FLIXOTIDE™ INHALER
Fluticasone propionate Inhaler 25µg per actuation
and
Fluticasone propionate (CFC-Free) Inhaler 50, 125 or 250µg per
actuation
Please read this leaflet carefully before you start using
Flixotide Inhaler or Flixotide CFC-free Inhaler.
What Flixotide Inhalers ('puffers') are used
for
You may know your Inhaler better as a 'puffer'. Flixotide
puffers contain a medicine called fluticasone propionate. This
medicine belongs to a group of medicines known as
corticosteroids, frequently called 'steroids'. They are not
'anabolic steroids' which are the steroids sometimes misused by
athletes.
Your Flixotide puffer provides a measured amount of steroid
for you to breathe into your lungs. By using your Flixotide
puffer regularly every day, the medicine reduces the swelling
and irritation in the walls of the small air passages in your
lungs. Your Flixotide puffer contains the type of asthma
medicine known as a 'preventer'. It does not give immediate
relief from an asthma attack and may take up to a week to start
to work. If your shortness of breath or wheeze does not get
better after 7 days, tell your doctor. When used every day, your
Flixotide puffer helps to ease breathing problems and
prevent asthma attacks.
This medicine is only one part of a general plan to help you
manage your asthma. You should discuss this plan with your
doctor. You may also be using a 'reliever puffer'. Keep using it
according to your doctor's advice. Ask your doctor to check your
treatment regularly.
Ask your doctor if you have any questions about why a
Flixotide puffer has been prescribed for you.
The medicine in Flixotide puffers is not addictive.
Flixotide puffers generally do not cause any problems with
your ability to drive a car or operate machinery.
Before you use your Flixotide puffer
When you must NOT use it
Do not use your Flixotide puffer if you have ever had an
allergic reaction to fluticasone propionate or any of the
ingredients listed at the end of this leaflet. See "Side
Effects" section for symptoms of an allergic reaction.
Do not use your Flixotide puffer if you are pregnant,
trying to become pregnant or breastfeeding, unless your doctor
says you should. It is important that asthma is managed well
during pregnancy and you should not stop your medicine without
asking your doctor.
Your doctor will discuss the risks and benefits of using your
Flixotide puffer if you are pregnant or breastfeeding.
Do not use your Flixotide puffer after the expiry date
(EXP) printed on the pack. If you use it after the expiry date
has passed, it may not work as well.
Do not use your Flixotide puffer if the packaging is torn
or shows signs of tampering.
If you're not sure whether you should be using a Flixotide
puffer, talk to your doctor.
Before you start using your inhaler
You must tell your doctor if:
you are taking other steroid medicines by mouth or
inhalation. If you are already taking steroid tablets, you
should carry a warning card about needing extra oral steroids
during periods of stress. Discuss this with your doctor.
you have ever had to stop taking other asthma medicines.
you have tuberculosis (TB) of the lung or other long term
lung infection.
you are allergic to foods, dyes, preservatives or any
other medicines.
you are taking any other medicines, including medicines
you buy without a prescription from a pharmacy, supermarket or
health food shop.
Some medicines may affect the way other medicines work. Your
doctor or pharmacist will be able to tell you what to do when
using your Flixotide puffer with other medicines.
Using your Flixotide puffer
How to use it
Remember that the medicine in your Flixotide puffer is taken
by inhalation only.
You will find the instructions on how to use your Flixotide
puffer on the leaflet in the pack. Follow the instructions
carefully.
How much to use
The pharmacist's label will usually tell you how many
inhalations and how often to use your Flixotide puffer. If you
are not sure, ask your doctor or pharmacist.
For adults and children over 16 years of age: The usual dose
is in the range of 100 to 1000 micrograms twice daily.
For children over 4 years: The usual dose is in the range of
50 to 200 micrograms twice daily.
For children from 1 to 4 years of age, the usual dose is 100
micrograms twice daily. The medicine is usually breathed in
using a device called a 'spacer', with a facemask. Your doctor
or pharmacist will explain to you what this is and how to use
it.
Your doctor will decide what dose you should take, how often
you should take it, and what strength of Flixotide puffer you
should use.
You should visit your doctor or pharmacist regularly to check
that you are using your Flixotide puffer correctly. If you are
not breathing the medicine in properly, the medicine may not be
helping you as much as it could.
If you find it difficult to breathe in and press your
Flixotide Inhaler at the same time, talk to your doctor or
pharmacist. It may be better for you to use something called a
Volumatic(tm) with your Flixotide Inhaler. Your doctor or
pharmacist will explain to you what this is and how to use it.
When not to use it
Do not use your Flixotide puffer to treat a sudden attack of
breathlessness. You will need a different kind of medicine
called a 'reliever' which your doctor will have told you to
take.
How long to use it
You must use your Flixotide puffer every
day. Do not stop using it, even if you feel better, unless your
doctor tells you.
If you forget to use it
You must use your Flixotide puffer every day. If you forget
to take a dose, do not worry. Just take the next dose when it is
due.
Do not take a double dose to make up for the dose that you
missed.
If you become wheezy or feel tight in the chest before the
next dose is due, use a 'reliever puffer' in the usual way. You
should get relief from your 'reliever puffer' within a few
minutes.
If you have used too much (overdose)
Immediately telephone your doctor or Poisons Information
Centre (0800 POISON or 0800 764 766) for advice, if you think
you may have taken too much of your medicine, even if there are
no signs of discomfort or poisoning. You may need urgent medical
attention.
Keep telephone numbers for these places handy.
If you are not sure what to do, contact your doctor or
pharmacist.
While you are using your Flixotide puffer
Things you must do
Tell your doctor or pharmacist that you are using a Flixotide
puffer if you are about to be started on any new medicines.
If you have to go into hospital for an operation, take your
Flixotide puffer with you and tell the doctor what medicine(s)
you are taking.
All doctors treating you need to be aware that you are on
inhaled steroids. If your body is stressed by, for example,
severe infection, surgical operation, an accident etc, you may
need steroid tablets or injections for a time.
Tell your doctor if you become pregnant or are trying to
become pregnant .
Tell your doctor if, for any reason, you have not taken your
medicine exactly as prescribed. Otherwise, your doctor may think
that your medicine was not effective and change your treatment
unnecessarily.
Things you must not do
Do not stop using your Flixotide puffer, or change the dose
without first checking with your doctor.
Do not give this medicine to anyone else, even if their
symptoms seem similar to yours.
Do not use your Flixotide puffer to treat any other
complaints unless your doctor says to.
If your Flixotide puffer does not have the
usual effect
If your chest condition gets worse, tell your doctor. Your
doctor may tell you to take extra puffs of your Flixotide puffer
or add another medicine (such as a 'reliever puffer') to your
treatment.
IMPORTANT: If your breathing suddenly becomes more difficult
just after you have used your Flixotide puffer, 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
Check with your doctor as soon as possible if you have any
problems while using your Flixotide puffer, even if you do not
think the problems are connected with the medicine, or are not
listed in this leaflet.
Like other medicines, Flixotide puffers may cause some
side-effects. If they occur, they are most likely to be minor
and temporary. However, some may be serious and need medical
attention.
The most commonly reported side-effects are:
a sore throat or tongue. This may be due to 'thrush' (candida
infection)
hoarseness or throat irritation.
For these, it may be helpful to rinse your mouth with water
and spit it out after using your Flixotide puffer. Your doctor
may prescribe a treatment for the 'thrush' in your mouth while
you continue to use your Flixotide puffer.
Rarely, Flixotide can cause swelling of the throat and face.
Taking high doses of steroids for a long time, may affect
bone density, or affect the rate of growth in children. It is
unclear what, if any, difference this makes to their final
height. Taking high doses of steroids for a long time could
affect the adrenal glands, which make the body's own steroid.
Your doctor may do tests to check how the adrenal glands are
working. Your doctor will be able to answer any questions you
may have.
If you feel unwell in any other way or have any symptoms that
you do not understand, you should ask your doctor immediately.
Ask your doctor or pharmacist to answer any questions you may
have.
If you think you are having an allergic reaction to your
Flixotide puffer, tell your doctor immediately or go to the
Accident and Emergency department at your nearest hospital.
Symptoms usually include some or all of the following:
wheezing
swelling of the lips/mouth
difficulty in breathing
hay fever
lumpy rash ("hives")
fainting.
This is not a complete list of all possible side-effects.
Others may occur in some people and there may be some
side-effects not yet known.
Tell your doctor if you notice anything else that is making
you feel unwell, even if it is not on this list.
Ask your doctor or pharmacist if you don't understand
anything in this list.
Do not be alarmed by this list of possible side-effects. You
may not experience any of them.
After using your Flixotide puffer
Storage
Keep this medicine where young children cannot reach it. A
locked cupboard at least one-and-a half metres above the ground
is a good place to store medicines.
Keep your Flixotide puffer away from heat (store below 30°C),
and bright sunlight.
Keep your Flixotide puffer away from frost. Do not put it in
the refrigerator.
Do not leave it in the car or on window sills. Heat can
destroy some medicines.
If your Flixotide puffer becomes very cold, it may not work
properly. To warm it, pull out the metal can from its plastic
holder and warm it in your hand for a few minutes. Do not warm
the can in any other way. Push the can firmly back into its
holder before using.
Glaxo Wellcome inhalers are designed to give out a metered
dose of medication until they are empty.
You can estimate the number of doses left in your puffer by
shaking the inhaler, or calculating approximately the number of
doses that have been used, or keeping a record of the number of
doses you have used up.
On average, Glaxo Wellcome includes 10% more active doses in
each inhaler than is specified on the label.
Floating the puffer in water to estimate the amount of doses
left in the puffer is not recommended. Water may enter the valve
in the puffer, which may affect the accuracy of later doses. The
humidity from the water may also encourage bacteria to grow in
the valve.
You should always carry a spare puffer.
Disposal
If your doctor tells you to stop using your Flixotide puffer,
or the product has passed its expiry date, ask your pharmacist
what to do with any Flixotide puffer left over.
WARNING: The metal can is pressurised. Do not burn it or
puncture it, even when it is empty.
You can recycle the plastic holder and cap of your Flixotide
puffer with other plastic things.
Product Description
What Flixotide puffer looks like
A Flixotide puffer consists of a plastic holder which
contains a small metal can. The holder has a mouthpiece which is
covered by a cap.
Ingredients
Flixotide puffers contain the medicine called fluticasone
propionate. They are available in the following strengths:
- Flixotide Inhaler, containing 25 micrograms of fluticasone
propionate in each puff.
- Flixotide Inhaler (CFC-free), containing 50 micrograms of
fluticasone propionate in each puff.
- Flixotide (CFC-free) Inhaler, containing 125 micrograms of
fluticasone propionate in each puff.
- Flixotide (CFC-free) Inhaler, containing 250 micrograms of
fluticasone propionate in each puff.
Flixotide Inhaler puffers also contain the inactive
ingredients lecithin, trichlorofluoromethane and
dichlorodifluoromethane.
Flixotide (CFC-free) Inhaler puffers contain the inactive
ingredient norflurane.
Each Flixotide can contains 120 puffs.
Other types of asthma medicines
Your Flixotide puffer contains the kind of asthma medicine
known as a 'preventer'. There are other types of inhalers that
relieve your breathing problems when you are
wheezing or your chest is tight. These medicines are called
'relievers'. Your doctor may tell you to use a 'reliever' in
addition to your Flixotide puffer.
