GIBITER EASYHALER 320 micrograms/9 micrograms powder for inhalation

Introduction

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Leaflet: Information for the user

GIBITEREasyhaler 320micrograms/9micrograms/inhalation, Powder for inhalation

Budesonide/formoterol fumarate dihydrate

Read the entire leaflet carefully before starting to use this medication, 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 medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Gibiter Easyhaler 320 micrograms/9 micrograms and what is it used for
2. What you need to know before starting to use Gibiter Easyhaler 320 micrograms/9 micrograms
3. How to use Gibiter Easyhaler 320 micrograms/9 micrograms
4. Possible side effects
5. Storage of Gibiter Easyhaler 320 micrograms/9 micrograms
6. Package contents and additional information

1. What is Gibiter Easyhaler 320 micrograms/9 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 medications: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medications called "corticosteroids". It works 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". It works by relaxing the muscles of the airways, making it easier to breathe.

Asthma

For the treatment of asthma, your doctor will prescribe two different inhalers: Gibiter Easyhaler 320 micrograms/9 micrograms and a separate "reliever inhaler".

• Use Gibiter Easyhaler daily. This helps prevent the onset of asthma symptoms.
• Use your "reliever inhaler" when you experience asthma symptoms, to facilitate breathing.

Do not use Gibiter Easyhaler 320 micrograms/9 micrograms as a "reliever inhaler".

Chronic Obstructive Pulmonary Disease (COPD)

Gibiter Easyhaler 320 micrograms/9 micrograms can 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 starting to use Gibiter Easyhaler 320 micrograms/9 micrograms

Do not use Gibiter Easyhaler 320 micrograms/9 micrograms:

• If you are allergic to budesonide, formoterol fumarate dihydrate, or any other component of this medication (including lactose, which contains small amounts of milk proteins).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Gibiter Easyhaler 320 micrograms/9 micrograms:

• If you have diabetes
• If you have a lung infection
• If you have high blood pressure or have ever had 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 prevent fungal infections in the mouth.

Using Gibiter Easyhaler 320 micrograms/9 micrograms with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription.

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

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

• Beta-blocker medications (such as atenolol and propranolol for high blood pressure), including eye drops (such as timolol for glaucoma);
• Medications to treat rapid or irregular heartbeat (such as quinidine);
• Medications like digoxin, commonly used to treat heart failure;
• Diuretics (such as furosemide), used to treat high blood pressure;
• Oral steroid medications (such as prednisolone);
• Xanthine medications (such as theophylline or aminophylline), commonly used for asthma;
• Other bronchodilators (such as salbutamol);
• Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone;
• Phenothiazine medications (such as chlorpromazine and prochlorperazine);
• Medications to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, and telithromycin);
• Medications for the treatment of Parkinson's disease (such as levodopa);
• Medications 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 plan to become pregnant, consult your doctor or pharmacist before using this medication
• 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 and consult your doctor immediately.

Driving and using machines

The influence of Gibiter Easyhaler on the ability to drive and use machines is negligible.

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 certain sugars, consult with them before using this medication.

3. How to use Gibiter Easyhaler 320 micrograms/9 micrograms

• Follow your doctor's instructions for using this medication exactly. If you are unsure, consult your doctor or pharmacist again.
• It is essential 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 oral 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 oral 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 oral 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 muscle and joint pain, and skin rash (eczema). If any of these symptoms concern you, or if you experience any other symptoms such as headache, fatigue, nausea, or vomiting, contact your doctor immediately. If you develop allergic or arthritic symptoms, you may need to take another medication. You should consult your doctor if you are concerned about whether you should continue using Gibiter Easyhaler.

Your doctor may consider adding oral steroid tablets to your regular 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 using 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 immediate different or additional treatment.

ASTHMA

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

Adults (from 18 years)

• The usual dose is 1 inhalation, twice a day.
• Your doctor may prescribe up to 2 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)

• The usual dose is 1 inhalation, 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 medication 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 to use when needed. Do not use Gibiter Easyhaler to treat asthma symptoms; use your reliever inhaler instead.

Chronic Obstructive Pulmonary Disease (COPD)

• Use only in adults (over 18 years).
• The usual dose is 1 inhalation, twice a day.

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

If you use more Gibiter Easyhaler than you should

It is essential to 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 320 micrograms/9 micrograms than you should are tremors, headache, and rapid heartbeat.

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

If you forget to use Gibiter Easyhaler

• If you forget any of the doses 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 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.

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

4. Possible side effects

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

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

• Your face swells, particularly around the mouth (tongue and/or throat) or you experience hives along with difficulty breathing (angioedema) and/or a sudden feeling of fainting, which indicates that you may be experiencing an allergic reaction. This occurs rarely, affecting less than 1 in 1,000 patients.
• You experience 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 "reliever 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 experience any of the following side effects while taking Gibiter Easyhaler, which 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 common side effect (affects less than 1 in 10 patients).

Other possible side effects:

Common (affects less than 1 in 10 patients)

• Palpitations (feeling your heartbeat), tremors. When these effects occur, they are usually mild and disappear with continued use of 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

Uncommon (affects less than 1 in 100 patients)

• Agitation, restlessness, nervousness
• Difficulty sleeping
• Dizziness
• Nausea (discomfort)
• Rapid heartbeat
• Bruising
• Muscle cramps
• Blurred vision.

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

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

Very rare (affects 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
• Changes in taste, 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 (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 next to the kidneys).

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Gibiter Easyhaler 320 micrograms/9 micrograms

• Keep this medication out of sight and reach of children.
• Do not use this medication after the expiration date shown on the box, aluminum bag, and inhaler label after EXP. 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 moisture. You can use a protective cover with your Easyhaler inhaler.
• If your Gibiter Easyhaler inhaler becomes damp, you should replace it with a new one.
• Replace the Gibiter Easyhaler inhaler 4 months after opening the aluminum bag. Write the date it was opened to help you remember.

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

6. Container Contents and Additional Information

Composition of Gibiter Easyhaler 320micrograms/9micrograms

• The active ingredients are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
• The other component is lactose monohydrate (which contains milk proteins).

Appearance of the Product and Container Contents

Gibiter Easyhaler 320 micrograms/9 micrograms is an inhaler that contains your medication. The inhalation powder is white to yellowish in color. Each inhaler contains 60 doses and consists of a white body and a red top.

Gibiter Easyhaler 320 micrograms/9 micrograms is available in packs of 1 or 3 inhaler(s).

Only some pack sizes may be marketed.

Your pack 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 Last Revision of this Leaflet: 06/2025

Detailed information on this medicinal product 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 medication 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/78803.

QR Code to https://cima.aemps.es/info/78803

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 medication. This could make you feel very ill 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 unsure, 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/78803.

When You First Acquire 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 triggered 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 Questions About the Use of This Product, Consult Your Doctor or Pharmacist.