BECLOMETHASONE/FORMOTEROL CIPLA 100 micrograms/6 micrograms/inhalation pressurized solution

Introduction

Package Leaflet: Information for the User

Beclometasone/Formoterol Cipla 100 micrograms/6 micrograms/puff, inhalation solution in a pressurised container.

beclometasone dipropionate/formoterol fumarate dihydrate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Beclometasone/Formoterol Cipla is and what it is used for
2. What you need to know before you use Beclometasone/Formoterol Cipla
3. How to use Beclometasone/Formoterol Cipla
4. Possible side effects
5. Storage of Beclometasone/Formoterol Cipla
6. Contents of the pack and other information

1. What Beclometasone/Formoterol Cipla is and what it is used for

Beclometasone/Formoterol Cipla is an inhalation solution in a pressurised container that contains two active substances that 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 that have an anti-inflammatory action that reduces inflammation and irritation of your 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.

These two active substances combined facilitate breathing, as they provide relief from symptoms such as difficulty breathing, wheezing, and coughing in asthmatic patients or those with COPD, and also help 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 used "as needed".

or:

• Asthma is well controlled with a combination treatment 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 disease of the lung airways caused mainly by smoking cigarettes.

2. What you need to know before you use Beclometasone/Formoterol Cipla

Do not use Beclometasone/Formoterol Cipla:

• 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

Consult your doctor, pharmacist, or nurse before starting to use Beclometasone/Formoterol Cipla:

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

• If you have narrowing of the arteries (also called arteriosclerosis), if you have high blood pressure, or if you know you have an aneurysm (an abnormal bulge in the vascular wall).

• If you have heart rhythm disorders, such as increased heart rate or irregular heart rate, have a rapid pulse, or suffer from 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 may need to undergo additional blood tests to control blood sugar when you start using the inhaler and from time to time during treatment).

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

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

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

• If you cannot drink alcohol for any reason.

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

If you have or have had medical problems or allergies, or if you are not sure if you can use this medicine, consult your doctor, nurse, or pharmacist before using this medicine.

Treatment with a β2 agonist like the formoterol contained in this medicine may cause a sudden drop in serum potassium levels (hypokalemia).

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

If you take higher doses of inhaled corticosteroids for prolonged periods, you may need corticosteroids in stressful situations. These situations include hospitalization after an accident, having a serious injury, or before surgery. In such cases, the doctor treating you will decide if it is necessary to increase the dose of corticosteroids and may prescribe steroid tablets or injections.

In case you go to the hospital, remember to bring all your medications and inhalers, including beclometasone/formoterol and other medications or tablets 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 and adolescents under 18 years of age until more data is available.

Other medicines and Beclometasone/Formoterol Cipla

Tell your doctor or pharmacist if you are using, have recently used, or might use other medicines, including medicines for asthma and COPD, or other medicines purchased 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 for HIV: ritonavir, cobicistat).

Do not use beta-blockers with this medicine

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 enhance the effects of formoterol.

The combined use of Beclometasone/Formoterol Cipla with:

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

• Medicines for treating Parkinson's disease (L-dopa) or for treating 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 mental disorders, may cause an increase in blood pressure.

• Medicines for treating heart disease (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 anesthetics 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 plan to become pregnant, or if you are breastfeeding, unless your doctor advises you to do so.

Driving and using machines

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

Beclometasone/Formoterol Cipla contains alcohol

This medicine contains 7 mg of alcohol (ethanol) in each puff. The amount of alcohol in a puff 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 Beclometasone/Formoterol Cipla

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

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Asthma

Your doctor will regularly review your treatment to ensure that 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 medicine 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 for 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 sudden worsening of asthma symptoms, such as difficulty breathing, wheezing, and coughing.

1. Using Beclometasone/Formoterol Cipla with a separate "rescue" inhaler:

Adults and elderly patients:

The recommended dose of this medicine is one to two puffs twice daily. The maximum daily dose is 4 puffs.

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

1. Using Beclometasone/Formoterol Cipla as the only inhaler for asthma:

Adults and elderly patients:

The recommended dose of this medicine is one puff in the morning and one puff in the evening.

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 6 rescue puffs of beclometasone/formoterol per day.

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

If you think 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 MUST 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 in the evening.

Patients at risk:

Elderly patients do not need to have their dose adjusted. 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 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 that contained beclometasone dipropionate, your doctor will advise you on the exact dose of this medication 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.

Method of administration

Beclometasone/Formoterol Cipla is for inhalation use

This medication is in a pressurized cartridge inside a plastic casing 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 decrements one dose. Be careful not to drop the inhaler as this could cause the counter to decrement.

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 firmly press 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 doses are left. If the dose counter shows "0", there are no doses left: discard your inhaler and obtain a new one.

1. Remove the protective cap from the mouthpiece and check that it is clean and free of dust and dirt or other foreign particles.
2. Exhale 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. Inhale slowly and deeply through your mouth and, just as you start to inhale, firmly press 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 for as long as you can and, finally, remove the inhaler from your mouth and exhale slowly. Do not blow into the inhaler.

In case you need to inhale a new 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 with 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 be sufficient to take the full dose.

If you notice a "mist" escaping from the top of the inhaler or from the corner of your lips, it means that the medication is not going to reach 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 device spacer. Consult your doctor, pharmacist, or nurse about using this device.

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

Cleaning

You must 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 mouthpiece cap from the inhaler.
2. Pass a clean, dry cloth or paper through the inside and outside of the mouthpiece and actuator.
3. Replace the mouthpiece cap.

If you use more Beclometasone/Formoterol Cipla than you should

• If you use more formoterol than you should, you may experience the following adverse effects: nausea, vomiting, rapid heartbeat, palpitations, heart rhythm disorders, certain electrocardiographic changes (heart signal), headache, tremors, drowsiness, excess acid in the blood, low potassium levels in the blood, and high glucose levels in the blood. Your doctor may ask you for blood tests to check your potassium and glucose levels in the blood.
• Taking too much beclometasone dipropionate may cause short-term changes in the functioning of the adrenal glands. This situation will improve in a few days. However, your doctor may check your cortisol level in serum.

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 make up for a forgotten 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. Even if you 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 your asthma worsens

If your symptoms worsen or you find it difficult to control them (for example, if you increase the frequency of use of the rapid-acting inhaler or beclometasone/formoterol as a rescue inhaler), or if the rapid-acting inhaler or beclometasone/formoterol does not help improve your symptoms, go to 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 other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

As with other inhaler treatments, there is a risk of worsening breathing difficulties and wheezing immediately after using beclometasone/formoterol, which is known as paradoxical bronchospasm. If this happens, STOP using beclometasone/formoterol and use your rapid-acting inhaler immediatelyto treat breathing difficulty and wheezing symptoms. Contact your doctor immediately.

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

Other side effects are listed below by frequency.

Frequent(affect 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 have any of the following symptoms while inhaling this medication, they could be symptoms of a lung infection:

• fever or chills
• increased mucus production, change in mucus color
• increased coughing or increased breathing difficulties

Uncommon(affect less than 1 in 100 people):

• exceptionally fast heartbeat and heart rhythm disorders
• certain electrocardiographic changes (ECG)
• asthma attacks
• tremors
• restlessness
• dizziness
• palpitations
• flu-like symptoms
• fungal infections in the vagina
• breast tenderness
• ear inflammation
• throat irritation
• cough and productive cough
• nausea
• changes or decrease in taste
• lip burning
• dry mouth
• difficulty swallowing
• indigestion
• gastric upset
• diarrhea
• muscle pain and cramps
• redness of the face
• excessive sweating
• increased blood flow in certain tissues of the body
• rhinitis

Changes in certain components of the blood:

• decrease in the number of white blood cells
• increase in the number of platelets
• decrease in potassium levels in the blood
• increase in glucose levels in the blood
• increase in insulin, free fatty acids, and ketones in the blood
• rash or hives

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

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

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

• feeling of chest tightness
• feeling of loss of heartbeats
• increase or decrease in blood pressure
• kidney inflammation
• swelling of the skin and mucous membranes that persists for several days

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

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

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

• problems with the functioning of the adrenal glands (suppression of adrenal function)
• increased intraocular pressure (glaucoma)
• cataracts
• growth delay (slow growth in children and adolescents)
• decrease in bone mineral density (weakening of bones)

Unknown (frequency cannot be estimated from available data)

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

These effects may occur especially in children.

• blurred vision

Reporting of side effects

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

5. Storage of Beclometasone/Formoterol Cipla

• Keep this medication out of the sight and reach of children.
• Before dispensing: store in the 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 EXP. 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 cold, warm it up with your hands for a few minutes before use. Never heat it by artificial means.

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

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

6. Package contents and additional information

Composition of Beclometasone/Formoterol Cipla

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

Appearance of Beclometasone/Formoterol Cipla and package contents

Beclometasone/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 is provided with a plastic protective cap.

Package sizes:

1 pressurized container that provides 120 puffs or

2 pressurized containers that provide 120 puffs each

Only some package sizes may be marketed.

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 (Pharmos a.s. facility),

Czech Republic

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Cipla Europe NV branch 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: Beclometasone/Formoterol Cipla 100 micrograms/6 micrograms per puff pressurized inhalation solution

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

Czech Republic: Beklometason/Formoterol Cipla

Germany: Beclometasone/Formoterol Cipla 100 micrograms/6 micrograms per puff pressurized inhalation solution

Spain: Beclometasone/Formoterol Cipla 100 micrograms/6 micrograms/puff pressurized inhalation solution

France: BÉCLOMÉTASONE/FORMOTÉROL CIPLA 100/6 micrograms/dose, solution for inhalation in a pressurized container

Italy: Beclometasone and Formoterol Cipla

Norway: Beklometasondipropionat/Formoterol Cipla

Romania: Beclometazona/Formoterol Cipla 100/6 micrograms per dose pressurized inhalation solution

Sweden: Brofobec

Slovakia: BIBECFO 100/6 micrograms per inhalation pressurized inhalation solution

Date of the last revision of this leaflet:January 2025

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