Leaflet: Information for the patient

BufomixEasyhaler 160micrograms/4.5micrograms/inhalation, Powder for inhalation

Budesonide/formoterol fumarate dihydrate

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Bufomix Easyhaler is an inhalerthat is used for the treatment of asthma in adults andadolescents 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. Contains two different medications: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medications called “corticosteroids”. It acts by reducing and preventing inflammation in your lungs.
• Formoterol fumarate dihydrate belongs to a group of medications called “long-acting beta2adrenergic agonists” or “bronchodilators”. It acts by relaxing the muscles of the airways, making it easier for you to breathe.

Asthma

Bufomix Easyhaler 160 microgramos/4.5 microgramos can be prescribed for asthma in two different ways:

a) For some people, two inhalers are prescribed: Bufomix Easyhaler 160microgramos/ 4.5microgramos and a separate “reliever” inhaler.

• They use Bufomix Easyhaler daily, which helps to prevent the onset of asthma symptoms.
• They use their “reliever” inhaler when asthma symptoms appear, to breathe normally again.

b) For some people, Bufomix Easyhaler 160microgramos/4.5microgramos is prescribed as a single inhaler.

• They use Bufomix Easyhaler daily, which helps to prevent the onset of asthma symptoms.
• They also use Bufomix Easyhaler when extra doses are needed to relieve asthma symptoms, to breathe normally again, and, if their doctor has indicated, to prevent the onset of 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 microgramos/4.5 microgramos can also be used to treat COPD symptoms in adults. COPD is a prolonged disease of the airways, usually caused by smoking.

Do not use Bufomix Easyhaler 160micrograms/4.5micrograms:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Bufomix Easyhalerif:

• You have diabetes
• You have any lung infection
• You have high blood pressure, or have 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 levels of potassium in the blood
• You have severe liver problems

Get in touch with 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.

Use of Bufomix Easyhaler with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or might have to take any other medicine, including those bought without a prescription.

Some medicines may increase the effects of Bufomix Easyhaler and your doctor may consider monitoring you closely 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 to treat rapid or irregular heartbeats (for example quinidina);
• Medicines like digoxin, used commonly to treat heart failure;
• Diuretics (such as furosemide), used to treat high blood pressure;
• Oral steroids (such as prednisolone);
• Xanthine medicines (such as theophylline or aminophylline), used commonly 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 to treat Parkinson's disease (such as levo-dopa);
• Medicines to treat thyroid problems (such as levo-thyroxine).

If you find yourself 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 to undergo general anaesthesia for a surgical operation or dental treatment.

Pregnancy and breastfeeding

• If you are pregnant, or breastfeeding, think you might be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.
• Do not use Bufomix Easyhaler unless your doctor tells you to.
• If you become pregnant while taking Bufomix Easyhaler, do not stop using it but consult your doctor immediately.

Driving and operating machines

The influence of Bufomix Easyhaler on the ability to drive and operate machinery is negligible or insignificant.

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

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

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

• Follow exactly the administration instructions of this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
• It is essential to use Bufomix Easyhaler daily, even if you do not have asthma or COPD symptoms at the time.
• Your doctor will want to check regularly 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 do blood tests from time to time. You may feel unwell in general when your oral steroid tablets are reduced, even if your lung symptoms are improving.

You may experience some symptoms such as congestion or runny nose, weakness or pain in muscles and joints, and skin rash (eczema). 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 medication. 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 regular treatment during periods of stress (for example, when you have a chest infection or before surgery).

Important information about asthma or COPD symptoms:

If you experience difficulty breathing or wheezing while using Bufomix Easyhaler, 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 feeling chest tightness in the morning, or the 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

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

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

1. UsingBufomix Easyhaler and a separate reliever inhaler for symptoms

Use Bufomix Easyhalerdaily, as it helps prevent asthma symptoms from appearing.

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 may ask you to use the medication once a day.

Adolescents (12 to 17 years old)

• 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.

There is a lower concentration of budesonide/formoterol for children aged 6-11 years.

Bufomix Easyhaler is not recommended for children under 6 years old.

Your doctor (or nurse) will help you manage your asthma. They will adjust the dose of this medication to the lowest dose that controls your asthma. However, do not adjust the dose without first speaking with your doctor or nurse.

Use your other “reliever inhaler” when asthma symptoms appear.Always carry this “reliever inhaler” with you so you can use it when you need it. Do not use Bufomix Easyhaler to treat asthma symptoms, but your reliever inhaler.

1. Using Bufomix Easyhaler as a single inhaler for asthma

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

Use Bufomix Easyhaler 160 micrograms/4.5 micrograms every day. This helps prevent asthma symptoms from appearing. You can 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 appear and to prevent asthma symptoms from appearing (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 at a time.

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

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

If you usually need to take 8 or more inhalations a day, ask 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 essential to talk to your doctor about using Bufomix Easyhaler as a preventive for asthma symptoms; the frequency of your exercise or exposure to allergens may affect the treatment prescribed.

Chronic Obstructive Pulmonary Disease (COPD)

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

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

If you use more Bufomix Easyhaler than you should

It is essential to use the dose indicated by the pharmacist in the box 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 you should are shakiness, headache, and rapid heartbeat.

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

If you forgot to use Bufomix Easyhaler

• If you forget 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 not take a double dose to compensate for the missed dose.

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• Your face becomes swollen, particularly around the mouth (tongue and/or throat and/or difficulty swallowing) or you experience urticaria along with difficulty breathing (angioedema) and/or a sudden feeling of faintness, indicating that you may be experiencing an allergic reaction. This occurs rarely, affecting fewer than 1 in 1,000 patients.
• You experience acute wheezing or difficulty breathing immediately after using your inhaler.If any of these symptoms occur, 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 fewer than 1 in 10,000 patients.

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

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

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

Other possible side effects:

Frequent (affects fewer than 1 in 10 patients)

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

Infrequent (affects fewer than 1 in 100 patients)

• Restlessness, anxiety, nervousness.
• Difficulty sleeping.
• Dizziness.
• Nausea (discomfort).
• Accelerated heart rate.
• Skin hematomas.
• Muscle cramps.
• Blurred vision.

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

• Rash, itching.
• Asthma bronchospasm (contraction of the respiratory tract muscles, causing wheezing). If this occurs 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 fewer than 1 in 10,000 patients)

• Depression.
• Changes in behavior, especially in children.
• Chest pain or pressure (angina pectoris).
• Increased blood glucose levels.
• Alterations in taste, such as an unpleasant mouth taste.
• Variations in blood pressure.

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

• Bone mineral density changes (bone thinning).
• 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 near the kidneys).

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the box, aluminum bag, and the label of your inhalerafter CAD. The expiration date is the last day of the month indicated.
• After opening the aluminum bag, do not store at a temperature above 25°C and store protected from moisture. It is recommended to keep the BufomixEasyhaler inhaler inside the protective cover.
• If your BufomixEasyhaler inhaler becomes wet, you must replace it with a new one.
• Replace the BufomixEasyhaler inhaler 4 months after opening the aluminum bag. Write the date it was opened to help you remember.
• Medications should not be thrown down the drains or in the trash. Deposit the containers and medications you do not need at the SIGREpoint of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medications you do not need. In this way, you will help protect the environment.

Composition of BufomixEasyhaler 160micrograms/4.5micrograms

• The active principles 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 package

Bufomix Easyhaler 160 micrograms/4.5 micrograms is an inhaler that contains your medication. The powder for inhalation 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 160micrograms/4.5 micrograms is available in packages of 1 or 3 inhalers, and also in packages of 2 inhalers with 120 doses.

Only some package sizes may be marketed.

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

Marketing Authorization Holder and Responsible for Manufacturing

Marketing Authorization Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Responsible for Manufacturing

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

Last review date of this leaflet:January 2020.

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 smartphone. You can also access this information on the following internet address:https://cima.aemps.es/info/78807

QR code

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (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. Therefore, it is very important that you use it correctly, otherwise, you may not receive the right amount of medication. This could make you feel unwell or may be the cause of your asthma or COPD not being treated properly.

Your doctor, nurse, or pharmacist will teach you how to use your inhaler correctly. Make sure you understand how to use it correctly. 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-Activate-Inhale.

After using the inhaler:

• Put the cap back on the mouthpiece, which will prevent the inhaler from accidentally activating.
• After inhaling, rinse your mouth with water and then spit it out.

Cleaning of 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 using this medication, ask your doctor or pharmacist.