INFORMATION FOR CONSUMERS
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Please read this leaflet carefully before you start taking Flixotide Accuhaler
This leaflet answers some common questions about Flixotide Accuhaler. It does not contain all of 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 Flixotide Accuhaler against the benefits this medicine is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
Flixotide Accuhaler contains 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 Accuhaler provides a measured amount of steroid for you to breathe into your lungs. By using your Flixotide Accuhaler regularly every day, the medicine reduces the swelling and irritation in the walls of the small air passages in your lungs. Your Flixotide Accuhaler 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 Accuhaler 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 Flixotide Accuhaler has been prescribed for you.
The medicine in Flixotide Accuhaler is not addictive.
Flixotide Accuhaler generally does not cause any problems with your ability to drive a car or operate machinery.
If you're not sure whether you should be using Flixotide Accuhaler, talk to your doctor.
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 other medicines work. Your doctor or pharmacist will be able to tell you what to do when using Flixotide Accuhaler with other medicines.
Remember that the medicine in your Flixotide Accuhaler is taken by inhalation only.
You will find the instructions on how to use your Flixotide Accuhaler in the pack. Follow the instructions carefully.
The pharmacist's label will usually tell you how many inhalations and how often to use your Flixotide Accuhaler. 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.
Your doctor will decide what dose you should take, how often you should take it, and what strength of Flixotide Accuhaler you should use.
You should visit your doctor or pharmacist regularly to check that you are using your Flixotide Accuhaler in the right way. If you are not breathing the medicine in correctly, the medicine may not be helping you as much as it could.
Do not use your Flixotide Accuhaler 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.
You must use your Flixotide Accuhaler every day. Do not stop using it, even if you feel better, unless your doctor tells you.
You must use your Flixotide Accuhaler 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.
Immediately telephone your doctor or Poisons Information Centre for advice (0800 POISON or 0800 764 766), 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.
Tell your doctor or pharmacist that you are using Flixotide Accuhaler if you are about to be started on any new medicines.
If you have to go into hospital for an operation, take your Flixotide Accuhaler 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.
Do not stop using Flixotide Accuhaler, 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 Flixotide Accuhaler to treat any other complaints unless your doctor says to.
If your chest condition gets worse, tell your doctor. Your doctor may tell you to take extra puffs of your Flixotide Accuhaler 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 Accuhaler, you will need to use a 'reliever puffer' and tell your doctor immediately.
Tell your doctor as soon as
possible if:
Check with your doctor as soon as possible if you have any problems while using Flixotide Accuhaler, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
Like other medicines, Flixotide Accuhaler can 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:
For these, it may be helpful to rinse your mouth with water and spit it out after using your Flixotide Accuhaler. Your doctor may prescribe treatment for the 'thrush' in your mouth while you continue to use your Flixotide Accuhaler.
Very rarely, Flixotide can cause swelling of the throat and face. There may also be an increase in sugar (glucose) in your blood.
Very rarely the person taking the medicine may feel anxious, have disturbed sleep or notice increased irritability (mainly in children).
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 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.
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 Flixotide Accuhaler, 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:
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.
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 Flixotide Accuhaler in a dry place away from heat (store below 30°C).
Do not leave it in the car or on window sills.
Heat can destroy some medicines.
If your doctor tells you to stop using Flixotide Accuhaler, or the product has passed its expiry date, ask your pharmacist what to do with any Flixotide Accuhaler left over.
The Flixotide Accuhaler is a plastic device which contains a foil strip inside. The foil strip has pockets (called blisters) which contain your medicine. The plastic device is labelled, "Flixotide Accuhaler".
Flixotide Accuhaler contains the medicine called fluticasone propionate. It also contains lactose (a milk protein) powder as a non-active ingredient.
Flixotide Accuhaler is available in three strengths:
Each device contains 60 blisters. Your Flixotide Accuhaler has a dose counter which tells you how many doses are left. To let you know when you have reached the last five doses, the numbers appear in red.
Your Flixotide Accuhaler 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 Accuhaler.
Your Flixotide Accuhaler is supplied by:
GlaxoSmithKline NZ Ltd
Quay Tower
Cnr Albert and Customs St
Private Bag 106600
Downtown Auckland
New Zealand
Ph: (09) 367 2900
Fax (09) 367 2910
Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition. You may also be able to find general information about your disease and its treatment from books, for example in public libraries.
Do not throw this leaflet away. You may need to read it again.
The information provided applies to: Flixotide Accuhaler™ ™Flixotide and Accuhaler are trademarks of the GlaxoSmithKline Group of Companies.
This leaflet is copyrighted to GlaxoSmithKline and may be reproduced but not altered in any way.
Issue 6, January 2005