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EASYHALER BECLOMETASONE 200 MICROGRAMS/DOSE INHALATION POWDER

Active substance(s): BECLOMETASONE DIPROPIONATE / BECLOMETASONE DIPROPIONATE / BECLOMETASONE DIPROPIONATE

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Package Leaflet: Information for the user

Easyhaler® Beclometasone
200 micrograms/dose inhalation powder
Beclometasone dipropionate
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.
–– This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
–– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in
this leaflet. See section 4.
What is in this leaflet
1. What Easyhaler® Beclometasone is and what it is used
for
2. What you need to know before you use Easyhaler®
Beclometasone
3. How to use Easyhaler® Beclometasone
4. Possible side effects
5. How to store Easyhaler® Beclometasone
6. Contents of the pack and other information
1. WHAT EASYHALER® BECLOMETASONE IS
AND WHAT IT IS USED FOR
Easyhaler® Beclometasone is packed in an inhaler called
Easyhaler. Beclometasone dipropionate belongs to a
group of medicines called corticosteroids (often just called
steroids). A very small dose of steroid is needed when it is
inhaled. This is because it is inhaled straight to your lungs.
Easyhaler® Beclometasone works by reducing swelling and
irritation in the lungs. They have what is called an ‘antiinflammatory action’.
Easyhaler® Beclometasone helps to prevent asthma in
people who need regular treatment. This is why they
are sometimes called ‘preventers’. They need to be used
regularly, every day.
Easyhaler® Beclometasone will not help treat sudden
asthma attacks where you feel breathless.
• A different medicine is used for treating sudden
attacks (called a ‘reliever’).
• If you have more than one medicine, be careful not to
confuse them.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
EASYHALER® BECLOMETASONE
Do not use Easyhaler® Beclometasone if you are allergic
(hypersensitive) to:
• beclometasone dipropionate
• lactose (which contains small amount of milk
proteins)
• any of the other ingredients of Easyhaler ®
Beclometasone (listed in Section 6).
Do not use Easyhaler® Beclometasone if any of the above
apply to you. If you are not sure, talk to your doctor, nurse
or pharmacist before using Easyhaler® Beclometasone.
Warnings and precautions
Talk to your doctor, nurse or pharmacist before using
Easyhaler® Beclometasone:
• if you have ever been treated for tuberculosis (TB)
• If you are using Easyhaler® Beclometasone at the
same time as taking steroid tablets. Also if you have
just finished taking steroid tablets. In both cases, you
should carry a steroid warning card until your doctor
tells you not to carry one.
Contact your doctor if you experience blurred vision or other
visual disturbances.
If you are not sure if any of the above apply to you, talk to
your doctor, nurse or pharmacist before using Easyhaler®
Beclometasone.
Children
Easyhaler® Beclometasone is not recommended for use in
children
Other medicines and Easyhaler® Beclometasone
Tell your doctor, nurse or pharmacist if you are taking, have
recently taken or might take any other medicines, including
herbal medicines and medicines obtained without a
prescription. Remember to take this medicine with you if
you have to go into hospital.
Some medicines may increase the effects of Easyhaler®
Beclometasone and your doctor may wish to monitor you
carefully if you are taking these medicines (including some
medicines for HIV: ritonavir, cobicistat).
Easyhaler® Beclometasone with food and drink
You can use Easyhaler® Beclometasone at any time of day,
with or without food.
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.
Driving and using machines
Easyhaler® Beclometasone is not likely to affect you being
able to drive or use any tools or machines.
Easyhaler® Beclometasone contains lactose
Lactose contains small amounts of milk proteins, which
may cause allergic reaction. If you have been told by your
doctor that you do not tolerate certain kinds of sugars, talk
to your doctor before using this medicine. The amount of
lactose in Easyhaler® Beclometasone (approximately 7mg
per dose) does not normally cause problems in lactose
intolerant people.
3. HOW TO USE EASYHALER® BECLOMETASONE
Always use this medicine exactly as your doctor has told
you. Check with your doctor, nurse or pharmacist if you are
not sure.
Using this medicine
• Instructions on how to use this Easyhaler® are given
as a step-by step guide below
• It takes a few days for this medicine to work and it
is very important that you use it regularly.
The usual dose for Easyhaler Beclometasone is:
Adults (over 18 years) including the Older people:
Your doctor will start you on a dose appropriate to your
condition.
For prevention and long-term use the usual starting dose is
one puff (actuation) (200 micrograms) twice a day. This may
be increased to three to four puffs (actuations)
(600-800 micrograms) per day, and then reduced when
your condition has improved. The total daily dose may be
given in two, three or four divided doses.
Children:
Easyhaler® Beclometasone is not recommended for use in
children.
If you are using high doses of an inhaled steroid for a
long time you may sometimes need extra steroids for
example during stressful circumstances such as a road
traffic accident or before an operation. Your doctor may
decide to give you extra steroid medicines during this
time.
If you use more Easyhaler® Beclometasone than you
should
If you use more than you should, talk to your doctor as
soon as possible.
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® Beclometasone
• Take the next dose when it is due.
• Do not take a double dose to make up for a forgotten
dose.
If you stop using Easyhaler® Beclometasone
• Do not stop treatment even if you feel better unless
told to do so by your doctor.
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you notice any of the following serious side effects,
stop using this medicine and talk to your doctor
straight away. You may need urgent medical treatment.
• allergic reactions (affects less than 1 in 100 people)
– the signs include skin rashes, redness, itching or
weals like nettle rash or hives
• severe allergic reactions (affects less than 1 in 10,000
people) - the signs include swelling of your face, lips,
mouth, tongue or throat which may cause difficulty
in swallowing or breathing, itchy rash, feeling faint
and light headed and collapse
• your breathing or wheezing gets worse straight after
using your inhaler.
Talk to your doctor as soon as possible if:
• after 7 days of using Easyhaler® Beclometasone your
shortness of breath or wheezing does not get better,
or gets worse.
Other side effects include:
Very Common (may affect more than 1 in 10 people)
• thrush in the mouth and throat
Common (may affect up to 1 in 10 people)
• sore tongue or throat
• hoarseness of voice
• cough
Problems with your mouth and throat can be reduced by
doing certain things straight after inhaling your dose. These
are brushing your teeth, rinsing your mouth or gargling
with water and spitting it out. Tell your doctor if you have
these problems with your mouth or throat, but do not stop
treatment unless you are told to.
Very rare (may affect up to 1 in 10,000 people)
• a round, puffy face (called ‘moon face’)
• weight gain, especially on the neck and shoulders
• shortness of breath
Using high-dose inhaled corticosteroids over a long
time can cause, in very rare cases, systemic effects.
These include:
• decrease in bone mineral density (thinning bones)
• growth retardation (slowing of growth) in children
and adolescents. Your doctor may wish to check the
height of your children regularly
• increase pressure in your eyes (glaucoma)
• cataract
• lower respiratory tract infection
• problems with how your adrenal glands work (adrenosuppression) - causing loss of appetite, abdominal
pain, weight loss, tiredness, feeling sick, being sick,
feeling faint, sweating and possible fits, you should
consult your doctor. This is particularly important
if you have been exposed to stress such as surgery,
infection, an acute attack of asthma, or other serious
illness.
Your doctor may carry out blood test from time to
time to monitor the level of steroids in your body.
Your doctor will help stop this happening by making sure
you use the lowest dose of steroid which controls your
symptoms.
Not known (frequency cannot be estimated from the
available data)
Although the frequency is not known, the following side
effects may also occur:
• Sleeping problems, depression or feeling worried,
restless, nervous over-excited or irritable. These effects
are more likely to occur in children.
• Blurred vision
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in
this leaflet. You can also report side effect directly via the
Yellow Card Scheme at: 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® BECLOMETASONE

• 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 25 °C protected from moisture. It is recommended to keep the Easyhaler® in its protective cover.
If your Easyhaler® Beclometasone gets damp, you
need to replace it with a new one.
Replace Easyhaler® Beclometasone with a new one
at the latest 6 months after you opened the laminate
pouch, write down the date you opened the pouch
to help you remember.
Do not use Easyhaler® Beclometasone after the expiry
date which is stated on the Easyhaler® Beclometasone
label and carton (EXP). The expiry date refers to the
last day of that month.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
If you are told to stop using this medicine return any
unused Easyhaler® Beclometasone to your pharmacist
to be destroyed.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Easyhaler® Beclometasone contains
• The active substance is Belometasone dipropionate
• The other ingredient is lactose monohydrate (which
contains small amounts of milk proteins).
What Easyhaler® Beclometasone looks like and contents
of the pack
The Easyhaler® Beclometasone comes in a laminate pouch
to keep the powder dry. Please see the section below which
identifies each part of your Easyhaler®.
Marketing Authorisation Holder and Manufacturer
Orion Corporation, Orionintie 1, FIN-02200, Espoo, Finland
This leaflet was last revised in April 2017

120206-10

10.05.2017/MR

PROOF COLOURS:

Black
Pharmacode - 3996
Size : 200 x 620 mm
Minimum Font 10 pt

INSTRUCTIONS FOR USING YOUR EASYHALER®

Figure 1.

Easyhaler Beclometasone 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® (Figures 1 and 2)
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.
A protective cover is optional. If you do not use the
protective cover, move on to section “Taking a dose from
Easyhaler Beclometasone”.

Figure 2.

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

Figure 3a.

Figure 3b.

Remove the dust cap.
A. Shake (Figure 3a or 3b)
Shake the Easyhaler vigorously up and down 3–5 times, to
allow proper powder flow and a correct dose. After shaking,
hold the Easyhaler in the upright position.
Figure 4a.

Figure 4b.

B. Click (Figure 4a or 4b)
Press the Easyhaler once between your finger and thumb
until you hear a click 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!” see below (Figure 6a or 6b).

Figure 5a.

C. Inhale (Figure 5a or 5b)
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 below “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).

Figure 5b.

Figure 6a.

Figure 6b.

NOTE! (Figures 6a or 6b)
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.
GETTING A NEW EASYHALER® (Figures 7a, 7b and 8)
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.
Replace your Easyhaler beclometasone with a new one no
later than 6 months after you opened the laminate pouch.
Write down the date you opened the pouch to help you
remember.

Figure 7a.

Figure 7b.

Figure 8.

Expand Transcript

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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