Bufomix easyhaler

QR code for the website www.oeh.fi/bfpl
To obtain information on how to use the Easyhaler inhaler, please scan this QR code. The same
information is also available at the website: www.oeh.fi/bfpl
Package leaflet: Information for the patient
Bufomix Easyhaler, (80 micrograms + 4.5 micrograms)/inhalation dose, inhalation powder
Budesonide + Formoterol fumarate dihydrate
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• 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 a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Bufomix Easyhaler 80 + 4.5 is and what it is used for
2. What you need to know before using Bufomix Easyhaler 80 + 4.5
3. How to use Bufomix Easyhaler 80 + 4.5
4. Possible side effects
5. How to store Bufomix Easyhaler 80 + 4.5
6. Contents of the pack and other information

1. What Bufomix Easyhaler 80 + 4.5 is and what it is used for

Bufomix Easyhaler is an inhaler used for the treatment of asthma in adults, adolescents, and children aged 6 years and older. 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 swelling and inflammation in the lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines known as long-acting beta2-adrenergic agonists or bronchodilators. It works by relaxing the muscles in the airways, making it easier for the patient to breathe.

This medicine is not suitable for patients with severe asthma. Bufomix Easyhaler may be prescribed for asthma treatment in two different ways.
a) Some patients are prescribed two asthma inhalers: Bufomix Easyhaler 80 + 4.5 and a separate rescue inhaler.

• Bufomix Easyhaler is used daily. Its regular use helps prevent asthma symptoms.
• A rescue inhaler is used when asthma symptoms occur, to help ease breathing.

b) For some patients, Bufomix Easyhaler 80 + 4.5 is prescribed as the only inhaler for asthma treatment.

• Bufomix Easyhaler is used daily. Regular use helps prevent asthma symptoms.
• Bufomix Easyhaler is also used when additional doses are needed to relieve asthma symptoms and ease breathing. These patients do not require a separate rescue inhaler.

2. Important information before using Bufomix Easyhaler 80 + 4.5

When not to use Bufomix Easyhaler 80 + 4.5:

• if the patient is allergic to budesonide, formoterol, or any other ingredient of this medicine (listed in section 6), namely lactose (which contains small amounts of milk proteins).

Warnings and precautions
Before starting treatment with Bufomix Easyhaler, discuss this with the doctor or pharmacist,
especially if the patient has:

• diabetes,
• a lung infection,
• high blood pressure or heart problems (including irregular heartbeat, very fast heart rate, narrowed arteries, or heart failure),
• thyroid or adrenal gland problems,
• low potassium levels in the blood,
• severe liver problems.

If the patient experiences blurred vision or other visual disturbances, they should contact a doctor.
After inhalation, rinse the mouth with water to prevent fungal infection of the oral cavity.
Bufomix Easyhaler and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to take, including those available without a prescription.
Some medicines may increase the effects of Bufomix Easyhaler, and the doctor may need to closely monitor the patient taking such medicines (including certain HIV medications: ritonavir, cobicistat).
Inform the doctor or pharmacist especially if taking any of the following medicines:

• beta-blockers (e.g. atenolol or propranolol, used for high blood pressure), including eye drops (e.g. timolol, used for glaucoma);
• medicines used for fast or irregular heartbeat (e.g. quinidine);
• medicines such as digoxin, used in the treatment of heart failure;
• diuretics, also known as water pills (e.g. furosemide), used in the treatment of high blood pressure;
• oral steroids (e.g. prednisolone);
• xanthine derivatives (e.g. theophylline or aminophylline), often used in the treatment of asthma;
• other bronchodilators (e.g. salbutamol);
• tricyclic antidepressants (e.g. amitriptyline) and the antidepressant nefazodone;
• phenothiazine derivatives (e.g. chlorpromazine and prochlorperazine);
• medicines used to treat infections (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, and telithromycin);
• medicines used in the treatment of Parkinson's disease (e.g. levodopa);
• medicines used for thyroid disorders (e.g. levothyroxine).

If the patient has any of the above conditions or has any doubts, they should contact the doctor or pharmacist before taking Bufomix Easyhaler.
The doctor or pharmacist should also be informed about any planned surgery or dental procedure under general anaesthesia.
Pregnancy and breastfeeding

• If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
• Do not use Bufomix Easyhaler without consulting a doctor.
• If pregnancy occurs during treatment with Bufomix Easyhaler, do not stop using the medicine and contact a doctor immediately.

Driving and using machines
Bufomix Easyhaler has no effect or negligible effect on the ability to drive and operate machinery.
Bufomix Easyhaler contains lactose, a type of sugar. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before using this medicine.
The amount of lactose contained in the medicine usually does not cause problems in people with lactose intolerance.
The excipient lactose contains small amounts of milk proteins, which may cause an allergic reaction.

3. How to use Bufomix Easyhaler 80 + 4.5

• This medicine should always be used exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.
• It is important to use Bufomix Easyhaler every day, even if you currently do not have any asthma symptoms.
• Your doctor should regularly monitor your asthma symptoms.

If you have previously taken oral steroids for asthma, your doctor may reduce the number of tablets after you start using Bufomix Easyhaler. If you have taken oral steroids for a long time, your doctor may occasionally order blood tests. While reducing the dose of oral steroid tablets, you may experience general discomfort despite improvement in chest symptoms. Symptoms such as nasal congestion or watery nasal discharge, weakness, joint or muscle pain, and skin rash (eczema) may occur. If any of these symptoms concern you, or if you experience headache, fatigue, nausea, or vomiting, you should seek medical advice immediately. If allergic symptoms or joint-related symptoms occur, another medicine may need to be used. If you have any doubts about continuing treatment with Bufomix Easyhaler, consult your doctor.
During periods of physical stress (e.g. chest infection or before surgery), your doctor may decide to add oral steroid tablets to your usual medications.

Important information about asthma symptoms
If you experience shortness of breath or wheezing while using Bufomix Easyhaler, continue using the medicine but seek immediate medical advice, as additional treatment may be necessary.

Contact your doctor immediately if:

• breathing difficulties worsen or you frequently wake up at night due to asthma symptoms;
• you feel chest tightness in the morning or the tightness lasts longer than usual. These symptoms may indicate that your asthma is not well controlled and may require immediate changes in therapy or additional medications.

ASTHMA
Bufomix Easyhaler 80 + 4.5 can be prescribed for asthma in two ways. The dose and timing of Bufomix Easyhaler depend on your doctor's instructions.

a) If you have been prescribed Bufomix Easyhaler and a separate reliever inhaler, read section "A) Using Bufomix Easyhaler with a separate reliever inhaler".
b) If you have been prescribed Bufomix Easyhaler as your only inhaler, read section "B) Using Bufomix Easyhaler as the only inhaler for asthma treatment".

A) Using Bufomix Easyhaler with a separate reliever inhaler
Bufomix Easyhaler should be used every day. This helps prevent asthma symptoms.

Adults (aged 18 years and above)

• The usual dose is 1 or 2 inhalations twice daily.
• Your doctor may increase the dose to up to 4 inhalations twice daily.
• If symptoms are well controlled, your doctor may recommend using the medicine once daily.

Adolescents (aged 12 to 17 years)

• The usual dose is 1 or 2 inhalations twice daily.
• If symptoms are well controlled, your doctor may recommend using the medicine once daily.

Children (aged 6 to 11 years)

• The usual dose is 2 inhalations twice daily.

Bufomix Easyhaler 80 + 4.5 is not recommended for children under 6 years of age.
Your doctor (or nurse) will help you manage your asthma symptoms. They will adjust your dose to the lowest effective dose that controls your asthma. However, do not change your dose without consulting your doctor (or nurse).

Use a separate reliever inhaler whenever asthma symptoms occur.
Always keep your reliever inhaler with you in case symptoms appear.
Do not use Bufomix Easyhaler to treat asthma symptoms – use the reliever inhaler instead.

B) Using Bufomix Easyhaler as the only inhaler for asthma treatment
Bufomix Easyhaler should only be used this way if your doctor has specifically instructed you to do so and if you are over 12 years of age.

Bufomix Easyhaler 80 + 4.5 should be used every day. This helps prevent asthma symptoms. You may use:

• 1 inhalation in the morning and 1 inhalation in the evening or
• 2 inhalations in the morning or
• 2 inhalations in the evening

Bufomix Easyhaler 80 + 4.5 should also be used as a reliever inhaler if asthma symptoms occur.

• If asthma symptoms occur, take 1 inhalation and wait a few minutes.
• If there is no improvement, take another inhalation.
• Do not use more than 6 inhalations at once.

Always keep your Bufomix Easyhaler with you so it is available when needed.
Usually, a daily dose higher than 8 inhalations is not required. However, your doctor may prescribe up to 12 inhalations per day for a short period.
If you regularly need to use 8 or more inhalations per day, consult your doctor or nurse. A change in treatment may be necessary.
Do not use more than 12 inhalations within 24 hours.

If asthma symptoms occur during physical exertion, use Bufomix Easyhaler as described in this leaflet. However, Bufomix Easyhaler should not be used to prevent asthma symptoms triggered by exercise.

Using more Bufomix Easyhaler than prescribed
It is important to use the medicine exactly as directed by your doctor or pharmacist. Do not exceed the prescribed dose without consulting your doctor.
The most common symptoms after using more than the recommended dose of Bufomix Easyhaler are tremor, headache, or rapid heartbeat.

If you miss a dose of Bufomix Easyhaler

• If you forget to take a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a missed dose.

If you have any further questions about using this medicine, consult your doctor or pharmacist.
Instructions for using the inhaler are located at the end of this leaflet.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, stop using the medicine
Bufomix Easyhaler and contact your doctor immediately:

• swelling of the face, particularly around the mouth (tongue and/or throat) and/or difficulty swallowing, or hives together with breathing difficulties (angioedema) and/or sudden fainting. This may indicate that the patient is experiencing an allergic reaction. This is rare and may occur in fewer than 1 in 1,000 people;
• sudden, acute wheezing or breathlessness immediately after using the inhaler. If any of these symptoms occur, stop using the Bufomix Easyhaler inhaler immediately and use a rescue medicine to relieve symptoms. Contact your doctor immediately, as a change of medicine may be necessary. This is very rare and may occur in fewer than 1 in 10,000 people.

Other possible adverse reactions:
Common (may occur in fewer than 1 in 10 people)

• palpitations (sensation of strong heartbeat), tremor. If these occur, they are usually mild and tend to subside with continued treatment with Bufomix Easyhaler;
• oral candidiasis (fungal infection of the mouth). This is less likely if the patient rinses their mouth with water after using Bufomix Easyhaler;
• mild sore throat, cough, hoarseness;
• headache.

Uncommon (may occur in fewer than 1 in 100 people)

• anxiety, nervousness, or restlessness;
• sleep disturbances;
• dizziness;
• nausea;
• rapid heartbeat;
• skin cyanosis (bluish discoloration of the skin);
• muscle cramps;
• blurred vision.

Rare (may occur in fewer than 1 in 1,000 people)

• rash, itching;
• bronchospasm (constriction of the airway muscles, causing wheezing). If wheezing occurs suddenly after using Bufomix Easyhaler, stop using the medicine and seek medical advice immediately;
• low blood potassium levels;
• irregular heartbeat.

Very rare (may occur in fewer than 1 in 10,000 people)

• depression;
• behavioural changes, particularly in children;
• chest pain or tightness (angina pectoris);
• increased blood glucose (sugar) levels;
• taste disturbances, e.g. unpleasant taste in the mouth;
• changes in blood pressure.

Inhaled corticosteroids may affect the normal production of steroid hormones
in the body, particularly if the patient is undergoing long-term treatment with high doses.
Such effects include:

• changes in bone mineral density (thinning of the bones);
• cataract (clouding of the eye lens);
• glaucoma (increased pressure within the eyeball);
• slowed growth rate in children and adolescents;
• effects on the adrenal glands (small glands near the kidneys).

The likelihood of these adverse reactions is significantly lower with inhaled corticosteroids
than with oral corticosteroid tablets.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Bufomix Easyhaler 80 + 4.5

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the cardboard box, pouch, and inhaler label after EXP. The expiry date refers to the last day of the stated month.
• After opening the laminated pouch, do not store at temperatures above 25 °C and protect from moisture. The Easyhaler inhaler may be used with its protective cover.
• If the Bufomix Easyhaler inhalator becomes damp, it must be replaced with a new one.
• The Bufomix Easyhaler inhaler must be replaced 4 months after opening the laminated pouch. The date of opening the pouch should be recorded.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the package and other information

What Bufomix Easyhaler 80 + 4.5 contains

• The active substances in this medicine are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 80 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
• The other ingredient is monohydrate lactose (which contains milk proteins).

What Bufomix Easyhaler 80 + 4.5 looks like and contents of the pack
Bufomix Easyhaler 80 + 4.5 is a medicine-filled inhaler. The inhalation powder is white to yellowish in colour. Each inhaler contains 60 or 120 doses and has a white body with a red top part.
Bufomix Easyhaler 80 + 4.5 is available in the following pack sizes:

• 1 inhaler with 60 doses, with a protective case,
• 1 inhaler with 120 doses, with a protective case.

Not all pack sizes may be marketed.
Depending on the country, a protective case may be included in the pack. If the patient requires a protective case, they should contact the Marketing Authorisation Holder (details provided below).

Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer
Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

Detailed and up-to-date information on the use of this medicine is available by scanning the QR code below (also located on the outer packaging and on the inhaler label) with a smartphone. The same information is available on the website: www.oeh.fi/bfpl
QR code for the website www.oeh.fi/bfpl

How to use the Easyhaler inhaler
Information about the Easyhaler inhaler
The Bufomix Easyhaler inhaler may differ from inhalers previously used by the patient.
Therefore, it is very important to use it correctly, as incorrect use may result in the patient not receiving the proper dose of medicine. This could lead to worsening of the patient's condition or inadequate treatment of asthma.
The doctor, nurse or pharmacist will show the patient how to use the inhaler correctly.
The patient should ensure they understand the correct way to use the inhaler. If in doubt, contact the doctor, nurse or pharmacist. As with all inhalers, caregivers should ensure that children prescribed Bufomix Easyhaler use the correct inhalation technique as described below. Instructional videos are also available at: www.oeh.fi/bfpl

First-time use of the Easyhaler inhaler

The Easyhaler inhaler is supplied in a laminated pouch. The pouch should not be opened until the start of treatment, as it helps to keep the dry powder in the inhaler dry. If the patient is ready to start treatment, open the pouch and record the date of opening, for example in a calendar. The inhaler can be used for 4 months after removal from the laminated pouch.

HOW TO USE THE INHALER CORRECTLY

Step 1: SHAKING Remove the mouthpiece cover. Holding the inhaler upright, shake it up and down 3 to 5 times.	SHAKE 3 TO 5 TIMES	Important information to remember It is important to keep the inhaler in an upright position. If the inhaler accidentally clicks during shaking, remove the powder from the mouthpiece as instructed below.
Step 2: CLICKING Hold the inhaler upright, gripping it between your thumb and index finger. Press down on the inhaler until you hear a click, then release the pressure until you hear a second click. This releases the dose of medication. You can only click once.	CLICK ONCE	Important information to remember The inhaler will not click if the mouthpiece cover has not been removed. You can only click once. If you click more than once, remove the powder from the mouthpiece—see instructions below. To release the dose of medication, press down before inhaling, but not at the same time. Keep the inhaler upright during pressing and inhaling to prevent powder from falling out of the inhalation channel before inhalation.
Step 3: INHALATION Hold the inhaler upright. Breathe normally. Place the mouthpiece in your mouth between your teeth and close your lips tightly around it. Take a strong and deep breath in. Remove the inhaler from your mouth, then breathe normally.	INHALATION	Important information to remember Make sure the entire mouthpiece is in your mouth to ensure proper delivery of medication to the lungs. Ensure your lips are tightly sealed around the mouthpiece. Do not exhale into the inhaler. This is important: it may block the inhaler. If you accidentally exhale into the inhaler, remove the powder from the mouthpiece—see below.

If another inhalation is necessary, repeat steps 1–3: Shaking-Clicking-Inhalation.
After using the inhaler:

• Replace the cap on the mouthpiece to prevent accidental activation of the inhaler.
• After administration of the dose, rinse the mouth with water and spit out the water.

How to remove powder from the mouthpiece If the inhaler is accidentally activated, activated multiple times, or if you have exhaled into the inhaler, remove the powder from the mouthpiece: Tap the mouthpiece on the table or your hand to remove the powder. Then restart the “Shake-Click-Inhale” steps.

Cleaning the Easyhaler inhaler
The inhalator should be kept dry and clean. If necessary, the mouthpiece of the inhalator may be cleaned with a dry cloth or wipe. Do not use water. The powder in the Easyhaler inhalator is sensitive to moisture.

Use of the Easyhaler inhaler in the protective case The Easyhaler inhaler can be used within the protective case, which may help increase the product's shelf life. Before placing the inhaler into the protective case, ensure that the cap covers the mouthpiece to prevent accidental activation of the inhaler. The inhaler can be used without removing it from the protective case. Use according to the instructions above: 1. Shaking, 2. Clicking, 3. Inhaling. Keep the inhaler upright during clicking and inhalation. Replace the cap over the mouthpiece after taking the dose to prevent accidental activation of the inhaler.

Switching to a new Easyhaler inhaler The inhaler is equipped with a dose counter indicating the number of doses remaining. The counter rotates every five actuations. When the dose counter turns red, this indicates that 20 doses remain. If the patient does not yet have a new Easyhaler inhaler, they should contact their doctor to obtain a new prescription. When the counter shows 0, the Easyhaler inhaler must be replaced. If the patient uses a protective case, it should be kept and used for the new inhaler.

To remember

• 1. Shake, 2. Click, 3. Inhale.
• After administration of the dose, rinse the mouth with water and spit the water out.
• Do not allow the inhaler to get wet; protect it from moisture.

If you have any further questions regarding the use of this medicine, please consult your
doctor or pharmacist.