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Prospecto: information for the user

Budesonide Easyhaler 400 micrograms/dose powder for inhalation

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you should 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, pharmacist, or nurse, even if they are not listed in this prospectus. See section 4.

1. What isBudesonide Easyhalerand for what it is used

2. What you need to know before starting to useBudesonide Easyhaler

3. How to useBudesonide Easyhaler

4. Possible adverse effects

5. Storage ofBudesonide Easyhaler

6. Contents of the package and additional information

The active ingredient of Budesonida Easyhaler is budesonide. Budesonide powder is presented in an inhaler. When inhaled through the mouthpiece, the powder enters the lungs with the inhaled air. Budesonide acts by reducing and preventing the swelling and inflammation of the lungs.

Budesonida Easyhaler is a medication called “preventive”. It is used to prevent the symptoms of asthma. It belongs to a group of medications called corticosteroids.

Budesonide will NOT stop an asthma attack once it has already started. Therefore, it is necessary to always have a rapid-acting bronchodilator “calmative” (a beta2agonist) on hand.

The effect of budesonide begins after a few days of treatment and reaches its maximum after a few weeks. Take Budesonida Easyhaler regularly to prevent asthma inflammation. Continue taking this medication regularly, according to the usage instructions, even if you do not have symptoms.

Do not use Budesonida Easyhaler if you are allergic:

• to budesonide or
• to another component ofthis medication (including in section 6) which is lactose (which contains small amounts of lactose proteins)

Inform your doctor so that your medication can be changed for another one.

Warnings and precautions

Consult your doctorbeforestarting to use Budesonida Easyhaler if you have:

• pulmonary tuberculosis

• untreated bacterial, viral or fungal infection in your mouth, respiratory tract 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 prevent fungal infection in the mouth.

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

Other medications and Budesonida Easyhaler

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medication, including those acquired without a prescription.

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

Inform your doctor if you are using:

• nasal sprays containing corticosteroids
• oral corticosteroids
• antifungal medications containingketoconazole anditraconazole

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor before using this medication. It is essential for both the fetus and the mother to maintain adequate asthma treatment during pregnancy. Like other medications administered during pregnancy, the administration of budesonide to the mother should be evaluated in terms of benefit to the fetus versus risk. The lowest effective dose of budesonide should be used to maintain adequate asthma control.

Driving and operating machinery

There is no indication that Budesonida Easyhaler may affect your ability to drive and operate machinery.

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

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

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

Your doctor has prescribed the appropriate dose and duration of Budesonida Easyhaler for you. Follow your doctor's instructions carefully.

Switching from oral corticosteroids to Budesonida Easyhaler:

Consult your doctor if you take oral corticosteroids (e.g. prednisone tablets) to treat your asthma. Your doctor may gradually reduce the number of tablets until you eventually stop treatment in a few weeks. If you do not feel well during this transfer period, consult your doctor but do not stop using Budesonida Easyhaler.

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

• 1-2 inhalations in the morning and evening or once a day in the evening.

Use in children 6 to 11 years:

• 1-2 inhalations in the morning and evening or once a day in the evening.

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

Make sure the child can use Budesonida Easyhaler correctly if it is administered to them.

In addition to the preventive Budesonida Easyhaler, you may also need a bronchodilator reliever:

Budesonida will not stop an asthma attack once it has started. Therefore, it is necessary to always have a quick-acting bronchodilator reliever (beta2 agonist) on hand in case of acute asthma symptoms.

If you use a reliever inhaler (beta2 agonist), you should inhale it before Budesonida Easyhaler (preventive).

Worsening of asthma symptoms during treatment:

Consult your doctor as soon as possible if:

• Your wheezing (jadeo) or chest pain worsens during treatment
• You need to use the reliever inhaler more often than before
• Your reliever inhaler does not relieve you as well as before

Your asthma may worsen and you may need additional treatment.

If you use more Budesonida Easyhaler than you should:

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

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

If you forget to use Budesonida Easyhaler:

If you forget to administer a dose, take one as soon as possible, or you can take the next dose when it is due. Take the medication at the same time of day.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Budesonida Easyhaler:

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

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

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

To prevent the previously mentioned adverse effects, you can rinse your mouth and throat with water or brush your teeth after each dose. Do not swallow the rinse water, spit it out.

Possibly frequent(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):

Low or high cortisol levels in the blood. Hypoactive adrenal gland (gland near the kidneys). Skin eruptions, itching, bruises, hoarseness, anxiety, and nervousness. Growth delay in children. Behavioral changes, especially in children.

Acute allergic reaction rare:

If you experience any of the following shortly after taking a dose, seek medical attention immediately:

• Stop taking Budesonida Easyhaler
• Seek medical advice immediately

Immediate shortness of breath after the dose:

Rarely, inhaled medications can cause an increase in wheezing and shortness of breath (bronchospasm) immediately after the dose. If this occurs:

• Stop taking Budesonida Easyhaler
• Take a rapid-acting bronchodilator
• Seek medical advice immediately

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

Glaucoma. Decreased bone density (bone weakening).

Unknown frequency (cannot be estimated from available data):

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

If you believe 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 adverse effects

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

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

Before first use: store in the original packaging.

Once the aluminum bag is opened: store below30°Cand protected from moisture. It is recommended to store Budesonida Easyhaler in the protective cover.

Replace Budesonida Easyhaler with a new one 6 months after opening the aluminum bag. Write the date it was opened to help you remember.______________

If Budesonida Easyhaler becomes damp, replace it with a new one.

Do not use this medication after the expiration date indicated on the label and packaging.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need.This will help protect the environment.

Composition of Budesonide Easyhaler

- The active ingredient is budesonide

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

Appearance of the product and contents of the package

White or almost white powder.

BudesonideEasyhaler 400 micrograms/dose powder for inhalation

• 100 doses + protective case
• 100 doses
• 2 x 100 doses
• 3 x 100 doses

Only some package sizes may 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.

Phone: +349 159 9 86 01

This medicine is authorized in the Member States of the European Economic Area with the following names:

Last review date of this leaflet:05/2021

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

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