Budesonide/formoterol Cipla 320 micrograms/9 micrograms/inhalation powder for inhalation (unit dose)

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Budesonide/Formoterol Cipla 320 micrograms/9 micrograms/inhalation, powder for inhalation (unit dose)

Budesonide/formoterol fumarate dihydrate

Read the entire 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 questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Budesonide/Formoterol Cipla is and what it is used for
2. What you need to know before 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 other information

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

Budesonida/Formoterol Cipla is an inhaler used for the treatment of asthma in adults and adolescents aged 12 to 17 years. It is also used for 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 works by reducing and preventing inflammation in your lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called "long-acting beta2-adrenergic agonists" or "bronchodilators", and works by relaxing the muscles in the airways, helping you to breathe more easily.

Asthma

Your doctor will prescribe you two different asthma inhalers: Budesonida/Formoterol Cipla and another separate inhaler “for relief of symptoms”.

• Use Budesonida/Formoterol Cipla daily, as it helps prevent the occurrence of asthma symptoms.
• Use your “reliever inhaler” when you have asthma symptoms, to help you breathe more easily.

Do not use Budesonida/Formoterol Cipla as a “reliever inhaler”.

Chronic obstructive pulmonary disease (COPD)

Budesonida/Formoterol Cipla may also be used for the treatment of COPD symptoms in adults. COPD is a chronic lung airway disease, usually caused by smoking.

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

Do not use Budesonida/Formoterol Cipla:

if you are allergic to budesonide, formoterol, or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Budesonida/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, narrowed arteries, or heart failure),
• you have thyroid or adrenal gland problems,
• you have low levels of potassium in your blood,
• you have severe liver problems.

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

Other medicines and Budesonida/Formoterol Cipla

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor or pharmacist if you are taking 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 fast or irregular heartbeat (such as quinidine, disopyramide, procainamide),
• medicines for allergies, also called antihistamines, such as terfenadine,
• oxytocin, a medicine used to assist childbirth,
• procarbazine, a medicine used 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 used to treat depression, also called tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone,
  • medicines used to treat mental disorders, nausea or vomiting, called phenothiazine medicines (such as chlorpromazine and prochlorperazine),
  • medicines for fungal infections (such as ketoconazole, itraconazole, voriconazole, posaconazole) and bacterial infections (such as clarithromycin and telithromycin, furazolidone),
  • medicines for Parkinson's disease (such as levodopa),
  • medicines for thyroid problems (such as levothyroxine),
  • medicines called “HIV protease inhibitors” (such as ritonavir, cobicistat) used to treat HIV infections. The effects of Budesonida/Formoterol Cipla may be increased, and your doctor may wish to monitor you carefully.

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

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

Pregnancy, breastfeeding and fertility

• If you are pregnant or planning to become pregnant, consult your doctor before using Budesonida/Formoterol Cipla unless your doctor has instructed you otherwise.
• If you become pregnant while being treated with Budesonida/Formoterol Cipla, do not stop using it and contact your doctor immediately.
• If you are breastfeeding, consult your doctor before using Budesonida/Formoterol Cipla.

Driving and use of machinery

The influence of Budesonida/Formoterol Cipla on the ability to drive and operate machinery is none or negligible.

Budesonida/Formoterol Cipla contains lactose

This medicine contains lactose. It may cause allergic reactions in patients with allergy to cow's milk protein. If your doctor has informed you that you have an intolerance to certain sugars, consult him before using this medicine.

3. How to use Budesonide/Formoterol Cipla

• Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
• It is important to use Budesonide/Formoterol Cipla daily, even if you do not have asthma or COPD symptoms at that time.
• If you are using Budesonide/Formoterol Cipla for asthma, your doctor will want to regularly check how your symptoms are progressing.

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 occasional blood tests. You may feel generally unwell when your dose of oral corticosteroids is reduced, even though your lung symptoms may be improving. You may experience symptoms such as nasal congestion or runny nose, joint or muscle weakness or pain, or skin rash (urticaria). If you are concerned about any of these symptoms, or if you develop symptoms such as headache, fatigue, nausea, or vomiting, contact your doctor immediately. You may need to take another medicine if you develop allergic or arthritic symptoms. You should consult your doctor if you have concerns about how to continue using Budesonide/Formoterol Cipla.

Your doctor may consider adding corticosteroid tablets to your usual 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 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 worsens or you often wake up at night with asthma symptoms.
• You begin to feel chest tightness in the morning, or chest tightness lasts longer than usual. These signs may indicate that your asthma or COPD is not adequately controlled, and you may need a different or additional treatment immediately.

Asthma

Use Budesonide/Formoterol Cipla daily, as it helps prevent asthma symptoms from occurring.

Adults (18 years and older)

• The usual dose is 1 inhalation, twice daily.
• Your doctor may increase your dose up to a maximum of 2 inhalations, twice daily.
• If your symptoms are well controlled, your doctor may instruct you to use the medication once daily.

Adolescents (12 to 17 years of age)

• The usual dose is 1 inhalation, twice daily.
• If your symptoms are well controlled, your doctor may instruct you to use the medication once daily.

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

Your doctor (or nurse) will help manage your asthma. They will adjust the dose of this medicine 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 needed. Do not use Budesonide/Formoterol Cipla to treat asthma symptoms—use your reliever inhaler instead.

Chronic Obstructive Pulmonary Disease (COPD)

Use only in adults (over 18 years of age).

• The usual dose is 1 inhalation, twice daily.

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

Instructions for use:

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

The inhaler contains 60 doses of powdered medicine in a coiled aluminum strip. It has a dose counter that shows how many doses remain, counting down from 60 to 0. When the last 10 doses remain, the numbers appear on a red background.

The inhaler is not refillable. It must be discarded when empty and replaced with a new one.

Before using the inhaler:

• You must open the transparent side chamber of the inhaler.
• The aluminum strip must be pulled carefully through the "teeth" of the side chamber to cut it, as shown below. Do not pull or tear the strip forcefully.

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

Important:

As the inhaler is used, the side chamber gradually fills with the used aluminum strip. Aluminum strips with black lines do not contain medicine. Eventually, the numbered sections of the strip will appear in the side chamber.

Never allow more than 2 sections of aluminum foil in the side chamber, as this may cause the inhaler to jam. The excess strip should be carefully cut as described above and stored safely.

Using the inhaler:

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

1. Opening

• The protective cap must be opened downward to expose the mouthpiece.
• Check the dose counter to see how many doses remain.

2. Preparing the dose

• The edge of the white lever must be pushed upward. Make sure the side chamber is closed.

Remember: Only manipulate the white lever when the patient is ready to inhale their dose. If the patient plays with the white lever, doses may be wasted.

• Opening: The white lever must be fully opened to its stop and until it clicks. This action moves a new dose into position, with its corresponding number appearing on the dose counter.

• Closing: Then, the white lever must be fully closed until it clicks again into its original position. This prepares the inhaler for immediate use.

3. Inhaling the dose

• With the inhaler mouthpiece away from the mouth, the patient should exhale as much as possible until comfortable. Never exhale directly into the inhaler, as this may affect the dose.
• The inhaler must be held with the protective cap facing downward.
• Close lips firmly around the mouthpiece.
• The patient must inhale as deeply and as forcefully as possible through the inhaler, without breathing through the nose.

• Then, remove the inhaler from the mouth and hold breath for 5 to 10 seconds, or as long as possible without discomfort.

• Then, the patient should begin breathing slowly, but not into the inhaler.

• Close the protective cap over the mouthpiece.

• Rinse the mouth with water and then spit it out. This may help prevent fungal infections in the mouth and reduce hoarseness.

Cleaning

• If necessary, the outer part of the mouthpiece may be cleaned with a dry tissue.
• Never disassemble the inhaler parts for cleaning or any other purpose!
• Do not clean the inhaler parts 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 your inhaler!

If you use more Budesonide/Formoterol Cipla than you should

It is important to use the dose stated in the leaflet or prescribed by your doctor. Do not increase your dose without consulting your doctor.

The most common symptoms and signs that may occur after using more Budesonide/Formoterol Cipla than recommended are tremors, headache, and rapid heartbeat.

If you have used more Budesonide/Formoterol Cipla than you should, contact your doctor, nurse, or call the Toxicology Information Service immediately at: 91 562 04 20, stating the medicine and the amount used.

If you forget to use Budesonide/Formoterol Cipla

• If you miss 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 not take a double dose to make up for missed doses.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• Swelling of the face, particularly around the mouth (tongue and/or throat and/or difficulty swallowing) or hives together with breathing difficulties (angioedema) and/or a sudden feeling of collapse, which may indicate you are having an allergic reaction. This occurs rarely (may affect up to 1 in 1,000 patients).
• High-pitched whistling sounds or breathing difficulties immediately after using your inhaler. If you experience any of these symptoms, stop using Budesonida/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 adverse effects:

Frequent (may affect up to 1 in 10 people)

• Palpitations (awareness of heartbeat), tremors. When these effects occur, they are usually mild and tend to disappear with continued use of Budesonida/Formoterol Cipla.
• Oral thrush (fungal infection in the mouth). This effect is less likely if you rinse your mouth with water after using 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 using Budesonida/Formoterol Cipla, as they may be signs of a lung infection:

• Fever or chills,
• Increased mucus production, change in mucus color,
• Worsening cough or increased breathing difficulties.

Uncommon (may affect up to 1 in 100 people)

• Aggression.
• Anxiety.
• Restlessness, nervousness, or agitation.
• Difficulty sleeping.
• Dizziness.
• Nausea (feeling unwell).
• Rapid heartbeat.
• Bruising of the skin.
• Muscle cramps.
• Blurred vision.

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

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

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

• Depression.
• Changes in behaviour, especially in children.
• Chest pain or tightness (angina).
• Increased blood sugar (glucose) levels.
• Taste disturbances, such as an unpleasant taste in the mouth.
• Changes in blood pressure.
• Weight gain, moon-shaped 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 (reduced bone strength),
• Cataracts (loss of transparency of the eye's lens),
• Glaucoma (increased eye pressure),
• Growth retardation in children and adolescents,
• Effects on the adrenal glands (small glands located above the kidneys),
• Cushingoid features,
• Increased susceptibility to infections and impaired ability to respond to stress may also occur.

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Budesonide/Formoterol Cipla

Keep this medicine out of the sight and reach of children.

Do not store above 30 °C.

Do not use this medicine after the expiry date stated on the pack or label of the inhaler after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Budesonida/Formoterol Cipla

• The active substances are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate, corresponding 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).

Presentation of the product and contents of the pack

Budesonida/Formoterol Cipla is a red/white plastic inhaler containing your medicine. 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 lumps.

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

Only certain 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Cipla Europe NV, Spanish branch
C/Guzmán el Bueno, 133, Edif. Britannia - 28003 Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area (EEA) under the following names:

Belgium: Airbufo Forspiro 160 microgram/4.5 microgram/inhalatie, inhalatiepoeder, Voorverdeeld
Denmark: AirBuFo Forspiro
Finland: AEROCOMP Forspiro 160 mikrog/4.5 mikrog/annos, inhalaatiojauhe, Annosteltu
France: AirBuFo Forspiro 160 microgrammes/4.5 microgrammes/dose, poudre pour inhalation en récipient unidose
Ireland: AirBuFo Forspiro 160 microgram/4.5 microgram/dose inhalation powder, pre-dispensed
Italy: AirBuFo Forspiro
Norway: AirBuFo Forspiro
Portugal: AirBuFo Forspiro
Sweden: Airbufo Forspiro 160 mikrog/4.5 mikrog/dos, inhalationspulver, avdelad dos

Date of the most recent revision of this summary: February 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) at http://www.aemps.gob.es/.

You can access detailed and up-to-date information on how to administer this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You may also access this information at the following internet address: https://cima.aemps.es/info/85833.