Gibiter Easyhaler 160 micrograms/4.5 micrograms/inhalation powder for inhalation

Package leaflet: Information for the user

Introduction

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To view the instructions on how to use the Easyhaler inhaler, scan this code or visit https://cima.aemps.es/info/78813

Package leaflet: Information for the user

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

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, as 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, and you must not pass it on to other people, even if they have the same symptoms as you, because it could 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.

Leaflet contents

1. What Gibiter Easyhaler 160 micrograms/4.5 micrograms is and what it is used for
2. What you need to know before using Gibiter Easyhaler 160 micrograms/4.5 micrograms
3. How to use Gibiter Easyhaler 160 micrograms/4.5 micrograms
4. Possible side effects
5. How to store Gibiter Easyhaler 160 micrograms/4.5 micrograms
6. Contents of the pack and other information

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

Gibiter Easyhaler is an inhaler used for the treatment of asthma in adults and adolescents aged 12 to 17 years. 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 known as "long-acting beta2-adrenergic agonists" or "bronchodilators". It works by relaxing the muscles in the airways, helping you to breathe more easily.

Asthma

Gibiter Easyhaler 160 micrograms/4.5 micrograms may 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 must use Gibiter Easyhaler daily. This helps prevent asthma symptoms from occurring.
  • You must use your "reliever inhaler" when you experience asthma symptoms, to help you breathe more easily.

• Some people are prescribed Gibiter Easyhaler 160 micrograms/4.5 micrograms as a single inhaler for asthma.

  • You must use Gibiter Easyhaler daily. This helps prevent asthma symptoms from occurring.
  • You must also use Gibiter Easyhaler whenever you need extra doses to relieve asthma symptoms, to help you breathe more easily and, if agreed with your doctor, also to prevent asthma symptoms from occurring (for example, during exercise or exposure to allergens). A separate reliever inhaler is not required.

Chronic Obstructive Pulmonary Disease (COPD)

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

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

Do not use Gibiter Easyhaler 160 micrograms/4.5 micrograms:

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

Warnings and precautions

Talk to your doctor or pharmacist before using Gibiter Easyhaler 160 micrograms/4.5 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, narrowed arteries, or heart failure)
• If you have thyroid or adrenal gland problems
• If you have low levels of potassium in your blood
• If you have severe liver problems

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

Rinse your mouth with water after inhaling your dose to prevent fungal infections in the mouth.

Using Gibiter Easyhaler 160 micrograms/4.5 micrograms with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those purchased 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 certain medicines for the treatment of HIV/AIDS: ritonavir, cobicistat).

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

• Beta-blockers (such as atenolol and propranolol for high blood pressure), including eye drops (such as timolol for glaucoma);
• Medicines to treat fast or irregular heartbeat (e.g., quinidine);
• Medicines such as 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 amitriptiline) and the antidepressant nefazodone;
• Phenothiazine medicines (such as chlorpromazine and prochlorperazine);
• Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, and telithromycin);
• Medicines for 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 due 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 medicine.
• Do not use Gibiter Easyhaler unless your doctor has instructed you to do so.
• If you become pregnant while being treated with Gibiter Easyhaler, do not stop using it and contact your doctor immediately.

Driving and using machines

The effect of Gibiter Easyhaler on the ability to drive or operate machinery is negligible or none.

Gibiter Easyhaler contains lactose, a type of sugar.

It may cause allergic reactions in patients allergic to cow's milk protein.

If your doctor has told you that you have an intolerance to certain sugars, consult him before using this medicine.

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

• Follow exactly the instructions given by your doctor for using this medicine. If in doubt, consult your doctor or pharmacist again.

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

• Your doctor will want to regularly monitor how your asthma symptoms are progressing.

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 oral steroid tablets for a long time, your doctor may want to carry out occasional blood tests. You may feel generally unwell when your dose of oral steroids is reduced, even though your lung symptoms may be improving. Some symptoms such as nasal congestion or runny nose, weakness or muscle and joint pain, and skin rash (eczema) may appear. If any of these symptoms concern you, or if you develop other symptoms such as headache, fatigue, nausea, or vomiting, contact your doctor immediately. If allergic or arthritic symptoms develop, 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 (for example, 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 worsens or you often wake up at night with asthma symptoms.
• You begin to experience chest tightness in the morning, or chest tightness lasts longer than usual.

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

ASTHMA

Gibiter Easyhaler 160 micrograms/4.5 micrograms may be prescribed for asthma in two different ways. The amount of Gibiter Easyhaler 160 micrograms/4.5 micrograms you will use and when you 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 titled "A) Use of Gibiter Easyhaler and a separate reliever inhaler"

2. If you have been prescribed Gibiter Easyhaler as a single inhaler, read the section titled "B) Use of Gibiter Easyhaler as a single inhaler for asthma"

3. Use of Gibiter Easyhaler and a separate reliever inhaler

Use Gibiter Easyhaler daily, as it helps prevent asthma symptoms from occurring.

Adults (aged 18 years and older)

• The usual dose is 1 or 2 inhalations twice daily.
• Your doctor may prescribe up to 4 inhalations twice daily.
• If your symptoms are well controlled, your doctor may instruct you to use the medication once daily.

Adolescents (aged 12 to 17 years)

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

A lower strength of budesonide/formoterol is available for children aged 6–11 years.

Use of Gibiter Easyhaler is not recommended 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 first talking to your doctor or nurse.

Use your other "reliever inhaler" when asthma symptoms occur. Always keep this "reliever inhaler" with you so you can use it when needed. Do not use Gibiter Easyhaler to treat asthma symptoms—use your reliever inhaler instead.

1. Use of Gibiter Easyhaler as a single inhaler for asthma

Only use Gibiter Easyhaler in this way if your doctor has instructed you to do so and you are aged 12 years or older.

Use Gibiter Easyhaler 160 micrograms/4.5 micrograms every day. This helps prevent asthma symptoms from occurring.

You may take:

• 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 daily.

Also use Gibiter Easyhaler as a "reliever inhaler" to treat asthma symptoms when they occur, and to prevent asthma symptoms from appearing (for example, when exercising or when exposed to allergens).

• 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 on a single occasion.

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

Normally, a total daily dose exceeding 8 inhalations is not required. However, your doctor may allow you to take up to 12 inhalations per day for a limited period.

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

Do not use more than 12 inhalations in any 24-hour period.

If you exercise 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 asthma symptoms; how often you exercise or how frequently you are exposed to allergens may affect the treatment prescribed for you.

Chronic Obstructive Pulmonary Disease (COPD)

• For use only in adults (over 18 years of age).
• The usual dose is 2 inhalations twice daily.

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 to use the dose indicated by the pharmacist on the package 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 Gibiter Easyhaler 160 micrograms/4.5 micrograms than you should are tremors, headache, and rapid heartbeat.

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

If you forget to use Gibiter Easyhaler

• If you miss a dose of Gibiter Easyhaler, continue your 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 not take a double dose to make up for a missed dose.

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

Instructions on how to use the inhaler are at the end of the leaflet.

4. Possible adverse effects

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

If you experience any of the following, stop using Gibiter Easyhaler 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 faintness, which may indicate you are having an allergic reaction. This occurs rarely, affecting fewer than 1 in 1,000 patients.
• High-pitched "wheezing" or breathing difficulties immediately after using your inhaler. If you experience any of these symptoms, stop using your Gibiter Easyhaler immediately and use your "reliever inhaler". Contact your doctor immediately, as you may need to change your treatment. This occurs very rarely, affecting fewer than 1 in 10,000 patients.

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

• Fever or cold-like symptoms
• Increased mucus production, change in mucus color
• Increased coughing or worsening of breathing difficulties

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

Other possible adverse effects:

Common (affects fewer than 1 in 10 patients)

• Palpitations (awareness of heartbeat), tremors. When these occur, they are usually mild and tend to disappear with continued use of Gibiter Easyhaler.
• Oral 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 fewer than 1 in 100 patients)

• Restlessness, agitation, nervousness
• Difficulty sleeping
• Dizziness
• Nausea (feeling unwell)
• Fast heartbeat
• Bruising of the skin
• Muscle cramps
• Blurred vision

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

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

Very rare (affects fewer than 1 in 10,000 patients)

• Depression
• Changes in behaviour, especially in children
• Chest pain or tightness (angina)
• Increased blood sugar (glucose) levels
• Taste disturbances, such as unpleasant taste in the mouth
• Changes in blood pressure

Inhaled corticosteroids may affect the normal production of steroid hormones in your 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 lens in the eye)
• Glaucoma (increased pressure in the eye)
• Growth retardation in children and adolescents
• Effects on the adrenal glands (small glands located above the kidneys)

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

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date which is stated on the carton, the aluminium pouch, and the label of your inhaler after EXP. The expiry date refers to the last day of the month indicated.
• After opening the aluminium pouch, store below 25°C and protect from moisture. You may use a protective cover with your Easyhaler inhaler.
• If your Gibiter Easyhaler inhaler becomes wet, it must be replaced with a new one.
• Replace the Gibiter Easyhaler inhaler 4 months after opening the aluminium pouch. Write down the date it was opened to help you remember.
• Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gibiter Easyhaler 160 micrograms/4.5 micrograms

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

Appearance of the product and contents of the pack

Gibiter Easyhaler 160 micrograms/4.5 micrograms is an inhaler containing your medicine. The inhalation powder is white to slightly yellowish. 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 packs of 1 or 3 inhaler(s).

Only certain pack sizes may be marketed.

Your pack may include a protective cover, which is available depending on the country. If you require a protective cover, please contact the Marketing Authorization Holder (see details below).

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 most recent revision of this leaflet: 06/2025

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

You can access detailed information on how to administer this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet, carton, and inhaler label. You can also access this information at the following web 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 differ from other inhalers you have used previously. Therefore, it is very important that you use it correctly, as incorrect use may result in you not receiving the proper amount of medicine. This could make you feel worse or mean your asthma or COPD is not properly treated.

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 must ensure that children prescribed Gibiter Easyhaler perform the inhalation technique correctly, as described below. You can also view the instructional video at https://cima.aemps.es/info/78813.

When you first obtain your Easyhaler inhaler

The inhaler comes in an aluminum foil pouch. Do not open the aluminum foil pouch until you are ready to start using the medicine, as this helps keep the powder in the inhaler dry. When you are ready to begin treatment, open the pouch and record the date, e.g., on your calendar. Use the inhaler within 4 months after removing it from the aluminum foil pouch.

HOW TO USE IT CORRECTLY

Step 1: SHAKE Remove the protective dust cap Shake the inhaler 3 to 5 times while holding it in an upright position

SHAKE x 3-5

Important points to remember It is important to keep the inhaler in an upright position If you accidentally activate it while shaking, clear the powder from the mouthpiece as shown below

Step 2: ACTUATE Keep holding the inhaler upright with your index finger and thumb Press down until you hear a "click", then release until you hear a second "click". This releases one dose Actuate only once

ACTUATE ONCE

Important points to remember Do not actuate the inhaler if the cap is still on Actuate only once If you accidentally actuate it more than once, empty the powder from the mouthpiece—see below Actuate to release the dose before inhaling, not at the same time Keep the inhaler upright while actuating and while inhaling the dose. If you tilt it, the powder may fall out before you can inhale it

Step 3: INHALE Keep holding the inhaler in an upright position Breathe out normally Place the mouthpiece in your mouth, between your teeth, and close your lips tightly around the mouthpiece Breathe in deeply and forcefully Remove the inhaler from your mouth and breathe out normally

INHALE

Important points to remember Make sure the mouthpiece is fully placed inside your mouth so that the medication can reach your lungs Ensure your lips are tightly sealed around the mouthpiece Do not breathe out into the inhaler. This is important: it could block the inhaler. If you do breathe out into the inhaler, empty the powder from the mouthpiece, see below

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

After using the inhaler:

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

How to empty the powder from the mouthpiece If you have accidentally actuated the inhaler, if you have actuated it more than once, or if you have exhaled into the inhaler, empty the mouthpiece. Gently tap the mouthpiece on a flat surface or on the palm of your hand to remove the powder. Then repeat the Shake-Actuate-Inhale steps again.

Cleaning the inhaler

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

Use of the inhaler with a protective cover You may use a protective cover with your Easyhaler inhaler. This can help improve the product's durability. The first time you insert the inhaler into the protective cover, make sure the inhaler has its cap on, as this prevents accidental activation. You can use the inhaler without removing it from the protective cover. Follow the same instructions above: 1. Shake – 2. Activate – 3. Inhale. Remember: Keep the inhaler in an upright position when activating it Replace the cap after taking the dose, as this will prevent accidental activation of the inhaler.

When to start using a new inhaler The dose counter shows the number of doses remaining. The counter advances every 5 doses. When the dose counter starts turning red, 20 doses remain. If you do not yet have a new inhaler, contact your doctor for a new prescription. When the counter reaches 0 (zero), you must replace the inhaler. If you have a protective cover, you may keep it and insert your new inhaler into it.

Remember 1. Shake – 2. Actuate – 3. Inhale. After taking the dose, rinse your mouth with water and spit it out. Do not wet your inhaler; protect it from moisture.

If you have any further questions about the use of this product, consult your doctor or pharmacist.