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ALVESCO TAKEDA 80 INHALER
Active substance(s): CICLESONIDE
PACKAGE LEAFLET: INFORMATION FOR THE USER
Alvesco Takeda 40, 80 and 160 micrograms
pressurised inhalation, solution
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
- 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 Takeda is and what it is used for
2. What you need to know before you use
3. How to use Alvesco Takeda
4. Possible side effects
5. How to store Alvesco Takeda
6. Contents of the pack and other information
1. WHAT ALVESCO TAKEDA IS AND
WHAT IT IS USED FOR
What Alvesco Takeda is:
Alvesco Takeda 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).
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 Takeda
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 Takeda on pregnant
women, your doctor will discuss with you the
risks and benefits of using Alvesco Takeda.
- Ciclesonide (the active ingredient in Alvesco
Takeda) 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 Takeda, the smallest possible dose of
ciclesonide will be used to maintain asthma
- 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
Takeda during breast-feeding.
- It is not known whether inhaled ciclesonide
passes into the breast milk in humans.
- Prescribing Alvesco Takeda 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 Takeda and its ingredients have no or
negligible effects on the ability to drive or to use
3. HOW TO USE ALVESCO TAKEDA
What Alvesco Takeda is used for:
This medicine is prescribed to control persistent
asthma in adult and adolescent patients (12 years
old and more).
Always use this medicine exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
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.
• 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.
This medicine is not suitable for use in an
acute attack of breathlessness. For quick
relief from such an attack, use only your
2. WHAT YOU NEED TO KNOW BEFORE
YOU USE ALVESCO TAKEDA
Do not use Alvesco Takeda
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 Takeda
• 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 Takeda is the
right medicine for you.
During your treatment with Alvesco Takeda
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
(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
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
Alvesco Takeda can be used to replace your
tablets, or to reduce the number of tablets
you need to take. Please follow your doctor’s
- This will start about a week after you begin your
Alvesco Takeda 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 Takeda 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
- 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
- Your doctor will also do regular checks on your
- 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
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 Takeda
Please inform your doctor before using Alvesco
Takeda, if you are currently being treated for any
fungal or viral infections with medicine containing:
These may intensify the action of Alvesco Takeda
so that the probability of side effects cannot be
completely ruled out.
How much Alvesco Takeda 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 Takeda 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 Takeda 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 Takeda 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 Takeda 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
How do I use my Alvesco Takeda inhaler?
Follow the instructions below. If you have any
questions, ask your doctor, nurse or pharmacist.
Your Alvesco Takeda inhaler is fitted with a dose
indicator which shows you how much of your
medicine is left during use. The dose indicator
display will move every tenth time you take a
puff. The dose indicator display window will turn
red when there are only 20 puffs remaining. This
means that you need to replace your inhaler soon.
The canister should be discarded when the dose
indicator display window shows zero.
While your inhaler is fitted with a dose indicator to
help determine the approximate number of puffs
remaining, you should keep track of the number
of puffs used from each canister of Alvesco Takeda
(see Step 10 below).
On the first use of your Alvesco Takeda inhaler, as
with all aerosol medicine, you should “test spray”
the inhaler. To do this, remove the plastic cap and
check the dose indicator on top of the inhaler to
ensure that the dose indicator display window
pointer is before the “60” (for the 60 puff pack)
or “120” (for the 120 puff pack) inhalation mark
before the first use. The “test spray” should also
be done if the inhaler has not been used for a week
or more. Spray 3 times into the air, away from the
face by pressing firmly onto the centre (not ‘off
centre’) of the dose indicator button, indicated
by the middle of the three concentric rings on
the button (see Figure 1). Be sure the canister is
firmly seated in the actuator before each use and
that you press the inhaler slowly and firmly until it
moves no further in the actuator for each spray.
You do not need to shake your Alvesco Takeda
inhaler before using it. The medicine is already in a
very fine solution, mixed to ensure you receive the
correct dose with each puff.
Check the dose indicator before the first use after
the “test spray.” Check that the dose indicator
display window shows that the correct number of
inhalations is left in the inhaler. If you have been
prescribed a 60 puff pack, the dose indicator
display window should show that there are 60
inhalations left in the inhaler. If you have been
prescribed a 120 puff pack, the dose indicator
display window should show that there are 120
inhalations left in the inhaler. If this is not the case,
please return it to the pharmacy.
Instructions for use
It is important that a doctor, nurse or pharmacist
shows you first how to use your Alvesco Takeda
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
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 Takeda inhaler
properly. Make sure that none of your medicine is
escaping from the top or sides of your mouth.
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Alvesco Takeda 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
• 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 Takeda
are usually mild. In most cases you can continue
with your treatment. The side effects you may
Uncommon side effects (may affect up to 1 in 100
• burning, inflammation, irritation of mouth or throat
• oral thrush (oral fungal infection)
• bad taste
• dryness of mouth or throat
• nausea or vomiting
Rare side effects (may affect up to 1 in 1,000
• sensation of heartbeat (palpitations)
• discomfort or pain in the abdomen
• high blood pressure
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
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.
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 Takeda 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
Takeda. If you have been taking steroid tablets
before or during the use of Alvesco Takeda, 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 Takeda for you. Regular check-ups will also
identify any side effects early on and reduce the
chances of them worsening.
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:
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE ALVESCO TAKEDA
Keep out of the sight and reach of children.
7. If you have been instructed to take another
puff, wait about half a minute and repeat steps
3 to 6.
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.
8. After use, always replace the mouthpiece cover
to keep out dust. Replace firmly and snap into
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.
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 Takeda 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.
10 DISCARD THE ALVESCO TAKEDA INHALER
WHEN THE DOSE INDICATOR DISPLAY WINDOW
SHOWS ZERO. The correct amount of medicine in
each inhalation cannot be assured after this point.
Note: If the inhaler is dropped, do not rely on the
dose indicator. It is recommended to keep track of
the number of inhalations taken from your inhaler
based on your records.
If you begin to feel wheezy or tightness in the
chest after using your Alvesco Takeda inhaler:
• do not take any more puffs.
• use your reliever inhaler to help your
• 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 Takeda 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 Takeda 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
There is no specific treatment necessary if you
have used too much Alvesco Takeda 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 Takeda
If you have forgotten to use your Alvesco Takeda,
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 Takeda
Even if you feel better, you should not stop using
your Alvesco Takeda inhaler.
If you do stop using this medicine, you must tell
your doctor immediately.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.
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 Takeda 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
What Alvesco Takeda contains
- The active ingredient is ciclesonide. Each
actuation releases a puff (dose delivered through
the mouthpiece) that contains either 40, 80 or
160 micrograms of ciclesonide.
- The other ingredients are anhydrous ethanol
and propellant (HFA-134a, Norflurane).
What Alvesco Takeda looks like and contents
of the pack
Alvesco Takeda 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. The inhaler is fitted with a dose indicator to
show you how much of your medicine is left in the
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.
Marketing Authorisation Holder
This medicinal product is authorised in the
Member States of the EEA under the following
Alvesco Takeda 160<80><40> Inhalator
Alvesco Takeda160<80><40> Inhaler
This leaflet was last revised in 04/2015