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CICLESONIDE 160 MICROGRAMS INHALER

Active substance(s): CICLESONIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Alvesco® 160 Inhaler
(ciclesonide)
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.
Your product is called Alvesco 160 Inhaler, but will be called Alvesco
throughout the remainder of this leaflet.
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).
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.
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.
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.
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.
- 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.
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 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.
- 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 breastfeeding.
- 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 practise in front of the mirror for the first couple of
times until you are confident that you are using your Alvesco inhaler
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 inhaler 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.

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
• 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
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 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
should 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.

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.

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

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 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 Plus®. If you use the AeroChamber Plus® 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 inhaler.
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 (may affect up to 1 in 1,000 patients treated)

Keep out of the sight and reach of children.
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 expose to
temperatures higher than 50°C.
The container should not be punctured, broken or burnt even when
apparently 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 contains
- The active ingredient is ciclesonide. Each actuation (delivered
dose from the mouthpiece) contains 160 micrograms of
ciclesonide.
- The other ingredients are ethanol anhydrous and Norflurane
(HFA-134a).
What Alvesco looks like and contents of the pack
Alvesco consists of a clear and colourless pressurised inhalation
solution in an aluminium container sealed with a metering valve. The
container is fitted into a brick-red actuator with a mouthpiece and a
cover. Alvesco delivers through a mouthpiece an accurately measured
dose of ciclesonide in the form of a spray.
Pack size
Inhaler with 120 accurately measured puffs.
Each inhaler contains 120 puffs. Depending on the number of puffs per
day your physician has recommended you to use:
• the inhaler with 120 puffs contains enough medication for two to
four months.
Manufacturer
Takeda GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Germany or
3M Health Care Limited, Loughborough, Leicestershire,
United Kingdom.
Procured from within the EU.
Product licence holder: Ecosse Pharmaceuticals Limited,
3 Young Place, East Kilbride, G75 0TD.
Repackaged by Munro Wholesale Medical Supplies, 3 Young Place,
East Kilbride, G75 0TD
PL 19065/0474
POM
This leaflet was revised: 18/05/2016
E0474-2
Alvesco® is a registered trade mark of Takeda GmbH

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ciclesonide 160 microgram Inhaler

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

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.
Your product is called Ciclesonide 160 microgram Inhaler but will be
called Ciclesonide throughout the remainder of this leaflet.

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.
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

What is in this leaflet:

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.
- 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 breastfeeding.
- 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.

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).
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.
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.
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.
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.
- 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.

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 practise in front of the mirror for the first couple of
times until you are confident that you are using your Ciclesonide
inhaler 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 inhaler 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.

4. POSSIBLE SIDE EFFECTS
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)
• 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 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
should 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.

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 Plus®. If you use the AeroChamber Plus® 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
inhaler.
If you do stop using this medicine, you must tell your doctor
immediately.

5. HOW TO STORE CICLESONIDE
Keep out of the sight and reach of children.
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 expose to
temperatures higher than 50°C.
The container should not be punctured, broken or burnt even when
apparently 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 contains
- The active ingredient is ciclesonide. Each actuation (delivered
dose from the mouthpiece) contains 160 micrograms of
ciclesonide.
- The other ingredients are ethanol anhydrous and Norflurane
(HFA-134a).
What Ciclesonide looks like and contents of the pack
Ciclesonide consists of a clear and colourless pressurised inhalation
solution in an aluminium container sealed with a metering valve. The
container is fitted into a brick-red actuator with a mouthpiece and a
cover. Ciclesonide delivers through a mouthpiece an accurately
measured dose of ciclesonide in the form of a spray.
Pack size
Inhaler with 120 accurately measured puffs.
Each strength of inhaler contains enough for 30, 60 or 120 puffs.
Depending on the number of puffs per day your physician has
recommended you to use:
• the inhaler with 120 puffs contains enough medication for two to
four months.
Manufacturer
Takeda GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Germany or
3M Health Care, Loughborough, Leicestershire, United Kingdom
Procured from within the EU.
Product licence holder: Ecosse Pharmaceuticals Limited,
3 Young Place, East Kilbride, G75 0TD.
Repackaged by Munro Wholesale Medical Supplies, 3 Young Place,
East Kilbride, G75 0TD
PL 19065/0474
E0474c-2
POM
This leaflet was revised: 18/05/2016

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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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