interrupt treatment with Beclometasone/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 asthma worsens

If symptoms worsen or you find it difficult to control them (for example, if you increase the frequency of use of the separate "rescue" inhaler or beclometasone/formoterol as a rescue inhaler), or if the "rescue" inhaler or beclometasone/formoterol do not contribute to improving symptoms, see your doctor immediately. Your asthma may be worsening, and your doctor may need to increase the dose of beclometasone/formoterol or prescribe alternative treatment.

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

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

Like with other treatments using inhalers, there is a risk of worsening breathing difficulty and immediate sibilance after using beclometasona/formoterol, known asparadoxical bronchospasm. If this happens,STOP using beclometasona/formoterol and use your quick-acting inhaler right away to treat breathing difficulty and sibilance 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(affect less than 1 in 10 people):

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

Pneumonia in COPD patients: Inform your doctor if you have any of the following symptoms while inhaling this medicine, which may be symptoms of a lung infection:

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

Poorly frequent(affect less than 1 in 100 people):

• exceptionally fast heart rate and cardiac rhythm disturbances
• certain ECG alterations.
• asthma attacks
• shaking
• restlessness
• dizziness
• palpitations
• flu-like symptoms
• vaginal fungal infections
• breast inflammation
• ear inflammation
• throat irritation
• cough and productive cough
• nausea
• alterations or decrease in taste
• lip burning
• dry mouth
• difficulty swallowing
• indigestion
• gastric discomfort
• diarrhea
• muscle pain and cramps
• face redness
• excessive sweating
• increased blood circulation in certain body tissues,
• rhinitis

Blood component alterations:

• decrease in white blood cell count
• increase in platelet count
• decrease in potassium concentration in blood
• increase in blood glucose concentration
• increasein blood insulin, free fatty acids, and ketones concentration
• rash or hives

The following side effects have also been recorded as “poorly frequent” in patients with Chronic Obstructive Pulmonary Disease:

• reduction in cortisol concentration in blood; this is caused by the effect of corticosteroids on your adrenal gland
• irregular heartbeats

Rare(affect less than 1 in 1,000 people)

• chest tightness sensation
• sensation of lost heartbeats
• increase or decrease in blood pressure
• kidney inflammation
• skin and mucous membrane swelling persisting for several days

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

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

The inhalation of high doses of corticosteroids for a prolonged period may cause systemic effects in very rare cases.These include:

• suprarenal gland dysfunction (suppression of suprarenal function)
• increased intraocular pressure (glaucoma)
• cataracts
• growth delay (slow growth in children and adolescents)
• bone density reduction (bone weakening)

Unknown (frequency cannot be estimated from available data)

• sleep disorders
• depression or feeling anxious
• restlessness
• nervousness
• over-excitement or irritability.

These effects may occur especially 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 dispensing: Store in refrigerator (between 2 °C and 8 °C)
• After dispensing (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. This will help protect the environment..

Composition of Beclometasona/Formoterol Cipla

Appearance ofBeclometasona/Formoterol Ciplaand 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 plastic propylene 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. installation),

Czech Republic

For more information about this medicine, 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 medicine is authorized in the member states of the European Economic Area with 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: Beclometasona/Formoterol Cipla 100 microgramos/6 microgramos/pulsación solución para inhalación en envase a presión

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

Last review date of this leaflet:January 2025

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