BUDESONIDE Easyhaler 100 micrograms POWDER FOR INHALATION

2. What you need to know before taking Budesonide Easyhaler

Do not use Budesonide Easyhaler if you are allergic to:

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

Tell your doctor so that your medicine can be changed to another one.

Warnings and precautions

Consult your doctor beforestarting to use Budesonide Easyhaler if you have:

• pulmonary tuberculosis

• an 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.

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

Other medicines and Budesonide Easyhaler

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, including those bought without a prescription.

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

Tell your doctor if you are using:

• nasal medicines containing corticosteroids
• corticosteroid tablets
• antifungal medicines containing ketoconazole and itraconazole

Pregnancy and breastfeeding

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

Driving and using machines

There is no indication that Budesonide Easyhaler may affect the ability to drive and use machines.

Budesonide 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 told you that you have an intolerance to certain sugars, consult with them before using this medicine.

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

3. How to take Budesonide Easyhaler

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

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

Replacement of corticosteroid tablets with Budesonide Easyhaler:

Consult your doctor if you are taking corticosteroid tablets (e.g., cortisone tablets) to treat your asthma. Your doctor may gradually reduce the number of tablets until they are finally stopped within a few weeks. If you do not feel well during this transfer period, consult your doctor, but do not stop using Budesonide Easyhaler.

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

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

Use in children from 6 to 11 years:

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

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

If Budesonide Easyhaler is administered to children, ensure they can use it correctly.

In addition to the preventive Budesonide Easyhaler, you may also need a rapid-acting "reliever" bronchodilator:

Budesonide will not stop an asthma attack once it has started. Therefore, you should always have a rapid-acting "reliever" bronchodilator (a beta2 agonist) at hand in case you experience acute asthma symptoms.

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

Worsening of asthma symptoms during treatment:

Consult your doctor as soon as possible if:

• Your wheezing (shortness of breath) 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 Budesonide Easyhaler than you should:

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

It is important that you 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 Budesonide Easyhaler:

If you forget to take a dose, take one as soon as you remember, or you can take the next dose when it is due. Take the medicine at the same time each day.

Do not take a double dose to make up for forgotten doses.

If you stop taking Budesonide Easyhaler:

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

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

To prevent the above side effects, you can rinse your mouth and throat with water or brush your teeth after each dose. Do not swallow the water from the rinse, 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):

Low or high cortisol levels in the blood. Underactive adrenal gland (gland near the kidneys). Skin rash, itching, bruising, hoarseness, anxiety, and nervousness. Growth retardation in children. Changes in behavior, especially in children.

Acute allergic reaction(rare):

If, shortly after taking a dose, you experience itching, rash, redness, swelling of the eyelids, lips, face, or throat, wheezing, low blood pressure, or collapse, act as follows:

• Stop taking Budesonide Easyhaler
• Seek medical advice immediately

Shortness of breath immediately after the dose:

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

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

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

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

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

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

If you think you may have any of these rare side effects, or if you are concerned about the possibility of having them, consult your doctor.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side 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 package.

Once the aluminum bag is opened: store below 30°C and protected from moisture. It is recommended to store Budesonide Easyhaler in the protective cover.

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

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

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

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Budesonide Easyhaler

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

Appearance of the Product and Container Contents

White or almost white powder.

Budesonide Easyhaler 100 micrograms/dose powder for inhalation

• 200 doses + protective cap
• 200 doses
• 2 x 200 doses
• 600 doses (3 x 200 doses)

Only some pack 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 SL

Phone: +349 159 9 86 01

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of Last Revision of this Leaflet:05/2021

Detailed information on how to use this medicine is available by scanning this QR code (also included on the box and label) with your smartphone. The same information is also available on the following website: https://cima.aemps.es/info/66670

[QR code tohttps://cima.aemps.es/info/66670]

Detailed information on 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. It is very important that you use it correctly, otherwise, you may not receive the correct amount of medication. This can make you feel unwell or cause your asthma not to be treated properly.

Your doctor, nurse, or pharmacist will teach you how to use your inhaler correctly. Make sure you understand how to use the inhaler correctly. If you are not sure, contact your doctor, nurse, or pharmacist again. As with all inhalers, caregivers should ensure that children who have been prescribed Budesonide Easyhaler use the correct inhalation technique, as described below. You can also use the instruction video available at https://cima.aemps.es/info/66670

First Use of the Easyhaler

HOW TO USE CORRECTLY

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

After Using the Inhaler:

• Put the cap back on the mouthpiece. This will prevent the inhaler from being activated accidentally.
• After inhalation, rinse your mouth with water and then spit it out and/or brush your teeth. This reduces the risk of fungal infection and hoarseness.

Cleaning Your Easyhaler Inhaler

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

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