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 leaflet carefully before you start using this medicine, as 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.
• 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, even if they are not listed in this leaflet. See section 4.

1. What isBudesonide/Formoterol Ciplaand what it is used for

2. What you need to know before starting to useBudesonide/Formoterol Cipla

3. How to useBudesonide/Formoterol Cipla

4. Possible side effects

5. Storage ofBudesonide/Formoterol Cipla

6. Contents of the pack and additional information

Budesonida/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 old.

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

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

Asthma

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

a) Some patients are prescribed two separate inhalers:Budesonida/Formoterol Cipla and another inhaler separately “for symptom relief”.

• Patients use Budesonida/Formoterol Cipla daily, which helps to prevent the occurrence of asthma symptoms.
• Patients use their “relief inhaler” when they experience asthma symptoms, to facilitate breathing.

b) Some patients are prescribed Budesonida/Formoterol Cipla as a single inhaler for asthma.

• Patients use Budesonida/Formoterol Cipla daily, which helps to prevent the occurrence of asthma symptoms.
• Patients also use Budesonida/Formoterol Cipla when additional doses are needed for symptom relief, facilitating breathing, and they do not need another separate inhaler for this purpose.

Chronic Obstructive Pulmonary Disease (COPD)

Budesonida/Formoterol Cipla can also be used for the treatment of COPD symptoms in adults. COPD is a chronic disease characterized by persistent respiratory difficulties in the pulmonary airways, accompanied by cough and mucus. It is often caused by smoking.

Do not use Budesonida/Formoterol Cipla:

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

Warnings and precautions

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

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

Get in touch with 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 control tests.

Use of Budesonida/Formoterol Cipla with other medicines

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine.

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

• beta-blockers (such as atenolol or propranolol for high blood pressure), including eye drops (such as timolol for glaucoma),
• medicines to treat rapid or irregular heartbeats (such as quinidine, disopyramide, procainamide),
• allergy medicines, also called antihistamines, such as terfenadine.
• Oxytocin, a medicine to facilitate childbirth.
• Procarbazine, a medicine to treat cancer.
• medicines like digoxin, 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 levotiroxine).
• Ritonavir, cobicistat (medicines to treat HIV infections). The effects of Budesonida/Formoterol Cipla may increase and your doctor may wish to monitor it closely.

If you find yourself in any of these situations, or are unsure, ask your doctor or pharmacist before using Budesonida/Formoterol Cipla.

Also inform your doctor or pharmacist if you are to undergo general anesthesia for a surgical operation or dental treatment.

Pregnancy, breastfeeding and fertility

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

Driving and operating machines

The influence of Budesonida/Formoterol Cipla on the ability to drive and operate machinery is negligible or insignificant.

Budesonida/Formoterol Cipla contains lactose

Budesonida/Formoterol Cipla contains lactose, which is a type of sugar. If your doctor has told you that you suffer from an intolerance to certain sugars, consult with him before using this medicine. The amount of lactose in this medicine usually does not cause problems in people with lactose intolerance.

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

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

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 Budesonida/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 in general when your corticosteroid tablets are reduced, even if your lung symptoms are improving. You may experience symptoms such as congestion or nasal discharge, weakness or pain in the joints or muscles, and skin rash (urticaria). 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 Budesonida/Formoterol Cipla.

Your doctor may consider adding corticosteroid tablets to your regular treatment during periods of stress (for example, when you have a chest infection or before surgery).

Important information about asthma or COPD symptoms

If while using Budesonida/Formoterol Ciplayou feel difficulty breathing or emit "puffs" with breathing, you should continue using Budesonida/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 feeling chest tightness in the morning, or chest tightness lasts longer than usual.
• These signs may indicate that your asthma or COPD is not well controlled and you may need immediate different or additional treatment.

Asthma

Budesonida/Formoterol Cipla can be prescribed for asthma in two different ways, so the amount to use and when to use it depends on how your doctor has instructed you:

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

1. Using Budesonida/Formoterol Ciplaand another reliever inhaler separately for symptom relief

Use Budesonida/Formoterol Cipla daily,as it helps prevent asthma symptoms from appearing.

Adults (18 years and older)

• The usual dose is 1 or 2 inhalations, twice a day.
• Your doctor may increase this 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 (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.

Budesonida/Formoterol Cipla is not recommended for children under 12 years old.

Your doctor (or nurse) will help you manage 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 keep this "reliever inhaler" with you so you can use it when you need it. Do not use Budesonida/Formoterol Cipla to treat asthma symptoms, but your reliever inhaler instead.

1. Using Budesonida/Formoterol Ciplaas a single inhaler for asthma

Use Budesonida/Formoterol Cipla in this way only if your doctor has instructed you to and if you are 12 years old or older.

Use Budesonida/Formoterol Ciplaas it helps prevent asthma symptoms from appearing. You can use:

• 1 inhalation in the morningand1 inhalation at night

or

• 2 inhalations in the morning

or

• 2 inhalations at night.

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

Also use Budesonida/Formoterol Ciplaas a "reliever" 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 a time.

Always keep your Budesonida/Formoterol Cipla inhaler with you so you can use it when you need it.

Normally, you do not need more than 8 inhalations in total per day. 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, see your doctor or nurse, as they may need to change your treatment.

Do not take more than 12 inhalations in total in 24 hours.

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

Chronic Obstructive Pulmonary Disease (COPD)

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

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

Instructions for use:

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

The inhaler contains 60 doses of medication in a powder in a rolled aluminum strip. It has a dose counter that indicates how many doses are left in decreasing 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 inhalator:

• You must open the transparent side chamber of the inhalator.
• The aluminum strip must be cut from the side chamber by pulling it carefully against the "teeth" of the side chamber as shown below.Do not pull the strip too hardor tear it.

• Close the side chamber lid and discard the used strip.

Important:

As the inhalator is used, the side chamber will gradually fill with the used aluminum strip. The aluminum strips withblack lines do not contain medication. Eventually, the numbered sections of the strip will appear in the side chamber.

Never have more than 2 strip sectionsin the side chamber, as this may cause the inhalator to jam. The remaining strip must be cut carefully and left in a safe place.

Using the inhalator:

Take the inhalator in your hands, as shown in the images.

1. Opening

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

1. Preparing the dose

• Thewhite levermust be lifted upwards. Make sure the side chamber is closed.

Remember:Only manipulate the white lever when the patient is ready to inhale their dose of medication. If the patient plays with the white lever, they may waste doses.

• Opening:Thewhite lever must be opened completelyuntil it reaches its top anduntil it makes a "click" sound. This action moves a new dose to its position with its corresponding number above on the counter.

• Closing:Next, thewhite lever must be closed completelyuntil it makes“click” soundagain in its original position. This way, the inhalator is ready for immediate use.

1. Inhaling the dose

• With the mouthpiece of the inhalator away from the mouth, the patient must exhale as much as possible until they feel comfortable.Never exhale directly ontothe inhalator, as this may affect the dose.
• The inhalator must be held with theprotective cap facing downwards.
• The patient mustclose their lips firmlyaround the mouthpiece.
• The patient mustinhaleas deeplyandforcefullyas possiblethrough the inhalator, without breathing through the nose.

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

Cleaning

• If necessary, the exterior of the mouthpiece can be cleaned with a dry cloth.
• Never separate the parts of the inhalator to clean them or for any other purpose!
• Never clean the parts of the inhalator with water or damp cloths, as moisture may affect the dose!
• Never insert paper clips or any other sharp objects into the mouthpiece or any other part, as this may damage the inhalator!

If you use more Budesonida/Formoterol Ciplathan you should

It is essential to use the dose indicated in the leaflet or the dose 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 Budesonida/Formoterol Cipla than you should are tremors, headache, and rapid and irregular heartbeats.

If you have taken more Budesonida/Formoterol Cipla than you should, contact 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 Budesonida/Formoterol Cipla

• If you forget a dose, 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 nottake a double dose to compensate for the missed doses.

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

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

If any of the following situations occur, stop using Budesonida/Formoterol Cipla and consult your doctor immediately:

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

Other possible side effects:

Common(may affect up to 1 in 10 patients)

• Palpitations (note the heartbeats), tremors. When these effects appear, they are usually mild and disappear as you continue using your Budesonida/Formoterol Cipla.
• Oral thrush (fungal infection) in the mouth. This effect is less likely if you rinse your mouth with water after using your Budesonida/Formoterol Cipla.
• Mild throat irritation, cough, hoarseness.
• Headache.
• Pneumonia (lung infection) in patients with COPD.

Inform your doctor if you experience any of the following symptoms while inhaling Budesonida/Formoterol Cipla, which may be symptoms of a lung infection:

• Fever or chills,
• Increased mucus production, change in mucus color,
• Increased cough or difficulty breathing.

Uncommon(may affect up to 1 in 100 patients)

• Restlessness, anxiety, nervousness.
• Difficulty sleeping.
• Dizziness.
• Blurred vision.
• Nausea (discomfort).
• Accelerated heart rate.
• Skin hematomas.
• Muscle cramps.
• Aggression.
• Anxiety

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

• Rash, itching.
• Asthma bronchospasm (contraction of the respiratory tract muscles, causing wheezing). If wheezing occurs suddenly just after using Budesonida/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 pressure (angina pectoris).
• Increased blood sugar levels.
• Alterations in taste, such as unpleasant mouth taste.
• Variations in blood pressure.
• Weight gain, moon face, weakness, abdominal obesity (Cushing's syndrome).

Inhaled corticosteroids can 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 thinning),
• Cataracts (loss of transparency of the lens in the eye),
• Glaucoma (increased eye pressure),
• Delayed growth in children and adolescents,
• Effects on the adrenal glands (small glands located near the kidneys),
• Cushingoid characteristics,
• It may also occur an increased susceptibility to infections and the deterioration of the ability to adapt to stress.

These effects are much less likely with inhaled corticosteroids than with oral corticosteroids.

Reporting of side effects

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

Keepthis medicationout of the sight and reach of children.

Do not store at a temperature above 30 °C

Do not usethis medicationafter the expiration date that appears onthe inhaler container or labelafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment..

Composition ofBudesonida/Formoterol Cipla

• The active ingredients are budesonide and formoterol fumarate dihydrate. Each dose inhaled contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate, which corresponds to a measured dose (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 contents of the package

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

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cipla Europe NV

De Keyserlei 58-60, Box-19,

2018 Antwerp

Belgium

Responsible for manufacturing

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 subsidiary in Spain,

C/Guzmán el Bueno, 133 Edif Britannia-28003- Madrid

This medication is authorized in the member states of the European Economic Area with the following names:

Belgium:Airbufo Forspiro 160 microgram/4.5 microgram/inhalation, inhalation powder,Pre-measured

Denmark:AirBuFo Forspiro

Finland:AEROCOMP Forspiro160 mikrog/4.5 mikrog/year, inhalation powder,

Pre-measured

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

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

Italy:AirBuFo Forspiro

Norway:AirBuFo Forspiro

Portugal:AirBuFo Forspiro

Sweden:Airbufo Forspiro160 mikrog/4.5 mikrog/dose, inhalation powder, pre-measured dose

Last review date of thisleaflet: February 2023

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

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