BUDESONIDE/FORMOTEROL CIPLA 160 micrograms/4.5 micrograms inhalation powder (single dose)

Introduction

Package Leaflet: Information for the User

Budesonide/Formoterol Cipla 160 micrograms/4.5 micrograms/inhalation, powder for inhalation (single-dose)

Budesonide/formoterol fumarate dihydrate

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

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

Contents of the package leaflet

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

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

Budesonide/Formoterol Cipla is an inhaler used for the treatment of:

• asthma in adults and adolescents between 12 and 17 years of age.
• It is also used for the symptomatic treatment of Chronic Obstructive Pulmonary Disease (COPD) in adults over 18 years of age.

It contains two different medicines: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called “corticosteroids”, and acts by reducing and preventing inflammation of your lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called “long-acting beta2 adrenergic agonists” or “bronchodilators”, and acts by relaxing the muscles of the airways, making it easier to breathe.

Asthma

Budesonide/Formoterol Cipla may be prescribed for asthma in two different ways:

• Some patients are prescribed two separate inhalers: Budesonide/Formoterol Cipla and another inhaler for “relief of symptoms”.
• Patient uses Budesonide/Formoterol Cipla daily, which helps prevent the onset of asthma symptoms.
• Patient uses their “reliever inhaler” when they have asthma symptoms, to facilitate breathing.

• Some patients are prescribed Budesonide/Formoterol Cipla as the only inhaler for asthma.
• Patient uses Budesonide/Formoterol Cipla daily, which helps prevent the onset of asthma symptoms.
• Patient also uses Budesonide/Formoterol Cipla when they need additional doses for relief of asthma symptoms, facilitating breathing, and does not need another separate inhaler for this purpose.

Chronic Obstructive Pulmonary Disease (COPD)

Budesonide/Formoterol Cipla is also used for the treatment of COPD symptoms in adults. COPD is a chronic disease characterized by causing continuous breathing difficulties of the pulmonary airways, accompanied by cough and phlegm. It is often caused by smoking.

2. What you need to know before you start using Budesonide/Formoterol Cipla

Do not use Budesonide/Formoterol Cipla:

• if you are allergic to budesonide, formoterol or any of the other components of this medicine (listed in section 6), which includes lactose (contains small amounts of milk proteins).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Budesonide/Formoterol Cipla if:

• you have diabetes,
• you have a lung infection,
• you have high blood pressure, or have ever had any heart disease (including irregular heartbeat, rapid pulse, narrowing of the arteries, or heart failure),
• you have thyroid or adrenal gland problems,
• you have low potassium levels in your blood,
• you have severe liver problems.

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

Use in athletes

This medicine contains formoterol, which may produce a positive result in doping tests.

Use of Budesonide/Formoterol Cipla with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

In particular, tell your doctor or pharmacist if you are using any of the following medicines:

• beta-blocker medicines (such as atenolol or propranolol for high blood pressure), including eye drops (such as timolol for glaucoma),
• medicines to treat fast or irregular heartbeats (such as quinidine, disopyramide, procainamide),
• Medicines to treat allergies, also called antihistamines, such as terfenadine.
• Oxytocin, a medicine to facilitate childbirth.
• Procarbazine, a medicine to treat cancer.
• Medicines such as digoxin, commonly used to treat heart failure,
• diuretics (such as furosemide), used to treat high blood pressure,
• Corticosteroids (such as prednisolone). These are used to treat inflammation or prevent organ transplant rejection.
• Xanthine medicines (such as theophylline or aminophylline). These are often used to treat asthma.
• Other bronchodilators (such as salbutamol).
• Other medicines to widen the airways, also called bronchodilators (such as salbutamol).
• Medicines to treat depression, also called tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
• Medicines to treat mental disorders, nausea, or vomiting, called phenothiazine medicines (such as chlorpromazine and prochlorperazine).
• Medicines to treat fungal infections (such as ketoconazole, itraconazole, voriconazole, posaconazole) and bacterial infections (such as clarithromycin and telithromycin, furazolidone).
• Medicines to treat Parkinson's disease (such as levodopa).
• Medicines to treat thyroid problems (such as levothyroxine).
• Ritonavir, cobicistat (medicines to treat HIV infections). The effects of Budesonide/Formoterol Cipla may increase, and your doctor may want to monitor you closely.

If you are in any of these situations, or if you are not sure, ask your doctor or pharmacist before using Budesonide/Formoterol Cipla.

Also, inform your doctor or pharmacist if you are going to have a general anesthetic for a surgical operation or for dental treatment.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or planning to become pregnant, consult your doctor before using Budesonide/Formoterol Cipla, unless your doctor has told you to do so.
• If you become pregnant during treatment with Budesonide/Formoterol Cipla, do not stop using it and consult your doctor immediately.
• If you are breastfeeding, consult your doctor before using Budesonide/Formoterol Cipla.

Driving and using machines

Budesonide/Formoterol Cipla has no or negligible influence on the ability to drive and use machines.

Budesonide/Formoterol Cipla contains lactose

Budesonide/Formoterol Cipla contains lactose, which is a type of sugar. If your doctor has told you that you have an intolerance to some sugars, consult them before using this medicine. The amount of lactose in this medicine normally does not cause problems in people with lactose intolerance.

The excipient lactose contains small amounts of milk proteins that may cause allergic reactions in patients with cow's milk protein allergy.

3. How to use Budesonide/Formoterol Cipla

• Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
• It is essential to use Budesonide/Formoterol Cipla daily, even if you do not have symptoms of asthma or COPD at that time.
• If you are using Budesonide/Formoterol Cipla for asthma, your doctor will want to check your symptoms regularly.

If you have been taking corticosteroid tablets for asthma or COPD, your doctor may reduce the number of tablets you take once you start using Budesonide/Formoterol Cipla. If you have been taking oral corticosteroid tablets for a long time, your doctor may ask you to have blood tests from time to time. You may feel unwell when the number of oral corticosteroids is reduced, even if your lung symptoms are improving. You may experience symptoms such as nasal congestion or runny nose, weakness or pain in the joints or muscles, and skin rash (hives). If you are concerned about any of these symptoms, or if you experience symptoms such as headache, fatigue, nausea, or vomiting, contact your doctor immediately. You may need to take another medication if you develop allergic or arthritic symptoms. You should consult your doctor if you are concerned about how to continue using Budesonide/Formoterol Cipla.

Your doctor may consider adding corticosteroid tablets to your regular treatment during periods of stress (e.g., when you have a chest infection or before an operation).

Important information about asthma or COPD symptoms

If while using Budesonide/Formoterol Cipla you experience difficulty breathing or wheezing, you should continue using Budesonide/Formoterol Cipla but contact your doctor as soon as possible, as you may need additional treatment.

Contact your doctor immediately if:

• Your breathing is getting worse or you often wake up at night with asthma symptoms.
• You start to feel chest tightness in the morning, or the chest tightness lasts longer than usual.
• These signs may indicate that your asthma or COPD is not adequately controlled, and you may need immediate different or additional treatment.

Asthma

Budesonide/Formoterol Cipla may be prescribed for asthma in two different ways, so the amount to use and when to use it depends on how your doctor has indicated:

1. If your doctor has prescribed Budesonide/Formoterol Cipla and another reliever inhaler separately, read the section "a) Using Budesonide/Formoterol Cipla and another inhaler separately for symptom relief".
2. If your doctor has prescribed Budesonide/Formoterol Cipla as the only inhaler, read the section "b) Using Budesonide/Formoterol Cipla as the only inhaler for asthma".

1. Using Budesonide/Formoterol Cipla and another inhaler separately for symptom relief

Use Budesonide/Formoterol Cipla daily,as it helps prevent the onset of asthma symptoms.

Adults (from 18 years old)

• The usual dose is 1 or 2 inhalations, twice a day.
• Your doctor may increase the dose up to a maximum of 4 inhalations, twice a day.
• If your symptoms are well-controlled, your doctor may ask you to use the medication once a day.

Adolescents (from 12 to 17 years old)

• The usual dose is 1 or 2 inhalations, twice a day.
• If your symptoms are well-controlled, your doctor may ask you to use the medication once a day.

Budesonide/Formoterol Cipla is not recommended for use in children under 12 years old.

Your doctor (or nurse) will help you treat your asthma. They will adjust the dose of this medication to the lowest dose that controls your asthma. However, do not adjust the dose without first talking to your doctor or nurse.

Use your other "reliever inhaler" to treat asthma symptoms.Always carry this "reliever inhaler" with you to use when needed. Do not use Budesonide/Formoterol Cipla to treat asthma symptoms, but use your reliever inhaler.

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

Use Budesonide/Formoterol Cipla in this way only if your doctor has indicated it and if you are over 12 years old.

Use Budesonide/Formoterol Ciplaas it helps prevent the onset of asthma symptoms. You can use:

• 1 inhalation in the morning and 1 inhalation at night

or

• 2 inhalations in the morning

or

• 2 inhalations at night.

Your doctor may increase the dose to 2 inhalations, twice a day.

Also, use Budesonide/Formoterol Cipla as a "reliever inhaler" to treat asthma symptoms when they appear.

• If you have asthma symptoms, take 1 inhalation and wait a few minutes.
• If you do not feel better, take another inhalation.
• Do not take more than 6 inhalations at one time.

Always carry your Budesonide/Formoterol Cipla inhaler with you to use when needed.

Normally, a total dose of more than 8 inhalations per day is not required. However, your doctor may allow you to use up to 12 inhalations per day for a limited period.

If you usually need to use 8 or more inhalations per day, go to your doctor or nurse, as you may need to change your treatment.

Never take more than 12 inhalations in total in 24 hours.

If you are exercising and notice asthma symptoms, use Budesonide/Formoterol Cipla as described above, do not use it just before exercise to prevent symptoms.

Chronic Obstructive Pulmonary Disease (COPD)

• Use only in adults (over 18 years old).
• The usual dose is 2 inhalations, twice a day.

Your doctor may also prescribe other bronchodilator medications, such as anticholinergics (e.g., ipratropium bromide or tiotropium bromide), for your COPD.

Instructions for use:

Your doctor, nurse, or pharmacist should teach you how to use the inhaler and review periodically that you are using it correctly.

The inhaler contains 60 doses of medication in a powder form in a rolled-up aluminum strip. It has a dose counter that indicates how many doses are left in descending order from 60 to 0. When the last 10 doses are reached, the numbers appear on a red background.

The inhaler is not rechargeable; it must be discarded when empty and replaced with a new one.

Before using the inhaler:

• The transparent lateral chamber of the inhaler must be opened.
• The aluminum strip must be cut from the lateral chamber by carefully pulling the strip against the "teeth" of the lateral chamber as shown below. Do not pull the strip forcefully or tear it.

• Close the lateral chamber cap and discard the used strip.

Important:

As the inhaler is used, the lateral chamber is gradually filled with the used aluminum strip. The aluminum strips with black lines do not contain medication. Eventually, the numbered sections of the strip will appear in the lateral chamber.

There should never be more than 2 sections of aluminum stripin the lateral chamber, as this can cause the inhaler to jam. The excess strip should be carefully cut and left in a safe place.

Using the inhaler:

Hold the inhaler with your hands, as shown in the images.

1. Opening

• The protective capmust be opened downwardsto show the mouthpiece.
• Check the dose counter to see how many doses are left.

1. Dose preparation

• The white levermust be raised upwards. Make sure the lateral chamber is closed.

Remember:The white lever should only be manipulated when the patient is ready to inhale their dose of medication. If the patient plays with the white lever, they may waste doses.

• Opening:The white lever must be fully openeduntil it clicks. This action moves a new dose to its position with its corresponding number on top in the counter.

• Closing:Then, the white lever must be fully closeduntil it clicks again in its original position. This way, the inhaler is ready for immediate use.

1. Inhaling the dose

• With the inhaler mouthpiece away from the mouth, the patient must exhale as much as possible until they feel comfortable. Never exhale directly ontothe inhaler, as this can affect the dose.
• The inhaler must be held with the protective cap facing downwards.
• The lips must be closed firmly around the mouthpiece.
• The patient must inhaleas strongly and deeplyas possible through the inhaler, without breathing through the nose.

• Then, the inhaler must be removed from the mouth and breath held for 5 to 10 secondsor as long as possible without discomfort.
• Then, the patient must start breathing slowly, but outside the inhaler.
• The protective cap of the mouthpiece must be closed.
• The mouth must be rinsed with water, which must be spat out afterwards. This can help prevent fungal infections in the mouth and avoid hoarseness.

Cleaning

• If necessary, the outside of the mouthpiece can be cleaned with a dry cloth.
• Never separate the parts of the inhaler to clean them or for any other purpose!
• The parts of the inhaler cannot be cleaned with water or damp cloths, as moisture can affect the dose!
• Never insert pins or any other sharp object into the mouthpiece or any other part, as this can damage your inhaler!

If you use more Budesonide/Formoterol Cipla than you should

It is essential to use the dose indicated in the prospectus or prescribed by your doctor. Do not increase your dose without consulting your doctor.

The most common symptoms and signs that may occur if you use more Budesonide/Formoterol Cipla than you should are tremors, headache, and rapid and irregular heartbeats.

If you have taken more Budesonide/Formoterol Cipla than you should, consult your doctor, nurse, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to use Budesonide/Formoterol Cipla

• If you forget any of the doses, take it as soon as you remember. However, if it is almost time for your next dose, do not worry about the missed dose.
• Do notuse a double dose to make up for missed doses.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following situations, stop using Budesonide/Formoterol Cipla and consult your doctor immediately:

• Your face swells, particularly around the mouth (tongue and/or throat and/or difficulty swallowing) or hives along with difficulty breathing (angioedema) and/or a sudden feeling of fainting, which indicates that you may be suffering an allergic reaction. This occurs rarely (may affect up to 1 in 1,000 patients).
• You have acute wheezing or difficulty breathing immediately after using your inhaler. If you experience any of these symptoms, stop using Budesonide/Formoterol Cipla immediately and use your "reliever inhaler". Contact your doctor immediately, as you may need to change your treatment.This occurs very rarely (may affect up to 1 in 10,000 patients).

Other possible side effects:

Frequent(may affect up to 1 in 10 patients)

• Palpitations (noticing heartbeats), tremors. When these effects appear, they are usually mild and disappear when continuing to use Budesonide/Formoterol Cipla.
• Thrush (fungal infection) in the mouth. This effect is less likely if you rinse your mouth with water after using Budesonide/Formoterol Cipla.
• Mild throat irritation, cough, hoarseness.
• Headache.
• Pneumonia (lung infection) in patients with COPD.

Tell your doctor if you experience any of the following symptoms while inhaling Budesonide/Formoterol Cipla; they could be symptoms of a lung infection:

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

Uncommon(may affect up to 1 in 100 patients)

• Agitation, restlessness, nervousness.
• Difficulty sleeping.
• Dizziness.
• Blurred vision.
• Nausea (discomfort).
• Fast heart rate.
• Bruises on the skin.
• Muscle cramps.
• Aggressiveness.
• Anxiety.

Rare(may affect up to 1 in 1,000 patients)

• Rash, itching.
• Bronchospasm (contraction of the airway muscles, causing wheezing). If wheezing occurs suddenly just after using Budesonide/Formoterol Cipla, stop using it and consult your doctor immediately.
• Low potassium levels in the blood.
• Irregular heartbeat.

Very rare(may affect up to 1 in 10,000 patients)

• Depression.
• Changes in behavior, especially in children.
• Chest pain or tightness (angina pectoris).
• Increased blood sugar (glucose) levels.
• Taste disturbances, such as unpleasant mouth taste.
• Changes in blood pressure.
• Weight gain, moon face, weakness, abdominal obesity (Cushing's syndrome).

Inhaled corticosteroids may affect the normal production of steroid hormones in the body, especially if high doses are used for a long time. These effects include:

• changes in bone mineral density (bone loss),
• cataracts (loss of lens transparency in the eye),
• glaucoma (increased eye pressure),
• growth retardation in children and adolescents,
• effects on the adrenal glands (small glands located next to the kidneys),
• Cushing's syndrome-like features,
• it may also occur an increased susceptibility to infections and a deterioration in the ability to adapt to stress.

These effects are much less likely with inhaled corticosteroids than with corticosteroid tablets.

Reporting side effects

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

5. Storage of Budesonide/Formoterol Cipla

Keep this medication out of sight and reach of children.

Do not store at a temperature above 30 °C.

Do not use this medication after the expiration date shown on the packaging or label of the inhaler after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in 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. Container Content and Additional Information

Composition ofBudesonide/Formoterol Cipla

• The active ingredients are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate, which corresponds to a measured dose (a single dose contained in the blister) of 194.7 micrograms of budesonide and 6.1 micrograms of formoterol fumarate dihydrate.

• The other component is lactose monohydrate (which contains milk proteins).

Appearance of the Product and Container Content

Budesonide/Formoterol Cipla is a red/white plastic inhaler that contains its medication. Each inhaler contains an OPA/Al/PVC-Al blister with 60 pre-measured doses of mixed powder. The inhaled powder is white to off-white or slightly yellowish without agglomerates.

Budesonide/Formoterol Cipla is available in packs of 1, 2, 6 inhalers, each containing 60 doses.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Cipla Europe NV

De Keyserlei 60C, Bus-1301

2018 Antwerp

Belgium

Manufacturer

AEROPHARM GmbH

François-Mitterrand-Allee 1

07407 Rudolstadt

Germany

or

Lek Pharmaceuticals d.d.

Verovškova ulica 57

1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben, Saxony-Anhalt

Germany

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 Edif Britannia-28003- Madrid

This medication is authorized in the Member States of the European Economic Area under the following names:

Belgium:Airbufo Forspiro 160 micrograms/4.5 micrograms/inhalation, inhalation powder, pre-dispensed

Denmark: AirBuFo Forspiro

Finland: AEROCOMP Forspiro 160 micrograms/4.5 micrograms/dose, inhalation powder, pre-dispensed

France: AirBuFo Forspiro 160 micrograms/4.5 micrograms/dose, powder for inhalation in a single-dose container

Ireland: AirBuFo Forspiro 160 micrograms/4.5 micrograms/dose inhalation powder, pre-dispensed

Italy: AirBuFo Forspiro

Norway: AirBuFo Forspiro

Portugal: AirBuFo Forspiro

Sweden: Airbufo Forspiro 160 micrograms/4.5 micrograms/dose, inhalation powder, pre-dispensed

Date of the last revision of thisleaflet: February 2023

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

You can access detailed and updated information on how to administer this medication by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/info/83517.