ALVESCO 160 INHALER

Active substance: CICLESONIDE

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By shahs at 6:28 pm, Jun 11, 2012

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Patient Information Leaflet
®

ALVESCO 160 INHALER
ciclesonide

During your treatment with Alvesco contact your doctor
immediately if:


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.





Keep this leaflet. You may need to read it again.
If you have further questions, ask your doctor or your
pharmacist.
This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
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.

In this leaflet:
1. What Alvesco is and what it is used for?
2. Before you use Alvesco (this section contains
important information for your safety)
3. How to use Alvesco
4. Possible side effects
5. Storing Alvesco
6. Further information




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 medication is ciclesonide.
(for the other ingredients, see section 6)
What Alvesco is used for:
This medicine is prescribed to control persistent asthma
in adult and adolescent patients (12 years old or more).
It helps you 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.
This medicine is not suitable for use in an attack of
breathlessness.
For quick relief from such an attack, use only you reliever
inhaler.

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.

taking or have recently taken any other medicines,
including medicines obtained without a
prescription.
Using this medicine with food and drink
There is no interaction between Alvesco and food and
drink.
Pregnancy and breast-feeding
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.

















2. Before using Alvesco
Do not use Alvesco:
If you are allergic (hypersensitive) to ciclesonide or to
any of the other ingredients. (See section 6).

breathing becomes distressful and your symptoms,
coughing, breathlessness, wheezing, tightness in the
chest, increasing noises (rhonchi) or other symptoms
of narrowing of the bronchi 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.



1. What Alvesco is and what it is
used for?

variation 9 - To add a new manufacturing site ‘Nycomed GmbH,
Byk-Guilden Strasse
Please tell your doctor or pharmacist if you are 2, 78467 Konstanz, use my Alvesco?
When should I Germany’

previously assessed against the UK PIL granted 18/05/2011

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 reduction of the 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 disorder
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.
Using other medicines
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 Alvesco exactly as your doctor has
instructed you. You should check with your doctor or
pharmacist if you are unsure.


If you have just started to use Alvesco 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.

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?
It is important that a doctor, nurse or pharmacist shows
you first how to use your Alvesco 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 practise 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 of the inhaler 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
outside, to make sure
that it is 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 an
other 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 regularly
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:
 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 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:
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 adrenal function cannot be ruled out
and control of the adrenal function may be necessary.
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 forget to use Alvesco:
If you have forgotten to use your Alvesco, just take the
next 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
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 (fewer than 1 of 1,000 patients
treated)
• allergic reactions: skin rashes, redness, itching or
weals like nettle rash and hives (fewer than 1 in
every 100 patients treated)
• cough, or wheezing, which gets worse soon after
taking an inhalation (fewer than 1 in every 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 (fewer than 1 in every 100
patients treated):
 hoarseness
 burning, inflammation, irritation of mouth or throat
 oral thrush (oral fungal infection)
 headache
 bad taste
 dryness of mouth or throat
 nausea or vomiting
Rare side effects (fewer than 1 of 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.
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.

5. Storing Alvesco
Keep out of the reach and sight of children.
Do not pierce or burn container when empty.
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 that month.
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. Further 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,).
This medicinal product contains small amounts of
ethanol (alcohol), less than 100mg per 160 micrograms.
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 Nycomed 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 ALTANA Pharma
AG.
Date of preparation: 23rd January 2012

POM

Patient Information Leaflet

CICLESONIDE 160 INHALER
This product is called Ciclesonide 160 Inhaler but will be
referred to as Ciclesonide throughout this leaflet.

During your treatment with Ciclesonide contact your
doctor immediately if:


Read all of this leaflet carefully before you start using
this medicine.





Keep this leaflet. You may need to read it again.
If you have further questions, ask your doctor or your
pharmacist.
This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
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.

In this leaflet:
1. What Ciclesonide is and what it is used for?
2. Before you use Ciclesonide (this section contains
important information for your safety)
3. How to use Ciclesonide
4. Possible side effects
5. Storing Ciclesonide
6. Further information




breathing becomes distressful and your symptoms,
coughing, breathlessness, wheezing, tightness in the
chest, increasing noises (rhonchi) or other symptoms
of narrowing of the bronchi 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.

Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a
prescription.
Using this medicine with food and drink
There is no interaction between Ciclesonide and food
and drink.
Pregnancy and breast-feeding
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.



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.





1. What Ciclesonide is and what it is
used for?

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.








The active ingredient in this medication is ciclesonide.
(for the other ingredients, see section 6)



What Ciclesonide is used for:
This medicine is prescribed to control persistent asthma
in adult and adolescent patients (12 years old or more).



It helps you 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.
This medicine is not suitable for use in an attack of
breathlessness.
For quick relief from such an attack, use only you reliever
inhaler.

2. Before using Ciclesonide
Do not use Ciclesonide:
If you are allergic (hypersensitive) to ciclesonide or to
any of the other ingredients. (See 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.





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 reduction of the 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 disorder
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.
Using other medicines
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 Ciclesonide exactly as your doctor has
instructed you. You should check with your doctor or
pharmacist if you are unsure.


If you have just started to use Ciclesonide 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?
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?
It is important that a doctor, nurse or pharmacist shows
you first how to use your Ciclesonide 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 practise 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 of the inhaler 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
outside, to make sure
that it is 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.

If you find it difficult to use the inhaler, your doctor may
recommend the use of a spacer. The spacer that fits the
Ciclesonide 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:
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 adrenal function cannot be ruled out
and control of the adrenal function may be necessary.
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 forget to use Ciclesonide:
If you have forgotten to use your Ciclesonide, just take
the next 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.

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.

Like all medicines, Ciclesonide can cause side effects,
although not everybody gets them.

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.

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 (fewer than 1 of 1,000 patients
treated)
• allergic reactions: skin rashes, redness, itching or
weals like nettle rash and hives (fewer than 1 in
every 100 patients treated)
• cough, or wheezing, which gets worse soon after
taking an inhalation (fewer than 1 in every 100
patients treated)

It is important that you do not rush steps 3 to 6

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:

7. If you have been
instructed to take an
other 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 regularly
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:
 Do not take any more puffs.
 Use your reliever inhaler to help your breathing
 Contact your doctor immediately.

4. Possible side effects

Uncommon side effects (fewer than 1 in every 100
patients treated):
 hoarseness
 burning, inflammation, irritation of mouth or throat
 oral thrush (oral fungal infection)
 headache
 bad taste
 dryness of mouth or throat
 nausea or vomiting
Rare side effects (fewer than 1 of 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.

5. Storing Ciclesonide
Keep out of the reach and sight of children.
Do not pierce or burn container when empty
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 that month.
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. Further information
What Ciclesonide 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,).
This medicinal product contains small amounts of
ethanol (alcohol), less than 100mg per 160 micrograms.
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.
Ciclesonide 160 Inhaler is manufactured by 3M Health
Care Ltd., 3M House. Morley Street, Loughborough,
Leicestershire, UK or Nycomed GmbG, Byk-Gulden
Strasse 2, 78467 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

POM
rd

Date of preparation: 23 January 2012

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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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