Flixotide Nebules

For prophylactic management of severe chronic asthma in patients requiring high dose inhaled or oral corticosteroid therapy. On introduction of inhaled fluticasone propionate many patients currently treated with oral corticosteroids may be able to reduce significantly, or eliminate, their oral dose.

Garvan

Pharmacist - M.B.A. (Public Health) D.I.C.

Flixotide Nebules

What Flixotide Nebules are used for Flixotide…

Garvan J. Lynch
MBA (Public Health)

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What Flixotide Nebules are used for

  • Flixotide Nebules 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. Corticosteroids are used to treat asthma because they reduce the swelling and irritation in the walls of the small air passages in the lungs and so ease breathing problems.
  • Your doctor has chosen this medicine to suit you and your condition. Flixotide Nebules are used with a nebuliser (or 'pump') to help when your asthma is worse than normal, or to help your doctor to reduce or gradually stop the oral steroids you are taking. Flixotide Nebules are not used alone to control sudden attacks of breathlessness.
  • 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 will probably also be using a 'reliever puffer'. Keep using it according to your doctor's advice. Ask your doctor to check your treatment regularly.

The medicine in Flixotide Nebules is not addictive.

Flixotide Nebules generally does not cause any problems with your ability to drive a car or operate machinery.

When you must not use it

  • Do not use Flixotide Nebules if you have ever had an allergic reaction to Flixotide or fluticasone propionate.
  • 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, tongue or throat, difficulty in breathing, hayfever, lumpy rash ("hives") or fainting.
  • Do not use Flixotide Nebules if you are pregnant, trying to become pregnant or breastfeeding, unless your doctor says you should.
  • Your doctor will discuss the risks and benefits of using Flixotide Nebules if you are pregnant or breastfeeding.
  • Do not use Flixotide Nebules after the expiry date (Exp) printed on the pack.


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 e.g. worsening asthma attacks, chest infections, surgery, trauma and other major illnesses occurring at the same time. 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 have had thrush in your mouth.

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 Nebules works. If you are taking these medicines, consult your doctor or pharmacist who will advise on what you should do.

How to use Flixotide Nebules

  • The medicine in Flixotide Nebules is to be breathed into the lungs.
  • Flixotide Nebules should only be used with a jet nebuliser, not an ultrasonic nebuliser. The liquid in the Nebule is changed into a fine mist of droplets by the nebuliser. You should breathe the mist into your lungs, through your mouth. This is done through a mouthpiece, or a face mask, connected to the nebuliser. Some of the medicine is likely to be breathed in through your nose if you use a face mask. When you use a face mask, protect the skin exposed to the mist with barrier cream, and wash your face thoroughly after use.

This medication will be given to you under the direction of a doctor. The starting dose depends on how bad your asthma is, but it may then be changed as your condition improves.
Instructions for use and handling

  • Refer to the manufacturer's instructions on how to use the nebuliser properly. If you have any difficulties or do not understand the instructions for the nebuliser, ask your doctor or pharmacist.
  • It is important that the contents of your Nebule are well mixed before use. While holding the Nebule horizontally by the labelled tab, 'flick' the other end a few times and shake. Repeat this process several (at least three) times until the entire contents of the Nebule are completely mixed.
  • To open your Nebule, twist the tab at the top.
  • It is advisable to inhale your medicine using a mouthpiece. If you are using a face mask, protect your exposed facial skin with barrier cream, and wash your face well after using the medicine.
  • If you need to dilute your medicine, always use Sodium Chloride.
  • Throw away any medicine which remains in the nebuliser bowl after use.
  • Use your nebuliser in a well ventilated room.

How much to use

Adults and children over 16 years:

  • The dose is usually 2 mg twice daily.

Children and adolescents from 4 to 16 years:

  • The dose is usually 1 mg twice daily.

Your doctor will decide what dose you should use, how often you should use it, and what strength of Flixotide Nebules you should use.

When not to use it

Do not use only Flixotide Nebules 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 use. Tell your doctor if you need more of your 'reliever' than you usually do.

How long to use it

It takes a few days for this medication to work and it is very important that you use it regularly as told by your doctor. Do not stop treatment even if you feel better unless told to do so by your doctor. Also, do not increase your medicine unless told to do so by your doctor.

If you forget to use it

  • 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 your breathing or wheezing gets worse straight after taking your medicine, stop using it immediately and tell your doctor as soon as possible.
If your shortness of breath and wheeze actually gets worse over several days, despite taking your new medicine, or if you find you are increasing the use of your reliever puffer, tell your doctor immediately.

While you are using Flixotide Nebules

  • Tell your doctor or pharmacist that you are using Flixotide Nebules if you are about to be started on any new medicines.
  • If you have to go into hospital for an operation, take your Flixotide Nebules 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 you experience a change in your vision.
  • Tell your doctor if, for any reason, you have not used 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 Flixotide Nebules 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 Nebules to treat any other complaints unless your doctor says to.
  • If your Flixotide Nebules does not have the usual effect
  • If your chest condition gets worse, tell your doctor.

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

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, but do not stop treatment unless told to do so.
For these, it may be helpful to rinse your mouth with water and spit it out after using your Flixotide Nebules. Your doctor may prescribe treatment for the 'thrush' in your mouth while you continue to use your Flixotide Nebules.

It is possible that some people, particularly those taking higher doses of Flixotide Nebules 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.
  • soreness in the foodpipe (oesophagus)

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.

It is important that:

  • prolonged treatment with Flixotide Nebules 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).
  • There may be an increase in the amount of sugar (glucose) in your blood. If you have diabetes, more frequent blood sugar monitoring and possibly adjustment of your usual diabetes treatment may be required.
  • 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 Nebules, 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
  • difficulty in breathing
  • hay fever
  • lumpy rash ("hives")
  • fainting

This is not a complete list of all possible side-effects. For more on the risks and side effects talk to your Doctor or pharmacist.

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 Flixotide Nebules away from frost, direct heat or light. Do not freeze it. Store your Flixotide Nebules upright, at below 30°C.
  • Do not leave it in the car or on window sills. Heat can destroy some medicines.
  • Do not use after the date shown as 'Exp' on the carton and label.
  • Unused Nebules should be discarded 1 month after opening of the foil. Individual opened Nebules should be kept in a refrigerator, and thrown out if not used within 12 hours after opening.

References:

https://www.medicines.org.uk/emc/product/1407/smpc

https://www.nps.org.au/medicine-finder/flixotide-nebules-nebuliser-suspension

https://www.news-medical.net/drugs/Flixotide-Nebules.aspx

https://www.hpra.ie/img/uploaded/swedocuments/2185250.PPA0465_07

https://www.medicines.ie/medicines/flixotide-nebules-0-5mg-32174/patient-info

https://www.drugs.com/uk/flixotide-nebules-0-5mg-2ml-leaflet.html

 

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