Budesonide Easyhaler 400 micrograms powder for inhalation: detailed information

Patient Information Leaflet

Introduction

Three sequential illustrations show how to shake the

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Patient Information Leaflet

Budesonide Easyhaler 400 micrograms/dose powder for inhalation

Please read all of this leaflet carefully before you start using this medicine, as 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, pharmacist, or nurse.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Budesonide Easyhaler is and what it is used for
What you need to know before using Budesonide Easyhaler
How to use Budesonide Easyhaler
Possible side effects
How to store Budesonide Easyhaler
Contents of the pack and other information

1. What Budesonide Easyhaler is and what it is used for

The active substance in Budesonide Easyhaler is budesonide. Budesonide powder is presented in an inhaler. When you inhale through the mouthpiece, the powder enters the lungs with the inhaled air. Budesonide works by reducing and preventing swelling and inflammation in your lungs.

Budesonide Easyhaler is a medicine known as a "preventer". It is used to prevent asthma symptoms. It belongs to a group of medicines called corticosteroids.

Budesonide will not stop an asthma attack once it has already started. Therefore, you must always have a fast-acting bronchodilator "reliever" (a beta2 agonist) available.

The effect of budesonide starts after a few days of treatment and reaches its maximum effect after several weeks. Take Budesonide Easyhaler regularly to prevent asthmatic inflammation. Continue taking this medicine regularly as directed, even if you have no symptoms.

2. What you need to know before using Budesonida Easyhaler

Do not use Budesonida Easyhaler if you are allergic to:

budesonide, or
any of the other ingredients of this medicine (listed in section 6), which is lactose (containing small amounts of milk proteins)

Inform your doctor so that your medication can be switched to an alternative.

Warnings and precautions

Consult your doctor before starting to use Budesonida Easyhaler if you have:

pulmonary tuberculosis
an untreated bacterial, viral, or fungal infection in your mouth, airways, or lungs
severe liver problems

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

Rinse your mouth with water after each inhalation to help prevent fungal infection in the mouth.

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

Other medicines and Budesonida Easyhaler

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

Some medicines may increase the effects of Budesonida 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).

Inform your doctor if you are using:

nasal medicines containing corticosteroids
corticosteroid tablets
antifungal medicines containing ketoconazole or itraconazole

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. It is important for both the fetus and the mother to maintain adequate asthma control during pregnancy. As with other medicines taken during pregnancy, the benefit of administering budesonide to the mother should be weighed against any potential risk to the fetus. The lowest effective dose of budesonide should be used to maintain adequate asthma control.

Driving and using machines

There are no indications that Budesonida Easyhaler affects the ability to drive or operate machinery.

Budesonida Easyhaler inhalation powder contains a small amount of lactose, which is unlikely to cause problems even if you have lactose intolerance. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before using this medicine.

Lactose contains small amounts of milk proteins, which may cause an allergic reaction.

3. How to use Budesonide Easyhaler

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

Your doctor has prescribed the dose and duration of treatment with Budesonide Easyhaler most suitable for you. Follow your doctor's instructions carefully.

Switching from oral corticosteroid tablets to Budesonide Easyhaler:

Consult your doctor if you are taking oral corticosteroid tablets (e.g. cortisone tablets) for the treatment of your asthma. Your doctor may gradually reduce the number of tablets until treatment is eventually discontinued within a few weeks. If you do not feel well during this transition period, consult your doctor, but do not stop using Budesonide Easyhaler.

Use in adults (including elderly) and adolescents (12 to 17 years):

1–2 inhalations in the morning and evening, or once daily at night.

Use in children aged 6 to 11 years:

1–2 inhalations in the morning and evening, or once daily at night.

During treatment, your doctor will adjust your dose and prescribe the lowest dose that controls your asthma symptoms (maintenance dose).

If Budesonide Easyhaler is prescribed for a child, ensure that he/she can use it correctly.

In addition to preventive treatment with Budesonide Easyhaler, you may also need a reliever bronchodilator:

Budesonide does not stop an asthma attack once it has started. Therefore, it is essential that you always have a fast-acting reliever bronchodilator (a beta2 agonist) available to treat acute asthma symptoms.

If you use a reliever inhaler (a beta2 agonist), you should inhale it before using Budesonide Easyhaler (preventer).

Worsening of asthma symptoms during treatment:

Consult your doctor as soon as possible if:

Your wheezing (whistling) or chest tightness worsens during treatment
You need to use your reliever inhaler more often than before
Your reliever inhaler does not work as well as before

Your asthma may be worsening and you may require additional treatment.

If you use more Budesonide Easyhaler than you should:

If you use a higher dose of Budesonide Easyhaler than prescribed or take more doses than recommended, consult your doctor as soon as possible. You should continue using Budesonide Easyhaler unless your doctor tells you otherwise.

It is important to take your dose exactly as advised by your doctor or pharmacist. Do not increase or decrease your dose without medical advice.

If you forget to use Budesonide Easyhaler:

If you forget to take a dose, take it as soon as possible, or you may take the next dose at the usual time. Take the medicine at the same time each day.

Do not take a double dose to make up for a missed dose.

If you stop treatment with Budesonide Easyhaler:

Do not stop treatment with Budesonide Easyhaler without consulting your doctor. If you stop using the medicine abruptly, your asthma may worsen.

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

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

4. Possible adverse effects

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

Frequent (may affect up to 1 in 10 people):

Throat irritation, difficulty swallowing, cough, fungal infection of the mouth and throat (thrush). If you experience any of these adverse effects, do not stop using Budesonide Easyhaler. Consult your doctor.

To prevent the above-mentioned adverse effects, you may rinse your mouth and throat with water after each dose. Do not swallow the rinse water; spit it out.

Uncommon (may affect up to 1 in 100 people):

Anxiety, depression, cataracts, blurred vision, muscle spasms, and tremors.

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

Too little or too much cortisol in the blood. Underactive adrenal gland (a gland near the kidneys). Skin rashes, itching, bruising, dysphonia (hoarseness), anxiety, and restlessness. Growth retardation in children. Behavioural changes, especially in children.

Rare acute allergic reaction:

If, shortly after taking a dose, you experience itching, rash, skin redness, swelling of the eyelids, lips, face or throat, wheezing, low blood pressure, or collapse, take the following action:

Stop using Budesonide Easyhaler
Seek immediate medical advice

Immediate shortness of breath after dose:

Rarely, inhaled medicines may cause an increase in wheezing and shortness of breath (bronchospasm) immediately after dosing. If this occurs:

Stop using Budesonide Easyhaler
Take a fast-acting bronchodilator immediately
Seek immediate medical advice

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

Glaucoma. Decreased bone mineral density (weakening of the bones).

Frequency not known (cannot be estimated from available data):

Sleep disturbances, aggressive reactions, increased motor activity (difficulty staying still), and irritability. These effects are more likely in children.

If you think you may be experiencing any of these rare adverse effects, or if you are concerned about the possibility of experiencing them, consult your doctor.

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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Budesonide Easyhaler

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

Before first use: store in the original packaging.

After opening the aluminium bag: store below 30°C and protect from moisture. You may use a protective cover with your Easyhaler.

Replace Budesonide Easyhaler with a new one after 6 months from the date the aluminium bag was opened. Write down the date it was opened to help you remember. ______________

If Budesonide Easyhaler gets wet, replace it with a new one.

Do not use this medicine after the expiry date stated on the label and on the packaging.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Budesonide Easyhaler

The active substance is budesonide.
The other component is lactose monohydrate (which contains milk proteins).

Nature and contents of the product and pack

White or almost white powder.

Budesonide Easyhaler 400 micrograms/dose powder for inhalation

100 doses + protective cap
100 doses
2 x 100 doses
3 x 100 doses

Some pack sizes may not be marketed.

Marketing Authorization Holder:

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer:

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Local representative:

Orion Pharma S.L.

Telephone: +349 159 9 86 01

This medicinal product is authorized in the European Economic Area member states under the following names:

Finland, Hungary, Germany	Budesonid Easyhaler
Spain	Budesonida Easyhaler
Belgium, Poland	Budesonide Easyhaler
Slovenia	Budesonid Orion Easyhaler
Netherlands	Budesonide Orion Easyhaler
United Kingdom	Easyhaler Budesonide
Norway, Sweden, Denmark, Czech Republic, Slovakia, Estonia, Lithuania, Latvia, Malta	Giona Easyhaler

Date of the most recent review of this leaflet: 02/2026

Detailed information on how to use this medicine is available by scanning this QR code (also included on the carton and label) with your smartphone. The same information is also available on the following website: https://cima.aemps.es/info/66671

[QR code to https://cima.aemps.es/info/66671 ]

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/

How to use the Easyhaler inhaler

About your Easyhaler inhaler

Budesonide Easyhaler may be different from other inhalers you have used before. For this reason, it is very important that you use it correctly; otherwise, you may not receive the proper dose of medication. This could make you feel unwell or result in your asthma not being adequately treated.

Your doctor, nurse, or pharmacist will show you how to correctly use your inhaler. Make sure you understand the proper technique. If you are unsure, please contact your doctor, nurse, or pharmacist again. As with all inhalers, caregivers must ensure that children prescribed Budesonide Easyhaler use the correct inhalation technique, as described below. You may also use the instructional video available at https://cima.aemps.es/info/66671

First use of the Easyhaler

The Easyhaler inhaler comes in an aluminum foil pouch. Do not open the pouch until you are ready to start using it, as it keeps the powder inside the inhaler dry.

When you are ready to begin treatment, open the pouch and record the opening date, for example, in your diary.

Use the inhaler for 6 months from the date the aluminum foil pouch is opened.

Diagram of an inhaler with a white mouthpiece and black body, indicating the parts Boquilla and Tapa, with the label Inhalador

HOW TO USE CORRECTLY

Step 1: SHAKE

Remove the cap
Shake the inhaler 3 to 5 times while holding it in an upright position

SHAKE x 3 – 5

A hand holds a black and white inhaler with a vertical arrow indicating the downward pressing motion

Important points to remember

It is important to keep the inhaler in an upright position
If you accidentally actuate the inhaler while shaking it, empty the powder from the mouthpiece as shown later

Step 2: ACTUATE

Hold the inhaler upright between your thumb and index finger
Press down until you hear a "click", then release it to return to its initial position. This releases the dose of medication
Press only once

ACTUATE x 1

A hand presses the top button of a black and white medical device with the index finger, indicated by a downward-pointing arrow

Important points to remember

The inhaler will not actuate if the cap is still in place
It should only be actuated once
If you accidentally actuate it more than once, empty the powder from the mouthpiece as shown later
Actuate to release the dose before inhaling, not at the same time

Keep the inhaler upright while actuating and while inhaling the dose. If tilted, the powder may fall out and you will not be able to inhale it

Step 3: INHALATION

Keep the inhaler in an upright position
Breathe normally
Place the mouthpiece in your mouth between your teeth and close your lips firmly around the mouthpiece
Breathe in deeply and forcefully
Remove the inhaler from your mouth, hold your breath for at least 5 seconds, then breathe normally

INHALATION

Black and white drawing of a person holding an inhaler close to the mouth with an arrow indicating the

Important points to remember

Make sure the mouthpiece is fully inside your mouth so the powder can reach your lungs
Ensure your lips are tightly sealed around the mouthpiece
Do not exhale into the inhaler. This is important as it could block the inhaler. If you do exhale into the inhaler, empty the powder from the mouthpiece (see below)

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

After using the inhaler:

Replace the cap on the mouthpiece. This will prevent the inhaler from being accidentally activated.
After inhaling, rinse your mouth with water and then spit it out. This reduces the risk of developing a fungal infection or hoarseness.

How to empty 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.
Start again with the Shake-Actuate-Inhale steps.

Black and white drawing of a hand holding a medical device to apply it to a flat surface with a downward arrow

Cleaning your Easyhaler inhaler

Keep the inhaler dry and clean. If necessary, clean the outer part of the mouthpiece with a dry cloth. Do not use water: the powder inside the Easyhaler inhaler is sensitive to moisture.

Use of the Easyhaler with a protective cover

You may use a protective cover with your Easyhaler. This may enhance the product's durability. The first time you place the inhaler into the protective cover, make sure the cap covers the mouthpiece of the inhaler, as this will prevent the inhaler from being accidentally activated. You can use the inhaler without removing it from the protective cover.

Follow the instructions given above: 1. Shake - 2. Activate - 3. Inhale.

Remember to:

Keep the inhaler in an upright position when activating it.

Replace the cap after taking your dose to prevent accidental activation of the inhaler.

A hand holds a white medical device with a protective cap and a contoured base for drug administration

When to start using a new inhaler

The inhaler has a dose counter that informs you of the number of doses (inhalations) remaining in your inhaler. The dose counter moves every 5 actuations. When the dose counter starts turning red, 20 doses remain.

If you do not yet have a new Easyhaler, contact your doctor for a new prescription. When the indicator reaches 0 (zero), you must replace the inhaler.

If you use a protective cover, you may keep it and insert the new inhaler.

White inhaler with an inset showing the dose counter displaying the numbers 10 and 20 and the label Contador de dosis

Remember

1. Shake – 2. Actuate – 3. Inhale.
After inhaling, rinse your mouth with water and then spit it out.
Avoid wetting the inhaler; protect it from moisture.

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