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ASMABEC 250MCG CLICKHALER

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Feeling sick or being sick.
Unable to concentrate.
Headache.
Weakness, confusion, sweating.
Tiredness.
Sleeping problems, depression or feeling
worried, restless, nervous, over-excited or
irritable. These effects are more likley to occur
in children.

These may be made worse by trauma, surgery,
infections or suddenly reducing or stopping
treatment.
If any side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. HOW TO STORE YOUR INHALER









Do not store above 30°C. Store in a dry place
Do not use the inhaler after the date shown on
the base of the inhaler.
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Do not let your Asmabec Clickhaler get wet
Do not use inhaler 6 months after removal from
sealed foil pouch
It is important that the inhaler is kept dry
Replace the inhaler if it becomes immersed
in water or exposed to very damp
conditions.
Keep the mouthpiece cover on your inhaler
when you are not using it. This will keep the
mouthpiece clean and help to keep the powder
dry.

IMPORTANT
This medicine is for you, only a doctor can
prescribe it. Do not give this medicine to anyone
else, even if their symptoms are the same. Do not
use this medicine after the expiry date, which is
shown on the carton. This leaflet does not contain
everything about this medicine, if you have any
questions or are not sure about anything then
contact your doctor or pharmacist.

6. FURTHER INFORMATION
What Asmabec contains
Each actuation (puff) contains either 250
micrograms of the active ingredient
beclometasone dipropionate. Also contains the
inactive ingredient lactose monohydrate.

What Asmabec looks like and contents of the
pack
The inhaler is available in a carton containing a
plastic inhaler device incorporating a metering
pump and a mouthpiece enclosed within a
polyester/aluminium/polyethylene heat-sealed
sachet. The inhaler contains a dry white inhalation
powder.
There is also a coloured push button on the top of
the inhaler. The colour of the push button indicates
the strength: Asmabec 250 microgram Clickhaler
has a maroon push button. Your doctor will have
decided which strength you need.
Each Asmabec 250 microgram Clickhaler contains
100 actuations.
There will be a label on the foil pouch inside the
carton with a removable label attached to it. This
should be removed and stuck to the back of the
Clickhaler once you have removed it from the foil
pouch. Make sure you do not cover the dose
counter window. Write down the date you opened
the pouch on this label.
Manufacturer and Licence Holder
The Clickhaler is manufactured by Ashton
Pharmaceuticals Limited, Vale of Bardsley,
Ashton-under-Lyne, OL7 9RR, England and is
procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.

POM

PL 15184/0743
Asmabec 250 microgram Clickhaler

Asmabec is a registered trademark of Celltech
Pharma Europe Limited.
Clickhaler is a registered trademark of Innovata
Biomed Limited.
Leaflet revision date: 06/06/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET
®

ASMABEC 250 MICROGRAM CLICKHALER

Ref:0743/060613/1/F
®

(beclometasone dipropionate)
Please read this leaflet carefully before you
start to take your medicine.
• 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. Do
not pass it onto others. It may harm them, even
if their symptoms are the same as yours.
You medicine is called Asmabec 250 Microgram
Clickhaler however throughout this leaflet it will be
referred to as Asmabec Clickhaler.
The information in this leaflet is arranged as
follows:
1. What Asmabec Clickhaler is and what it is used
for
Before you use your inhaler
How to use your inhaler
Possible side effects
How to store your inhaler
Further information
2.
3.
4.
5.
6.

1. WHAT ASMABEC CLICKHALER IS AND
WHAT IT IS USED FOR
What Asmabec Clickhaler is:
• Asmabec Clickhaler is a dry powder inhaler for
you to breathe in through your mouth and into
your lungs.
• The medicine (beclometasone dipropionate)
belongs to a group of medicines called steroids.
These can help to control asthma.
What Asmabec Clickhaler is used for:
• This medicine is prescribed to control asthma in
adults and children 6 years and older.
• The medicine works by reducing the
inflammation in your lungs.
Do not use this medicine to treat a sudden
attack of breathlessness - it will not help you.
You will probably need a different kind of medicine
in a different colour pack which your doctor may
already have given you. If you have more than
one medicine be careful not to confuse them.
2. BEFORE YOU USE YOUR INHALER
Do not use the Asmabec Clickhaler if you are
allergic to either lactose or beclometasone
dipropionate.

Tell your doctor or pharmacist before taking
the medicine if the answer is YES to any of the
following questions:
1. Are you pregnant, thinking of becoming
pregnant or breastfeeding?
2. Do you have or had you had tuberculosis (TB)?
3. Do you have any infection in your eye, mouth
or chest?
4. Are you taking any of the following anti-fungal
or anti-viral drugs for infections:
ketoconazole, itrazonazole, nelfinavir or
ritonavir?
Tell your doctor if you are taking any other
medicines.
If you have an intolerance to any sugars tell your
doctor before taking this medicine.
Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or
breast-feeding, ask your doctor or pharmacist
before using Asmabec.
3. HOW TO USE YOUR INHALER
The instructions in Figure 1 show you how to use
your inhaler. Supervise children using the
Asmabec Clickhaler to ensure they use it
correctly.
How do I know how many puffs to take and
when?
The pharmacist’s label on the box should tell you
how many puffs to take and how often.
Asmabec Clickhaler is usually taken 2 or 4 times a
day (e.g. 2 puffs in the morning and evening). The
dose varies depending how severe the asthma is.
The lowest dose that keeps your asthma under
control should be used.
The following is a guide:
Adult starting dose:
200 to 400 micrograms/day up to a maximum of
2000 micrograms per day
Adult maintenance dose:
400 to 800 micrograms per day up to a maximum
of 2000 micrograms per day
Children (6 to 12 years): 200 to 400 micrograms
per day
Not suitable for children under 6 years

You must not inhale more doses or use your
inhaler more often than your doctor advises.
Figure 1. How to use your Asmabec Clickhaler
1. Remove mouthpiece cover from
the inhaler.

How do I use the counter on my Asmabec
Clickhaler?
Figure 2. Your Asmabec Clickhaler counter
How does the counter work?
• On the back of your inhaler is a counter to tell
you how many puffs you have taken.
Every time you use your Asmabec Clickhaler
the counter moves on by 1, for example:

Figure 3. How to clean your Asmabec
Clickhaler

1. Remove mouthpiece cover
from the inhaler.


2. Shake the inhaler.

3. Hold the inhaler upright with a
finger on the push button.
Press the dosing button down
firmly - once only until it clicks
and release.
Keep the inhaler upright.
4. Breathe out as far as is
comfortable. Do not blow into
the device at any time.
5. Place the mouthpiece in your
mouth and close your lips firmly
around it (do not bite it). Breathe
in through your mouth steadily
and deeply, to draw the
medicine into your lungs.
6. Hold your breath, take the
inhaler from your mouth and
continue holding your breath
for about 5 seconds, or as
long as is comfortable.

5 6

◄ ACTUATIONS TAKEN

Means 56
puffs have
been taken

How do you know when there are only 10 puffs
left?
When there are only ten puffs left, red warning
lines appear to remind you that your inhaler is
nearly empty and you must make sure you have
a replacement inhaler ready.
The first time you see these red warning lines it
means there are 10 puffs left in your inhaler:

◄ACTUATIONS TAKEN

◄ ACTUATIONS TAKEN

◄ ACTUATIONS TAKEN

Means 10
puffs have
been taken

2. Remove the mouthpiece.
Press downwards on the end
of the mouthpiece.

dry

Your inhaler is
now empty

4. Wipe the mouthpiece with a
cloth or tissue.
Do not use water.

5. Re-attach the mouthpiece to
the body of the inhaler and
then replace the mouthpiece
cover.

Means there
is 1 puff left

You can now breathe in your last dose
The inhaler is now empty.

0

Cleaning your inhaler
For hygiene reasons, it is important to clean the
mouthpiece cover and mouthpiece regularly.
Figure 3 shows you how to clean your inhaler.

How is the Asmabec Clickhaler different to
other inhalers?
As this is a dry powder inhaler and not an aerosol
spray:
• It may taste or feel different from other inhalers
you may have used.
• You cannot see any spray when the button is
pressed. This does not mean your inhaler isn’t
working.
How can you check your inhaler is working?
If you are concerned that your inhaler is not
working, you can reassure yourself by pressing
the button and then gently tapping the mouthpiece
on your hand. You will then see a tiny amount of
powder on your hand.
4. POSSIBLE SIDE EFFECTS

3. Wipe the body of the inhaler
with a dry cloth or tissue.
Do not use water.

The counter then counts up the final ten doses for
example:

0

How do you know when your Asmabec
Clickhaler is empty?
After you have pushed the button down for the last
puff in the inhaler, the push button will lock in a
pressed down position and the counter will again
show red warning lines and ‘0’:

9




If more puffs are needed, keep the inhaler
upright and repeat Steps 2-6.
7. Replace the mouthpiece cover to help keep
the mouthpiece clean and the powder dry.
Your dose may be reduced when your asthma is
under control. Your doctor or nurse may want to
regularly review your treatment to make sure you
are on the right dose.

Can I stop using my inhaler?
• Do not stop treatment even if you feel better
unless told to do so by your doctor.
It takes a few days for this medicine to work and
it is very important that you use it regularly.



If you take too much
If you accidentally take more puffs than
recommended tell your doctor.
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 your dose or
decrease your dose without seeking medical
advice.
If you miss a dose
If you forget to inhale a dose do not worry, take it
as soon as you remember unless it is nearly
time for your next dose. Do not take a double dose
to make up for the next dose.

Very rare side effects:
• Allergic reactions including skin rashes or
redness or swelling of the face or throat
causing difficulty breathing.
If you experience an allergic reaction, stop
taking this medicine and go to the nearest
hospital accident and emergency department as
soon as possible.
• Wheezing
Stop taking this medicine and tell your
doctor as soon as possible if you notice that
your shortness of breath and/or wheeze is
becoming worse.
Very occasional side effects:
Throat or tongue becomes sore.
Fungal infection of mouth or throat.
Voice becomes a little hoarse.





Rinsing your mouth with water after inhaling each
dose may help prevent these side-effects.
Side-effects if you use high doses for a long
period:
• Stop your body producing its own steroid
causing low blood pressure, dizziness,
increased heart rate, fatigue, lethargy.
• Bone thinning.
• Pain in the eye and blurred vision.
• Slow down growth in children and adolescents.
• Easy bruising of the skin.
• Cataracts (the lens of the eye becomes cloudy).
• Cushing’s syndrome (a condition of the adrenal
glands causing weight gain, rounded (moon
shaped) face and high blood pressure)
Other side-effects include:
Weight loss.
Stomach pains.
Convulsions (fits).





Ref: 0743/060613/1/B

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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