Bufomix Easyhaler 160 micrograms/4.5 micrograms/inhalation powder for inhalation

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Bufomix Easyhaler 160 micrograms/4.5 micrograms/inhalation, Inhalation powder

Budesonide/formoterol fumarate dihydrate

Read the entire leaflet carefully before you start using this medicine, because 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 you should not give it 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 effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Bufomix Easyhaler 160 micrograms/4.5 micrograms is and what it is used for
2. What you need to know before using Bufomix Easyhaler 160 micrograms/4.5 micrograms
3. How to use Bufomix Easyhaler 160 micrograms/4.5 micrograms
4. Possible adverse effects
5. How to store Bufomix Easyhaler 160 micrograms/4.5 micrograms
6. Contents of the pack and other information

1. What Bufomix Easyhaler 160 micrograms/4.5 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

Bufomix Easyhaler 160 micrograms/4.5 micrograms may be prescribed for asthma in two different ways:

• Some people are prescribed two inhalers: Bufomix Easyhaler 160 micrograms/4.5 micrograms and a separate "reliever inhaler".

  • They use Bufomix Easyhaler daily, which helps prevent asthma symptoms from occurring.
  • They use their "reliever inhaler" when asthma symptoms occur, to return to normal breathing.

• Some people are prescribed Bufomix Easyhaler 160 micrograms/4.5 micrograms as a single inhaler.

  • They use Bufomix Easyhaler daily, which helps prevent asthma symptoms.
  • They also use Bufomix Easyhaler when they need extra doses to relieve asthma symptoms, to return to normal breathing and, if directed by their doctor, to prevent asthma symptoms (for example, when exercising or exposed to allergens). They do not need a separate reliever inhaler.

Chronic Obstructive Pulmonary Disease (COPD)

Bufomix Easyhaler 160 micrograms/4.5 micrograms can also be used to treat symptoms of COPD in adults. COPD is a long-term respiratory disease, usually caused by smoking.

2. What you need to know before using 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 components 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 using 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 levels of potassium 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 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 for the treatment of 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 for treating 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 amitriptiline) 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 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 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 consult your doctor immediately.

Driving and using machines

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

Bufomix Easyhaler contains lactose, a type of sugar.

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

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

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

• Follow exactly the administration instructions for this medicine 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 asthma or COPD symptoms 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 occasionally want to perform a blood test. 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 postnasal drip, weakness or pain in muscles and joints, and skin rash (eczema) may appear. If any of these symptoms concern you, or if you experience any 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 is getting worse or you often wake up at night with asthma symptoms.
• You start experiencing 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

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

1. If you have been prescribed Bufomix Easyhaler and a separate reliever inhaler, read the section titled “A) Use of Bufomix Easyhaler and a separate reliever inhaler”

2. If you have been prescribed Bufomix Easyhaler as a single inhaler, read the section titled “B) Use of Bufomix Easyhaler as a single inhaler for asthma”

3. Use of Bufomix Easyhaler and a separate reliever inhaler

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

Adults (18 years and older)

• 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 might ask you to take the medication once a day.

Adolescents (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 might ask you to take the medication once a day.

There is a lower strength budesonide/formoterol product 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.

1. Use of Bufomix Easyhaler as a single inhaler for asthma

Only use Bufomix Easyhaler in this way if instructed by your doctor and if you are 12 years of age or older.

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

• 1 inhalation in the morning and 1 inhalation at night

or

• 2 inhalations in the morning

or

• 2 inhalations at night.

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

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

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

Normally, a total daily dose exceeding 8 inhalations is not required. However, your doctor may allow you to take up to 12 inhalations per day for a limited period.

If you regularly need 8 or more inhalations per day, make an appointment with your doctor or nurse. They may need to change your treatment.

Do not use more than 12 inhalations in any 24-hour period.

If you exercise and notice asthma symptoms, use Bufomix Easyhaler as described here. It is important that you speak with your doctor about using Bufomix Easyhaler to prevent asthma symptoms; how often you exercise or are exposed to allergens may affect the treatment prescribed to 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 (e.g., 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 your pharmacist on the package 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 160 micrograms/4.5 micrograms than prescribed 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, take it as soon as you remember. However, if it is almost time for your next dose, do not worry about the missed dose.
• Do not take 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.

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 will experience 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 an allergic reaction. This occurs rarely, affecting fewer than 1 in 1,000 patients.
• High-pitched whistling sounds ("wheezing") 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 while using Bufomix Easyhaler, as they may be symptoms of a lung infection:

• Fever or cold symptoms
• Increased mucus production or 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 occur, they are usually mild and 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).
• Fast heartbeat.
• Bruising of the skin.
• Muscle cramps.
• Blurred vision.

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

• Rash, itching.
• Bronchospasm (contraction of airway muscles, 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 behaviour, especially in children.
• Chest pain or tightness (angina).
• Increased blood sugar (glucose) levels.
• Taste disturbances, such as 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 lens).
• Glaucoma (increased pressure in 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 effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 160 micrograms/4.5 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, you must replace it 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 must not be disposed of via wastewater or household waste. Return any unused medicines and empty containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bufomix Easyhaler 160 micrograms/4.5 micrograms

• The active substances 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 contents of the pack

Bufomix Easyhaler 160 micrograms/4.5 micrograms is an inhaler containing your medicine. The inhalation powder is white to slightly yellowish. 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 packs of 1 or 3 inhaler(s), as well as in packs of 2 inhalers with 120 doses each.

Some pack sizes may not be marketed.

Your pack may include a protective cover, 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 most recent review of this 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 can also access this information at the following internet address: https://cima.aemps.es/info/78807

QR Code

Detailed and updated 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

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

The Easyhaler inhaler comes in an aluminum pouch. Only remove it from the pouch when you are ready to start using it, as this keeps the powder inside the inhaler dry. When you are ready to start treatment, open the pouch and record the opening date, for example in your diary. Use the inhaler for 4 months from the date the aluminum pouch was opened.

HOW TO USE CORRECTLY

Step 1: SHAKE Remove the cap Shake the inhaler 3 to 5 times, holding it in an upright position

SHAKE x 3–5

Important points to remember It is important to keep the inhaler in an upright position If you accidentally activate the inhaler while shaking it, empty the powder from the mouthpiece as shown later

Step 2: ACTUATE Hold the inhaler upright between your thumb and index finger Press it down until you hear a "click", then release it to return to its initial position. This releases the dose of medication Press only once

ACTUATE ONCE

Important points to remember The inhaler will not actuate if the cap is still in place It should be actuated only once If you accidentally actuate it more than once, empty the powder from the mouthpiece as shown later Actuate to release the dose before inhaling it, not at the same time Keep the inhaler upright while actuating and while inhaling the dose. If you tilt it, the powder may fall out and you will not be able to inhale it

Step 3: INHALE Keep the inhaler in an upright position Breathe normally Place the mouthpiece in your mouth between your teeth and close your lips tightly around the mouthpiece Inhale deeply and forcefully Remove the inhaler from your mouth and breathe normally

INHALE

Important points to remember Make sure the mouthpiece is fully placed inside your mouth so the powder can reach your lungs Ensure your lips are tightly sealed around the mouthpiece Do not exhale into the inhaler. This is important as it could block the inhaler. If you do exhale into the inhaler, empty the powder from the mouthpiece (see below)

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 help prevent accidental activation of the inhaler.
• After inhaling, rinse your mouth with water and then spit it out.

How to empty the powder from the mouthpiece If you have accidentally actuated the inhaler, if you have actuated it more than once, or if you have exhaled into the inhaler, empty the mouthpiece. Gently tap the mouthpiece on a flat surface or into the palm of your hand. Start again with the Shake-Actuate-Inhale steps.

Cleaning your Easyhaler inhaler

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

Use of the Easyhaler with a protective cover You can use a protective cover with your Easyhaler. This helps improve the product's durability. The first time you place the inhaler into the protective cover, make sure the cap covers the mouthpiece of the inhaler, as this will prevent accidental activation of the inhaler. You can use the inhaler without removing it from the protective cover. Follow the instructions given above: 1. Shake - 2. Activate - 3. Inhale. Remember to: Keep the inhaler in an upright position when activating it. Replace the cap after taking your dose to prevent accidental activation of the inhaler.

When to start using a new inhaler The inhaler has a dose counter that shows the number of doses (inhalations) remaining in your inhaler. The dose counter moves every 5 actuations. When the dose counter starts turning red, 20 doses remain. If you do not yet have a new Easyhaler, contact your doctor for a new prescription. When the indicator reaches 0 (zero), you will need to replace the inhaler. If you use a protective cover, keep it and insert the new inhaler.

Remember 1. Shake – 2. Actuate – 3. Inhale. After inhaling, rinse your mouth with water. Avoid wetting the inhaler and protect it from moisture.

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