Patient leaflet - Easyhaler Budesonide 200 micrograms/dose inhalation powder
1. WHAT EASYHALER® BUDESONIDE IS AND WHAT IT IS USED FOR
The active ingredient in Easyhaler® Budesonide is budesonide. Budesonide powder is packed in an inhaler. You inhale the powder into your lungs through the mouthpiece of the inhaler. Budesonide works by reducing and preventing swelling and inflammation in your lungs. Easyhaler® Budesonide is a medicine called “preventer”. It is used to prevent symptoms of asthma. It belongs to a group of medicines called corticosteroids.
Budesonide will NOT stop an asthma attack that has already started. Therefore you always need to have a fast acting bronchodilating “reliever” (a beta2-agonist) with you.
The effect of budesonide may be noticeable after a few days treatments but will only reach its maximum after a few weeks. You should use Easyhaler® Budesonide regularly to prevent the asthmatic inflammation. Go on taking this medicine regularly according to instructions, even if you don’t have any symptoms.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE EASYHALER® BUDESONIDE
Do not use Easyhaler® Budesonide, if you are allergic:
- to budesonide
- to the other ingredient of this medicine (listed in section 6) which is lactose (which contains small amounts of milk protein). Contact your doctor so that your medicine can be changed to another.
Warnings and Precautions
Tell your doctor before you use Easyhaler® Budesonide, if you have:
- pulmonary tuberculosis
- any untreated bacteria, virus or fungal infections in your mouth, airways or lungs
- severe liver disease.
Contact your doctor if you experience blurred vision or other visual disturbances.
Rinse your mouth after inhaling your dose in order to avoid fungal infection in the mouth.
Easyhaler® Budesonide is not recommended to be used in children who are younger than 6 years.
Other medicines and Easyhaler® Budesonide
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription.
Some medicines may increase the effects of Easyhaler® Budesonide and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat). Tell your doctor, if you are using:
- nasal medicines containing corticosteroids
- corticosteroid tablets
- itraconazol or ketoconazol containing antifungal medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. It is important for both foetus and mother to maintain an adequate asthma treatment during pregnancy. As with other drugs administered during pregnancy, the benefit of the administration of budesonide for the mother should be weighed against the risks to the foetus. The lowest effective dose of budesonide needed to maintain adequate asthma control should be used.
Driving and using machines
Easyhaler® Budesonide is not known to affect your ability to drive or operate machinery.
Easyhaler® Budesonide inhalation powder contains a small amount of lactose, which probably does not cause problems even if you have lactose intolerance. If you have been told by your doctor that you have intolerance to some sugars, talk to your doctor before using this medicine. Lactose contains small amounts of milk proteins, which may cause allergic reaction.
3. HOW TO USE EASYHALER® BUDESONIDE
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacies if you are not sure.
Your doctor has prescribed a suitable strength and dose for you. Follow your doctor’s instructions carefully.
Replacing corticosteroid tablets with Easyhaler® Budesonide: Tell your doctor, if you use corticosteroid tablets (e.g. cortisone tablets) to treat your asthma.
Your doctor may ask you to gradually reduce the number of tablets and finally stop the treatment within a few weeks. If you feel unwell during this transfer period, contact your doctor, but do not stop using Easyhaler® Budesonide.
Use in adults (including the elderly) and adolescents (12 to 17 years):
- 1–2 doses inhaled in the mornings and in the evenings or once a day in the evenings.
Use in children 6 to 11 years:
- 1–2 doses inhaled in the mornings and in the evenings or once a day in the evenings.
While the treatment continues your doctor may from time to time adjust the dose to find the lowest dose needed to control your asthma (the maintenance dose).
If Easyhaler® Budesonide is to be used by your child, make sure that he/she can use it correctly.
In addition to the preventer, Easyhaler® Budesonide, you also need a bronchodilating reliever:
Budesonide will NOT stop an asthma attack that has already started. Therefore you always need to have a fast acting bronchodilating reliever (a beta2-agonist) with you in case of acute symptoms of asthma. If you regularly use a reliever inhaler (beta2-agonist), you should inhale it before Easyhaler® Budesonide (preventer).
| 1.Shake | 2.Click | 3.Inhale |
Worsening of the asthma symptoms during the treatment:
Contact your doctor as soon as possible, if:
- your wheezing or chest tightness gets worse during the treatment
- you need to use your reliever inhaler more often than before
- your reliever inhaler doesn’t help as well as before Your asthma may be getting worse and you may need an extra treatment.
If you use more Easyhaler® Budesonide than you should
If you have taken a larger dose or more doses than you were told to, tell your doctor as soon as possible. You should continue to use Easyhaler® Budesonide unless your doctor tells you otherwise. It is important that you take your dose as stated on the pharmacist’s label or as advised by your doctor. You should not increase or decrease your dose without seeking medical advice.
If you forget to use Easyhaler® Budesonide
If you have missed a dose, take one as soon as possible, or you can just take the next dose when it is due. It is best to take your medicine at the same time each day.
Do not take a double dose to make up for a forgotten dose.
If you stop using Easyhaler® Budesonide
Do not stop using Easyhaler® Budesonide without consulting your doctor. If you stop using this medicine abruptly, it may make your asthma worse. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
The instructions on how to use the inhaler are at the end of the leaflet.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can also cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):
Irritation in throat, swallowing difficulties, cough and fungal infection (thrush) in mouth or throat. If you get any of these side effects, do not stop taking Easyhaler® Budesonide. Talk to your doctor. You can help to prevent the above mentioned side effects by rinsing your mouth and throat with water after every time you haven taken a dose. Do not swallow the rinsing water, spit it out.
Uncommon (may affect up to 1 in 100 people):
Anxiety, depression, cataract, blurred vision, muscle spasm and tremor.
Rare (may affect up to 1 in 1,000 people):
Too much or too little cortisol in blood. Underactive adrenal gland (gland next to kidneys). Skin rash, itching, bruising, hoarseness, restlessness and nervousness. Growth retardation in children. Behavioural changes especially in children.
Rare serious allergic reaction:
If itching, rash, reddened skin, swelling of the eye lids, lips, face or throat, wheezing, low blood pressure or collapse appear shortly after taking a dose, act in the following way:
- stop taking Easyhaler® Budesonide
- seek medical advice immediately.
Shortness of breath immediately after dosing:
Rarely, inhaled drugs can cause an increase in wheezing and shortness of breath (bronchospasm) immediately
after dosing. If this occurs:
- stop taking Easyhaler® Budesonide
- take fast acting bronchodilating reliever
- seek medical advice immediately.
Very rare (may affect up to 1 in 10,000 people):
Glaucoma. Decrease in bone mineral density (weakening of the bones).
Not known (frequency cannot be estimated from the available data):
Sleeping problems, aggressiveness, increased motor activity (difficulty to stay still) and irritable. These effects are more likely to occur in children. If you think you might have any of these rare side effects, or if you are worried about the possibility of them, talk to your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE EASYHALER® BUDESONIDE
- Keep out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
- Before the first use: store in unopened foil bag.
- After opening the foil bag, do not store above 30°C and protect from moisture. It is recommended to keep the Easyhaler® in its protective cover.
- Replace Easyhaler® Budesonide with a new at the latest 6 months after you opened the foil bag. Write down the date you opened the bag to help you remember.
- If your Easyhaler® Budesonide gets damp, you need to replace it with a new one.
- If your device shows any signs of deterioration or fails to work properly, consult pharmacist who will advise you what to do
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Easyhaler® Budesonide contains
The active substance is budesonide
Each metered dose contains budesonide 200 micrograms The other ingredient is lactose monohydrate (which contains milk protein)
What Easyhaler® Budesonide looks like and contents of the pack
White or almost white powder.
Easyhaler® Budesonide 200 micrograms/dose inhalation powder
- 200 doses + protective cover.
Manufactured by Orion Corporation, Orion Pharma, Orionintie 1, FI-02200 Espoo, Finland.
Procured from within the EU and repackaged by the Product Licence Holder Beachcourse Ltd., Unit 2-3, Townsend Industrial Estate, Waxlow Road, London, NW10 7NU.
Revision date: 02.07.2026
PL 16378/1349 POM
Easyhaler® is a registered trademark of Orion Corporation.
Blind or partially sighted?
Is this leaflet hard to see or read? Phone Beachcourse,
Tel: 020 8896 9054 for help. Ref. number: 1349/V1
Detailed and updated information on how to use this product is available by scanning this QR code (included also on outer carton and inhaler label) with a smartphone. The same information is also available on the following URL: www.oeh.fi/bugb
HOW TO USE THE EASYHALER® INHALER
About your Easyhaler®
Easyhaler® Budesonide may be different to inhalers you have used in the past. Therefore it is very important that you use it properly as using incorrectly can lead to you not receiving the right amount of medicine. This could make you very unwell or could lead to your asthma not being treated as it should.
Your doctor, nurse or pharmacist will show you how to use your inhaler properly. Make sure you understand the correct way to use the inhaler. If you are unsure contact your doctor, nurse or pharmacist. As with all inhalers, caregivers should ensure that children prescribed Easyhaler® Budesonide use correct inhalation technique, as described below. You can also use the instruction video at www.oeh.fi/bugb.
When you first get your Easyhaler®
The Easyhaler® comes in a foil bag. Do not
open the foil bag until you are
ready to start using the medicine
as it helps to keep the powder
dry in the inhaler.
When you are ready to start
treatment open the bag and
record the date e.g., in your
calendar.
Use the inhaler within 6
months of removing
from the foil bag.
HOW TO USE CORRECTLY
Step 1: SHAKE
| SHAKE x 3-5 | Important points to remember
|
Step 2: CLICK
| CLICK x 1 | Important points to remember
|
Step 3: INHALE
| INHALE | Important points to remember
|
If you need to take another inhalation, please repeat the steps 1-3 Shake-Click-Inhale.
After you have used the inhaler:
- Put the dust cap back on the mouthpiece. It stops the inhaler going off by accident.
- After you have taken the dose, rinse your mouth with water, and spit it out.
This may help to stop you getting thrush and becoming hoarse.
How to empty the powder from the mouthpiece
If you click the inhaler by accident, or if you might have clicked it more than once, or if you breathe out into it, empty the mouthpiece.
- Tap the mouthpiece to empty the powder onto a table top, or the palm of your hand.
Then start again with steps Shake-
Click-Inhale.
Cleaning the Easyhaler®
Keep your inhaler dry and clean. If necessary you may wipe the mouthpiece of your inhaler with a dry cloth or tissue. Do not use water: the powder in the Easyhaler® is sensitive to moisture.
Using the Easyhaler® with a protective cover
You may use a protective cover with your Easyhaler. This may help to improve durability of the product. When you first insert your inhaler in the protective cover make sure the dustcap is on the inhaler as this stops it going off by accident. You can use the inhaler without removing it from the protective cover.
Follow the same instructions as above, 1. Shake – 2. Click – 3.
Inhale.
Remember to:
- Keep the inhaler in the upright position when clicking it
- Replace the dustcap after taking the dose as this stops the inhaler going off by accident.
Dustcap Mouthpiece Inhaler