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EASYHALER BUDESONIDE 400 MICROGRAMS PER ACTUATION INHALATION POWDER

Active substance(s): BUDESONIDE

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Package leaflet: Information for the user

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
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, if you are using:
- nasal medicines containing corticosteroids
- corticosteroid tablets
- itraconazol or ketoconazol containing antifungal medicines.
Tell your doctor or pharmacist also if you are taking or have
recently taken any other medicines, including medicines obtained
without prescription.
Pregnancy and breast-feeding
Ask your doctor for advice before using Easyhaler Budesonide,
if you are pregnant, planning to become pregnant or if you are
breastfeeding. Inhaled budesonide during pregnancy has no
adverse effects on the health of the foetus / new born child.
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 medicinal product.
Lactose contains small amounts of milk proteins, which may cause
allergic reaction.
3. How to use Easyhaler Budesonide
See “Instructions for using your Easyhaler” at the end of this leaflet.
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).
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.

4. Possible side effects
Like all medicines, Easyhaler Budesonide can also cause side
effects, although not everybody gets them.
Common side effects (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.
Rare side effects (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 and hoarseness.
Growth retardation in children. Depression, restlessness and
nervousness. 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 side effects (may affect up to 1 in 10,000 people)
Cataract, glaucoma. Decrease in bone mineral density (weakening
of the bones).
Frequency not known, but may also occur:
Sleeping problems, anxiety, 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.
5. How to store Easyhaler Budesonide
Keep this medicine out of the sight and reach of children.
Before the first use: store in unopened laminate pouch.
After opening the laminate pouch: 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 laminate pouch. Write down the date you
opened the pouch 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.
6. 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 inahaltion powder
• 100 doses + protective cover
• 100 doses
• 2 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
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, Austria,
Estonia, Lithuania, Latvia
Giona Easyhaler
This leaflet was last revised in
08/2014

120022-12
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Myriad Pro / 9 pt

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.

If you stop using Easyhaler Budesonide
Do not stop using this medicine 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.

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

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.

1/1
Black

What is in this leaflet:
1. What Easyhaler Budesonide is and what it is used for
2. What you need to know before you use Easyhaler Budesonide
3. How to use Easyhaler Budesonide
4. Possible side effects
5. How to store Easyhaler Budesonide
6. Contents of the pack and other information

200 x 620
200 x 310

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

269874
120022-12
Taija Oksanen
26.8.2014
Orion Oyj

Easyhaler Budesonide 100 micrograms/dose
Easyhaler Budesonide 200 micorgrams/dose
Easyhaler Budesonide 400 micrograms/dose
inhalation powder
Budesonide

INSTRUCTIONS FOR USING YOUR EASYHALER
Easyhaler Budesonide is easy to use. Read through these instructions first: they tell you what you should do and what to look out for.

UNPACKING THE EASYHALER
The Easyhaler (Figure 1) comes in a laminate pouch to keep the
powder dry. Do not open the pouch until you are ready to start
using your Easyhaler.

Figure 1.

Mouthpiece

A protective cover is optional. If you do not use the protective
cover, move on to section “Taking a dose from Easyhaler
Budesonide” (See Figures b).
Open the protective cover and insert the Easyhaler into it (Figure 2).
Make sure the dust cap covers the mouthpiece of the Easyhaler
(this stops the Easyhaler going off by accident).

Figure 2.

Inhaler

Dust cap

Protective
cover

If you are not using the Easyhaler immediately, close the
protective cover.
TAKING A DOSE FROM EASYHALER BUDESONIDE
If you are also using a “reliever” inhaler, use it first.

Figure 3a.

Figure 3b.

Figure 4a.

Figure 4b.

Figure 5a.

Figure 5b.

Figure 6a.

Figure 6b.

Open the protective cover, if you are using it.
Remove the dust cap.
A. Shake
Shake the Easyhaler vigorously up and down three to five times
(Figure 3a or 3b), to allow proper powder flow and a correct dose.
After shaking, hold the Easyhaler in the upright position.
B. Click
Press the Easyhaler once between your finger and thumb until you
hear a click (Figure 4a or 4b), and let it click back again, to deliver
powder into the inhalation channel inside the mouthpiece. Keep
holding the Easyhaler in the upright position.
If you think that you have clicked the Easyhaler more than once,
see section NOTE! (Figure 6a or 6b).
C. Inhale
In the sitting or standing position
• Breathe out normally (but NOT into the Easyhaler).
• Place the mouthpiece in your mouth between your teeth and
seal your lips tightly around it.
• Take a strong and deep breath through the Easyhaler (Figure 5a
or 5b).
• Remove the Easyhaler from your mouth.
• Hold your breath for at least 5 seconds, then breathe normally.
Make sure that you do not breathe out into the Easyhaler, because
it could clog up the Easyhaler. If this happens, see section NOTE!
(Figures 6a or 6b).
If you have been prescribed more than one dose, repeat points A,
B and C.
Put the dust cap back on the mouthpiece.
Close the protective cover, if you are using it.
Rinse
Rinse your mouth and throat and spit out the water.
This reduces the risk of fungal infection (thrush).
NOTE
If you click the Easyhaler by accident, or if you have clicked it
more than once, or if you breathe out into it, tap the mouthpiece
to empty the powder onto a table top or the palm of your hand
(Figure 6a or 6b). This ensures proper dosing. Then start again with
steps A, B and C.
CLEANING
Clean the mouthpiece at least once a week with a clean dry
cloth or tissue. Do not use water or other liquids, the powder is
sensitive to moisture. If you use the protective cover, you can take
the Easyhaler out of it to wipe it. When putting it back into its
protective cover, put the dust cap on the mouthpiece to stop it
going off accidentally.

Figure 7.a

Figure 7b.

GETTING A NEW EASYHALER
The Easyhaler has a dose counter which shows how many doses
are left (Figure 7a or 7b). The counter turns after every fifth
actuation (dose). When the numbers turn 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, you need
to replace the Easyhaler even though you can still observe the
powder in the clear window on the back of the Easyhaler
(Figure 8).
Keep the protective cover for the next Easyhaler.

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Dose
counter

Dose
counter

Figure 8.

Window

26.8.2014 14.07

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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