BUFOMIX EASYHALER 320 micrograms/9 micrograms/inhalation POWDER FOR INHALATION

Introduction

Patient Information Leaflet: Information for the Patient

BufomixEasyhaler320micrograms/9micrograms/inhalation, Powder for Inhalation

Budesonide/formoterol fumarate dihydrate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Bufomix Easyhaler 320 micrograms/9 micrograms is and what it is used for
2. What you need to know before you use Bufomix Easyhaler 320 micrograms/9 micrograms
3. How to use Bufomix Easyhaler 320 micrograms/9 micrograms
4. Possible side effects
5. Storing Bufomix Easyhaler 320 micrograms/9 micrograms
6. Contents of the pack and further information

1. What Bufomix Easyhaler 320 micrograms/9 micrograms is and what it is used for

Bufomix Easyhaler is an inhaler 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. It contains two different medicines: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called “corticosteroids”. It works by reducing and preventing inflammation in your lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called “long-acting beta2 adrenergic agonists” or “bronchodilators”. It works by relaxing the muscles of the airways, making it easier to breathe.

Asthma

For the treatment of asthma, your doctor will prescribe two different inhalers: Bufomix Easyhaler 320 micrograms/9 micrograms and a separate "reliever inhaler".

• Use Bufomix Easyhaler daily, this will help prevent the onset of asthma symptoms.
• Use your "reliever inhaler" when asthma symptoms appear, to breathe normally again.

Do not use Bufomix Easyhaler 320 micrograms/9 micrograms as a "reliever inhaler".

Chronic Obstructive Pulmonary Disease (COPD)

Bufomix Easyhaler 320 micrograms/9 micrograms can also be used to treat the symptoms of COPD in adults. COPD is a long-term disease of the airways, usually caused by smoking.

2. What you need to know before you use Bufomix Easyhaler 320 micrograms/9 micrograms

Do not use Bufomix Easyhaler 320micrograms/9micrograms:

• 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 pulse, 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 prevent fungal infections in the mouth.

Using Bufomix Easyhaler 320micrograms/9micrograms 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 rapid or irregular heartbeats (such as quinidine);
• Medicines like digoxin, commonly 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 for treating infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, and telithromycin);
• Medicines for treating 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 undergo general anesthesia for surgery 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 tells 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 320 micrograms/9 micrograms

• Follow exactly the instructions for administration of this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
• It is important to use Bufomix Easyhaler daily, even if you do not have symptoms of asthma or COPD at that 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 oral steroid tablets for a long time, your doctor may want to do a blood test from time to time. You may feel unwell when the number of steroid tablets is reduced, even if your lung symptoms are 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 periods of stress (for example, when you have a chest infection or before surgery).

Important information about asthma or COPD symptoms:

If while using Bufomix Easyhaler you feel 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 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 immediate different or additional treatment.

ASTHMA

Use Bufomix Easyhaler daily,as it helps prevent the onset of asthma symptoms.

Adults (from 18 years)

• The usual dose is 1 inhalation, twice a day.
• Your doctor may prescribe up to 2 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 17years of age)

• The usual dose is 1 inhalation, 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 use in 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 appear.Always carry this "reliever inhaler" with you to use when you need it. Do not use Bufomix Easyhaler to treat asthma symptoms, use your reliever inhaler instead.

COPD (Chronic Obstructive Pulmonary Disease)

• Use only in adults (over 18 years).
• The usual dose is 1 inhalation, 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 indicated on the box 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 320 micrograms/9 micrograms than you should are tremors, headache, and rapid heartbeat.

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

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 on 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 side effects

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

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

• Your face, particularly around the mouth (tongue and/or throat and/or difficulty swallowing) swells or you have hives along with difficulty breathing (angioedema) and/or a sudden feeling of fainting, which indicates that you may be having an allergic reaction. This happens 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 BufomixEasyhaler inhaler immediately and use your "reliever inhaler". Contact your doctor immediately as you may need to change your treatment.This happens 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, they can be symptoms of a lung infection:

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

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

Other possible side effects:

Common (affects less than 1 in 10patients)

• Palpitations (feeling your heart beating), tremors. When these effects appear, 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 100patients)

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

Rare (affects less than 1 in 1000patients)

• Rash, itching.
• Bronchospasm (contraction of the airway muscles, causing wheezing). If this happens suddenly just 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 10000patients)

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to 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. Storing Bufomix Easyhaler 320 micrograms/9 micrograms

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton, the aluminum bag, and the label on your inhaler after EXP. The expiry date is the last day of the month stated.
• 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. Return the containers and any unused medicines to the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Bufomix Easyhaler 320 micrograms/9 microgramsmicrograms/9micrograms

• The active ingredients are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
• The other component is lactose monohydrate (which contains milk proteins).

Appearance of the Product and Container Contents

Bufomix Easyhaler 320 micrograms/9 micrograms is an inhaler that contains your medication. The inhalation powder is white to yellowish in color. Each inhaler contains 60 doses and consists of a white body and a red top.

Bufomix Easyhaler 320 micrograms/9 micrograms is available in packs of 1, 2, or 3 inhaler(s).

Only some pack sizes may be marketed.

Your pack may contain a protective cap, which is available depending on the country. If you need a protective cap, 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 medication by scanning the QR code included in the leaflet, packaging, and labeling with your mobile phone (smartphone). You can also access this information on the following internet address: https://cima.aemps.es/info/78808

QR Code

Detailed and updated information on this medication 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 medication. 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 who have been 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. This will prevent the inhaler from being activated accidentally.
• After inhaling, rinse your mouth with water and then spit it out.

Cleaning the Easyhaler Inhaler

Keep your inhaler dry and clean. If necessary, you can clean 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 medication, ask your doctor or pharmacist.