GIBITER EASYHALER 160 micrograms/4.5 micrograms/inhalation POWDER FOR INHALATION

Introduction

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Leaflet: Information for the user

GIBITER Easyhaler 160micrograms/4.5micrograms/inhalation, Powder for inhalation

Budesonide/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, as 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Gibiter Easyhaler 160 micrograms/4.5 micrograms and what is it used for
2. What you need to know before you use Gibiter Easyhaler 160 micrograms/4.5 micrograms
3. How to use Gibiter Easyhaler 160 micrograms/4.5 micrograms
4. Possible side effects
5. Storage of Gibiter Easyhaler 160 micrograms/4.5 micrograms
6. Pack contents and further information

1. What is Gibiter Easyhaler 160 micrograms/4.5 micrograms and what is it used for

Gibiter Easyhaler 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”. It 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”. It works by relaxing the muscles of the airways, making it easier to breathe.

Asthma

Gibiter Easyhaler 160micrograms/4.5microgramscan be prescribed for asthma in two different ways:

• Some people are prescribed two inhalers: Gibiter Easyhaler 160 micrograms/4.5 micrograms and a separate “reliever” inhaler.
• You should use Gibiter Easyhaler daily. This helps prevent the onset of asthma symptoms.
• You should use your “reliever” inhaler when you experience asthma symptoms, to facilitate breathing.

• Some people are prescribed Gibiter Easyhaler 160 micrograms/4.5 micrograms as a single inhaler for asthma.
• You should use Gibiter Easyhaler daily. This helps prevent the onset of asthma symptoms.
• You should also use Gibiter Easyhaler when you need extra doses to relieve asthma symptoms, to facilitate breathing and, if agreed with your doctor, also to prevent the onset of asthma symptoms (e.g., when exercising or exposed to allergens). You do not need a separate reliever inhaler.

Chronic Obstructive Pulmonary Disease (COPD)

Gibiter Easyhaler 160micrograms/4.5microgramscan also be used to treat the symptoms of COPD in adults. COPD is a long-term disease of the airways, often caused by smoking.

2. What you need to know before you use Gibiter Easyhaler 160 micrograms/4.5 micrograms

Do not use Gibiter Easyhaler 160micrograms/4.5micrograms:

• If you are allergic to budesonide, formoterol fumarate dihydrate, or any other component of this medicine (listed in section 6), which includes lactose (containing small amounts of milk proteins).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Gibiter Easyhaler 160 micrograms/4.5 micrograms:

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

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

Rinse your mouth after inhaling your dose to avoid fungal infections in the mouth.

Using Gibiter Easyhaler 160micrograms/4.5microgramswith other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines may increase the effects of Gibiter Easyhaler, and your doctor may consider close monitoring if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).

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

• Beta-blocker medicines (such as atenolol and propranolol for high blood pressure), including eye drops (such as timolol for glaucoma);
• Medicines for treating rapid or irregular heartbeat (such as quinidine);
• Medicines like digoxin, commonly used to treat heart failure;
• Diuretics (such as furosemide), used to treat high blood pressure;
• Oral steroid medicines (such as prednisolone);
• Xanthine medicines (such as theophylline or aminophylline), commonly used for asthma;
• Other bronchodilators (such as salbutamol);
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone;
• Phenothiazine medicines (such as chlorpromazine and prochlorperazine);
• Medicines for treating infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, and telithromycin);
• Medicines for treating Parkinson's disease (such as levodopa);
• Medicines for thyroid problems (such as levothyroxine).

If you are in any of these situations, or if you are unsure, ask your doctor or pharmacist before using Gibiter Easyhaler.

Also, inform your doctor or pharmacist if you are going to undergo general anesthesia for surgery or dental treatment.

Pregnancy and breastfeeding

• If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
• Do not use Gibiter Easyhaler unless your doctor tells you to.
• If you become pregnant during treatment with Gibiter Easyhaler, do not stop using it, but consult your doctor immediately.

Driving and using machines

Gibiter Easyhaler has no or negligible influence on the ability to drive and use machines.

Gibiter Easyhaler contains lactose,which is a type of sugar.

It may cause allergic reactions in patients with milk protein allergy.

If your doctor has told you that you have an intolerance to some sugars, consult with them before using this medicine.

3. How to use Gibiter Easyhaler 160 micrograms/4.5 micrograms

• Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor or pharmacist again.

• It is important to use Gibiter Easyhaler daily, even if you do not have symptoms of asthma or COPD at that time.

• Your doctor will want to check your asthma symptoms regularly.

If you have been taking steroid tablets for asthma or COPD, your doctor may reduce the number of tablets you take once you start treatment with Gibiter Easyhaler. If you have been taking steroid tablets for a long time, your doctor may want to do a blood test from time to time. You may feel unwell when your steroid tablets are reduced, even if your lung symptoms are improving. You may experience some symptoms such as nasal congestion or runny nose, weakness or pain in the muscles and joints, and skin rash (eczema). If any of these symptoms worry you, or if you experience any other symptoms such as headache, tiredness, nausea, or vomiting, contact your doctor immediately. If you develop allergic or arthritic symptoms, you may need to take another medicine. You should consult your doctor if you are concerned about whether you should continue using Gibiter Easyhaler.

Your doctor may consider adding steroid tablets to your usual treatment during periods of stress (e.g., when you have a chest infection or before surgery).

Important information about asthma or COPD symptoms:

If while using Gibiter Easyhaler you experience difficulty breathing or wheezing, you should continue to use it and 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 wake up at night with asthma symptoms.
• You start to feel chest tightness in the morning, or chest tightness lasts longer than usual.

These signs may indicate that your disease is not adequately controlled, and you may need a different or additional treatment immediately.

ASTHMA

Gibiter Easyhaler 160 micrograms/4.5 micrograms can be prescribed for asthma in two different ways. The amount of Gibiter Easyhaler 160 micrograms/4.5 micrograms you will use and when you will use it depends on how it has been prescribed for you.

1. If you have been prescribed Gibiter Easyhaler 160 micrograms/4.5 micrograms and a separate reliever inhaler, read the section called "A) Using Gibiter Easyhaler and a separate reliever inhaler for symptoms"
2. If you have been prescribed Gibiter Easyhaler as a single inhaler for asthma, read the section called "B) Using Gibiter Easyhaler as a single inhaler for asthma"

1. Using Gibiter Easyhaler and a separate reliever inhaler for symptoms

Use Gibiter Easyhaler daily,as it helps prevent the onset of asthma symptoms.

Adults (from 18 years)

• The usual dose is 1 or 2 inhalations, twice a day.
• Your doctor may prescribe up to 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 of age)

• 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.

A lower concentration of budesonide/formoterol is available for children aged 6-11 years.

Gibiter Easyhaler is not recommended for use in children under 6 years of age.

Your doctor (or nurse) will help you 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 talking to your doctor or nurse first.

Use your other “reliever inhaler” when you experience asthma symptoms.Always carry this “reliever inhaler” with you so you can use it when you need it. Do not use Gibiter Easyhaler to treat asthma symptoms, but use your reliever inhaler instead.

1. Using Gibiter Easyhaler as a single inhaler for asthma

Only use Gibiter Easyhaler in this way if your doctor tells you to and you are 12 years old or older.

Use Gibiter Easyhaler160 micrograms/4.5 micrograms every day.This helps prevent asthma symptoms from appearing.

You can take:

• 1 inhalation in the morning and1 inhalation in the evening

or

• 2 inhalations in the morning

or

• 2 inhalations in the evening

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

Also, use Gibiter Easyhaler as a "reliever inhaler" to treat asthma symptoms when they appearand to prevent the onset of asthma symptoms (e.g., when exercising or exposed to allergens).

• If you experience 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 on one occasion.

Always carry your Gibiter Easyhaler inhaler with you and use it when you need it.

Normally, you do not need a daily total dose of more than 8 inhalations. However, your doctor may allow you to take up to 12 inhalations per day for a limited period.

If you usually need to take 8 or more inhalations per day, make an appointment with your doctor or nurse. They may need to change your treatment.

Do not take more than 12 inhalations in a 24-hour period.

If you are exercising and notice asthma symptoms, use Gibiter Easyhaler as described here. It is important that you talk to your doctor about using Gibiter Easyhaler to prevent the onset of asthma symptoms; the frequency with which you exercise or are exposed to allergens may influence the treatment prescribed for you.

Chronic Obstructive Pulmonary Disease (COPD)

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

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

If you use more Gibiter Easyhaler than you should

It is important that you use the dose that your pharmacist has indicated on the box or that your doctor has prescribed. Do not increase your dose without consulting your doctor.

The most common symptoms and signs that may occur if you use more Gibiter Easyhaler 160 micrograms/4.5 micrograms than you should are tremors, headache, and rapid heartbeat.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Gibiter Easyhaler

• If you forget to take a dose of Gibiter Easyhaler, follow the recommended treatment 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 make up for missed doses.

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

The instructions for using the inhaler are at the end of the leaflet.

4. Possible Adverse Effects

Like all medicines, this medicine may cause adverse effects, although not all people suffer from them.

If you experience any of the following situations, stop using Gibiter Easyhaler and consult your doctor immediately:

• Your face swells, particularly around the mouth (tongue and/or throat and/or difficulty swallowing) or you have hives along with breathing difficulties (angioedema) and/or a sudden feeling of fainting, which indicates that you may be suffering from an allergic reaction. This occurs rarely, affecting less than 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 your Gibiter Easyhaler inhaler immediately and use your "relief inhaler". Contact your doctor immediately as you may need to change your treatment.This occurs very rarely, affecting less than 1 in 10,000 patients.

Tell your doctor if you have any of the following effects while taking Gibiter Easyhaler, as they may be symptoms of a lung infection:

• Fever or cold
• Increased mucus production, change in mucus color
• Increased coughing or difficulty breathing

Pneumonia (lung infection) in patients with COPD is a frequent adverse effect (affects less than 1 in 10 patients).

Other possible adverse effects:

Frequent (affect less than 1 in 10 patients)

• Palpitations (noticing heartbeats), tremors. When these effects appear, they are usually mild and disappear when continuing to use Gibiter Easyhaler.
• Thrush (fungal infection) in the mouth; this effect is less likely if you rinse your mouth with water after using Gibiter Easyhaler
• Mild throat irritation, cough, hoarseness
• Headache

Infrequent (affect less than 1 in 100 patients)

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

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

• Rash, itching
• Bronchospasm (contraction of the airway muscles, causing wheezing). If this happens suddenly right after using Gibiter Easyhaler, stop using it and consult your doctor immediately
• Low potassium levels in the blood
• Irregular heartbeat

Very rare (affect less than 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

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

• Changes in bone mineral density (decrease in bone mass)
• 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 next to the kidneys).

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

Reporting adverse effects

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

5. Storage of Gibiter Easyhaler 160 micrograms/4.5 micrograms

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiration date that appears on the box, aluminum bag, and label of your inhaler after CAD. The expiration date is the last day of the month indicated.
• After opening the aluminum bag, do not store above 25°C and keep protected from humidity. You can use a protective cover with your Easyhaler inhaler.
• If your Gibiter Easyhaler inhaler becomes damp, you must replace it with a new one.
• Replace the Gibiter Easyhaler inhaler 4 months after opening the aluminum bag. Write down the date it was opened to help you remember.
• Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines 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 medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Gibiter Easyhaler 160 micrograms/4.5 micrograms

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

Appearance of the Product and Package Contents

Gibiter Easyhaler 160 micrograms/4.5 micrograms is an inhaler that contains your medicine. The inhalation powder is white to yellowish in color. Each inhaler contains 60 or 120 doses and consists of a white body and a red top.

Gibiter Easyhaler 160 micrograms/4.5 micrograms is available in packages of 1 or 3 inhaler(s).

Only some package sizes may be marketed.

Your package may contain a protective cover that is available depending on the country. If you need a protective cover, please contact the Marketing Authorization Holder (see details below).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Menarini International Operations Luxembourg, S.A.

1, Avenue de la Gare L-1611

Luxembourg

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Local Representative

Laboratorios Menarini, S.A.

Alfons XII, 587 – E 08918 Badalona (Barcelona)

• +34 934 628 800 e-mail: [email protected]

Date of the Last Revision of this Leaflet: 06/2025

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

You can access detailed information on how to administer this medicine by scanning the QR code included in the leaflet, packaging, and label of the inhaler with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/info/78813.

QR code to https://cima.aemps.es/info/78813

How to Use the Easyhaler Inhaler

About Your Easyhaler Inhaler

Gibiter Easyhaler may be different from other inhalers you may have used in the past. Therefore, it is very important that you use it correctly, as incorrect use can make you not receive the correct amount of medicine. This could make you feel very bad or that your asthma and COPD are not being treated properly.

Your doctor, nurse, or pharmacist will show you how to use your inhaler correctly. Make sure you understand the correct way to use the inhaler. If you are not sure, contact your doctor, nurse, or pharmacist. As with all inhalers, caregivers should ensure that children who have been prescribed Gibiter Easyhaler perform the inhalation technique correctly, as described below. You can also watch the instruction video at https://cima.aemps.es/info/78813.

When You First Get Your Easyhaler Inhaler

HOW TO USE IT CORRECTLY

If you need to take another inhalation, repeat steps 1-3: Shake-Actuate-Inhale.

After using the inhaler:

• Put the cap back on the mouthpiece. This will prevent the inhaler from being activated accidentally.
• After taking the dose, rinse your mouth with water and spit it out.

Cleaning the Inhaler

Keep your inhaler dry and clean. If necessary, you can clean the mouthpiece of the inhaler with a dry cloth or handkerchief. Do not use water: the powder inside the inhaler is sensitive to moisture.

If you have any additional doubts about using this product, consult your doctor or pharmacist.