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Consumer Medicine Information
Product Information (Intended for Healthcare Professional)
Flixotide®
What FLIXOTIDE is used for
Before you use your FLIXOTIDE
While you are using your FLIXOTIDE
Side-Effects?
The following text appears in the FLIXOTIDE JUNIOR INHALER, CFC-FREE INHALER and JUNIOR CFC-FREE INHALER ['PUFFER'] Consumer Medicine Information. This information is intended for patients who have been prescribed [BrandName] FLIXOTIDE JUNIOR INHALER, CFC-FREE INHALER and JUNIOR CFC-FREE INHALER ['PUFFER']. Please view Consumer Medicine Information and see your doctor for more information.
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 onepart 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.
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Before you take your Flixotide puffer
When you must not use it
- Do not use your Flixotide Junior (CFC-Free) and Flixotide (CFC-Free) puffer if you have ever had an allergic reaction to fluticasone propionate or any of the ingredients listed at the end of this leaflet.
Do not use your Flixotide Junior puffer if you have ever had an allergic reaction to fluticasone propionate, lecithin, soya or related food products such as soybeans or any of the ingredients listed at the end of this leaflet.
- 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 an Flixotide puffer, talk to your doctor.
Symptoms of an allergic reaction may be mild or severe. They usually include some or all of the following: wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash ("hives") or fainting.
Before you start to use it
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.
Taking other medicines
Tell your doctor if 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 others work. For example, medicines like ketoconazole, used to treat fungal infection, and ritonavir used to treat HIV infection, may affect how Flixotide puffer works. If you are taking these medicines, consult your doctor or pharmacist who will advise on what you should do.
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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.
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.
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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
Tell your doctor or pharmacist immediately if you notice any of these signs.
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 treatment for the ‘thrush’ in your mouth while you continue to use your Flixotide puffer.
It is possible that some people, particularly those taking higher doses of Flixotide puffer for a long time, may rarely suffer from the following side effects:
- rounded face
- loss of bone density
- eye problems (eg. cataract, glaucoma)
- slowing 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 this 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.
It is important that:
- treatment with your Flixotide puffer should not be stopped suddenly
- all doctors treating you are 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.
Very rarely the person taking the medicine may feel anxious, have disturbed sleep or notice increased irritability (mainly in children).
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 casualty department at your nearest hospital. Symptoms usually include some or all of the following:
- wheezing
- swelling of the lips/mouth, tongue or throat
- difficulty in breathing
- hay fever
- lumpy rash ("hives")
- fainting
This is not a complete list of all possible sideeffects. Others may occur in some people and there may be some sideeffects 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.
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