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ALVESCO 80 INHALER

Active substance: CICLESONIDE

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PATIENT INFORMATION LEAFLET

2636
16.03.15[2]

Alvesco® 80 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 medicine is available by using the above name but will be referred to
as Alvesco throughout the leaflet. Alvesco Inhaler is also available in
other strengths.
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.

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 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.

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.

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.

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

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.

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.

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.

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.

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.

2.

When the canister is completely empty you will not feel or hear any of the
propellant being discharged.

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.

If you begin to feel wheezy or tightness in the chest after using your
Alvesco inhaler:
 do not take any more puffs.
 use your reliever inhaler to help your breathing.
 contact your doctor immediately.

If you find it difficult to use the inhaler, your doctor may recommend the
use of a spacer. The spacer that fits the Alvesco inhaler is called
AeroChamber PlusTM. If you use the AeroChamber PlusTM device, please
follow the instructions provided with it. Your doctor or pharmacist will be
able to advise you about the device.
If you use more Alvesco than you should
It is important that you take your dose as advised by your doctor. You
should not increase or decrease your dose without seeking medical
advice.
There is no specific treatment necessary if you have used too much
Alvesco but you should inform your doctor. If high doses are used over
long periods, a certain degree of reduction in adrenal function cannot be
ruled out and control of the adrenal function may be necessary.
If you forget to use Alvesco
If you have forgotten to use your Alvesco, just take your usual dose when
it is next due. Do not take a double number of puffs to make up for the
forgotten dose.
If you stop using Alvesco
Even if you feel better, you should not stop using your Alvesco 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)
 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 rare side effects may include:
 reduced rate of growth in adolescents
 a thinning of the bones
 possible clouding of the lens of the eye (cataracts) causing blurred
vision
 loss of vision caused by abnormally high pressure in the eye
(glaucoma)
 moon-shaped face, weight gain in the upper body and thinning arms
and legs (Cushingoid features or Cushing syndrome).
Adolescents who are receiving treatment for a long period of time will
have their height checked regularly by their doctor. If your growth rate is
slowed, your doctor will adjust your treatment if possible to the lowest
dose at which effective control of asthma is maintained.
Corticosteroid tablets can lead to more side effects than a corticosteroid
inhaler such as Alvesco. If you have been taking steroid tablets before or
during the use of Alvesco, the risk of side effects from the tablets may
continue for a period of time. Regular check-ups with your doctor will
ensure that you are taking the right dose of Alvesco for you. Regular
check-ups will also identify any side effects early on and reduce the
chances of them worsening.
Please remember:
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible
side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Alvesco
Keep out of the sight and reach of children.
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.
The container contains a pressurised liquid. Do not store above
50°C.
The container should not be punctured, broken or burned even if it seems
empty.
As with most inhaled medicines in pressurised containers, the healing
effect of this medicinal product may become smaller when the container
is cold. However, Alvesco delivers the same level of dose from minus
10°C to plus 40°C.
If your doctor decides to stop treatment or if the inhaler is empty, return it
to your pharmacist for safe disposal. This is important as traces of
medicine could remain in the container even if you have the impression
that it might be empty.
If the inhaler fails to work properly or shows signs of any deterioration you
should seek the advice of your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. Contents of the pack and other information
What Alvesco contains
 The active ingredient is ciclesonide. Each actuation releases a puff
(dose delivered through the mouthpiece) that contains 80 micrograms
of ciclesonide.
 The other ingredients are anhydrous ethanol and propellant (HFA134a, Norflurane).
What Alvesco looks like and contents of the pack
Alvesco consists of a clear and colourless liquid in a pressurised
aluminium container which delivers through a mouthpiece with a brown
plastic casing and a brick red cap an accurately measured dose of
ciclesonide in the form of a spray.
Pack sizes:
Inhaler with 60 accurately measured puffs.
Two Inhalers with 60 accurately measured puffs.
Inhaler with 120 accurately measured puffs.
Each 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.

Manufacturer and Product Licence Holder
Manufactured by Takeda GmbH, Byk-Gulden-Strasse. 2, D-78467
Konstanz, Germany and procured from the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL. No: 20636/2636

This leaflet was revised on 16.03.15[2]
Alvesco is a trademark of Takeda GmbH.

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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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