Bufomix Easihaler

1. What is Bufomix Easyhaler 160 + 4.5 and what is it used for

Bufomix Easyhaler is an inhaler used to treat asthma in adults and adolescents aged 12 to 17 years. It is also used to treat 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 called long-acting beta2-adrenergic agonists or bronchodilators. It works by relaxing the muscles in the airways. This makes it easier for the patient to breathe.

Asthma

Bufomix Easyhaler 160 + 4.5 may be prescribed for asthma in two different ways.
a)

Some patients are prescribed two medicines in inhalers for asthma: Bufomix Easyhaler 160 + 4.5 and a separate reliever inhaler.

Bufomix Easyhaler is used every day. Its use helps prevent asthma symptoms.

• Bufomix Easyhaler is used every day. Its use helps prevent asthma symptoms.
• The reliever inhaler is used when asthma symptoms occur, to make breathing easier.

b)

Some patients are prescribed Bufomix Easyhaler 160 + 4.5 as the only inhaler for asthma.

• Bufomix Easyhaler is used every day. Its use helps prevent asthma symptoms.
• Bufomix Easyhaler is also used when additional doses are needed to relieve asthma symptoms and make breathing easier, and, if agreed with the doctor, to prevent asthma symptoms (for example, during physical exercise or exposure to allergens). These patients do not need a separate reliever inhaler.

Chronic Obstructive Pulmonary Disease (COPD)

Bufomix Easyhaler 160 + 4.5 can also be used to treat COPD symptoms in adults.
COPD is a long-term lung disease that is often caused by smoking.

2. Important information before using Bufomix Easyhaler 160 + 4.5

When not to use Bufomix Easyhaler 160 + 4.5:

Warnings and precautions

Before starting to use Bufomix Easyhaler, the patient should discuss it with their doctor or pharmacist, especially if they have:

• diabetes,
• lung infection,
• high blood pressure or heart problems (including irregular heartbeat, very fast pulse, narrowing of the 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 vision disturbances, they should contact their doctor.
After inhalation, the patient should rinse their mouth with water to prevent fungal infection of the mouth.

Bufomix Easyhaler and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
Some medicines may increase the effects of Bufomix Easyhaler, and the doctor may want to monitor the patient's condition closely when taking such medicines (including certain HIV medicines: ritonavir, cobicistat).
The patient should inform their doctor or pharmacist especially if they are taking any of the following medicines:

• beta-blockers (such as atenolol or propranolol, used for high blood pressure), including eye drops (such as timolol, used for glaucoma);
• medicines used for fast or irregular heartbeat (such as quinidine);
• medicines such as digoxin, used to treat heart failure;
• diuretics, also known as water pills (such as furosemide), used to treat high blood pressure;
• oral steroids (such as prednisolone);
• xanthine derivatives (such as theophylline or aminophylline), often used to treat asthma;
• other bronchodilators (such as salbutamol);
• tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone;
• phenothiazine derivatives (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 used to treat thyroid disorders (such as levothyroxine).

If the patient has any of these conditions or has any doubts, they should consult their doctor or pharmacist before taking Bufomix Easyhaler.
The doctor or pharmacist should also be informed about any planned surgery or dental procedure under general anesthesia.

Pregnancy and breastfeeding

• If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using this medicine.
• Bufomix Easyhaler should not be used without consulting a doctor.
• If the patient becomes pregnant during treatment with Bufomix Easyhaler, they should not stop using it and should consult their doctor as soon as possible.

Driving and using machines

Bufomix Easyhaler has no or negligible influence on the ability to drive and use machines.
Bufomix Easyhaler contains lactose, a type of sugar. If the patient has previously been found to be intolerant to some sugars, they should consult their doctor before using this medicine.
The amount of lactose in the medicine is unlikely to cause problems in patients with lactose intolerance.
The excipient, lactose, contains small amounts of milk proteins, which may cause an allergic reaction.

3. How to use Bufomix Easyhaler 160 + 4.5

• This medicine should always be used as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
• It is important to use Bufomix Easyhaler every day, even if the patient does not have any symptoms of asthma or COPD.
• The doctor should regularly monitor the patient's asthma symptoms.

If the patient has been taking oral steroids for asthma or COPD, the doctor may reduce the number of tablets taken after starting Bufomix Easyhaler.
If the patient has been taking oral steroids for a long time, the doctor may occasionally order blood tests.
When reducing the number of oral steroid tablets, the patient may feel unwell, despite the improvement in chest symptoms.
Such symptoms may include a stuffy or runny nose, weakness or muscle pain, and a rash (eczema).
If any of these symptoms worry the patient or occur, they should consult their doctor immediately.
If allergic reactions or joint symptoms occur, it may be necessary to use another medicine.
If the patient has any doubts about continuing treatment with Bufomix Easyhaler, they should consult their doctor.
In periods of stress (such as a chest infection or before surgery), the doctor may decide to add a steroid tablet to the usual medicines.

Important information about asthma or COPD symptoms

If the patient experiences shortness of breath or wheezing while using Bufomix Easyhaler, they should continue to use it, but consult their doctor as soon as possible, as additional medicines may be needed.
The patient should consult their doctor immediately if:

• breathing problems worsen or the patient wakes up at night with asthma symptoms;
• the patient experiences chest tightness in the morning or chest tightness that lasts longer than usual.
  Such symptoms may indicate that the asthma or COPD is not well controlled and may require immediate changes to the treatment or the addition of other medicines.

ASTHMA

Bufomix Easyhaler 160 + 4.5 can be prescribed for asthma in two ways. The dose of Bufomix Easyhaler and the time of administration depend on the doctor's instructions.
a)
If the patient has been prescribed Bufomix Easyhaler and a separate reliever inhaler, they should read the section "A) Using Bufomix Easyhaler with a separate reliever inhaler".
b)
If the patient has been prescribed Bufomix Easyhaler as the only inhaler, they should read the section "B) Using Bufomix Easyhaler as the only inhaler for asthma".

A) Using Bufomix Easyhaler with a separate reliever inhaler

Bufomix Easyhaler should be used every day.This will help prevent asthma symptoms.

Adults (aged 18 and over)

• The typical dose is 1 or 2 inhalations, twice a day.
• The doctor may increase the dose to 4 inhalations, twice a day.
• If the symptoms are well controlled, the doctor may recommend using the medicine once a day.

Adolescents (aged 12 to 17)

• The typical dose is 1 or 2 inhalations, twice a day.
• If the symptoms are well controlled, the doctor may recommend using the medicine once a day.

For children aged 6 to 11, a lower-strength Bufomix Easyhaler is available.
Bufomix Easyhaler should not be used in children under 6 years of age.
The doctor (or nurse) will help the patient manage their asthma symptoms.
They will adjust the dose to the smallest dose that controls the asthma symptoms.
However, the patient should not change the dose without consulting their doctor (or nurse).

A separate reliever inhaler should be used when asthma symptoms occur.

The reliever inhaler should always be carried with the patient in case symptoms occur.
Bufomix Easyhaler should not be used to treat asthma symptoms – the reliever inhaler should be used.

B) Using Bufomix Easyhaler as the only inhaler for asthma

Bufomix Easyhaler should only be used in this way if the doctor has recommended it and if the patient is 12 years or older.
Bufomix Easyhaler 160 + 4.5 should be used every day.This will help prevent asthma symptoms.
The patient can use:

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

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

Bufomix Easyhaler 160 + 4.5 should also be used as a reliever inhaler when asthma symptoms occur, and to prevent asthma symptoms (for example, during physical exercise or exposure to allergens).

If asthma symptoms occur, the patient should use 1 inhalation and wait a few minutes.

• If there is no improvement, the patient should use another inhalation.
• The patient should not use more than 6 inhalations at the same time.

Bufomix Easyhaler should always be carried with the patient so that it can be used if needed.
Normally, a daily dose greater than 8 inhalations is not needed.
However, the doctor may recommend using 12 inhalations per day for a short period.
If the patient regularly needs to use at least 8 inhalations per day, they should consult their doctor or nurse.
A change of medicine may be necessary.
The patient should not use more than 12 inhalations in 24 hours.
If asthma symptoms occur during physical exercise, Bufomix Easyhaler should be used as described in this leaflet.
It is essential to discuss the use of Bufomix Easyhaler with the doctor to prevent asthma symptoms; how often the patient engages in intense physical activity or is exposed to allergens, which may affect the prescribed treatment.

COPD (Chronic Obstructive Pulmonary Disease)

• For use only in adults (aged 18 and over).
• The usual dose is 2 inhalations, twice a day.

For patients with COPD, the doctor may also prescribe another bronchodilator, such as an anticholinergic (such as tiotropium bromide or ipratropium bromide).

Using a higher dose of Bufomix Easyhaler than recommended

It is essential to take the dose as directed by the doctor or pharmacist.
Do not take a higher dose than recommended without consulting a doctor.
The most common symptoms that may occur after using a higher dose of Bufomix Easyhaler 160 + 4.5 than recommended are tremors, headache, or rapid heartbeat.

Missing a dose of Bufomix Easyhaler

• If a dose is missed, it should be taken as soon as possible.
  However, if it is almost time for the next dose, the missed dose should be skipped.
• Do nottake a double dose to make up for a missed dose.

If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

Instructions for using the inhaler are at the end of the leaflet.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the patient experiences any of the following side effects, they should stop using Bufomix Easyhaler and consult their doctor immediately:

Bufomix Easyhaler and consult their doctor immediately:

• swelling of the face, particularly around the mouth (tongue and/or throat and/or difficulty swallowing) or hives, together with difficulties in breathing (angioedema) and/or sudden fainting.
  This may mean that the patient has had an allergic reaction.
  This happens rarely and may occur less often than in 1 in 1,000 people;
• sudden acute wheezing or shortness of breath immediately after using the inhaler.
  If any of these symptoms occur, the patient should stop using the Bufomix Easyhaler inhaler and use a reliever inhaler.

Easyhaler and consult their doctor immediately, as a change of medicine may be necessary.

This happens very rarely and may occur less often than in 1 in 10,000 people.
The patient should tell their doctor if they experience any of the following symptoms while using Bufomix Easyhaler; these may be symptoms of a lung infection:

• fever or chills,
• increased production of mucus, change in the color of mucus,
• worsening cough or increased breathing difficulties.

Pneumonia (lung infection) is a common side effect in patients with COPD (may occur in less than 1 in 10 people).

Other possible side effects:

Common (may occur in less than 1 in 10 people)

• palpitations (feeling of heart pounding), tremors.
  These effects are usually mild and usually disappear when continuing treatment with Bufomix Easyhaler;
• 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 less than 1 in 100 people)

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

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

• rash, itching;
• bronchospasm (constriction of the airway muscles, which causes wheezing).
  If wheezing occurs suddenly after using Bufomix Easyhaler, the patient should stop using it and consult their doctor immediately;
• low potassium levels in the blood;
• irregular heartbeat.

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

• depression;
• changes in behavior, especially in children;
• chest pain or tightness (angina pectoris);
• 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 the body, especially if the patient is taking long-term treatment with high doses.
These effects include:

• changes in bone density (thinning of the bones);
• cataracts (clouding of the lens in the eye);
• glaucoma (increased pressure in the eye);
• slowing of growth in children and adolescents;
• effects on the adrenal glands (small glands near the kidneys).

The likelihood of these side effects is much lower when using inhaled corticosteroids than when taking corticosteroid tablets.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Bufomix Easyhaler 160 + 4.5

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton, pouch, and inhaler label after EXP.
  The expiry date refers to the last day of the month stated.
• After opening the pouch, do not store above 25°C, protect from moisture.
  It is recommended to store the Easyhaler inhaler in its protective packaging.
• If the Bufomix Easyhaler inhaler gets damp, it should be replaced with a new one.
• The Bufomix Easyhaler inhaler should be replaced 4 months after opening the pouch.
  The date of opening the pouch should be recorded.
• Medicines should not be disposed of via wastewater or household waste.
  The patient should ask their pharmacist how to dispose of medicines no longer required.
  Such measures will help protect the environment.

6. Contents of the packaging and other information

What Bufomix Easyhaler 160 + 4.5 contains

• The active substances are budesonide and formoterol fumarate dihydrate.
  Each dose delivered via the inhaler contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
• The other ingredient is lactose monohydrate (which contains milk proteins).

What Bufomix Easyhaler 160 + 4.5 looks like and contents of the pack

Bufomix Easyhaler 160 + 4.5 is an inhaler containing the medicine.
The inhalation powder is white to yellowish in color.
Each inhaler contains 60 or 120 doses and has a white body with a red upper part.
Bufomix Easyhaler 160 + 4.5 is available in packs of:

• 1 inhaler of 60 doses, with protective packaging,
• 1 inhaler of 120 doses, with protective packaging.

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

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

Date of last revision of the leaflet:

To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
kontakt@orionpharma.info.pl
Detailed and up-to-date information about the use of this medicine is available after scanning the QR code (located on both the outer packaging and the inhaler label) using 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 the patient has used before.
Therefore, it is crucial to use it correctly, as incorrect use may result in the patient not receiving the correct amount of medicine.
This may lead to a worsening of the patient's condition or asthma/COPD not being treated properly.
The doctor, nurse, or pharmacist will show the patient how to use the inhaler correctly.
The patient should make sure they understand how to use the inhaler correctly.
If they have any doubts, they should consult their doctor, nurse, or pharmacist.
As with all inhalers, caregivers should ensure that children prescribed Bufomix Easyhaler use the correct inhalation technique, as described below.
A video tutorial is also available at: www.oeh.fi/bfpl

Using the Easyhaler inhaler for the first time

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

HOW TO USE THE EASYHALER INHALER

Step 1: SHAKING Remove the mouthpiece cover. Holding the inhaler upright, shake the inhaler up and down 3 to 5 times.

SHAKE 3 TO 5 TIMES

Important information to remember It is essential to hold the inhaler upright. If the inhaler is clicked accidentally while shaking, the powder should be removed from the mouthpiece, as described below.

Step 2: CLICKING Hold the inhaler upright, gripping it with the index finger and thumb. Press the inhaler until a click is heard, and then release the pressure on the inhaler until a click is heard again. This will release a dose of the medicine. The inhaler can only be clicked once.

CLICK ONCE

Important information to remember The inhaler will not click if the mouthpiece cover is not removed. The inhaler can only be clicked once. If the inhaler is clicked more than once, the powder should be removed from the mouthpiece, as described below. To release a dose of the medicine, press the inhaler before inhaling, but not at the same time. While pressing and inhaling the dose, hold the inhaler upright, which prevents the powder from falling out of the inhalation channel before inhaling.

Breathe in strongly and deeply. Remove the inhaler from the mouth, then breathe normally.

Do not breathe out into the inhaler. This is important: it may cause the inhaler to become blocked. If the patient breathes out into the inhaler, they should remove the powder from the mouthpiece, as described below.

If another inhalation is needed, the patient should repeat steps 1-3: Shaking-Clicking-Inhalation.

After using the inhaler:

• Replace the mouthpiece cover to prevent accidental activation of the inhaler.
• After administering the dose, the patient should rinse their mouth with water and spit it out.

How to remove powder from the mouthpiece If the inhaler is clicked accidentally or clicked multiple times, or if the patient breathes out into the inhaler, they should remove the powder from the mouthpiece: Tap the mouthpiece against a table or hand to remove the powder. Then, start again from the "Shaking-Clicking-Inhalation" 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.

Using the Easyhaler inhaler in the protective packaging The inhaler can be used in the protective packaging, which helps to extend the product's shelf life. Before placing the inhaler in the protective packaging, make sure the mouthpiece cover is covering the mouthpiece, which prevents accidental activation of the inhaler. The inhaler can be used without removing it from the protective packaging. Use as described above, 1. Shaking, 2. Clicking, 3. Inhalation. Remember to:

Replacing the Easyhaler inhaler with a new one The inhaler has a dose counter that shows the number of doses left. The counter turns every five activations. When the dose counter turns red, it means there are 20 doses left. If the patient does not have a new Easyhaler inhaler, they should contact their doctor to obtain a new prescription. When the counter shows 0, the Easyhaler inhaler should be replaced. If the patient is using the protective packaging, they should keep it and place the new inhaler in it.

To remember

• 1. Shaking, 2. Clicking, 3. Inhalation.
• After administering the dose, the patient should rinse their mouth with water and spit it out.
• The inhaler should not be allowed to get damp, and it should be protected from moisture.

If the patient has any further questions about using this medicine, they should consult their doctor or pharmacist.