BUFOMIX EASYHALER 160 micrograms/4.5 micrograms/inhalation powder for inhalation

2. What you need to know before you use Bufomix Easyhaler 160 micrograms/4.5 micrograms

Do not use Bufomix Easyhaler 160 micrograms/4.5 micrograms:

• If you are allergic to budesonide, formoterol, 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

Consult your doctor or pharmacist before starting to use Bufomix Easyhaler if:

• You have diabetes
• You have any lung infection
• You have high blood pressure or have ever had any heart disease (including irregular heartbeats, rapid heartbeat, narrowing of the arteries, or heart failure)
• You have thyroid or adrenal gland problems
• You have low potassium levels in your blood
• You have severe liver problems

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

Rinse your mouth after inhaling your dose to avoid fungal infections in the mouth.

Using Bufomix Easyhaler with other medicines

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

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

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

• Beta-blocker medicines (such as atenolol and propranolol for high blood pressure), including eye drops (such as timolol for glaucoma);
• Medicines to treat fast or irregular heartbeats (such as quinidine);
• Medicines like digoxin, 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 to treat asthma;
• Other bronchodilators (such as salbutamol);
• Tricyclic antidepressants (such as amitriptyline) 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 the treatment of 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 not sure, ask your doctor or pharmacist before using Bufomix Easyhaler.

Also, inform your doctor or pharmacist if you are going to have a general anesthetic for a surgical operation or dental treatment.

Pregnancy and breastfeeding

• If you are pregnant, or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
• Do not use Bufomix Easyhaler unless your doctor has told you to.
• If you become pregnant while using Bufomix Easyhaler, do not stop using it but consult your doctor immediately.

Driving and using machines

Bufomix Easyhaler has no or negligible influence on the ability to drive and use machines.

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

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

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

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

• Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.
• It is important to use Bufomix Easyhaler every day, even if you do not have any symptoms of asthma or COPD at the time.
• Your doctor will want to check your asthma symptoms regularly.

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 Bufomix Easyhaler. If you have been taking steroid tablets for a long time, your doctor may want to do a blood test from time to time. You may feel unwell when your steroid tablets are reduced, even though your lung symptoms may be improving.

You may experience some symptoms such as nasal congestion or runny nose, weakness or pain in the muscles and joints, and skin rash (eczema). If any of these symptoms worry you, or if you have any other symptoms such as headache, tiredness, nausea, or vomiting, contact your doctor immediately. If you develop allergic or arthritic symptoms, you may need to take another medicine. You should consult your doctor if you are concerned about whether you should continue using Bufomix Easyhaler.

Your doctor may consider adding steroid tablets to your usual treatment during stressful periods (for example, when you have a chest infection or before a surgical operation).

Important information about asthma or COPD symptoms:

If, while using Bufomix Easyhaler, you experience difficulty breathing or wheezing, you should continue to use 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 wake up at night with asthma symptoms.
• You start to feel chest tightness in the morning, or chest tightness lasts longer than usual.

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

ASTHMA

Bufomix Easyhaler 160 micrograms/4.5 microgramscan be prescribed for asthma in two different ways. The amount of Bufomix Easyhaleryou will use and when you will use it will depend on how it has been prescribed for you.

1. If you have been prescribed Bufomix Easyhalerand a separate reliever inhaler, read the section called “A) Using Bufomix Easyhalerand a separate reliever inhaler”
2. If you have been prescribed Bufomix Easyhaleras a single inhaler, read the section called “B) Using Bufomix Easyhaleras a single inhaler for asthma”

1. Using Bufomix Easyhaler and a separate reliever inhaler

Use Bufomix Easyhaler every day, as it helps to prevent asthma symptoms from occurring.

Adults (from 18 years)

• 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 (from 12 to 17 years of age)

• 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.

A lower concentration of budesonide/formoterol is available for children aged 6-11 years.

Bufomix Easyhaler is not recommended for 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 talking to your doctor or nurse first.

Use your other “reliever” inhaler when asthma symptoms occur. Always carry your “reliever” inhaler with you to use when you need it. Do not use Bufomix Easyhaler to treat asthma symptoms; use your reliever inhaler instead.

1. Using Bufomix Easyhaler as a single inhaler for asthma

Only use Bufomix Easyhaler in this way if your doctor has told you to and you are 12 years old or older.

Use Bufomix Easyhaler 160 micrograms/4.5 micrograms every day. This helps to prevent asthma symptoms from occurring. You can take:

• 1 inhalation in the morning and 1 inhalation in the evening

or

• 2 inhalations in the morning

or

• 2 inhalations in the evening

Your doctor may increase the dose to 2 inhalations twice a day.

Also, use Bufomix Easyhaler 160 micrograms/4.5 micrograms as a “reliever” inhaler to treat asthma symptoms when they occur and to prevent asthma symptoms from occurring (for example, when exercising or 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 one occasion.

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

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

If you regularly need to take 8 or more inhalations per day, make an appointment with your doctor or nurse. They 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 Bufomix Easyhaler as described here. It is important that you talk to your doctor about using Bufomix Easyhaler to prevent asthma symptoms; the frequency of exercise or exposure to allergens may affect the treatment prescribed for you.

Chronic Obstructive Pulmonary Disease (COPD)

• Use only in adults (over 18 years of age).
• The usual dose is 2 inhalations, twice a day.

Your doctor may also prescribe other bronchodilator medicines, such as anticholinergics (like ipratropium bromide or tiotropium), for your COPD.

If you use more Bufomix Easyhaler than you should

It is important that you use the dose that your pharmacist has recommended or that your doctor has prescribed. Do not increase your dose without consulting your doctor.

The most common symptoms that may occur if you use more Bufomix Easyhaler 160 micrograms/4.5 micrograms than you should are tremors, headache, and rapid heartbeat.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to use Bufomix Easyhaler

• If you forget to take a dose of Bufomix 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 nottake a double dose to make up for missed doses.

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience any of the following situations, stop using Bufomix Easyhaler and consult your doctor immediately:

• Your face swells, particularly around the mouth (tongue and/or throat and/or difficulty swallowing) or you have hives along with breathing difficulties (angioedema) and/or a sudden feeling of fainting, which indicates that you may be suffering from an allergic reaction. This occurs rarely, affecting less than 1 in 1,000 patients.
• You have acute wheezing or difficulty breathing immediately after using your inhaler. If you experience any of these symptoms, stop using your Bufomix 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 less than 1 in 10,000 patients.

Tell your doctor if you have any of the following effects while using Bufomix Easyhaler, as they may be symptoms of a lung infection:

• Fever or cold
• Increased mucus production, change in mucus color
• Increased coughing or difficulty breathing

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

Other possible adverse effects:

Frequent (affects less than 1 in 10 patients)

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

Uncommon (affects less than 1 in 100 patients)

• Agitation, restlessness, nervousness.
• Difficulty sleeping.
• Dizziness.
• Nausea (discomfort).
• Fast heart rate.
• Bruises on the skin.
• Muscle cramps.
• Blurred vision.

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

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

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

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

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

• Changes in bone mineral density (decrease in bone mass).
• 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 next to the kidneys).

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

Reporting adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects 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 adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Bufomix Easyhaler 160 micrograms/4.5 micrograms

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiration date shown on the box, aluminum bag, and label on your inhaler after CAD. The expiration date is the last day of the month indicated.
• After opening the aluminum bag, do not store above 25°C and keep protected from moisture. You can use a protective cover with your Easyhaler.
• If your Bufomix Easyhaler inhaler gets wet, you should replace it with a new one.
• Replace the Bufomix Easyhaler inhaler 4 months after opening the aluminum bag. Write the date it was opened to help you remember.
• Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Bufomix Easyhaler 160 micrograms/4.5 micrograms

• The active ingredients 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 Package Contents

Bufomix Easyhaler 160 micrograms/4.5 micrograms is an inhaler that contains your medicine. The inhalation powder is white to yellowish in color. Each inhaler contains 60 or 120 doses and consists of a white body and a red top.

Bufomix Easyhaler 160 micrograms/4.5 micrograms is available in packages of 1 or 3 inhaler(s), also available in packages of 2 inhalers of 120 doses.

Only some package sizes may be marketed.

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

Marketing Authorization Holder and Manufacturer

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.

Avda. Alberto Alcocer 46B

28016 Madrid

Tel.: 91 599 86 01

Date of the last revision of this leaflet: April 2025.

You can access detailed and updated information on how to administer this medicine by scanning the QR code included in the leaflet, packaging, and labeling with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/info/78807

QR Code

Detailed and updated 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

Bufomix 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 medicine. This could make you feel unwell or could be the cause that your asthma or COPD is not 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 prescribed Bufomix Easyhaler use the correct inhalation technique, as described below.

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 to avoid accidental activation.
• After inhalation, rinse your mouth with water and then spit it out.

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 is sensitive to moisture.

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