Bufomix easyhaler

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To obtain information on how to use the Easyhaler inhaler, please scan this QR code. The same
information is also available on the website: www.oeh.fi/bfpl
Package leaflet: Information for the patient
Bufomix Easyhaler, (320 micrograms + 9 micrograms)/inhalation dose, powder for inhalation
Budesonide + Formoterol fumarate dihydrate
Please read this leaflet carefully before 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 further questions, please 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 as yours.
• 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 320 + 9 is and what it is used for
2. What you need to know before using Bufomix Easyhaler 320 + 9
3. How to use Bufomix Easyhaler 320 + 9
4. Possible side effects
5. How to store Bufomix Easyhaler 320 + 9
6. Contents of the pack and other information

1. What Bufomix Easyhaler 320 + 9 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 the treatment of symptoms of chronic obstructive pulmonary disease (COPD) in adults aged 18 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 long-acting bronchodilators. It works by relaxing the muscles in the airways, making it easier for the patient to breathe.

Asthma
In asthma, your doctor will prescribe two inhaled medicines: Bufomix Easyhaler 320 + 9 and another medicine for immediate use.

• Bufomix Easyhaler should be used daily. Regular use helps prevent asthma symptoms.
• The reliever inhaler should be used when asthma symptoms occur to help ease breathing.

Bufomix Easyhaler 320 + 9 must not be used as a reliever medicine when symptoms occur.
Chronic obstructive pulmonary disease (COPD)
Bufomix Easyhaler 320 + 9 may also be used to treat symptoms of COPD in adults. COPD is a long-term lung disease, often caused by smoking.

2. Important information before using Bufomix Easyhaler 320 + 9

When not to use Bufomix Easyhaler 320 + 9:

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

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

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

If the patient experiences blurred vision or any other visual disturbances, medical advice should be sought.
After inhalation, the mouth should be rinsed to prevent fungal infection of the mouth.
Bufomix Easyhaler and other medicines
Inform the doctor or pharmacist about all medicines currently used,
recently taken, or planned to be used, including those available without a prescription.
Some medicines may enhance the effect of Bufomix Easyhaler, and the doctor may need to monitor
the patient closely when such medicines are used (including certain HIV medications: ritonavir, cobicistat).
Inform the doctor or pharmacist especially if the patient is 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 tablets (e.g. furosemide), used in the treatment of high blood pressure;
• oral corticosteroids (e.g. prednisolone);
• xanthine derivatives (e.g. theophylline or aminophylline), often used in asthma treatment;
• 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 consult a doctor or pharmacist before using 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 might be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
• Bufomix Easyhaler should not be used without consulting a doctor.
• If pregnancy occurs during treatment with Bufomix Easyhaler, do not stop using the medicine and seek immediate medical advice.

Driving and operating machinery
Bufomix Easyhaler has no effect or has a 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 320 + 9

• This medicine should always be used exactly as your doctor has told you. 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 symptoms of asthma or COPD.
• Your doctor should regularly monitor your asthma symptoms.

If you have previously taken oral steroids due to asthma or COPD, your doctor may reduce the number of
oral steroid tablets after you start using Bufomix Easyhaler. If you have taken oral steroids for a long time,
your doctor may occasionally recommend blood tests. While reducing the number of oral steroid tablets,
you may experience general malaise despite improvement in chest symptoms. Symptoms such as nasal
congestion or watery nasal discharge, weakness, or joint or muscle pain, as well as skin rash (eczema), may
occur. If any of these symptoms concern you, or if you experience headache, fatigue, nausea, or vomiting,
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 stress (e.g., chest infection or prior to surgery), your doctor may decide to
add oral steroid tablets to your usual medications.

Important information about asthma or COPD symptoms
If you experience shortness of breath or wheezing while using Bufomix Easyhaler, continue using the
medicine but contact your doctor immediately, 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 experience chest tightness in the morning or the tightness lasts longer than usual. These symptoms may indicate that your asthma or COPD is not adequately controlled and may require immediate changes in therapy or additional medications.

ASTHMA
Bufomix Easyhaler should be used daily. This will help prevent asthma symptoms.

Adults (aged over 18 years)

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

Bufomix Easyhaler with a lower strength is available for children aged 6 to 11 years.
Bufomix Easyhaler 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 symptoms. However, do not change the dose of your medicine
without consulting your doctor (or nurse).

You should use a separate reliever inhaler when asthma symptoms occur.
Always keep your reliever inhaler with you in case symptoms occur.
Do not use Bufomix Easyhaler to treat sudden asthma symptoms – use your reliever inhaler instead.

COPD (Chronic Obstructive Pulmonary Disease)

• For use only in adults (aged 18 years and older).
• The usual dose is 1 inhalation twice daily.

Your doctor may also prescribe another bronchodilator medicine for COPD, such as an anticholinergic
(e.g., tiotropium bromide or ipratropium).

Taking more Bufomix Easyhaler than recommended
It is important to take the dose as instructed by your doctor or pharmacist. Do not take a higher dose
than recommended without consulting your doctor.
The most common symptoms that may occur after taking a higher than recommended dose of Bufomix
Easyhaler 320 + 9 are tremor, headache, or rapid heartbeat.

If you forget to take Bufomix Easyhaler

• If you miss 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 the use of 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 everybody gets 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 accompanied by breathing difficulties (angioedema) and (or) sudden fainting. This may indicate that the patient has experienced 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 reliever medicine. 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.

Tell your doctor if any of the following symptoms occur during treatment with
Bufomix Easyhaler; these may be signs of a lung infection:

• fever or chills,
• increased mucus production, change in mucus colour,
• worsening cough or increased difficulty in breathing. Pneumonia (lung infection) is a commonly occurring adverse reaction in patients with COPD (may occur in fewer than 1 in 10 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 as treatment with Bufomix Easyhaler continues;
• oral thrush (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);
• 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 it immediately and consult your doctor without delay;
• 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);
• increased blood sugar (glucose) 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 (bone thinning);
• 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 considerably lower with inhaled corticosteroids than with oral corticosteroid tablets.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported
directly to the Department for Monitoring 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Bufomix Easyhaler 320 + 9

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the cardboard box, pouch, and label of the inhaler following 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 kept in its protective case.
• If the Bufomix Easyhaler inhaler 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. This will help protect the environment.

6. Contents of the package and other information

What Bufomix Easyhaler 320 + 9 contains

• The active substances in this medicine are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
• The other ingredient is monohydrate lactose (which contains milk proteins).

What Bufomix Easyhaler 320 + 9 looks like and contents of the pack
Bufomix Easyhaler 320 + 9 is a pre-filled inhaler. The inhalation powder is white to slightly yellowish. Each inhaler contains 60 doses and has a white body with a red upper part.
Bufomix Easyhaler 320 + 9 is available in the following pack sizes:

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

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 about this medicine is available by scanning the QR code (located on both the outer packaging and the inhaler label) with a smartphone.
The same information is also 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 or COPD.
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. An instructional video is also available at: www.oeh.fi/bfpl
First use of the Easyhaler inhaler

The Easyhaler inhaler is supplied in a laminated pouch. The pouch must not be opened until the medicine is to be used, as it helps keep the dry powder in the inhaler dry. When 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. Hold the inhaler upright and 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 is accidentally actuated during shaking, remove the powder from the mouthpiece according to the instructions provided below.
Step 2: ACTUATING Hold the inhaler upright, gripping it with your index finger and thumb. Press down on the inhaler until you hear a click, then release pressure until you hear a second click. This releases the dose of medication. Actuation can only be performed once.	ACTIVATE ONCE	Important information to remember The inhaler will not actuate if the mouthpiece cover has not been removed. Actuation can only be performed once. If actuated more than once, remove the powder from the mouthpiece—see below. To release the medication dose, press down before inhaling, but not at the same time. Keep the inhaler in an upright position while pressing and inhaling the medication dose to prevent powder from escaping the inhalation channel before inhalation.
Step 3: INHALATION Hold the inhaler upright. Breathe normally. Place the mouthpiece 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 Ensure the entire mouthpiece is inside your mouth to allow proper delivery of medication to the lungs. Ensure your lips are sealed tightly around the mouthpiece. Do not exhale into the inhaler. This is important: it may cause blockage of the inhaler. If you accidentally exhale into the inhaler, remove the powder from the mouthpiece—see below.

If another inhalation is required, repeat steps 1–3: Shake–Click–Inhale.
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 against the table or your hand to remove the powder. Then restart the "Shake-Click-Inhale" steps.

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

Use of the Easyhaler inhaler in the protective case The Easyhaler inhaler can be used within the protective case, which helps extend the product's shelf life. Before placing the inhaler into the protective case, ensure that the mouthpiece cover is closed to prevent accidental actuation. The inhaler can be used without removing it from the protective case. Use according to the instructions above: 1. Shaking, 2. Clicking, 3. Inhalation. Keep the inhaler upright during clicking and inhalation. Replace the mouthpiece cover after each dose to prevent accidental actuation 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 reaches 0, the Easyhaler inhaler must be replaced. If the patient uses a protective case, it should be retained 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 out the water.
• Do not allow the inhaler to get wet; protect it from moisture.

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