General Information
Consumer Medicine Information
What is in
this leaflet
This leaflet answers some
common questions about Alvesco.
It does
not contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines
have risks and benefits. Your doctor has
weighed the risks of you using Alvesco against
the benefits he/she expects it will have for
you.
If you have any concerns about
using this medicine, ask your doctor or
pharmacist.
Keep this leaflet with the
medicine. You may need to read it again.
What Alvesco is used for
Alvesco is
inhaled into the lungs for the treatment of
asthma. Asthma is a disease where the lining of
the lungs becomes inflamed (red and swollen),
making it difficult to breathe.
Alvesco
contains a medicine called ciclesonide, which
belongs to a family of medicines called
corticosteroids.
Alvesco metered dose
inhalers deliver a measured amount of
ciclesonide, which acts directly on your air
passages to reduce inflammation and help keep
the air passages open.
In doing so, this
medication helps to improve your condition and
to prevent asthma attacks from occurring. It is
a 'preventer' and needs to be taken regularly.
Alvesco will NOT give you immediate
relief of wheezing or breathlessness during
sudden, severe or continuous asthma attacks. In
this situation you should use a quick acting
"reliever" inhaler, which contains a different
medicine, a so-called bronchodilator.
Your doctor may prescribe Alvesco to
replace corticosteroid tablets, which will mean
that you need to take both medicines for a
short period of time. It is important to follow
your doctor's instructions for taking your
medicines.
Alvesco is available only
with a doctor's prescription.
Before you
use Alvesco
When you must not use it
Do not use Alvesco if you have an allergy
to ciclesonide or any of the ingredients listed
at the end of this leaflet. Some of the
symptoms of an allergic reaction may include
shortness of breath, wheezing or difficulty
breathing; swelling of the face, lips, tongue
or other parts of the body; rash, itching or
hives on the skin.
Do not use Alvesco to
treat an acute asthma attack.
Alvesco is
not recommended for use in children under 5
years of age.
Do not use Alvesco after
the expiry date (EXP) printed on the pack. If
you take this medication after the expiry date
has passed, it may not work as well.
Do
not use Alvesco if the packaging is torn or
shows signs of tampering.
If you are not
sure whether you should start using Alvesco,
contact your doctor.
Before you start to
use it
Tell your doctor if you have
allergies to:
any other medicines
to any
other substances, such as foods, preservatives
or dyes
Tell your doctor if you are
being treated for any fungal infections. Some
treatments may interact with Alvesco.
Tell your doctor if you are pregnant or
intend to become pregnant. Like most medicines
Alvesco is not recommended during pregnancy. If
it is necessary for you to use Alvesco, your
doctor will discuss the risks and benefits of
using it during pregnancy.
Tell your
doctor if you are breastfeeding or plan to
breastfeed. Your doctor will discuss the
possible risks and benefits of using Alvesco
while breastfeeding.
Tell your doctor if
you currently have an infection. If you take
Alvesco while you have an infection, the
medication may hide some of the signs of an
infection.
This may make you think,
mistakenly, that you are better or that it is
not serious.
Tell your doctor if you
have or have had tuberculosis (TB).
Also
tell your doctor if you have or are currently
suffering from liver disease.
Using
other medicines
Tell your doctor if you
are using any other medicines, including any
that you buy without a prescription from your
pharmacy, supermarket or health food shop.
It is especially important that you notify
your doctor if you are taking any medicine to
treat fungal infections, such as ketoconazole,
as these medicines may affect the way Alvesco
works.
How to use Alvesco
The
correct way to use your Alvesco inhaler is
explained on the instructions for use leaflet
that comes inside the Alvesco package. If you
do not use your Alvesco inhaler correctly your
lungs might get less medicine than needed. So
please read these instructions carefully before
you start.
To make sure your Alvesco
inhaler delivers the correct dose you should
clean it regularly as outlined in the
instruction leaflet.
Your doctor may
have advised that you use a spacer device with
your inhaler. This is also recommended for
children 6-11 years of age.
If so, the
AeroChamber Plus is considered a suitable
device for use with Alvesco.
If you are
not sure how to use an inhaler, ask your doctor
or pharmacist.
How much to use
Your doctor will have spoken to you about
how much of your medicine you need to take and
this will depend on your individual need.
Your doctor will normally start you on 80
micrograms once daily, if you are not currently
using a preventer medication. Otherwise your
starting dose will depend on your current
medication and how well your asthma is
controlled.
There are 2 strengths of
Alvesco and your doctor will have chosen the
one which best suits your asthma. The number of
puffs you are required to take daily will
depend on the strength of Alvesco you are
using.
Your doctor may adjust your dose
so that you are taking the lowest dose of
Alvesco that will control your symptoms.
When your doctor is changing you from a
corticosteroid tablet to Alvesco, you will be
asked to take both medicines for a period of
time. Your dose of corticosteroid tablets will
gradually be reduced to the lowest possible
level. It is important you follow your doctor's
instructions.
If you forget to use
it
If you forget to use your Alvesco
inhaler, just take the next dose when it is
due. DO NOT take a double number of puffs to
make up for the missed dose.
If you are
not sure what to do, ask your doctor or
pharmacist.
How long to use it
Alvesco helps control your asthma .
Therefore you must use Alvesco every day.
Continue using Alvesco for as long as your
doctor tells you.
Do not stop using it
unless your doctor tells you to - even if you
feel better.
If you use too much
(overdose)
Do not use more puffs than
the recommended dose unless your doctor tells
you to.
The risk of effects from taking
too many puffs of Alvesco is low. But, if you
are worried that you or anyone else may have
used too much Alvesco telephone your doctor or
pharmacist, or the Poisons Information Centre
(in Australia call 131126; in New Zealand call
0800 764 766).
While you are using
Alvesco
Things you must do
If you
have an Asthma Management plan continue to
follow it closely.
Tell your doctor or
pharmacist that you are using Alvesco if you
are about to be started on any new medicines.
Tell your doctor or pharmacist if you
feel the effect of Alvesco is too strong or too
weak.
If you plan to have surgery (that
needs a general anaesthetic), tell your doctor
or dentist that you are using Alvesco.
If you become pregnant while using Alvesco,
tell your doctor.
Things you must not
do
Do not take any other medicines for
your breathing problems without checking with
your doctor.
Do not give Alvesco to
anyone else, even if they have the same
condition as you.
Do not use Alvesco to
treat any other complaints unless your doctor
or pharmacist tells you to.
Do not stop
using Alvesco, or lower the dosage, without
checking with your doctor or pharmacist.
Things to be careful of
If Alvesco
does not have its usual effect
If your
asthma gets worse, tell your doctor. Your
doctor may tell you to take extra puffs of
Alvesco or add another medicine (such as a
'reliever puffer') to your treatment.
If
your breathing suddenly becomes more difficult
just after you have used Alvesco, you will need
to use a 'reliever puffer' and tell your doctor
immediately.
Tell your doctor as soon as
possible if:
your 'reliever puffer' does not
help your breathing as much as usual
the
effect of your 'reliever puffer' does not last
as long as usual
you need more puffs of
your 'reliever puffer' than usual to get
relief.
Side effects
Tell your
doctor or pharmacist as soon as possible if you
do not feel well while you are using Alvesco.
All medicines can have side effects. Sometimes
they are serious, most of the time they are
not. You may need medical treatment if you get
some of the side effects.
Ask your
doctor or pharmacist to answer any questions
you may have.
Tell your doctor or
pharmacist if you notice any of the following
and they worry you:
hoarse voice
increased difficulty in breathing
immediately following the use of Alvesco.
If you experience any of the following,
tell your doctor immediately or go to Accident
and Emergency at your nearest hospital:
swelling of the lips, mouth or tongue.
You may need urgent medical attention or
hospitalisation.
Other side effects not
listed above may occur in some patients. Tell
your doctor or pharmacist if you notice
anything else that is making you feel unwell.
Corticosteroid tablets can lead to more
side effects than a corticosteroid inhaler such
as Alvesco. If you have been taking
corticosteroids before or during the use of
Alvesco, the risk of these side effects may
continue for a period of time.
If you
get any side effects, do not stop using Alvesco
without first talking to your doctor or
pharmacist.
Alvesco does not cause any
problems with your ability to drive a car or
operate machinery.
There is no evidence
that Alvesco is addictive.
After using
Alvesco
Cleaning
The correct way
to clean your Alvesco inhaler is explained on
the instructions for use leaflet that comes
inside the Alvesco package.
Storage
Keep your inhaler in a cool dry place where
the temperature stays below 25°C.
Do not
store Alvesco or any other medicine in the
bathroom or near a sink.
Do not leave it
in the car on hot days or on windowsills. Heat
and dampness can destroy some medicines.
Keep it where children cannot reach it. A
locked cupboard at least one-and-a-half metres
above the ground is a good place to store
Alvesco.
Disposal
If your doctor
tells you to stop using Alvesco or it has
passed its expiry date, ask your pharmacist
what to do with any of the medicine that is
left over.
Do not puncture or incinerate
even when empty as the canister may explode.
Product description
What it
looks like
The Alvesco inhaler comprises
an aluminium canister inside a plastic inhaler
unit. The inhaler unit has a mouthpiece and a
plastic cover.
Alvesco comes in two
different strengths:
Alvesco 80 (AUST R
93724) - each puff delivers 80 micrograms of
ciclesonide.
Each inhaler contains 120
puffs.
Alvesco 160 (AUST R 93725) - each
puff delivers 160 micrograms of ciclesonide.
Alvesco 160 is available containing
either 60 puffs or 120 puffs.
Ingredients
Active ingredients:
ciclesonide
Other ingredients:
norflurane (a non-CFC propellant which does
not deplete ozone from the atmosphere)
ethanol
Alvesco does not contain
lactose, sucrose, gluten, tartrazine or any
other azo dyes.
Sponsor/Distributor
Nycomed Pty Ltd
2-4 Lyonpark
Road
North Ryde NSW 2113
Australia
For
medical enquiries, call (AUST) 1800 675 957
Alvesco® is a registered trademark of
Nycomed GmbH.
This leaflet was prepared
in July 2008.