FLIXONASE 50 MICROGRAMS Nasal spray, suspension

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1. Flixonase 50 micrograms/spray Nasal Spray, Suspension
   1. WHAT IS FLIXONASE AND WHAT IS IT USED FOR
   2. BEFORE USING FLIXONASE
   3. HOW TO USE FLIXONASE
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE FLIXONASE
   6. FURTHER INFORMATION
   7. STEP-BY-STEP INSTRUCTIONS

Flixonase 50 micrograms/spray Nasal Spray, Suspension

Fluticasone propionate

Read this leaflet carefully before using this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any of the side effects gets worse, or if you notice any side effect

Contents of this leaflet:

• 1. What Flixonase is and what it is used for
• 2. Before using Flixonase
• 3. How to use Flixonase
• 4. Possible side effects
• 5. How to store Flixonase
• 6. Further information
• 7. Step-by-step instructions

1. WHAT IS FLIXONASE AND WHAT IS IT USED FOR

Flixonase 50 micrograms/actuation Nasal Spray, Suspension (called Flixonase in this
inflammation of the nose which is accompanied by the following symptoms: swelling and irritation of the nose,
blocked or runny nose, sneezing and itchy nose.

• 1. Flixonase is used for the prophylaxis and treatment of:
• Inflammation of the nasal mucosa (allergic rhinitis) due to seasonal allergies such as hay fever
• Inflammation of the nasal mucosa (allergic rhinitis) due to allergies throughout the year (chronic) such as allergies to animals, house dust mites or moulds
• Vasomotor rhinitis.
• 2. Flixonase can also be used for the treatment of small formations (polyps) inside the nose, in mild and moderate forms associated with symptoms of nasal obstruction.

2. BEFORE USING FLIXONASE

Do not use Flixonase:

• if you are allergic (hypersensitive) to fluticasone propionate or any of the excipients of Flixonase listed in section 6
• if you have local viral or tuberculous infections

Take special care with Flixonase
Before you use Flixonase your doctor must know:

• if you have an infection in the nose
• if you have ever been told that you have an underactive adrenal gland (Addison's disease)
• if you are taking a medicine called ritonavir.

Check with your doctor if you think this applies to you.
Systemic effects of nasal corticosteroids can occur particularly when
administered at high doses prescribed for prolonged periods of time. These effects vary between patients and
for different corticosteroids.
In children treated with some nasal corticosteroids at authorised doses, growth retardation has been reported.
It is recommended to regularly check the height of children treated for long
periods with nasal corticosteroids. If growth is slowed, therapy should be reconsidered in order to reduce the dose of the nasal corticosteroid, if possible, to the minimum dose at which
effective symptom control is maintained. It should also be considered to subject the
patient to a specialist paediatric visit.

Important information about some excipients
Benzalkonium chloride (BAC)contained as a preservative in Flixonase, especially when used for
long periods, can cause swelling of the nasal mucosa. If you suspect such a reaction
(persistent nasal congestion), a nasal medicine without
BAC should be used, if possible. If such nasal medicines without BAC are not available, another pharmaceutical form should be considered.
It can cause bronchospasm.
Contact your doctor in case of blurred vision or other visual disturbances, which may be caused by
cataract or glaucoma.

Taking Flixonase with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken or are about to take
any other medicines. This includes medicines you buy without a prescription.
Some medicines can have an effect on how Flixonase works or make it more likely that you may

• ritonavir (used to treat HIV)
• ketoconazole (used to treat fungal infections)
• steroids taken for long periods, taken both by injection and orally.

Tell your doctor or pharmacist if you are taking any of these medicines.

Pregnancy and breastfeeding
If you are pregnant, or think you may be or are planning a pregnancy do not use Flixonase
without first consulting your doctor. The doctor will make an assessment of the benefit for you and the risk
to your baby of taking Flixonase while you are pregnant.
It is not known whether the active substance and excipients of Flixonase can pass into breast milk. If you
are breastfeeding, you should consult your doctor before using Flixonase.

Important information about some excipients of Flixonase
The medicine contains benzalkonium chloride which can be irritating to the mucous membranes.

3. HOW TO USE FLIXONASE

Always use Flixonase following exactly the doctor's instructions. If you have any doubts, consult your doctor or
pharmacist.
doctor. You should only use the dose of medication recommended by your doctor; using higher or
lower doses may worsen your symptoms.

Use of the medication
For the treatment of allergic rhinitis
Adults and children 12 years of age and over

• The usual starting dose is 2 sprays per nostril once a day, preferably in the morning.
• If necessary, your doctor may increase the dose to a maximum of 2 sprays in each nostril twice a day (morning and evening) until symptoms are under control. The maximum dose should not exceed 4 sprays per nostril per day.

Elderly

• The dosage is the same as for adult patients.

Children aged between 4 and 11 years

• The usual starting dose is 1 spray per nostril once a day, preferably in the morning.
• If necessary, your doctor may increase the dose to 1 spray in each nostril twice a day (morning and evening) until symptoms are under control. The maximum allowed dose should not exceed 2 sprays in each nostril.

For the treatment of nasal polyps
Adults

• The usual initial dose is two sprays per nostril twice a day (morning and evening) for 1-2 months until symptoms are controlled. The maximum daily dose should not exceed 4 sprays per nostril per day.
• This is usually followed by 2 sprays a day in each nostril for 3 months.

How to use the nasal spray
Flixonase is administered nasally as a fine mist.
The first time you use the nebulizer, you must verify that it is functioning correctly.
Follow the step-by-step instructions carefully in section 7.
Avoid contact with eyes

If you forget to use Flixonase
Do not take an extra dose to make up for a missed dose. Take the next dose
when scheduled.

If you use more Flixonase than you should
If you use more Flixonase, contact your doctor or pharmacist for advice. If possible, show them the
Flixonase packaging.
If you have any doubts about using Flixonase, consult your doctor or pharmacist.

Do not interrupt the treatment with Flixonase without your doctor's advice
Treatment of allergic rhinitis
It takes 3 to 4 days for Flixonase to work well and it is important that you take
Flixonase regularly.

Treatment of nasal polyps
It may take several weeks for Flixonase to work properly.
Take Flixonase for the period prescribed by your doctor. Do not interrupt treatment unless
your doctor tells you to.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Flixonase can cause side effects, although not everybody gets them.
If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Conditions to which attention should be paid
Allergic reactions: these are very rare in people taking Flixonase. The signs include:

• skin rash (urticaria) or redness
• swelling around the face, mouth and tongue which can cause difficulty in swallowing
• very wheezy breathing, coughing or difficulty breathing
• sudden feeling of weakness or dizziness (can lead to fainting and loss of consciousness)

Contact your doctor immediately if you experience any of these symptoms. Stop taking Flixonase.

Very common(affects more than 1 in 10 people)

• nosebleeds

Common(affects up to 1 in 10 people)

• dry or irritated throat or nose - you may notice streaks of blood when blowing your nose
• headache, unpleasant taste and smell.

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

• allergic reactions
• clouding of the lens of the eye (cataract), increased pressure in the eye causing problems with vision (glaucoma). These eye problems occur in people who use Flixonase for long periods
• small holes (perforations) in the nasal septum separating the nostrils

Frequency not known, but may happen:

• Blurred vision
• sores in the nose

Tell your doctor immediately if you have any of these symptoms.
The use, especially if prolonged, of topical products can lead to sensitization.
Systemic effects can occur with intranasal corticosteroids, particularly if prescribed at
high doses for prolonged periods. These can include delayed growth in children and
adolescents.

Reporting of side effects
If you get any side effects,including any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. HOW TO STORE FLIXONASE

• Keep Flixonase out of the reach and sight of children.
• Do not use Flixonase after the expiry date indicated on the packaging. The expiry date refers to the last day of the month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. FURTHER INFORMATION

What Flixonase contains

• The active ingredient is fluticasone propionate.
• The excipients are: anhydrous glucose, microcrystalline cellulose-sodium carboxymethylcellulose, 2-phenylethanol, benzalkonium chloride, polysorbate 80, purified water. See also section 2.

Description of the appearance of Flixonase and contents of the pack

• Flixonase is an aqueous suspension at 0.050% w/w of micronised fluticasone propionate for topical administration to the nasal mucosa via a metered-dose nasal spray with a nebuliser.
• The nebuliser contains 6 or 12 g of suspension and delivers 60 or 120 sprays. Each spray, of 100 mg, delivered via the nasal adapter, contains 50 micrograms of fluticasone propionate.

Marketing Authorisation Holder
GlaxoSmithKline S.p.A.
Via Alessandro Fleming, 2 - Verona

Manufacturer
Glaxo Operations UK Ltd - Harmire Road - Barnard Castle - Great Britain
Glaxo Wellcome S.A. – Avenida de Extremadura, 3 – Aranda De Duero (Burgos) - Spain

7. STEP-BY-STEP INSTRUCTIONS

Nasal spray
The nasal spray has a dust cap that protects the nasal applicator and keeps it clean.
Remember to remove it before using the nasal spray. A new nasal spray (or one that has not been
used for a few days) may not work the first time, so it is necessary to prepare the spray
nasal following the instructions in the “Preparing the nasal spray” section.

Preparing the nasal spray
Prepare the nasal spray:
Before using it for the first time
If you have not used it for a few days
If you have just cleaned it following the instructions in the “Cleaning the nasal spray” section
Preparing the nasal spray helps to ensure that you
always get the entire dose of the medicine.
Follow these steps:

Shake the nasal spray and remove the
dust cap by gently pressing the sides with the index and
thumb and pulling the cap upwards.
Do not unscrew. (Figure 1)
Keep the nasal spray in a
vertical position and direct the spray away from
yourself.
Figure 1
Place your index and middle fingers on the collar on the sides
of the nasal applicator and place your thumb
under the bottle. (Figure 2)

Keeping your thumb steady, press firmly on the
collar with your fingers until a
fine mist is released into the air. (Figure 2)
The nasal spray is now ready for use.
If you think the nasal applicator is
blocked, do not use a needle or anything
sharp to clear it.
You can clean the nasal applicator following
the instructions in the “Cleaning the Figure 2
nasal spray” section.

Using the nasal spray

• 1.Shake the nasal spray and remove the dust cap.

• 2.Blow your nose to clear your nostrils.
• 3.Close one nostril with a finger and carefully insert the nasal applicator into the other nostril. Tilt your head slightly forward and hold the nasal spray vertically. (Figures 3a and 3b)
• 4.While inhaling through your nose, press firmly on the collar with your fingers. (Figures 3a and 3b) Figure 3a
• 5.Exhale through your mouth.

• 6.Repeat steps 3 to 4 for the other nostril.
• 7.After using the nasal spray, carefully clean the applicator with a tissue or cloth handkerchief.
• 8.Replace the dust cap (Figure 4)

Figure 3b

Figure 4

Cleaning the nasal spray
Clean the nasal spray at least once a
week to prevent the nasal applicator from becoming
blocked. Follow these steps:

Remove the dust cap.
Remove the nasal applicator by pressing
under the collar and pulling it slightly
upwards. (Figure 5)
Soak the nasal applicator and the
dust cap in lukewarm water for
a few minutes.
Rinse under running water.
Remove excess water and allow to
dry thoroughly.
Reattach the nasal applicator to the spray.
Figure 5
Prepare the nasal spray following the
instructions in the “Preparing the
nasal spray” section so that it is ready for
use.