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PIRINASE ALLERGY 0.05% NASAL SPRAY

Active substance(s): FLUTICASONE PROPIONATE MICRONISED / FLUTICASONE PROPIONATE MICRONISED / FLUTICASONE PROPIONATE MICRONISED

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M1-3-1-a4-text-flixonase 160202st

February 2016

Flixonase Allergy Nasal Spray
(PL 00079/0616)
GlaxoSmithKline Consumer Healthcare

Flixonase Allergy Nasal Spray
Fluticasone Propionate
Please read right through this leaflet before you start using this medicine.
This medicine is available without prescription, but you still need to use Flixonase Allergy Nasal Spray
carefully to get the best results from it.



Keep this leaflet you may need to read it again.
If you have any questions, or if there is anything you do not understand, ask your
pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Flixonase does
Check before you use Flixonase
How to use Flixonase
Possible side effects
How to store Flixonase
Further information

1.

What Flixonase does

Flixonase is used to treat and prevent the allergic symptoms of hayfever and other airborne
allergies e.g. pet, house dust mite and mould spore allergies. It relieves symptoms including
sneezing, itchy and watery eyes and a runny, itchy or blocked-up nose, for up to 24 hours.
The active ingredient is fluticasone propionate, a corticosteroid which, when used every day, has an
anti-inflammatory action and works in a similar way to natural body chemicals to control
inflammation. This spray helps control your body’s reactions to allergens (“triggers’) in the
environment.
2.

Check before you use Flixonase

[X symbol] Do not use Flixonase:



if you have ever had an allergic reaction to fluticasone propionate or to any of the other
ingredients (listed in Section 6).
If you are under 18 years.

[! Symbol] Take special care with Flixonase


Talk to your doctor or pharmacist before using Flixonase if you have an infection in your
nose or sinuses, if you have a high temperature or you have recently had surgery, an injury
or ulcers in your nose.

M1-3-1-a4-text-flixonase 160202st

February 2016



Flixonase Allergy Nasal Spray
(PL 00079/0616)
GlaxoSmithKline Consumer Healthcare

If your symptoms do not improve, or are not well controlled, after 7 days, talk to your
doctor or pharmacist.
Do not use continuously for more than 3 months unless your doctor tells you to.

[! Symbol] If you are taking other medicines
Talk to your doctor or pharmacist before using this medicine if you are taking any prescribed
medicines; particularly corticosteroid medicines (including eczema creams, asthma inhalers, tablets,
injections, nasal sprays, and eye or nose drops); ritonavir (an anti-HIV medicine) or ketoconazole
(for fungal infections).

[! Symbol] Pregnancy and breast feeding
Talk to your doctor before using Flixonase if you are pregnant, trying to become pregnant or are
breast feeding.

3.

How to use Flixonase

Always shake well before use. Only use in the nose. Do not swallow.
Flixonase quickly starts to reduce inflammation and swelling in your nose, although it may take 3 or
4 days to build up to its maximum protective effect. To prevent the onset of symptoms, start to use
Flixonase before exposure to one of your usual ‘triggers’. You should try to use the spray in the
morning.
[tick Symbol alongside points below ]
Adults aged 18 years and over:
Spray two puffs into each nostril daily.
Once your symptoms have improved, you may be able to reduce the dose to one puff into
each nostril once daily.
If your symptoms are especially bad, you may need to spray two puffs into each nostril
twice daily until your symptoms improve.
[! Symbol alongside below bullet points]





Do not spray more than 8 sprays (400 micrograms) in a day.
Use the lowest dose possible to control your symptoms.
If your symptoms do not improve, or are not well controlled, after 7 days, talk to
your doctor or pharmacist.
Do not use more than the recommended dose.

If your use too many sprays

M1-3-1-a4-text-flixonase 160202st

February 2016

Flixonase Allergy Nasal Spray
(PL 00079/0616)
GlaxoSmithKline Consumer Healthcare

Tell your doctor.

If you forget to use the spray
Take your next dose at the usual time. Never take two doses together.
Before using a new bottle of Flixonase:

Your Flixonase spray has a dust cap which protects the nozzle and keeps it clean. Remember
to take it off before you use the spray (Picture 1).

Before you start to use a new bottle of Flixonase, or if you have not used the spray for a few
days press the pump down several times until you get a fine spray.

Hold the bottle as shown with your forefinger and middle finger on the collar either side of
the nozzle and your thumb underneath the bottle.

Keeping your thumb still, press down with your fingers to pump the spray (Picture 2).

When doing this make sure you do not point the nozzle at yourself or someone else.

If the spray still doesn’t work, try to clean it as described under the ‘To clean the spray’
section. Do not try to unblock or enlarge the tiny spray hole with a pin or other sharp
objects because this will destroy the spray mechanism.
[Picture 1]

[Picture 2]

[tick Symbol] Using Flixonase:
1. Shake the bottle well and remove the dust cap.
2. Blow your nose gently.
3. Close one nostril 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 (Picture 3).
4. Start to breathe in slowly through your nose. While you are breathing in, squirt a spray of
fine mist into your nostril by pressing down firmly on the collar with your fingers (Picture 4).
5. Breathe out through your mouth. Repeat step 4 to take a second spray in the same nostril.
6. Remove the nozzle from this nostril and breathe out through your mouth (Picture 5).
7. Repeat steps 3 to 6 for the other nostril.
8. After using the spray, wipe the nozzle carefully with a clean tissue or handkerchief and
replace the dust cap.
[Picture 3]

[Picture 4]
[Picture 5]

To clean the spray:
1. Take the dust cap and nozzle off (Picture 6).
2. Soak the nozzle and dust cap in warm water for a few minutes and then rinse under a
running tap.

M1-3-1-a4-text-flixonase 160202st

February 2016

Flixonase Allergy Nasal Spray
(PL 00079/0616)
GlaxoSmithKline Consumer Healthcare

3. Shake off the excess water and allow to dry in a warm place – not too hot!
4. Re-fit the nozzle.
5. If necessary, press the pump down several times until you get a fine spray.
[Picture 6]

4.

Possible side effects

Like all medicines, Flixonase can have side effects, but not everybody gets them.
Stop taking the medicine and seek immediate medical help if you experience:


Allergic reactions. These may include developing a rash, swelling of the mouth or face or
having difficulty breathing.

Stop taking the medicine and tell your doctor if you experience:



Eye problems such as pain or blurred vision.
Nasal problems such as pain and/or persistent bleeding.

The following effects may occur:






Sneezing after using the spray but this soon stops.
You may notice an unpleasant taste or smell.
Nose bleeds.
Dryness or irritation in the nose or throat.
Headache.

It is important to follow the dose instructions shown in Section 3. Using Flixonase at higher doses or
for longer than 3 months at a time can cause a number of changes in your body such as catching
infections more easily. If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

M1-3-1-a4-text-flixonase 160202st

February 2016
5.

Flixonase Allergy Nasal Spray
(PL 00079/0616)
GlaxoSmithKline Consumer Healthcare

How to store Flixonase:

Keep out of the reach and sight of children.
Do not use this medicine after the ‘EXP’ date shown on the pack.
Use within three months of first use.
Do not store above 30˚C.

6.

Further Information:

Active ingredient Each spray contains Fluticasone Propionate 50 micrograms.
Other ingredients Dextrose (anhydrous), microcrystalline cellulose, carboxymethylcellulose sodium,
phenylethyl alcohol, benzalkonium chloride, polysorbate 80, purified water and dilute hydrochloric
acid.
This bottle contains 60 sprays.
The marketing authorisation holder is
GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K. and all enquiries should be sent to
this address.
The manufacturer is Glaxo Wellcome SA, 09400 Aranda de Duero, Burgos, Spain.
This text was last revised in February 2016.
This information in this leaflet only applies to Flixonase Allergy Nasal Spray.
Flixonase and the Flixonase logo are trademarks of the GSK group of companies.
[GSK logo]

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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