Budesonide easyhaler

Poland
Brand name Budesonide easyhaler
Form powder for inhalation
Active substance / Dosage
budesonide · 100 mcg
Prescription type Prescription only
ATC code
R03BA02
Registration number 100145089
Manufacturer Orion Corporation Orion Pharma
Budesonide easyhaler powder for inhalation

Table of Contents

Three steps of using the inhaler: 1. shaking the device, 2. pressing once, 3. inhaling with the inhaler placed in the mouth

QR code for the website www.oeh.fi/bupl
To obtain 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
powder for inhalation
Budesonidum
Please read this leaflet carefully before using this 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, ask your doctor, pharmacist, or nurse.
  • 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 reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

  1. What Budesonide Easyhaler is and what it is used for
  2. What you should know before using Budesonide Easyhaler
  3. How to use Budesonide Easyhaler
  4. Possible side effects
  5. How to store Budesonide Easyhaler
  6. Contents of the pack 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 not occur until several days of treatment, and maximum effect may take several weeks. Budesonide Easyhaler should be used regularly to prevent the inflammation associated with asthma. This medicine should be taken regularly as directed, even if you are not experiencing any 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, please contact the treating physician, who will change the medicine to another one.
Warnings and precautions
Inform your 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 the lungs,
  • severe liver disease.

If the patient experiences blurred vision or other visual disturbances, contact a doctor.
After inhalation, rinse the mouth thoroughly to prevent fungal infection of the mouth.
Budesonide Easyhaler is not recommended for use in children under 6 years of age.
Budesonide Easyhaler and other medicines
Tell your 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 obtained without a prescription.
Some medicines may increase the effect of Budesonide Easyhaler, and the doctor may need to closely monitor the patient's condition when such medicines are used (including certain HIV medications: ritonavir, cobicistat).
Tell the doctor if the patient is using:

  • nasal medicines containing corticosteroids,
  • 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 mother and the unborn child that asthma is properly treated during pregnancy. As with other medicines used during pregnancy, the potential benefit 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 directed by your doctor. If you have any doubts, 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 tapering period 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 occasionally 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 reliever medicine for immediate relief:
Budesonide does not relieve an asthma attack once it has started. Therefore, you must always carry a fast-acting reliever bronchodilator (beta-agonist) to use in case of sudden asthma symptoms.
If you are using a reliever inhaler (beta-agonist) regularly, use it before inhaling Budesonide Easyhaler (the preventive medicine).

Worsening 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.

Taking more than the recommended dose of Budesonide Easyhaler
If you take 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 increase or decrease the dose on your own without consulting your doctor.

If you miss a dose of Budesonide Easyhaler
If you forget to take a dose, take it as soon as you remember, or take the next dose according to your regular 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 using this medicine, consult your doctor, pharmacist, or nurse.
Instructions for using the inhaler are provided at the end of this leaflet.

4. Possible side effects

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

Common (may affect up to 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.
Do not swallow the water after rinsing; spit it out.

Uncommon (may affect up to 1 in 100 people):
Anxiety, depression, cataract, blurred vision, muscle spasms, and tremor.

Rare (may affect up to 1 in 1,000 people):
Abnormally high or low cortisol levels 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 shortly after taking a dose of the medicine, you should:

  • stop using Budesonide Easyhaler immediately
  • contact your doctor immediately.

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

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

Very rare (may affect up to 1 in 10,000 people):
Glaucoma. Decreased bone mineral density (weakening of bones).

Not known (frequency cannot be estimated from 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, talk to your doctor.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can also 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. 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the responsible entity.

Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Budesonide Easyhaler

Keep this medicine out of the sight and reach of children.
Before first use: store in the sealed foil bag.
After opening the foil bag: 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 bag.
To help you remember the date when the foil bag was opened, write the date down here: __________
If the Budesonide Easyhaler becomes 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 must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 of the medicine 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 about this medicine, contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland sp. z o.o.
[email protected]
This medicine is authorised for sale in the European Economic Area 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 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 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. 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 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
First-time use of the Easyhaler inhaler

The Easyhaler inhaler is supplied in a foil pouch.
Do not open the pouch until starting treatment,
as it helps keep the dry powder in the inhaler dry.
When the patient is ready to start treatment, the pouch 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.		Diagram of the inhaler with labels indicating the black mouthpiece cover, white mouthpiece, and the upper part of the device in black and white

HOW TO USE THE INHALER CORRECTLY

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

SHAKE 3 TO 5 TIMES
Hand holding a black-and-white inhaler with a vertical arrow 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: ACTUATING
  • 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.
  • Only actuate once.

ACTUATE ONCE
Hand holding a white inhaler with a black tip, positioned upward under an arrow indicating thumb pressure movement on the device
Important information to remember
  • The inhaler will not actuate if the mouthpiece cover has not been removed.
  • Only actuate once.
  • If actuated more than once, remove the powder from the mouthpiece—see instructions below.
  • To release the medication dose, press the inhaler before inhaling, but not during inhalation.
  • Keep the inhaler in an upright position while actuating and inhaling the dose to prevent powder from spilling out of the inhalation channel before inhalation.

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

INHALATION
Side view of a person's face holding the inhaler to the mouth, with white arrows indicating the direction of medication release into the oral cavity and throat
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: doing so may block the inhaler. If you accidentally exhale into the inhaler, remove the powder from the mouthpiece—see instructions below.

If an additional inhalation is necessary, 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, rinse the mouth with water and spit the water out. This will reduce the risk of developing fungal infection (thrush) and hoarseness.
How to remove powder from the mouthpiece
If the inhaler is accidentally activated or activated 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.

Hand holding a white-gray inhaler pointed downward over a flat surface, releasing a fine powder or aerosol

Cleaning the Easyhaler inhaler
Keep the inhaler dry and clean. If necessary, the mouthpiece 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 a protective case
The Easyhaler inhaler can be used with a protective case, which may help extend the medicine's shelf life. Before placing the inhaler into the protective case, ensure that the mouthpiece cover is closed 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. 1. Shaking, 2. Clicking, 3. Inhalation.

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


Right hand holding a white medical device, gripping it from above with fingers and from below with the thumb to ensure correct preparation for use
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 dose counter shows 0, the Easyhaler inhaler must be replaced.
If the patient uses a protective case, they should keep it and place the new inhaler inside it.		White inhaler with a black upper part and an enlarged circle showing the dose counter with visible numbers 10, 20, and 30

To remember

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

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