FLIXONASE AQUEOUS NASAL SPRAY - patient leaflet, side effects, dosage

Patient leaflet - FLIXONASE AQUEOUS NASAL SPRAY

r 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 ‚cortico-steroids‘).

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.

r 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

Contact your doctor if you experience blurred vision or other visual disturbances.

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) or cobicistat containing products which may increase the effects of fluticasone propionate. Your doctor may wish to monitor you carefully if you are taking these medicines
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 0.02 mg benzalkonium chloride in each unit dose

Benzalkonium chloride may cause problems with your breathing (bronchospasm). Benzalkonium chloride may also cause irritation or swelling inside the nose, especially if used for a long time.

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.

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.

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).

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.

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Using your spray

1 Shake the bottle and take off the dust cap.
2 Blow your nose gently.
3 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.
4 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 mistwill go into your nostril
5 Breathe out through your mouth.
6 Repeat step 4 to use a second spray in the same nostril.
7 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 sgueezing 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.
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.

If you forget to use Flixonase

If you miss a dose, just use the next dose when it is due. Do not take a double dose to make up for the forgotten dose.

If you stop taking Flixonase

Do not stop treatment even if you feel better, unless your doctor tells you to stop. If you do stop, the symptoms may come back.

If you have any further guestions on the use of this medicine, ask your doctor or pharmacist.

r 4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Allergic reactions: get a doctor's help straight away

A small number of people get allergic reactions to Flixonase, which can develop into a more serious, even life-threatening problem if not treated. Symptoms include;

becoming very wheezy, coughing or having difficulty with breathing
suddenly feeling weak or light-headed (which may lead to collapse or loss of consciousness)
swelling around the face, mouth or tongue
skin rashes or redness

If this happens, tell your doctor straight away-you may need urgent medical treatment.

Allergic reactions to Flixonase are very rare (These affect less than 1 in 10,000 people).

Immediately after you use your spray

You may sneeze a little, but this soon stops.
Very occasionally you may find you get an unpleasant taste or smell.

Tell your doctor as soon as possible if you notice any of the following side effects:

Other side effects include:

Very common (may affect more than 1 in 10 people) Nose bleeds.
Common (may affect up to 1 in 10 people) Headache.
Unpleasant taste.
Unpleasant smell.
A dry or painful nose or throat.

Very rare (may affect up to 1 in 10,000 people)

Skin reaction – which can range from red, itchy rash and blotches to a more severe skin reaction such as dry, cracked and peeling skin.
Problems with your eyes such as pain or blurred vision.
Damage to your nose

Not known: freguency cannot be estimated from the available data

Blurred vision
Sores in the nose

Very rarely, the normal production of steroids in your body may be affected. This is more likely to happen if you use high doses for a long time. Your doctor will help stop this happening by making sure you use the lowest dose of steroid which controls your symptoms. In children this side effect can rarely cause them to grow more slowly than others. Children who receive this treatment for a long period of time will have their height checked regularly by their doctor.

Reporting of side effects

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: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

r 5 How to store Flixonase

Keep out of the sight and reach of children.

Protect from frost and light.
Do not store above 30°C.
Do not put in a refrigerator.
Do not use this medicine after the expiry date which is stated on the label and carton after ‚EXP‘. The expiry date refers to the last day of that month.
If you are told to stop taking this medicine return any unused spray to your pharmacist to be destroyed.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6 Contents of the pack and other Information

What Flixonase Aqueous Nasal Spray contains

The active substance is fluticasone propionate
The other ingredients are cellulose microcrystalline, carmellose sodium, glucose, polysorbate 80, water purified and the preservatives benzalkonium chloride and phenylethyl alcohol. These other ingredients are needed to make a stable suspension which will not go off.

What Flixonase Aqueous Nasal Spray looks like and contents of the pack

Each amber coloured glass bottle delivers 150 sprays. Each spray contains 50 micrograms of fluticasone propionate.

Marketing Authorisation Holder

Glaxo Wellcome UK Ltd

980 Great West Road

Brentford

Middlesex

TW8 9GS

Manufacturer

Glaxo Wellcome SA, Aranda de Duero, Burgos, Spain

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name Flixonase Aqueous Nasal Spray

Reference number 10949/0036

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in August 2020

Trade marks are owned by or licensed to the GSK group of companies

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PHARMA CODE N° 7563