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Prospect: Information for the User

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

Budesonide/formoterol fumarate dihydrate

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Gibiter Easyhaler is a inhalerthat is 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. Contains two different medications: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medications called “corticosteroids”. It acts by reducing and preventing inflammation in your lungs.
• Formoterol fumarate dihydrate belongs to a group of medications called “long-acting beta2adrenergic agonists” or “bronchodilators”. It acts by relaxing the muscles of the airways, making it easier for you to breathe.

Asthma

Gibiter Easyhaler160micrograms/4,5micrograms can be prescribed for asthma in two different ways:

a) Some people are prescribed two inhalers:Gibiter Easyhaler 160 micrograms/ 4,5micrograms and a separate “reliever” inhaler.

• They should use Gibiter Easyhaler daily. This helps to prevent the onset of asthma symptoms.
• They should use their “reliever” inhaler when they experience asthma symptoms, to facilitate breathing.

b) Some people are prescribedGibiter Easyhaler 160micrograms/4,5 micrograms as a single inhaler for asthma.

• They should use Gibiter Easyhaler daily. This helps to prevent the onset of asthma symptoms.
• They should also use Gibiter Easyhaler when they need extra doses to relieve asthma symptoms, to facilitate breathing and, if agreed with the doctor, also to prevent the onset of asthma symptoms (for example, during exercise or exposure to allergens). A separate “reliever” inhaler is not necessary.

Chronic Obstructive Pulmonary Disease (COPD)

Gibiter Easyhaler160micrograms/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.

Do not use Gibiter Easyhaler 160micrograms/4.5micrograms:

• 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 160micrograms/ 4.5micrograms:

• 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 heartbeats, rapid pulse, narrowed arteries, or heart failure)
• If you have thyroid problems or adrenal gland problems
• If you have low potassium levels in the blood
• If you have severe liver problems

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

Swallow the mouthpiece after inhaling your dose to prevent fungal infections in the mouth.

Use of Gibiter Easyhaler 160micrograms/4.5microgramswith other medications

Inform your doctor or pharmacist if you are taking, have taken recently, 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 some medications for HIV treatment: ritonavir, cobicistat).

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

• beta-blockers (such as atenolol and propranolol for high blood pressure), including eye drops (such as timolol for glaucoma);
• Medications to treat rapid or irregular heartbeats (for example quinidina);
• Medications like digoxin, used commonly to treat heart failure;
• Diuretics (such as furosemide), used to treat high blood pressure;
• Oral steroids (such as prednisolone);
• Xanthine medications (such as theophylline or aminophylline), used commonly 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 to treat Parkinson's disease (such as levodopa);
• Medications to treat 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 to undergo general anesthesia for surgery or dental treatment.

Pregnancy and breastfeeding

• If you are pregnant, or breastfeeding, think you may be pregnant, or intend 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 operating machinery

The influence of Gibiter Easyhaler on the ability to drive and operate machinery is negligible or insignificant.

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

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

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

• Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

• Your doctor will want to check regularly 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 do blood tests from time to time. You may feel unwell in general when your oral steroid tablets are reduced, even if your lung symptoms are improving. You may experience some symptoms such as congestion, 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 allergic or arthritic symptoms develop, 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 steroid 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 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 often wake up at night with asthma symptoms.
• You start feeling chest tightness in the morning, or the 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

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 use and when you use it will depend on how it has been prescribed.

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

1. Use of Gibiter Easyhaler and a separate reliever inhaler for symptoms

Use Gibiter Easyhaler 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 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 (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.

There is a lower concentration of budesonide/formoterol for children aged 6-11 years.

Gibiter Easyhaler is not recommended for children under 6 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" when asthma symptoms appear.Always carry this "reliever inhaler" with you and use it when you need it. Do not use Gibiter Easyhaler to treat asthma symptoms, but your reliever inhaler.

1. Use of 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 Easyhaler 160 micrograms/4.5 micrograms every day.This helps prevent asthma symptoms from appearing.

You can 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 a day.

Also use Gibiter Easyhaler as a "reliever" to treat asthma symptoms when they appear and to prevent asthma symptoms from appearing (for example, during exercise or exposure 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 at a time.

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

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

If you usually need to take 8 or more inhalations a day, ask your doctor or nurse. You may need to change your treatment.

Do not take more than 12 inhalations in 24 hours.

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

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.

If you use more Gibiter Easyhaler than you should

It is essential to use the dose indicated by the pharmacist in the box 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 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Gibiter Easyhaler

• If you forget 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 not take a double dose to compensate for the missed doses.

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

The instructions on how to use the inhaler are at the end of the prospectus.

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

If any of the following situations occur, 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 experience urticaria along with difficulty breathing (angioedema) and/or sudden feeling of fainting, indicating that you may be experiencing an allergic reaction. This occurs rarely, affecting fewer than 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 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 fewer than 1 in 10,000 patients.

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

• Fever or cold
• Increased mucous production, change in mucous color
• Increased cough or difficulty breathing

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

Other possible side effects:

Frequent (affects fewer than 1 in 10 patients)

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

Rare (affects fewer than 1 in 100 patients)

• Agitation, restlessness, nervousness
• Difficulty sleeping
• Dizziness
• Nausea (discomfort)
• Accelerated heart rate
• Skin hematomas
• Muscle cramps
• Blurred vision.

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

• Rash, itching
• Asthma bronchospasm (contraction of the respiratory tract 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 fewer than 1 in 10,000 patients)

• Depression
• Changes in behavior, especially in children
• Chest pain or pressure (angina pectoris)
• Increased blood glucose levels
• Alterations in taste, such as unpleasant mouth taste
• Changes in blood pressure

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

• Bone mineral density changes (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).

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the box, aluminum bag, and the 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 at a temperature above 25°C and keep protected from moisture. It is recommended to keep the Gibiter Easyhaler inhaler inside the protective cover.
• If your Gibiter Easyhaler inhaler becomes wet, you must 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 thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Gibiter Easyhaler 160micrograms/4.5micrograms

• The active principles 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 package

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

Gibiter Easyhaler 160micrograms/4.5microgramsis available in packages of 1 or 3 inhalers.

Only some package sizes may be marketed.

Your package may contain a protective cover. If you need a protective cover, please contact the Marketing Authorization Holder (see details below).

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Menarini International Operations Luxembourg, S.A.

1, Avenue de la Gare L-1611

Luxembourg

Responsible Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Local Representative

Laboratorios Menarini, S.A.

Alfons XII, 587 – E 08918 Badalona (Barcelona)

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

Last review date of this leaflet:April 2021

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (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 inhaler label with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/info/78813.

QR code tohttps://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 properly, as improper use may result in you not receiving the correct amount of medication. This could make you feel very unwell or that your asthma and COPD are not being treated properly.

Your doctor, nurse, or pharmacist will show you how to use your inhaler properly. 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 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 acquire the inhaler for the first time

HOW TO USE IT PROPERLY

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

After using the inhaler:

• Put the powder cap back on the mouthpiece. This will prevent the inhaler from accidentally activating.

• 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. Do not use water: the powder inside the inhaler is sensitive to moisture.

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