Easyhaler Budesonide 200 mcg Micrograms Per Actuation Instructions
- June 3, 2024
- Easyhaler
Table of Contents
Easyhaler Budesonide 200 mcg Micrograms Per Actuation
HOW TO USE
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See the end of this leaflet, scan this code or visit
www.oeh.fi/bugb to see instructions on how to use
Easyhaler
Package leaflet: Information for the user
Easyhaler Budesonide 100 micrograms/dose Easyhaler Budesonide 200
micorgrams/dose Easyhaler Budesonide 400 micrograms/dose inhalation powder
budesonide
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet?
- What Easyhaler Budesonide is and what it is used for
- What you need to know before you use Easyhaler Budesonide
- How to use Easyhaler Budesonide
- Possible side effects
- How to store Easyhaler Budesonide
- Contents of the pack and other information
FAQs
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 a “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 bronchodilator “reliever” (a
beta2-agonist) with you.
The effect of budesonide may be noticeable after a few days treatment but will
only reach its maximum after a few weeks. You should use Easyhaler Budesonide
regularly to prevent asthmatic inflammation. Go on taking this medicine
regularly according to instructions, even if you don’t have any symptoms.
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.
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 are 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 are 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
bronchodilator 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).
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.
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 or brushing your teeth 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 spasms and tremors.
Rare (may affect up to 1 in 1,000 people):
Too much or too little cortisol in the 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 eyelids, 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 or 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,
www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information on the safety of this
medicine.
How to store Easyhaler Budesonide?
Keep this medicine out of the sight and reach of children.
Before the first use: store in unopened foil bag.
After opening the foil bag: store below 30°C protected 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.
Do not use this medicine after the expiry date which is stated on the label
and carton.
Do not throw away any medicines via household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help to protect
the environment.
Contents of the pack and other information
What Easyhaler Budesonide contains?
- The active substance is budesonide
- 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 100 microg/dose and 200 microg/dose inhalation powder
- 200 doses + protective cover
- 200 doses
- 2 x 200 doses
Easyhaler Budesonide 400 microg/dose inhalation powder
- 100 doses + protective cover
- 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
FI-02200 Espoo
Finland
For any information about this medicine, please contact the local
representative of the Marketing Authorisation Holder:
Orion Pharma (UK) Limited, Abbey Gardens, 4 Abbey Street, Reading, RG1 3BA
This medicinal product is authorised in the Member States of the EEA under the following names:
- Finland, Hungary, Germany
- Budesonid Easyhaler
- Spain
- Budesonida Easyhaler
- Belgium, Poland
- Budesonide Easyhaler
- Netherlands
- Budesonide Orion Easyhaler
- United Kingdom
- Easyhaler Budesonide
- Slovenia
- Budesonid Orion Easyhaler
- Norway, Sweden, Denmark, Czech Republic, Slovakia, Estonia, Lithuania, Latvia, Malta
- Giona Easyhaler
This leaflet was last revised on 21/07/2021
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
QR code to 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.
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HOW TO USE CORRECTLY
Step 1: SHAKE
• Remove the dustcap
• Shake the inhaler 3 to 5 times holding it in the upright position
| SHAKE x 3-5
| Important points to remember
• It is important to keep the inhaler in the upright position
• If you accidentally click while you shake the inhaler, empty the powder from the mouthpiece as shown below
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Step 2 : CLICK
• Keep holding the inhaler upright between your forefinger and thumb
• Press down until you hear a click, and let the inhaler click back again. This releases a dose
• Only click down once
| CLICK x 1
| Important points to remember
• The inhaler will not click if the dustcap is still on
• Only click down once
• If you accidentally click more than once, empty the powder from the mouthpiece, see below
• Click to release dose before you inhale, not at the same time
• Keep the inhaler upright when you click it and when you inhale the dose. If you tip it, the powder could fall out before you are able to inhale it
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Step 3 : INHALE
• Keep holding the inhaler upright
• Breathe out 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
• Take the inhaler out of your mouth, hold breath for at least 5 seconds , then breathe out normally.
| INHALE
| Important points to remember
• Make sure the whole mouthpiece is well inside your mouth, so that the medication gets into your lungs
• Make sure your lips make a good seal around the mouthpiece
• Do not breathe out into the inhaler. This is important: it could clog up the inhaler. If you breathed out into the inhaler, empty the powder from mouthpiece, see below
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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 and/or brush your teeth. 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.
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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 inhaler. This helps 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.
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When to switch to a new Easyhaler
The dose counter shows the number of remaining doses. The counter turns after every 5th click. When the dose counter starts turning red, there are 20 doses left.
If you do not already have a new Easyhaler, contact your doctor for a new prescription. When the counter reaches 0 (zero), you need to replace the Easyhaler.
If you use the protective cover, you can keep it and insert your new inhaler into it.
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Remember
- Shake
- Click
- Inhale.
- After you have taken the dose, rinse your mouth with water and spit it out and/or brush your teeth.
- Do not get your inhaler wet, protect it from moisture.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Documents / Resources
|
Easyhaler Budesonide 200 mcg Micrograms Per
Actuation
[pdf] Instructions
Budesonide 200 mcg, Micrograms Per Actuation, Per Actuation, Micrograms
Actuation, Actuation, Budesonide 200 mcg
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