Bufomix Easyhaler 320 micrograms/9 micrograms/inhalation powder for inhalation

Patient Information Leaflet

Introduction

Patient Information Leaflet

Bufomix Easyhaler 320 micrograms/9 micrograms/inhalation, Powder for inhalation

Budesonide/formoterol fumarate dihydrate

Read the entire 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 or pharmacist.
• 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, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Bufomix Easyhaler 320 micrograms/9 micrograms is and what it is used for
2. What you need to know before using Bufomix Easyhaler 320 micrograms/9 micrograms
3. How to use Bufomix Easyhaler 320 micrograms/9 micrograms
4. Possible side effects
5. How to store Bufomix Easyhaler 320 micrograms/9 micrograms
6. Contents of the pack and other 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 aged 12 to 17 years. It is also used for 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 in the airways, helping you to breathe more easily.

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 asthma symptoms from occurring.
• Use your "reliever inhaler" when asthma symptoms occur, to help you 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 using Bufomix Easyhaler 320 micrograms/9 micrograms

Do not use Bufomix Easyhaler 320 micrograms/9 micrograms:

• If you are allergic to budesonide, formoterol, or any of the other ingredients of this medicine (listed in section 6), including lactose (which contains small amounts of milk proteins).

Warnings and precautions

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

• You have diabetes
• You have a lung infection
• You have high blood pressure, or have ever had heart disease (including irregular heartbeat, rapid pulse, narrowed 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 with water after inhaling your dose to help prevent fungal infections in the mouth.

Using Bufomix Easyhaler 320 micrograms/9 micrograms with other medicines

Tell 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 Bufomix Easyhaler, and your doctor may consider close monitoring if you are taking these medicines (including some medicines used to treat HIV/AIDS: ritonavir, cobicistat).

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

• Beta-blockers (such as atenolol and propranolol for high blood pressure), including eye drops (such as timolol for glaucoma);
• Medicines to treat fast or irregular heartbeat (e.g., quinidine);
• Medicines such as 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 used to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, and telithromycin);
• Medicines used to treat 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 unsure, ask your doctor or pharmacist before using Bufomix Easyhaler.

Also inform your doctor or pharmacist if you are due to have general anaesthesia for surgery or dental treatment.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
• Do not use Bufomix Easyhaler unless your doctor has instructed you to do so.
• If you become pregnant while being treated with Bufomix Easyhaler, do not stop using it, but contact your doctor immediately.

Driving and using machines

The effect of Bufomix Easyhaler on the ability to drive and use machinery is negligible or none.

Bufomix Easyhaler contains lactose, a type of sugar.

It may cause allergic reactions in patients with allergy to cow's milk protein.

If your doctor has informed you that you have an intolerance to certain sugars, consult him or her before using this medicine.

3. How to use Bufomix Easyhaler 320 micrograms/9 micrograms

• Follow exactly the instructions for administering this medicine as given 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 regularly check how your asthma symptoms are progressing.

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 carry out occasional blood tests. You may feel generally unwell when your dose of oral steroids is reduced, even though your lung symptoms may be improving. Some symptoms such as nasal congestion or runny nose, weakness or muscle and joint pain, and skin rash (eczema) may appear. If any of these symptoms concern you, or if you experience other symptoms such as headache, fatigue, nausea, or vomiting, contact your doctor immediately. If allergic or arthritic symptoms develop, 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 experience 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 worsens or you often 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 condition is not adequately controlled, and you may need a different or additional treatment immediately.

ASTHMA

Use Bufomix Easyhaler daily, as it helps prevent asthma symptoms from occurring.

Adults (aged 18 years and over)

• The usual dose is 1 inhalation twice daily.
• Your doctor may prescribe up to 2 inhalations twice daily.
• If your symptoms are well controlled, your doctor may instruct you to use the medication once daily.

Adolescents (aged 12 to 17 years)

• The usual dose is 1 inhalation twice daily.
• If your symptoms are well controlled, your doctor may instruct you to use the medication once daily.

A lower strength 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 first speaking to your doctor or nurse.

Use your other “reliever inhaler” when asthma symptoms occur. Always keep this reliever inhaler with you so you can use it when needed. Do not use Bufomix Easyhaler to treat asthma symptoms—use your reliever inhaler instead.

COPD (Chronic Obstructive Pulmonary Disease)

• Use only in adults (aged over 18 years).
• The usual dose is 1 inhalation twice daily.

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

If you use more Bufomix Easyhaler than you should

It is important to use the dose indicated by the pharmacist on the packaging or the dose prescribed by your doctor. 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, contact the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to use Bufomix Easyhaler

• If you miss a dose of Bufomix Easyhaler, continue your 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 not use a double dose to make up for a missed dose.

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

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 experiences them.

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

• Swelling of the face, particularly around the mouth (tongue and/or throat) and/or difficulty swallowing, or hives accompanied by breathing difficulties (angioedema) and/or a sudden feeling of collapse, which may indicate you are having an allergic reaction. This occurs rarely, affecting fewer than 1 in 1,000 patients.
• High-pitched whistling sounds or breathing difficulties immediately after using your inhaler. If you experience any of these symptoms, stop using your Bufomix Easyhaler immediately and use your "reliever inhaler". Contact your doctor immediately, as you may need to change your treatment. This occurs very rarely, affecting fewer than 1 in 10,000 patients.

Inform your doctor if you experience any of the following symptoms while using Bufomix Easyhaler, as they may be signs of a lung infection:

• Fever or cold symptoms
• Increased mucus production or a change in mucus color
• Worsening cough or breathing difficulties

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

Other possible adverse effects:

Common (affects fewer than 1 in 10 patients)

• Palpitations (awareness of heartbeat), tremors. When these effects occur, they are usually mild and tend to disappear with continued use of Bufomix Easyhaler.
• Oral 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 fewer than 1 in 100 patients)

• Restlessness, agitation, nervousness.
• Difficulty sleeping.
• Dizziness.
• Nausea (feeling unwell).
• Rapid heartbeat.
• Bruising of the skin.
• Muscle cramps.
• Blurred vision.

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

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

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

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

Inhaled corticosteroids may affect the normal production of steroid hormones in your body, especially if high doses are used for prolonged periods. These effects include:

• Changes in bone mineral density (reduced bone strength).
• Cataracts (loss of transparency of the eye's lens).
• Glaucoma (increased pressure inside the eye).
• Growth retardation in children and adolescents.
• Effects on the adrenal glands (small glands located above the kidneys).

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

Reporting of 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 may 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 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 stated on the carton, the aluminium pouch, and the label of your inhaler after EXP. The expiry date refers to the last day of the month indicated.

• After opening the aluminium pouch, do not store at temperatures above 25°C and protect from moisture. You may use a protective cover with your Easyhaler.

• If your Bufomix Easyhaler inhaler gets wet, it must be replaced with a new one.

• Replace the Bufomix Easyhaler inhaler 4 months after opening the aluminium pouch. Write down the date it was opened to help you remember.

• Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Bufomix Easyhaler 320 micrograms/9 micrograms

• The active substances 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 Contents of the Pack

Bufomix Easyhaler 320 micrograms/9 micrograms is an inhaler containing your medicine. The inhalation powder is white to slightly yellowish in colour. 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 certain pack sizes may be marketed.

Your pack may include a protective cover, depending on the country. If you require a protective cover, please contact the Marketing Authorisation Holder (see details below).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent review of this Patient Information Leaflet: April 2025

You can access detailed and up-to-date information on how to administer this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet, packaging and labelling. You may also access this information at the following internet address: https://cima.aemps.es/info/78808

QR Code

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

How to Use the Easyhaler Inhaler

About Your Easyhaler Inhaler

Bufomix Easyhaler may differ from other inhalers you have used previously. Therefore, it is very important that you use it correctly; otherwise, you may not receive the proper dose of medicine. This could make you feel unwell or could result in your asthma or COPD not being adequately treated.

Your doctor, nurse or pharmacist will show you how to use your inhaler correctly. Make sure you understand how to use the inhaler properly. If you are unsure, contact your doctor, nurse or pharmacist again. As with all inhalers, caregivers must 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:

• 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.

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 further questions about the use of this medicine, ask your doctor or pharmacist.