BUFOMIX 80 mcg + 4.5 mcg Powder

Contents of the leaflet

1. What is Bufomix Easyhaler 80 + 4.5 and what is it used for
   1. Easyhaler 80 + 4.5 and a separate reliever inhaler.
2. Important information before using Bufomix Easyhaler 80 + 4.5
   1. When not to use Bufomix Easyhaler 80 + 4.5:
   2. Warnings and precautions
   3. Bufomix Easyhaler and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
3. How to use Bufomix Easyhaler 80 + 4.5
   1. Important information about asthma symptoms
   2. ASTHMA
   3. A) Using Bufomix with a separate reliever inhaler
   4. Adults (over 18 years old)
   5. Adolescents (12-17 years old)
   6. Children (6-11 years old)
   7. A separate reliever inhaler should be used when asthma symptoms occur.
   8. B) Using Bufomix Easyhaler as the only inhaler for asthma
   9. Bufomix Easyhaler 80 + 4.5 should also be used as a reliever inhaler
   10. Using a higher dose of Bufomix Easyhaler than recommended
   11. Missing a dose of Bufomix Easyhaler
   12. Instructions for using the Easyhaler inhaler are at the end of the leaflet.
4. Possible side effects
   1. If the patient experiences any of the following side effects, they should stop using Bufomix Easyhaler and consult their doctor immediately:
   2. Bufomix Easyhaler and consult their doctor immediately:
   3. Bufomix Easyhaler and use a reliever inhaler.The patient should consult their doctor immediately, as a change in medication may be necessary.
   4. Other possible side effects:
   5. Common (may occur in less than 1 in 10 people)
   6. Uncommon (may occur in less than 1 in 100 people)
   7. Rare (may occur in less than 1 in 1,000 people)
   8. Very rare (may occur in less than 1 in 10,000 people)
   9. Reporting side effects
5. How to store Bufomix Easyhaler 80 + 4.5
6. Contents of the packaging and other information
   1. What Bufomix Easyhaler 80 + 4.5 contains
   2. What Bufomix Easyhaler 80 + 4.5 looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:
   6. How to use the Easyhaler inhaler
   7. Information about the Easyhaler inhaler
   8. Using the Easyhaler inhaler for the first time
   9. HOW TO USE THE EASYHALER INHALER
   10. Cleaning the Easyhaler inhaler
   11. To remember
   12. If the patient has any further questions about using this medicine, they should consult their doctor or pharmacist.

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

Bufomix Easyhaler is an inhaler used to treat asthma in adults, adolescents, and children aged 6 and above. 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 receptor 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 in two different ways.
a) Some patients are prescribed two medicines in inhalers for asthma: Bufomix

Easyhaler 80 + 4.5 and a separate reliever inhaler.

• Bufomix Easyhaler is used daily. Its use helps prevent the occurrence of asthma symptoms.
• The reliever inhaler is used when asthma symptoms occur to make breathing easier.

b) Some patients are prescribed Bufomix Easyhaler 80 + 4.5 as the only inhaler
for asthma.

• Bufomix Easyhaler is used daily. Its use helps prevent the occurrence of asthma symptoms.
• Bufomix Easyhaler is also used when additional doses are needed to relieve asthma symptoms and make breathing easier. These patients do not need a separate reliever inhaler.

2. Important information before using Bufomix Easyhaler 80 + 4.5

When not to use Bufomix Easyhaler 80 + 4.5:

Warnings and precautions

Before starting to use Bufomix Easyhaler, you should discuss it with your doctor or pharmacist, especially if you have:

• diabetes,
• lung infection,
• high blood pressure or heart problems (including irregular heartbeat, very fast pulse, narrowed arteries, or heart failure),
• thyroid or adrenal 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 to prevent fungal infection of the mouth.

Bufomix Easyhaler and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
Some medicines may enhance the effect of Bufomix Easyhaler, and your doctor may want to monitor your condition closely when taking such medicines (including certain HIV medicines: ritonavir, cobicistat).
You should inform your doctor or pharmacist especially if you are 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 to treat heart failure;
• diuretics, also known as water pills (e.g., furosemide), used to treat high blood pressure;
• oral steroids (e.g., prednisolone);
• xanthine derivatives (e.g., theophylline or aminophylline), often used to treat 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 to treat Parkinson's disease (e.g., levodopa);
• medicines used to treat thyroid disorders (e.g., levothyroxine).

If the patient has any of the above 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 child, 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 while taking Bufomix Easyhaler, they should not stop taking it and should consult their doctor immediately.

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 diagnosed with intolerance to certain sugars, they should consult their doctor before using this medicine.
The amount of lactose in the medicine usually does not cause problems for 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 as directed by the doctor. If in doubt, the patient should consult their doctor or pharmacist.
• It is essential to take Bufomix Easyhaler daily, even if the patient does not experience asthma symptoms at the time.
• The doctor should regularly monitor the patient's asthma symptoms.

If the patient has been taking oral steroids for asthma, 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.
During the reduction of oral steroid tablets, the patient may experience general malaise despite the improvement of chest symptoms.
Such symptoms may include nasal congestion or runny nose, weakness, or joint or muscle pain, and rash (eczema).
If any of these symptoms concern 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 in doubt about continuing treatment with Bufomix Easyhaler, the patient should consult their doctor.

Important information about asthma symptoms

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

• breathing problems worsen or the patient wakes up frequently at night due to asthma symptoms;
• the patient experiences chest tightness in the morning or the tightness lasts longer than usual.
  Such symptoms may indicate that the asthma is not well-controlled, and a change in therapy or the introduction of additional medication may be necessary.

ASTHMA

Bufomix Easyhaler 80 + 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 with a separate reliever inhaler

Bufomix Easyhaler should be used daily.This will help prevent the occurrence of asthma symptoms.

Adults (over 18 years old)

• 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 (12-17 years old)

• 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.

Children (6-11 years old)

• The typical dose is 2 inhalations, twice a day.

Bufomix Easyhaler 80 + 4.5 is not recommended for children under 6 years old.
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 kept at hand in case of an asthma attack.
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 over 12 years old.
Bufomix Easyhaler 80 + 4.5 should be used daily.This will help prevent the occurrence of 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

Bufomix Easyhaler 80 + 4.5 should also be used as a reliever inhaler

for asthma symptoms, if they occur.

• 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 kept at hand, so that it can be used if needed.
Usually, a daily dose greater than 8 inhalations is not necessary.
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 in medication may be necessary.
The patient should not use more than 12 inhalations in 24 hours.
If asthma symptoms occur during physical exertion, Bufomix Easyhaler should be used as described in this leaflet.
However, Bufomix Easyhaler should not be used to prevent asthma symptoms.

Using a higher dose of Bufomix Easyhaler than recommended

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

Missing a dose of Bufomix Easyhaler

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

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

Instructions for using the Easyhaler 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, especially around the mouth (tongue and/or throat) or hives, with difficulty breathing (angioedema) and/or fainting.
  This may indicate that the patient has had an allergic reaction.
  This occurs 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 the patient experiences any of these symptoms, they should stop using the inhaler immediately

Bufomix Easyhaler and use a reliever inhaler.
The patient should consult their doctor immediately, as a change in medication may be necessary.

This occurs very rarely and may occur less often than in 1 in 10,000 people.

Other possible side effects:

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

• palpitations (feeling of a strong heartbeat), tremors.
  If these occur, they are usually mild and usually disappear with continued 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)

• anxiety, nervousness, or restlessness;
• 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;
• behavioral changes, especially in children;
• chest pain or tightness (angina pectoris);
• 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, especially if the patient is undergoing 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);
• slowed growth rate 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 this 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,
Jerozolimskie Avenue 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, you can help provide more information on the safety of this medicine.

5. How to store Bufomix Easyhaler 80 + 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 laminated 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 becomes damp, it should be replaced with a new one.
• The Bufomix Easyhaler inhaler should be replaced after 4 months of opening the laminated 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 80 + 4.5 contains

• The active substances are budesonide and formoterol fumarate dihydrate.
  Each dose delivered via the inhaler contains 80 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
• The other ingredient is lactose monohydrate (which contains milk proteins).

What Bufomix Easyhaler 80 + 4.5 looks like and contents of the pack

Bufomix Easyhaler 80 + 4.5 is an inhaler containing the medicine.
The inhalation powder is white to yellowish.
Each inhaler contains 60 or 120 doses and has a white body with a red upper part.
Bufomix Easyhaler 80 + 4.5 is available in:

• 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.
[email protected]
Detailed and up-to-date information about the use of this medicine is available by scanning the QR code below (also found on the outer packaging and the inhaler label) using a smartphone.
Such 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 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 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 how to use the inhaler correctly.
If in doubt, the patient 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.

Using the Easyhaler inhaler for the first time

The Easyhaler inhaler is supplied in a laminated pouch. Do not open the pouch until you are ready to start using the medicine, as it helps keep the powder in the inhaler dry. If you are ready to start treatment, open the pouch and record the opening date, e.g., in a calendar. The inhaler can be used for 4 months after removal from the laminated pouch.

HOW TO USE THE EASYHALER INHALER

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

SHAKE 3-5 TIMES

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

Step 2: CLICKING Hold the inhaler upright, gripping it with your index finger and thumb. Press the inhaler until you hear a click, then release the pressure until you hear another click. This will release a dose of the medicine. You can only click once.

CLICK ONCE

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

Step 3: INHALATION Hold the inhaler upright. Breathe normally. Place the mouthpiece in your mouth between your teeth and close your lips tightly around the mouthpiece. 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, allowing the medicine to be delivered correctly to the lungs. Make sure your lips are sealed tightly around the mouthpiece. Do not exhale into the inhaler. This is important: it may block the inhaler. If you exhale into the inhaler, you should remove the powder from the mouthpiece, see below.

How to remove powder from the mouthpiece In case of accidental clicking of the inhaler or multiple clicking, or exhaling into the inhaler, the powder should be removed from the mouthpiece: Tap the mouthpiece on 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 its protective packaging The inhaler can be used in its protective packaging, which helps to prolong the life of the product. Before placing the inhaler in the protective packaging, ensure the mouthpiece cover is in place, 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, which 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 dose counter shows 0, the Easyhaler inhaler should be replaced.

To remember

• 1. Shaking, 2. Clicking, 3. Inhalation.
• After using the dose, rinse your mouth with water and spit it out.
• Do not let the inhaler get damp, and protect it from moisture.

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