Flixonase

PACKAGE LEAFLET: INFORMATION FOR THE USER

Flixonase 50 micrograms/dose 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What Flixonase is and what it is used for
2. Before you use 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 FLEXONASE IS AND WHAT IT IS USED FOR

Flixonase 50 micrograms/dose Nasal Spray, Suspension (referred to as Flixonase in this
leaflet) belongs to a group of medicines called corticosteroids. Flixonase reduces
inflammation of the nose associated with the following symptoms: swelling and irritation of the nose,
blocked or runny nose, sneezing, and nasal itching.

1. Flixonase is used for the prevention 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 year-round (chronic) allergies such as allergies to animals, house dust mites, or moulds
   • Vasomotor rhinitis.
2. Flixonase may also be used for the treatment of small nasal growths (polyps) in mild to moderate cases associated with nasal obstruction symptoms.

2. BEFORE USING FLIXONASE

Do not use Flixonase:

• if you are allergic (hypersensitive) to fluticasone propionate or to 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 should know:

• if you have a nasal infection
• if you have ever been told that you have underactive adrenal glands (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 intranasal corticosteroids may occur, particularly when administered at high doses over prolonged periods. These effects vary between patients and among different corticosteroids.
In children treated with certain intranasal corticosteroids at approved doses, growth retardation has been reported. It is recommended that the height of children receiving long-term intranasal corticosteroid therapy be monitored regularly. If growth is slowed, therapy should be re-evaluated with the aim of reducing the dose of the intranasal corticosteroid, if possible, to the lowest dose at which effective symptom control is maintained. Consideration should also be given to referring the patient for specialist paediatric assessment.

Important information about certain excipients
Benzalkonium chloride (BAC), included as a preservative in Flixonase, may, especially when used for prolonged periods, cause swelling of the nasal mucosa. If such a reaction is suspected (persistent nasal congestion), a nasal medication without BAC should be used if possible. If BAC-free nasal medications are not available, an alternative pharmaceutical form should be considered. BAC may cause bronchospasm.

Contact your doctor if you experience blurred vision or other visual disturbances, which may be due to cataract or glaucoma.

Taking Flixonase with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken, or might take any other medicines. This includes medicines obtained without a prescription.
Some medicines may affect how Flixonase works or increase the likelihood of side effects. These medicines include:

• ritonavir (used to treat HIV)
• ketoconazole (used to treat fungal infections)
• steroids administered over long periods, whether by injection or orally.

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

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, or are planning to become pregnant, do not use Flixonase without first consulting your doctor. Your doctor will assess the benefit to you and the risk to your unborn child of using Flixonase during pregnancy.
It is not known whether the active substance or excipients in Flixonase pass into breast milk. If you are breastfeeding, you should consult your doctor before using Flixonase.

Important information about certain excipients in Flixonase
The medicine contains benzalkonium chloride, which may be irritating to mucous membranes.

3. HOW TO USE FLIXONASE

Always use Flixonase exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
It is important to take the dose of medication as indicated in this leaflet or as prescribed by your doctor. You should use only the dose recommended by your doctor; using higher or lower doses may cause your symptoms to worsen.

Use of the medicine
For the treatment of allergic rhinitis
Adults and children aged 12 years and over

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

Elderly

• The dosage is the same as for adult patients.

Children aged 4 to 11 years

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

For the treatment of nasal polyps
Adults

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

How to use the nasal spray
Flixonase is administered intranasally as a fine mist.
The first time you use the spray, you must ensure that it is working properly.
Carefully follow the step-by-step instructions in section 7.
Avoid contact with the eyes.

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

If you use more Flixonase than you should
If you use more Flixonase than recommended, contact your doctor or pharmacist for advice. If possible, show them the Flixonase packaging.

If you have any doubts about how to use Flixonase, consult your doctor or pharmacist.
Do not stop treatment with Flixonase without consulting your doctor.

Treatment of allergic rhinitis
It may take 3 to 4 days for Flixonase to work effectively, and it is important that you use Flixonase regularly.

Treatment of nasal polyps
It may take several weeks for Flixonase to work properly.
Take Flixonase for the length of time prescribed by your doctor. Do not stop treatment unless your doctor tells you to do so.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, Flixonase can cause adverse effects, although not everyone experiences them.
If any of the adverse effects worsen, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Conditions requiring attention
Allergic reactions: these are very rare in people taking Flixonase. Signs include:

• skin rash (urticaria) or redness
• swelling around the face, mouth, and tongue that may cause difficulty swallowing
• severe shortness of breath, cough, or breathing difficulties
• sudden feeling of weakness or dizziness (may 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 or smell

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

• allergic reactions
• clouding of the eye lens (cataract), increased eye pressure causing vision problems (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 possible:

• Blurred vision
• sores in the nose

Inform your doctor immediately if you experience any of these symptoms.
The use, especially if prolonged, of topical products may lead to sensitization phenomena.
Systemic effects may occur with intranasal corticosteroids, particularly when prescribed at high doses over long periods. These may include growth retardation in children and adolescents.
Following the instructions provided in this leaflet reduces the risk of adverse effects.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse effects, you can help provide further 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 stated on the packaging. The expiry date refers to the last day of the month.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. OTHER INFORMATION

What Flixonase contains

• The active substance is fluticasone propionate.
• The excipients are: anhydrous glucose, microcrystalline cellulose-sodium carmellose, 2-phenylethyl alcohol, 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 containing 0.050% w/w micronized fluticasone propionate for topical administration to the nasal mucosa via a metered nasal spray pump.
• The spray pump contains 6 or 12 g of suspension and delivers 60 or 120 sprays. Each 100 mg spray, administered through the nasal applicator, delivers 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 - United Kingdom
Glaxo Wellcome S.A. – Avenida de Extremadura, 3 – Aranda De Duero (Burgos) - Spain
This patient information leaflet was last approved on

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 several days) may not work the first time, so it is necessary to prime the nasal spray by following the instructions in the section “Priming the Nasal Spray”.
Primming the Nasal Spray
Prime the nasal spray:
Before using it for the first time
If it has not been used for several days
If it has just been cleaned according to the instructions in the section “Cleaning the Nasal Spray”
Priming the nasal spray helps ensure that

you always receive the full dose of the medicine.
Follow these steps:
Shake the nasal spray and remove the
dust cap by gently pressing the ribbed
sides with your index finger and thumb
and pulling the cap upward.
Do not unscrew. (Figure 1)
Hold the nasal spray upright and point
the nozzle away from yourself.
Figure 1
Place your index and middle fingers on
the collar on either side of the nasal
applicator and place your thumb

under the bottle. (Figure 2)
While 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 any sharp
object to unblock it.
You can clean the nasal applicator by
following the instructions in the section “Cleaning the Figura 2
nasal spray”.
Using the Nasal Spray

1. Shake the nasal spray and remove the

dust cap.

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

6. Repeat steps 3 to 4 for the other nostril.
7. After using the nasal spray, clean the nasal applicator carefully with a paper tissue or a 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 gently upward. (Figure 5)
Soak the nasal applicator and 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.
Prime the nasal spray by following the
Figura 5
instructions in the section “Priming the
Nasal Spray” so that it is ready for use.