Budesonide easyhaler

Poland
Brand name Budesonide easyhaler
Form powder for inhalation
Active substance / Dosage
budesonide · 200 mcg
Prescription type Prescription only
ATC code
R03BA02
Registration number 100145072
Manufacturer Orion Corporation Orion Pharma
Budesonide easyhaler powder for inhalation

Table of Contents

Three diagrams showing inhaler use: 1. shaking with hand, 2. pressing the device once, 3. inhaling the medication into the mouth during inspiration

QR code for the website www.oeh.fi/bupl
For instructions on how to use the Easyhaler inhaler, please refer to the information
at the end of this leaflet or scan this QR code. The same information is also available at the
website: www.oeh.fi/bupl
Package leaflet: Information for the patient
Budesonide Easyhaler, 100 micrograms/dose
Budesonide Easyhaler, 200 micrograms/dose
Budesonide Easyhaler, 400 micrograms/dose
inhalation powder
Budesonidum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

  • Keep this leaflet for future reference.
  • If you have any questions, consult your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
  • If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

  1. What Budesonide Easyhaler is and what it is used for
  2. Important information before using Budesonide Easyhaler
  3. How to use Budesonide Easyhaler
  4. Possible side effects
  5. How to store Budesonide Easyhaler
  6. Contents of the package and other information

1. What Budesonide Easyhaler is and what it is used for

The active substance in Budesonide Easyhaler is budesonide. Budesonide in powder form is contained
in an inhaler called Easyhaler. The powder is inhaled through the mouthpiece into the lungs. Budesonide
works by reducing and preventing inflammation and swelling in the lungs.
Budesonide Easyhaler belongs to a group of medicines used preventively. It is used to prevent asthma symptoms. It belongs to a group of medicines called corticosteroids.
Budesonide does not relieve an asthma attack that has already started. Therefore, you should always have with you a fast-acting "rescue" bronchodilator (beta-agonist).
Noticeable effects of budesonide may take several days to appear, and maximum effect may take several weeks. Budesonide Easyhaler should be used regularly to prevent inflammation associated with asthma. This medicine must be taken regularly as directed, even if the patient has no symptoms.

2. Important information before using Budesonide Easyhaler

When not to use Budesonide Easyhaler
If the patient is allergic to:

  • budesonide
  • any of the other ingredients of this medicine (listed in section 6), which is lactose (containing small amounts of milk protein).

In such a case, contact the treating physician, who will change the medicine to another one.
Warnings and precautions
Inform the doctor before using Budesonide Easyhaler if the patient has been diagnosed with:

  • pulmonary tuberculosis,
  • any untreated bacterial, viral or fungal infections of the mouth or respiratory tract, including lungs,
  • severe liver disease.

If the patient experiences blurred vision or other disturbances of vision, contact a doctor.
After inhalation, rinse the mouth thoroughly to prevent fungal infection of the oral cavity.
Budesonide Easyhaler is not recommended for use in children under 6 years of age.
Budesonide Easyhaler and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Some medicines may increase the effect of Budesonide Easyhaler, and the doctor may wish to monitor the patient closely when such medicines are used (including certain HIV medications: ritonavir, cobicistat).
Tell the doctor if the patient is using:

  • nasal corticosteroid medicines,
  • oral corticosteroid tablets,
  • antifungal medicines containing itraconazole or ketoconazole.

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 before using this medicine. It is important for both the unborn child and the mother that asthma is properly managed during pregnancy. As with other medicines used during pregnancy, the benefits of using budesonide for the mother should be weighed against any potential risk to the fetus. The lowest effective dose of budesonide should be used to maintain adequate asthma control.
Driving and operating machinery
Budesonide Easyhaler has not been shown to affect the ability to drive or operate machinery.
Budesonide Easyhaler inhalation powder contains a small amount of lactose, which is unlikely to cause problems even if the patient has lactose intolerance. However, if the patient has been diagnosed with intolerance to certain sugars, the patient should consult a doctor before using this medicine.
Lactose contains small amounts of milk protein, which may cause an allergic reaction.

3. How to use Budesonide Easyhaler

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Your doctor has prescribed the appropriate strength and dose of this medicine for you. Always follow your
doctor's instructions precisely.
Switching from oral corticosteroids to Budesonide Easyhaler:
Inform your doctor if you have been taking oral corticosteroids (e.g. oral cortisone) for asthma treatment. Your doctor may recommend gradually reducing the number of tablets, eventually stopping them completely over several weeks. If during this period of gradual withdrawal you feel unwell, contact your doctor, but do not stop using Budesonide Easyhaler.
Use in adults (including elderly patients) and adolescents (aged 12 to 17 years):

  • 1 - 2 doses inhaled in the morning and evening, or once daily in the evening.

Use in children aged 6 to 11 years:

  • 1 - 2 doses inhaled in the morning and evening, or once daily in the evening.

During treatment, your doctor may from time to time adjust the dose to determine the lowest effective dose needed to control your asthma (maintenance dose).
If Budesonide Easyhaler is to be used by a child, ensure that the child is able to use the medicine correctly.
In addition to the preventive medicine Budesonide Easyhaler, you also need a fast-acting reliever medicine:
Budesonide does NOT relieve an asthma attack that has already started. Therefore, you must always carry a fast-acting reliever bronchodilator (beta-agonist) to use in case of sudden asthma symptoms.
If you regularly use a reliever inhaler (beta-agonist), use it before taking Budesonide Easyhaler (the preventive medicine).
Worsening of asthma symptoms during treatment:
Contact your doctor immediately if:

  • wheezing or chest tightness worsens during treatment
  • you need to use your reliever medicine more often than before
  • your reliever medicine becomes less effective than before. This may indicate worsening asthma and the need for additional treatment.

Use of a higher than recommended dose of Budesonide Easyhaler
If you use more doses or a higher dose than recommended, inform your doctor as soon as possible. Unless your doctor advises otherwise, continue using Budesonide Easyhaler as prescribed.
It is important to take the medicine exactly as instructed in this leaflet or as directed by your doctor. Do not change the dose on your own without consulting your doctor.
Missing a dose of Budesonide Easyhaler
If you miss a dose, take it as soon as possible, or take the next dose according to your regular dosing schedule. It is best to take the medicine at the same time each day.
Do not take a double dose to make up for a missed dose.
Stopping Budesonide Easyhaler
Do not stop using Budesonide Easyhaler without consulting your doctor. If you suddenly stop using this medicine, your asthma symptoms may worsen.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.
Instructions for using the inhaler are located at the end of this leaflet.

4. Possible side effects

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

Common (may occur in less than 1 in 10 people):
Throat irritation, difficulty in swallowing, cough, and fungal infections (thrush) in the mouth or throat.
If any of these side effects occur, do not stop using Budesonide Easyhaler. Consult your doctor.
You can reduce the risk of these side effects by rinsing your mouth and throat with water after each dose of the medicine. Do not swallow the water after rinsing; spit it out.

Uncommon (may occur in less than 1 in 100 people):
Anxiety, depression, cataract, blurred vision, muscle cramps, and tremor.

Rare (may occur in less than 1 in 1,000 people):
Abnormally high or low levels of cortisol in the blood. Adrenal suppression (reduced function of the glands located near the kidneys). Skin rash, itching, bruising, hoarseness, restlessness, and nervousness. Growth retardation in children. Behavioural changes, particularly in children.

Rarely occurring severe allergic reactions:
If itching, rash, redness of the skin, swelling of the eyelids, lips, face or throat, wheezing, low blood pressure or collapse occur soon after taking a dose of the medicine, you must:

  • stop using Budesonide Easyhaler
  • contact your doctor immediately.

Breathlessness immediately after taking the medicine:
Rarely, inhaled medicines may cause worsening of wheezing and breathlessness (bronchospasm) immediately after taking the medicine. In such a case, you must:

  • stop using Budesonide Easyhaler
  • use a fast-acting bronchodilator
  • contact your doctor immediately.

Very rare (may occur in less than 1 in 10,000 people):
Glaucoma. Decreased bone mineral density (weakening of bones).

Not known (frequency cannot be estimated from the available data):
Sleep problems, aggression, psychomotor hyperactivity (difficulty in staying still), and irritability. These side effects are more likely to occur in children.

If you think you have experienced any of these rare side effects, or are concerned that they may occur, you should speak with your doctor.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 responsible entity.

By reporting side effects, more information on the safety of this medicine can be collected.

5. How to store Budesonide Easyhaler

Keep the medicine out of the sight and reach of children.
Before first use: store in the sealed foil pouch.
After opening the foil pouch: store below 30 °C, protect from moisture. The Easyhaler inhaler may be kept in its protective case.
The Budesonide Easyhaler inhaler can be used for up to 6 months after opening the foil pouch.
To help remember the date of opening, write it down: __________
If the Budesonide Easyhaler medicine gets wet, it must be replaced with a new one.
Do not use this medicine after the expiry date stated on the label and carton following "EXP".
Medicines should 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 pack and other information

What Budesonide Easyhaler contains

  • The active substance is budesonide.
  • The other ingredient is lactose monohydrate (which contains milk proteins).

What Budesonide Easyhaler looks like and contents of the pack
White or almost white powder.
Budesonide Easyhaler powder inhaler, 100 micrograms/dose

  • 200 doses + protective case for the inhaler
  • 200 doses
  • 2 x 200 doses
  • 600 doses (3 x 200 doses)

Budesonide Easyhaler powder inhaler, 200 micrograms/dose

  • 120 doses
  • 200 doses + protective case for the inhaler
  • 200 doses
  • 2 x 200 doses
  • 600 doses (3 x 200 doses)

Budesonide Easyhaler powder inhaler, 400 micrograms/dose

  • 100 doses + protective case for the inhaler
  • 100 doses
  • 2 x 100 doses
  • 3 x 100 doses

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation, Orion Pharma
Orionintie 1
02200 Espoo
Finland
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland sp. z o.o.
[email protected]
This medicinal product is authorised for marketing in the following European Economic Area countries under the following names:
Finland, Hungary, Germany Budesonid Easyhaler
Spain Budesonida Easyhaler
Belgium, Poland Budesonide Easyhaler
Slovenia Budesonid Orion Easyhaler
Netherlands Budesonide Orion Easyhaler
United Kingdom Easyhaler Budesonide
Norway, Sweden, Denmark, Czech Republic, Slovakia, Estonia, Lithuania, Latvia, Malta Giona Easyhaler
Detailed and up-to-date information on the use of this medicinal product is available by scanning the QR code (located on both the outer packaging and the inhaler label) with a smartphone.
The same information is available on the website: www.oeh.fi/bupl
QR code for the website www.oeh.fi/bupl
How to use the Easyhaler inhaler
Information about the Easyhaler inhaler
The Budesonide Easyhaler inhaler may differ from inhalers previously used by the patient. It is therefore 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 how to use the inhaler properly. If in doubt, contact the doctor, nurse, or pharmacist. As with all inhalers, caregivers should ensure that children prescribed Budesonide Easyhaler use the correct inhalation technique as described below. An instructional video is also available at: www.oeh.fi/bupl
Using the Easyhaler inhaler for the first time

The Easyhaler inhaler is supplied in a foil pouch.
Do not open the pouch until starting to use the medicine,
as it helps keep the dry powder in the inhaler dry.
When the patient is ready to start treatment, the package should be opened
and the date of opening recorded, for example in a calendar.
The inhaler can be used for 6 months after removal from the foil pouch.		An inhaler with a white body, white mouthpiece, and a black mouthpiece cap placed beside it on a white background, with labels indicating device parts

HOW TO USE THE INHALER CORRECTLY

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

SHAKE 3 TO 5 TIMES
A hand holding a white inhaler with a black tip, with gray arrows indicating upward and downward movement of the device
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 as instructed below.

Step 2: ACTUATION
  • Hold the inhaler upright, using 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 occur once.

ACTIVATE ONCE
A hand holding a black-and-white inhaler with the thumb pressing down on the upper part of the device, with a downward-pointing arrow above it
Important information to remember
  • The inhaler will not actuate if the mouthpiece cover has not been removed.
  • Only one actuation is possible.
  • If actuated more than once, remove powder from the mouthpiece, see below.
  • To release the medication dose, press before inhaling, but not at the same time.
  • Keep the inhaler upright during actuation and inhalation to prevent powder from spilling out of the inhalation channel before inhalation.

Step 3: INHALATION
  • Hold the inhaler upright.
  • Breathe normally.
  • Place the mouthpiece in the mouth between the teeth and seal lips tightly around it.
  • Take a slow, deep breath in.
  • Remove the inhaler from the mouth, hold breath for at least 5 seconds, then breathe normally.

INHALATION
A side view of a person's face holding the inhaler to the mouth, with white arrows showing the direction of medication release into the oral cavity
Important information to remember
  • Ensure the entire mouthpiece is inside the mouth to allow proper delivery of medication to the lungs.
  • Ensure lips are tightly sealed around the mouthpiece.
  • Do not exhale into the inhaler. This is important: it may cause blockage of the inhaler. If you do exhale into the inhaler, remove powder from the mouthpiece as described below.

If an additional inhalation is required, repeat the steps described in points 1–3
"Shake, Click, Inhale."
After using the inhaler:

  • Replace the mouthpiece cover to prevent accidental activation of the inhaler.
  • After administration of the dose, rinse the mouth with water and spit out the water. This will reduce the risk of developing fungal infection (thrush) and hoarseness.
How to remove powder from the mouthpiece
If the inhaler is accidentally actuated, or actuated multiple times, or if you have exhaled into the inhaler, remove the powder from the mouthpiece:
  • Tap the mouthpiece against a table or your hand to remove the powder.
  • Then restart the "Shake-Click-Inhale" steps.

A hand holding a white-gray inhaler pointed downward over a flat surface, releasing a fine medication mist

Cleaning the Easyhaler inhaler
Keep the inhaler 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 case
The Easyhaler inhaler can be used within the protective case, which may help increase the medicine's shelf life. Before placing the inhaler into the protective case, ensure that the cap covers the mouthpiece to prevent accidental actuation of the inhaler. The inhaler can be used without removing it from the protective case. Use according to the instructions above:
  1. 1. Shaking, 2. Clicking, 3. Inhalation.
    Remember to:

  • Keep the inhaler upright during clicking and inhalation.
  • Replace the cap on the mouthpiece after taking a dose to prevent accidental actuation of the inhaler.


A hand holding a white medical device with a transparent cover, positioned at an angle, ready for medication administration or procedure
Switching to a new Easyhaler inhaler
The inhaler is equipped with a dose counter indicating the number of doses remaining. The counter rotates with 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 should be replaced.
If the patient uses a protective case, it should be kept and used to store the new inhaler.		A white inhaler with a black upper part and a close-up showing the numbers 10, 20, and 30 on the dose counter indicating remaining medication quantity

To remember

  • 1. Shake, 2. Click, 3. Inhale.
  • After administering 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.