FLIXONASE™ AQUEOUS NASAL SPRAY

(fluticasone propionate)

How much to use - children aged 4 to 11 years

•    The usual starting dose is one spray into each nostril once a day, preferably in the morning.

•    The most you would use over 24 hours is normally 4 sprays (2 sprays per nostril).

PATIENT INFORMATION LEAFLET

Your medicine is available using the name Flixonase Aqueous Nasal Spray but will be referred to as Flixonase throughout this leaflet.

Read all of this leaflet carefully before you start using 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Flixonase is and what it is used for

2.    What you need to know before you use Flixonase

3.    How to use Flixonase

4.    Possible side effects

5.    How to store Flixonase

6.    Contents of the pack and other information

1.    WHAT FLIXONASE IS AND WHAT IT IS USED FOR

Flixonase Aqueous Nasal Spray (called 'Flixonase' in this leaflet) contains a medicine called fluticasone propionate. This belongs to a group of medicines called steroids (also called 'corticosteroids').

•    Steroids work by reducing inflammation.

•    They reduce swelling and irritation in your nose.

•    This helps to relieve itching, sneezing and your blocked or runny nose.

Flixonase is used to prevent and treat:

• Inflammation in the lining of your nose (rhinitis) due to seasonal allergies, such as Hayfever.

• Inflammation in the lining of your nose (rhinitis) due to year round (perennial) allergies, such as animal allergies.

2.    WHAT YOU NEED TO KNOW BEFORE YOU USE FLIXONASE Do not use Flixonase if:

•    You are allergic to fluticasone propionate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Flixonase:

•    If you have ever had an operation on your nose.

•    If you have an infection in your nose

Other medicines and Flixonase

Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines.

Check with your doctor or pharmacist before using your medicine if:

•    you have had steroids for a long time, either as an injection or by your mouth

•    you are taking a type of antiviral medicine known as a protease inhibitor (e.g. ritonavir)

•    you are taking certain medicines used to treat fungal infections (e.g. ketoconazole)

Taking Flixonase with food and drink

You can use Flixonase 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

Flixonase is not likely to affect you being able to drive or use any tools or machines.

Flixonase contains benzalkonium chloride

Benzalkonium chloride may cause problems with your breathing (bronchospasm).

3.    HOW TO USE FLIXONASE

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

•    Do not use in children under 4 years old.

•    Only use in your nose, contact with eyes should be avoided.

•    It takes a few days for this medicine to work. So keep using it, even though you may not feel better straight away.

•    Use the spray every day.

If you use high doses of Flixonase

You may need extra steroids:

•    in times of extreme stress

•    during admission to hospital after a serious accident or injury

•    before a surgical operation.

Your doctor may give you extra steroid medication such as tablets or an injection.

Preparing your spray

Each spray has a dust cap which protects the nozzle and keeps it clean. Remember to take this off before using the spray.

A new spray (or one that has not been used for a few days),

may not work first time.

You need to 'prime' the spray by pumping the spray a few

times until a fine mist is produced.

1.    Hold the bottle as shown and make sure it is pointed away from you.

2.    Put your forefinger and middle finger on the collar either side of the nozzle and put your thumb underneath the bottle.

3.    Keep your thumb still, and press down with your fingers to pump the spray.

•    If the spray does not work and you think it may be blocked, you will need to clean it. Please see the section below, Cleaning your spray.

•    Never try to unblock or enlarge the tiny spray hole with a pin or other sharp object. This will damage the way the spray works.

Using your spray

1. Shake the bottle and take off the dust cap.

2.

3.

4.

5.

6. 7.

Blow your nose gently.

Close one nostril with your finger as shown, and put the nozzle in the other nostril. Tilt your head forward slightly and keep the bottle upright. Hold the bottle as shown.

Start to breathe in slowly through your nose. While you are breathing in press down firmly on the collar with your fingers. A spray of fine mist will go into your nostril.

Breathe out through your mouth.

Repeat step 4 to use a second spray in the same nostril.

Remove the nozzle from this nostril and breathe out through your mouth.

8. Repeat steps 3 to 6 for your other nostril.

9. After using your spray, wipe the nozzle carefully with a clean tissue or handkerchief, and replace the dust cap.

Cleaning your spray

Clean your spray at least once a week, or more often if it gets

blocked.

1.    Take the dust cap off by gently squeezing the ribbed sides between your finger and thumb and lifting it off. Do not twist it off.

2.    Pull upwards on the white collar to remove the nozzle.

3.    Soak the nozzle and dust cap in warm water for a few minutes.

4.    Then rinse under a running tap.

5.    Shake off the excess water and let them dry in a warm place.

6.    Put the nozzle back on the spray.

How much to use - adults and children (aged 12 and over)

•    The usual starting dose is 2 sprays into each nostril once a day, preferably in the morning.

•    The most you would use over 24 hours is normally 8 sprays (4 sprays per nostril).

•    As you become better, your doctor may ask you to use a lower dose - one spray into each nostril once a day.

•    If your symptoms then get worse, your dose may be increased back to the starting dose.

7. 'Prime' the bottle as described in the section above, Preparing your spray.

If you use more Flixonase than you should

Tell your doctor if you use more than you were told to.

It is important that you take your dose as stated on the pharmacist's label or as advised by your doctor. You should use only as much as your doctor recommends; using more or less may make your symptoms worse.