Flixotide Nebules 2mg/2ml
1. What Flixotide is and what it is used for
3. How to use Flixotide
PACKAGE LEAFLET: INFORMATION FOR THE USER FLIXOTIDE® NEBULES® 0.5mg/2ml (fluticasone propionate)
This product is available in the above name but will be referred to as Flixotide Nebules throughout the remainder of this leaflet.
This product is available in multiple strengths and all strengths will be referred to throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1 What Flixotide is and what it is used for
2 What you need to know before you use Flixotide
3 How to use Flixotide
4 Possible side effects
5 How to store Flixotide
6 Contents of the pack and other information
Flixotide Nebules contain a medicine called fluticasone propionate.
Fluticasone propionate belongs to a group of medicines called corticosteroids (often just called steroids). A very small dose of steroid is needed when it is inhaled. This is because it is inhaled straight to your lungs.
Flixotide works by reducing swelling and irritation in the lungs. It has what is called an 'anti-inflammatory action'.
Flixotide helps to prevent asthma attacks in people who need regular treatment. This is why they are sometimes called 'preventers'. They need to be used regularly, every day.
Flixotide will not help treat sudden asthma attacks where you feel breathless.
• A different medicine is used for treating sudden attacks (called a 'reliever').
• If you have more than one medicine, be careful not to confuse them.
2. What you need to know before you use Flixotide
Do not use:
• if you are allergic to fluticasone propionate or any of the other ingredients of this medicine (listed in Section 6).
Do not use Flixotide if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before using Flixotide.
Warnings and Precautions
Talk to your doctor, nurse or pharmacist before taking Flixotide if:
• you have ever been treated for tuberculosis (TB)
• you are using Flixotide at the same time as taking steroid tablets. Also if you have just finished taking steroid tablets. In both cases, you should carry a steroid warning card until your doctor tells you not to carry one
If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before using Flixotide.
Other medicines and Flixotide
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines. Remember to take this medicine with you if you have to go into hospital.
In particular tell your doctor or pharmacist if you are taking any of the following:
• a type of antiviral medicine known as a 'protease inhibitor' (such as ritonavir)
• medicines used to treat fungal infections (such as ketoconazole)
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Flixotide.
Using Flixotide with food and drink
You can use Flixotide at any time of day, with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and using machines
Flixotide is not likely to affect you being able to drive or use any tools or machines.
Flixotide Nebules come in two different strengths. Your doctor will have decided which strength you need. Always use this medicine exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure.
Using this medicine
• Do not inject or swallow the liquid. Flixotide Nebules should only be inhaled using your jet nebuliser. Using Flixotide Nebules with ultrasonic nebulisers is not generally recommended.
• The jet nebuliser produces a fine mist which you breathe in through a mouthpiece or face mask.
• Do not let the liquid, or the mist produced by the nebuliser get into your eyes. You can wear glasses or goggles to protect them.
• Each small plastic container (Nebule®) contains some liquid.
• The liquid is put into a nebuliser. This makes a fine mist for you to breathe in through a face mask or mouthpiece. Use of a mouthpiece prevents the medicine affecting the skin of your face, which may occur if you use a face mask over a long period of time. If you prefer to use a face mask, or you are using a face mask for your child, then you must protect the skin on your (or your child's) face with a barrier cream or wash your (or your child's) face thoroughly after treatment.
• Use your nebuliser in a well-ventilated room as some of the mist will be released into the air and may be breathed in by others.
• It takes a few days for this medicine to work and it is very important that you use it regularly.
Adults and Children over 16 years of age
• The usual starting dose is 0.5 to 2.0 mg (500 to 2000 micrograms) twice a day.
• Flixotide Nebules 0.5 mg/2 ml provides you with a dose of 500 micrograms.
• Flixotide Nebules 2.0 mg/2 ml provides you with a dose of 2000 micrograms.
Flixotide Nebules 2 mg/2 ml are not for use in children under 16 years of age.
It is recommended that children being treated with steroids, including Flixotide Nebules have their height checked regularly by their doctor.
If you are using high doses of an inhaled steroid for a long time you may sometimes need extra steroids for example during stressful circumstances such as a road traffic accident or before an operation. Your doctor may decide to give you extra steroid medicines during this time.
Patients who have been on high doses of steroids, including Flixotide Nebules for a long time, must not stop taking their medicine suddenly without talking to their doctor. Suddenly stopping treatment can make you feel unwell and may cause symptoms such as vomiting, drowsiness, nausea, headache, tiredness, loss of appetite, low blood sugar level and fitting.
Using your Nebules
1. the Nebules are in a foil pack. Do not open the pack until you need to use them 2. hold the top of the Nebule you have just removed. Twist the body to open it
3. put the open end of the Nebule into the nebuliser bowl and squeeze slowly to empty the content
4. assemble the nebuliser and use it as directed
5. repeat steps 2 to 4 to make up the dose needed if necessary
Diluting your Nebules
Do not dilute the contents of a Nebule unless you are told to
by your doctor
• if your doctor has told you to dilute the solution, empty the contents of the Nebule into the nebuliser bowl
• add the amount of sterile sodium chloride 0.9% solution your doctor has told you to use
• put the top on the nebuliser bowl and shake gently to mix the contents
If dilution is necessary then only sterile sodium chloride 0.9% solution should be used.
After use
• use a fresh Nebule for each dose. Only open a new one when you are ready to use it. If there is any liquid left over, throw it away. Do not save it to use again
• throw away any solution remaining in the nebuliser bowl
• clean your nebuliser in the recommended way
If you use more Flixotide than you should
If you use more than you were told, talk to your doctor as soon as possible.
It is important that you take your dose as stated on the pharmacist's label or as advised by your doctor. You should not increase or decrease your dose without seeking medical advice.
