ALVESCO 160 INHALER

Active substance: CICLESONIDE

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Patient Information Leaflet
ALVESCO® 160 INHALER
ciclesonide
This product is called Alvesco 160 Inhaler but will be
referred to as Alvesco throughout this leaflet.
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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

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

1. What Alvesco is and what it is
used for
What Alvesco is:
Alvesco is a clear and colourless aerosol spray for you
to breathe in through your mouth and into your lungs. It
is a Preventer medication (corticosteroid) that has to be
taken every day and which becomes active only after it
has been inhaled into your lungs.
The active ingredient in this medicine is ciclesonide.
(For the other ingredients, see Section 6).

During your treatment with Alvesco contact your doctor
immediately if:


breathing becomes difficult and your symptoms,
coughing, breathlessness, wheezing, tightness in the
chest, increasing noises (rhonchi) or other symptoms
of narrowing of the airways are getting worse.
(You should use your Reliever inhaler which will
normally lead quickly to an improvement.)
 you are waking up at night with your symptoms.
 you are not getting relief from using your Reliever
inhaler.
Your doctor will decide on your further treatment.

This medicine is not suitable for use in an acute attack of
breathlessness.
For quick relief from such an attack, use only your
Reliever inhaler.

2. What you need to know before
you use Alvesco
Do not use Alvesco
if you are allergic (hypersensitive) to ciclesonide or any
of the other ingredients of this medicine (listed in section
6).
Take special care with Alvesco
Before beginning treatment with this medicine, please
tell your doctor if:


you have ever been treated, or are currently being
treated, for pulmonary tuberculosis (TB), fungal, viral
or bacterial infections.

Check with your doctor if you are not sure. It is important
to make sure that Alvesco is the right medicine for you.

Using this medicine with food and drink
There is no interaction between Alvesco and food and
drink.
Pregnancy, breast-feeding and fertility
Tell your doctor if you are pregnant, want to become
pregnant or are breast-feeding.


Specific patient groups
Patients with severe asthma are at risk of acute
asthma attacks. For such patients the doctor will carry
out regular thorough asthma control checks, including a
lung function test.
Patients who are already taking corticosteroid
tablets:
Alvesco can be used to replace your tablets, or to
reduce the number of tablets you need to take. Please
follow your doctor's instructions carefully.








What Alvesco is used for:
This medicine is prescribed to control persistent asthma
in adult and adolescent patients (12 years old and
more).
It helps you to breathe more easily by decreasing the
symptoms of your asthma and by lessening the chances
of an asthma attack. The effect builds up over a period
of time, so this medicine needs to be taken every day,
even when you are feeling well.

Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a
prescription.





This will start about a week after you begin your
Alvesco inhalations.
The number of tablets you take will be reduced
with caution over a period of time.
During this period you may sometimes suffer from a
general feeling of being unwell.
In spite of this, it is important to continue both with
your Alvesco inhalations and with slowly reducing
the number of tablets you take.
If you get serious symptoms such as nausea (feeling
sick), vomiting (being sick), diarrhoea or a high
temperature, contact your doctor.
This process may sometimes reveal minor allergies
such as rhinitis (inflammation of the inside of the
nose) or eczema (itchy, reddening skin).
If you have changed over from tablets, you will
continue for a time to be at risk of reduced adrenal
function, which is related to the corticosteroid tablets
you take. The symptoms of reduced adrenal function
(e.g. dizziness, fainting, nausea, loss of appetite,
moodiness, decrease in body hair, inability to cope
with stress, weakness, headaches, memory
problems, allergies, food cravings, and blood sugar
disorders) may also continue for some time.
You may also need to see a specialist to determine
the extent of the reduction in adrenal function.
Your doctor will also do regular checks on your
adrenal function.
During periods of stress, for example, having an
operation, worsening asthma attacks, it is possible
that you will need extra corticosteroid tablets. If so,
you must carry a steroid warning card which says
so.

Patients with liver or kidney disorders
There is no need to adjust the dose of ciclesonide if you
have liver or kidney problems.
If you suffer from a severe liver condition, your doctor
will check you more carefully for possible side effects
resulting from disturbance of normal steroid production.
Children below 12 years of age:
This medicine is not recommended for children below
the age of 12 because of a lack of information about its
possible effects.
Other medicines and Alvesco
Please inform your doctor before using Alvesco, if you
are currently being treated for any fungal or viral
infections with medicine containing:





ketoconazole,
itraconazole,
ritonavir,
nelfinavir.

These may intensify the action of Alvesco so that the
probability of side effects cannot be completely ruled
out.








Because there is not enough information about the
effects of Alvesco on pregnant women, your doctor
will discuss with you the risks and benefits of using
Alvesco.
Ciclesonide (the active ingredient in Alvesco) may be
taken during pregnancy only when the possible
benefits to the mother justify the possible risk to the
developing baby. If your doctor decides that you can
continue using Alvesco, the smallest possible dose
of ciclesonide will be used to maintain asthma
control.
The adrenal function will be carefully monitored in
children of mothers who received corticosteroids
during pregnancy.
Talk to your doctor if you want to use Alvesco during
breast-feeding.
It is not known whether inhaled ciclesonide passes
into the breast milk in humans.
Prescribing Alvesco to women who are breast
feeding will therefore only be considered if the
expected benefit to the mother outweighs the
possible risk to the child.

Ask your doctor or pharmacist for advice before taking
any medicine.
Driving and using machines
Alvesco and its ingredients have no or negligible effects
on the ability to drive or to use machinery.

3. How to use Alvesco
Always use this medicine exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.


If you have just started to use this medicine instead
of, or as well as, taking corticosteroid tablets, see
section 2, Patients who are already taking
corticosteroid tablets.

How much Alvesco should I take each day?
Your doctor will have spoken to you about how much of
your medicine you need to take each day. This will
depend on your individual need.




The recommended dose of Alvesco is 160
micrograms once daily, which leads to asthma
control in the majority of patients.
In some patients a dose reduction to 80 micrograms,
once daily, may be an adequate dose for maintaining
effective control of their asthma.
An increased dosage of Alvesco may become
necessary for a short period of time in patients who
suffer a severe worsening of their asthma symptoms.
This can be up to 640 micrograms per day, delivered
as 320 micrograms twice daily but no data
confirming the additional therapeutic effect after 3
months with these higher doses are available.

If necessary, your doctor may also prescribe
corticosteroid tablets and/or, in the case of an infection,
an antibiotic.
 Your doctor will adjust your dose to the minimum
necessary to control your asthma.
 You should start to notice an improvement in your
symptoms (wheezing, tight chest and coughing)
within 24 hours.
When should I use my Alvesco Inhaler?
In most cases, either in the morning or in the evening as one or two puffs once a day. Follow your doctor's
instructions very carefully. It is important that you take
Alvesco regularly every day, even if you feel better.

If you find that you have to use your Reliever inhaler
more than 2-3 times a week, you should contact your
doctor to have your medicine reviewed.
How do I use my Alvesco Inhaler?
It is important that a doctor, nurse or pharmacist shows
you first how to use your Alvesco inhaler properly. A
good technique will make sure you are receiving the
correct amount into your lungs. Please use the
instructions in this leaflet as a reminder.
You may wish to practice in front of the mirror for the
first couple of times until you are confident that you are
using your Alvesco properly. Make sure that none of
your medicine is escaping from the top or sides of your
mouth.
If you have a new inhaler, or if you have not used your
inhaler for a week or more, it must be tested before you
use it. Remove the mouthpiece cover and press down
three times on the canister inside the inhaler to release
three puffs into the air - away from you.
You do not need to shake your Alvesco before using it.
The medicine is already in a very fine solution, mixed to
ensure you receive the correct dose with each puff.
During inhalation, you can either be sitting down or
standing up.
Follow these instructions carefully and use the
pictures to guide you.
1. Remove the
mouthpiece cover and
check the mouthpiece,
both the inside and
the outside, to make
sure that it is both
clean and dry.
2. Hold the inhaler
upside down
(base of the canister
at the top) with your
forefinger on the base
of the canister and
your thumb under
the mouthpiece.
3. Breathe out as far as is comfortable. Do not breathe
out through the inhaler.
4. Place the mouthpiece
in your mouth
and close your lips
firmly around it.

5. Just after starting to breathe in through your mouth,
press down with your forefinger on the top of the
inhaler to release a puff of the medicine while you
are still breathing in slowly and deeply. Please take
care that the puff of medicine does not escape
through the top, bottom or sides of your mouth.
6. Hold your breath,
take the inhaler
from your mouth
and remove your
finger from the
top of the inhaler.
Continue holding your
breath for about ten seconds or as long as is
comfortable.
Breathe out slowly through your mouth.
Do not breathe out through the inhaler.
It is important that you do not rush steps 3 to 6.
7. If you have been
instructed to take
another puff, wait
about half a minute
and repeat steps 3 to
6.

8. After use, always replace the mouthpiece cover to
keep out dust. Replace firmly and snap into position.





9. For hygiene reasons

Rare side effects (may affect up to 1 in 1,000 patients
treated):
 sensation of heartbeat (palpitations)
 discomfort or pain in the abdomen
 high blood pressure







please clean the
mouthpiece weekly
with a dry tissue, both
inside and out.
using a dry, folded
tissue, wipe over the
front of the small hole
where the medicine comes out.
do not use water or any other liquids.

A correct technique will ensure the right amount of
Alvesco is getting into your lungs every time you use
your inhaler. Your doctor will check your inhalation
technique regularly to ensure that your treatment can
have the very best effect.
When the canister is completely empty you will not feel
or hear any of the propellant being discharged.
If you begin to feel wheezy or tightness in the chest
after using your Alvesco inhaler:
 do not take any more puffs.
 use your reliever inhaler to help your breathing.
 contact your doctor immediately.
If you find it difficult to use the inhaler, your doctor may
recommend the use of a spacer. The spacer that fits the
Alvesco inhaler is called AeroChamber PlusTM. If you
use the AeroChamber PlusTM device, please follow the
instructions provided with it. Your doctor or pharmacist
will be able to advise you about the device.
If you use more Alvesco than you should
It is important that you take your dose as advised by
your doctor. You should not increase or decrease your
dose without seeking medical advice.
There is no specific treatment necessary if you have
used too much Alvesco but you should inform your
doctor. If high doses are used over long periods, a
certain degree of reduction in adrenal function cannot be
ruled out and control of the adrenal function may be
necessary.
If you forget to use Alvesco
If you have forgotten to use your Alvesco, just take your
usual dose when it is next due. Do not take a double
number of puffs to make up for the forgotten dose.
If you stop using Alvesco
Even if you feel better, you should not stop using your
Alvesco.
If you do stop using this medicine, you must tell
your doctor immediately.

4. Possible side effects

bad taste
dryness of mouth or throat
nausea or vomiting

Frequency not known, but may also occur:

Sleeping problems, depression or feeling worried,
restless, nervous, over-excited or irritable. These
effects are more likely to occur in children
Alvesco may affect the normal production of
corticosteroids in your body. This is usually seen in
patients taking high doses over a long period of time.
These rare side effects may include:
 reduced rate of growth in adolescents
 a thinning of the bones
 possible clouding of the lens of the eye (cataracts)
causing blurred vision
 loss of vision caused by abnormally high pressure in
the eye (glaucoma)
 moon-shaped face, weight gain in the upper body
and thinning arms and legs (Cushingoid features or
Cushing syndrome).
Adolescents who are receiving treatment for a long
period of time will have their height checked regularly by
their doctor. If your growth rate is slowed, your doctor
will adjust your treatment if possible to the lowest dose
at which effective control of asthma is maintained.
Corticosteroid tablets can lead to more side effects than
a corticosteroid inhaler such as Alvesco. If you have
been taking steroid tablets before or during the use of
Alvesco, the risk of side effects from the tablets may
continue for a period of time. Regular check-ups with
your doctor will ensure that you are taking the right dose
of Alvesco for you. Regular check-ups will also identify
any side effects early on and reduce the chances of
them worsening.
Please remember:
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor. 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
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Alvesco
Keep out of the sight and reach of children.

Like all medicines, Alvesco 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:
• severe allergic reactions such as swelling of lips,
tongue and throat (may affect up to 1 in 1,000
patients treated)
• allergic reactions: skin rashes, redness, itching or
weals like nettle rash and hives (may affect up to 1
in 100 patients treated)
• cough, or wheezing, which gets worse soon after
taking an inhalation (may affect up to 1 in 100
patients treated)
The other side effects seen with Alvesco are usually
mild. In most cases you can continue with your
treatment. The side effects you may experience are:
Uncommon side effects (may affect up to 1 in 100
patients treated):
 hoarseness
 burning, inflammation, irritation of mouth or throat
 oral thrush (oral fungal infection)
 headache

Do not use your inhaler after the expiry date which is
stated on the label and the carton after EXP. The expiry
date refers to the last day of the month. The container
contains a pressurised liquid. Do not store above
50°C. The container should not be punctured, broken or
burned even if it seems empty.
As with most inhaled medicines in pressurised
containers, the healing effect of this medicinal product
may become smaller when the container is cold.
However, Alvesco delivers the same level of dose from
minus 10°C to plus 40°C.
If your doctor decides to stop treatment or if the inhaler
is empty, return it to your pharmacist for safe disposal.
This is important as traces of medicine could remain in
the container even if you have the impression that it
might be empty.

6. Contents of the pack and other
information
What Alvesco 160 Inhaler contains
 The active ingredient is ciclesonide. Each
actuation releases a puff (dose delivered through the
mouthpiece) contains 160 micrograms of
ciclesonide.
 The other ingredients are ethanol anhydrous and
Norflurane (HFA-134a,).
What Alvesco 160 Inhaler looks like and contents of
the pack
Alvesco 160 Inhaler consists of a clear and colourless
liquid in a pressurised aluminium container which
delivers through a mouthpiece an accurately measured
dose of ciclesonide in the form of a spray.
Pack sizes:
Inhaler with 60 accurately measured puffs.
Inhaler with 120 accurately measured puffs.
Each strength of inhaler contains enough for 60 or 120
puffs. Depending on the number of puffs per day your
physician has recommended you to use:
 the inhaler with 60 puffs has enough medication for
one to two months.
 the inhaler with 120 puffs contains enough
medication for two to four months.
Not all pack sizes may be marketed in all countries.
Alvesco 160 Inhaler is manufactured by 3M Health
Care Ltd., 3M House. Morley Street, Loughborough,
Leicestershire, UK or Takeda GmbH, Byk-Gulden
Strasse 2, 78367 Konstanz, Germany.
Procured from within the EU and repackaged in the UK
by the Product Licence Holder: CD Pharma Limited, Unit
3, Manor Point, Manor Way, Borehamwood, Herts WD6
1EE.
Alvesco 160 Inhaler

PL No.: 20492/0206

Alvesco is a registered trademark of Takeda GmbH.
Date of preparation: 21st August 2014

POM

Patient Information Leaflet

CICLESONIDE 160 INHALER
This product is called Ciclesonide 160 Inhaler but will be
referred to as Ciclesonide throughout this leaflet.
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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

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

1. What Ciclesonide is and what it is
used for
What Ciclesonide is:
Ciclesonide is a clear and colourless aerosol spray for
you to breathe in through your mouth and into your
lungs. It is a Preventer medication (corticosteroid) that
has to be taken every day and which becomes active
only after it has been inhaled into your lungs.
The active ingredient in this medicine is ciclesonide.
(For the other ingredients, see Section 6).

During your treatment with Ciclesonide contact your
doctor immediately if:


breathing becomes difficult and your symptoms,
coughing, breathlessness, wheezing, tightness in the
chest, increasing noises (rhonchi) or other symptoms
of narrowing of the airways are getting worse.
(You should use your Reliever inhaler which will
normally lead quickly to an improvement.)
 you are waking up at night with your symptoms.
 you are not getting relief from using your Reliever
inhaler.
Your doctor will decide on your further treatment.

This medicine is not suitable for use in an acute attack of
breathlessness.
For quick relief from such an attack, use only your
Reliever inhaler.

2. What you need to know before
you use Ciclesonide
Do not use Ciclesonide
if you are allergic (hypersensitive) to ciclesonide or any
of the other ingredients of this medicine (listed in section
6).
Take special care with Ciclesonide
Before beginning treatment with this medicine, please
tell your doctor if:


you have ever been treated, or are currently being
treated, for pulmonary tuberculosis (TB), fungal, viral
or bacterial infections.

Check with your doctor if you are not sure. It is important
to make sure that Ciclesonide is the right medicine for
you.

Using this medicine with food and drink
There is no interaction between Ciclesonide and food
and drink.
Pregnancy, breast-feeding and fertility
Tell your doctor if you are pregnant, want to become
pregnant or are breast-feeding.


Specific patient groups
Patients with severe asthma are at risk of acute
asthma attacks. For such patients the doctor will carry
out regular thorough asthma control checks, including a
lung function test.
Patients who are already taking corticosteroid
tablets:
Ciclesonide can be used to replace your tablets, or to
reduce the number of tablets you need to take. Please
follow your doctor's instructions carefully.








What Ciclesonide is used for:
This medicine is prescribed to control persistent asthma
in adult and adolescent patients (12 years old and
more).
It helps you to breathe more easily by decreasing the
symptoms of your asthma and by lessening the chances
of an asthma attack. The effect builds up over a period
of time, so this medicine needs to be taken every day,
even when you are feeling well.

Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a
prescription.





This will start about a week after you begin your
Ciclesonide inhalations.
The number of tablets you take will be reduced
with caution over a period of time.
During this period you may sometimes suffer from a
general feeling of being unwell.
In spite of this, it is important to continue both with
your Ciclesonide inhalations and with slowly
reducing the number of tablets you take.
If you get serious symptoms such as nausea (feeling
sick), vomiting (being sick), diarrhoea or a high
temperature, contact your doctor.
This process may sometimes reveal minor allergies
such as rhinitis (inflammation of the inside of the
nose) or eczema (itchy, reddening skin).
If you have changed over from tablets, you will
continue for a time to be at risk of reduced adrenal
function, which is related to the corticosteroid tablets
you take. The symptoms of reduced adrenal function
(e.g. dizziness, fainting, nausea, loss of appetite,
moodiness, decrease in body hair, inability to cope
with stress, weakness, headaches, memory
problems, allergies, food cravings, and blood sugar
disorders) may also continue for some time.
You may also need to see a specialist to determine
the extent of the reduction in adrenal function.
Your doctor will also do regular checks on your
adrenal function.
During periods of stress, for example, having an
operation, worsening asthma attacks, it is possible
that you will need extra corticosteroid tablets. If so,
you must carry a steroid warning card which says
so.

Patients with liver or kidney disorders
There is no need to adjust the dose of ciclesonide if you
have liver or kidney problems.
If you suffer from a severe liver condition, your doctor
will check you more carefully for possible side effects
resulting from disturbance of normal steroid production.
Children below 12 years of age:
This medicine is not recommended for children below
the age of 12 because of a lack of information about its
possible effects.
Other medicines and Ciclesonide
Please inform your doctor before using Ciclesonide, if
you are currently being treated for any fungal or viral
infections with medicine containing:





ketoconazole,
itraconazole,
ritonavir,
nelfinavir.

These may intensify the action of Ciclesonide so that the
probability of side effects cannot be completely ruled
out.








Because there is not enough information about the
effects of Ciclesonide on pregnant women, your
doctor will discuss with you the risks and benefits of
using Ciclesonide.
Ciclesonide (the active ingredient in Ciclesonide)
may be taken during pregnancy only when the
possible benefits to the mother justify the possible
risk to the developing baby. If your doctor decides
that you can continue using Ciclesonide, the smallest
possible dose of ciclesonide will be used to maintain
asthma control.
The adrenal function will be carefully monitored in
children of mothers who received corticosteroids
during pregnancy.
Talk to your doctor if you want to use Ciclesonide
during breast-feeding.
It is not known whether inhaled ciclesonide passes
into the breast milk in humans.
Prescribing Ciclesonide to women who are breast
feeding will therefore only be considered if the
expected benefit to the mother outweighs the
possible risk to the child.

Ask your doctor or pharmacist for advice before taking
any medicine.
Driving and using machines
Ciclesonide and its ingredients have no or negligible
effects on the ability to drive or to use machinery.

3. How to use Ciclesonide
Always use this medicine exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.


If you have just started to use this medicine instead
of, or as well as, taking corticosteroid tablets, see
section 2, Patients who are already taking
corticosteroid tablets.

How much Ciclesonide should I take each day?
Your doctor will have spoken to you about how much of
your medicine you need to take each day. This will
depend on your individual need.




The recommended dose of Ciclesonide is 160
micrograms once daily, which leads to asthma
control in the majority of patients.
In some patients a dose reduction to 80 micrograms,
once daily, may be an adequate dose for maintaining
effective control of their asthma.
An increased dosage of Ciclesonide may become
necessary for a short period of time in patients who
suffer a severe worsening of their asthma symptoms.
This can be up to 640 micrograms per day, delivered
as 320 micrograms twice daily but no data
confirming the additional therapeutic effect after 3
months with these higher doses are available.

If necessary, your doctor may also prescribe
corticosteroid tablets and/or, in the case of an infection,
an antibiotic.
 Your doctor will adjust your dose to the minimum
necessary to control your asthma.
 You should start to notice an improvement in your
symptoms (wheezing, tight chest and coughing)
within 24 hours.
When should I use my Ciclesonide Inhaler?
In most cases, either in the morning or in the evening as one or two puffs once a day. Follow your doctor's
instructions very carefully. It is important that you take
Ciclesonide regularly every day, even if you feel better.

If you find that you have to use your Reliever inhaler
more than 2-3 times a week, you should contact your
doctor to have your medicine reviewed.
How do I use my Ciclesonide Inhaler?
It is important that a doctor, nurse or pharmacist shows
you first how to use your Ciclesonide inhaler properly. A
good technique will make sure you are receiving the
correct amount into your lungs. Please use the
instructions in this leaflet as a reminder.
You may wish to practice in front of the mirror for the
first couple of times until you are confident that you are
using your Ciclesonide properly. Make sure that none of
your medicine is escaping from the top or sides of your
mouth.
If you have a new inhaler, or if you have not used your
inhaler for a week or more, it must be tested before you
use it. Remove the mouthpiece cover and press down
three times on the canister inside the inhaler to release
three puffs into the air - away from you.
You do not need to shake your Ciclesonide before using
it. The medicine is already in a very fine solution, mixed
to ensure you receive the correct dose with each puff.
During inhalation, you can either be sitting down or
standing up.
Follow these instructions carefully and use the
pictures to guide you.
1. Remove the
mouthpiece cover and
check the mouthpiece,
both the inside and
the outside, to make
sure that it is both
clean and dry.
2. Hold the inhaler
upside down
(base of the canister
at the top) with your
forefinger on the base
of the canister and
your thumb under
the mouthpiece.
3. Breathe out as far as is comfortable. Do not breathe
out through the inhaler.
4. Place the mouthpiece
in your mouth
and close your lips
firmly around it.

5. Just after starting to breathe in through your mouth,
press down with your forefinger on the top of the
inhaler to release a puff of the medicine while you
are still breathing in slowly and deeply. Please take
care that the puff of medicine does not escape
through the top, bottom or sides of your mouth.
6. Hold your breath,
take the inhaler
from your mouth
and remove your
finger from the
top of the inhaler.
Continue holding your
breath for about ten seconds or as long as is
comfortable.
Breathe out slowly through your mouth.
Do not breathe out through the inhaler.
It is important that you do not rush steps 3 to 6.
7. If you have been
instructed to take
another puff, wait
about half a minute
and repeat steps 3 to
6.

8. After use, always replace the mouthpiece cover to
keep out dust. Replace firmly and snap into position.
9. For hygiene reasons






please clean the
mouthpiece weekly
with a dry tissue, both
inside and out.
using a dry, folded
tissue, wipe over the
front of the small hole
where the medicine comes out.
do not use water or any other liquids.

A correct technique will ensure the right amount of
Ciclesonide is getting into your lungs every time you use
your inhaler. Your doctor will check your inhalation
technique regularly to ensure that your treatment can
have the very best effect.
When the canister is completely empty you will not feel
or hear any of the propellant being discharged.
If you begin to feel wheezy or tightness in the chest
after using your Ciclesonide inhaler:
 do not take any more puffs.
 use your reliever inhaler to help your breathing.
 contact your doctor immediately.
If you find it difficult to use the inhaler, your doctor may
recommend the use of a spacer. The spacer that fits the
Ciclesonide inhaler is called AeroChamber PlusTM. If you
use the AeroChamber PlusTM device, please follow the
instructions provided with it. Your doctor or pharmacist
will be able to advise you about the device.
If you use more Ciclesonide than you should
It is important that you take your dose as advised by
your doctor. You should not increase or decrease your
dose without seeking medical advice.
There is no specific treatment necessary if you have
used too much Ciclesonide but you should inform your
doctor. If high doses are used over long periods, a
certain degree of reduction in adrenal function cannot be
ruled out and control of the adrenal function may be
necessary.
If you forget to use Ciclesonide
If you have forgotten to use your Ciclesonide, just take
your usual dose when it is next due. Do not take a
double number of puffs to make up for the forgotten
dose.
If you stop using Ciclesonide
Even if you feel better, you should not stop using your
Ciclesonide.
If you do stop using this medicine, you must tell
your doctor immediately.

4. Possible side effects






headache
bad taste
dryness of mouth or throat
nausea or vomiting

Rare side effects (may affect up to 1 in 1,000 patients
treated):
 sensation of heartbeat (palpitations)
 discomfort or pain in the abdomen
 high blood pressure
Frequency not known, but may also occur:

Sleeping problems, depression or feeling worried,
restless, nervous, over-excited or irritable. These
effects are more likely to occur in children
Ciclesonide may affect the normal production of
corticosteroids in your body. This is usually seen in
patients taking high doses over a long period of time.
These rare side effects may include:
 reduced rate of growth in adolescents
 a thinning of the bones
 possible clouding of the lens of the eye (cataracts)
causing blurred vision
 loss of vision caused by abnormally high pressure in
the eye (glaucoma)
 moon-shaped face, weight gain in the upper body
and thinning arms and legs (Cushingoid features or
Cushing syndrome).
Adolescents who are receiving treatment for a long
period of time will have their height checked regularly by
their doctor. If your growth rate is slowed, your doctor
will adjust your treatment if possible to the lowest dose
at which effective control of asthma is maintained.
Corticosteroid tablets can lead to more side effects than
a corticosteroid inhaler such as Ciclesonide. If you have
been taking steroid tablets before or during the use of
Ciclesonide, the risk of side effects from the tablets may
continue for a period of time. Regular check-ups with
your doctor will ensure that you are taking the right dose
of Ciclesonide for you. Regular check-ups will also
identify any side effects early on and reduce the
chances of them worsening.
Please remember:
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor. 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
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Ciclesonide
Keep out of the sight and reach of children.

Like all medicines, Ciclesonide 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:
• severe allergic reactions such as swelling of lips,
tongue and throat (may affect up to 1 in 1,000
patients treated)
• allergic reactions: skin rashes, redness, itching or
weals like nettle rash and hives (may affect up to 1
in 100 patients treated)
• cough, or wheezing, which gets worse soon after
taking an inhalation (may affect up to 1 in 100
patients treated)
The other side effects seen with Ciclesonide are usually
mild. In most cases you can continue with your
treatment. The side effects you may experience are:
Uncommon side effects (may affect up to 1 in 100
patients treated):
 hoarseness
 burning, inflammation, irritation of mouth or throat
 oral thrush (oral fungal infection)

Do not use your inhaler after the expiry date which is
stated on the label and the carton after EXP. The expiry
date refers to the last day of the month. The container
contains a pressurised liquid. Do not store above
50°C. The container should not be punctured, broken or
burned even if it seems empty.
As with most inhaled medicines in pressurised
containers, the healing effect of this medicinal product
may become smaller when the container is cold.
However, Ciclesonide delivers the same level of dose
from minus 10°C to plus 40°C.
If your doctor decides to stop treatment or if the inhaler
is empty, return it to your pharmacist for safe disposal.
This is important as traces of medicine could remain in
the container even if you have the impression that it
might be empty.

6. Contents of the pack and other
information
What Ciclesonide 160 Inhaler contains
 The active ingredient is ciclesonide. Each
actuation releases a puff (dose delivered through the
mouthpiece) contains 160 micrograms of
ciclesonide.
 The other ingredients are ethanol anhydrous and
Norflurane (HFA-134a,).
What Ciclesonide 160 Inhaler looks like and
contents of the pack
Ciclesonide 160 Inhaler consists of a clear and
colourless liquid in a pressurised aluminium container
which delivers through a mouthpiece an accurately
measured dose of ciclesonide in the form of a spray.
Pack sizes:
Inhaler with 60 accurately measured puffs.
Inhaler with 120 accurately measured puffs.
Each strength of inhaler contains enough for 60 or 120
puffs. Depending on the number of puffs per day your
physician has recommended you to use:
 the inhaler with 60 puffs has enough medication for
one to two months.
 the inhaler with 120 puffs contains enough
medication for two to four months.
Not all pack sizes may be marketed in all countries.
Ciclesonide 160 Inhaler is manufactured by 3M Health
Care Ltd., 3M House. Morley Street, Loughborough,
Leicestershire, UK or Takeda GmbH, Byk-Gulden
Strasse 2, 78367 Konstanz, Germany.
Procured from within the EU and repackaged in the UK
by the Product Licence Holder: CD Pharma Limited, Unit
3, Manor Point, Manor Way, Borehamwood, Herts WD6
1EE.
Ciclesonide 160 Inhaler

PL No.: 20492/0206

Date of preparation: 21st August 2014

POM

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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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