Leaflet: information for the user

Flixonase 50 micrograms/dose, nasal spray suspension

Fluticasone propionate

Read this leaflet carefully before you start using the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet (see section 4).

Flixonase is a medication from the corticosteroid family and is recommended for preventing and treating the symptoms of seasonal allergic rhinitis and perennial rhinitis, which may include: sneezing, itching, and nasal discharge, nasal blockage, congestion, poor nasal ventilation, nasal and eye pain and pressure (sinuses), in adults and children over 4 years old.

Corticosteroids prevent inflammation and reduce allergic reaction symptoms when administered directly into the nasal cavity.

Allergic rhinitis is caused by small particles inhaled through the nose that are not recognized by the body as its own and are called allergens. The body attempts to eliminate these substances, which cause sneezing, tearing, and eye itching, as well as nasal discharge that can block the nose. This can occur at the beginning of summer due to inhalation of pollen from grass or trees and is called seasonal allergic rhinitis (hay fever). Some people experience these problems throughout the year, which is then called perennial rhinitis, often due to dust mites or pet hair (cats, dogs).

Do not use Flixonase

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

Warnings and precautions

Consult your doctor or pharmacist:

- if you have or have had a recent nasal infection.

- if you have any kidney problems.

- if you are taking a medicine called ritonavir.

- if you observe growth delay, in children or adolescents, it is recommended to consult your pediatrician, as growth delay has been detected in children treated with some authorized nasal corticosteroids.

Contact your doctor if you experience blurred vision or other visual changes, which may be caused by cataracts or glaucoma.

Using Flixonase with other medicines

Inform your doctor or pharmacist that you are using, have used recently or may have to use any other medicine, including those purchased without a prescription.

Consult your doctor before using fluticasone propionate nasal spray if you are taking:

- medicines containing ritonavir or cobicistat (for the treatment of HIV or AIDS). Some medicines may increase the effects of Flixonase, so your doctor will make close checks if you are taking these medicines.

- oral medicines for the treatment of fungal infections (ketoconazole).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machines

No studies have described any effect of Flixonase on driving or operating machines. Check if Flixonase affects you, before driving or operating heavy machinery.

Flixonase contains benzalkonium chloride

This medicine contains 0.02 mg of benzalkonium chloride in each spray.

Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for long periods of treatment.

Use in athletes

Inform athletes that this medicine contains a component that may establish a positive analytical result in doping control.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. Do not exceed the recommended dose. In case of doubt, consult your doctor or pharmacist again.

Adults and children over 12 years

The recommended dose is 2 sprays in each nasal passage once a day, preferably in the morning. Your doctor may advise you to increase the dose to a maximum of 2 sprays in each nasal passage twice a day (morning and night).

Use in children from 4 to 11 years

The normal dose is one spray in each nasal passage once a day, preferably in the morning. Your doctor may advise you to increase the dose to one spray in each nasal passage twice a day (morning and night).

This medication begins to act after a few days. It is very important that you use it regularly. Do not stop treatment even if you feel better, unless your doctor tells you to.

Flixonase should only be used in the nose.

How to use the nasal spray

Appearance of the nasal spray

The nasal spray has a cap that protects the nasal applicator from dust and keeps it clean. Remember to remove the cap before using the spray. A new spray (or one that has not been used for a few days) may not work the first time, so you will have to follow the instructions for “Nasal spray preparation”.

Nasal spray preparation

You must 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 “Nasal spray cleaning” section

The nasal spray preparation helps to ensure that you always receive the full dose of medication. Follow these steps:

• Shake the nasal spray and remove the cap(see diagram 1).
• Hold the spray in a vertical position and orient the nasal applicator away from you.
• Place your index finger and middle finger on either side of the nasal applicator and your thumb under the bottle(see diagram 2).

DIAGRAM 1DIAGRAM 2

• Hold your thumb and press firmly down with your fingers to release a fine mist of spray into the air(see diagram 2).
• The nasal spray is now ready for use.
• If you think the nasal applicator may be blocked, do not use a pin or any other sharp object to clear it.
• Try to clean the spray following the instructions in “Nasal spray cleaning”.

Using the nasal spray

1. Shake the nasal spray and remove the cap.
2. Blow your nose to clear the nasal passages.
3. Close one nostril with your finger and place the nasal applicator in the other nostril.

nasal passage. Tilt your head slightly forward and hold the nasal spray in a vertical position(see diagrams 3a and 3b).

DIAGRAM 3aDIAGRAM 3b

1. Press firmly down with your fingers while inhaling through the nose(see diagrams 3a and 3b).
2. Remove the nasal applicator and exhale through your mouth.
3. Repeat steps 3 to 4 in the other nostril.
4. After using the spray, clean the nasal applicator carefully with a clean tissue.
5. Replace the cap.

Nasal spray cleaning

The nasal spray should be cleaned at least once a week to prevent the nasal applicator from becoming blocked. Follow these steps:

• Remove the protective cap.
• Soak the nasal applicator and cap in warm water for a few minutes.
• Then, rinse under the tap.
• Remove excess water by shaking and let it dry in a warm place.
• Place the nasal applicator back in the spray.
• Prepare the nasal spray following the instructions in “Nasal spray preparation” so it is ready for use.

If you use more Flixonase than you should

If you have used more Flixonase than you should, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone: 91 562 04 20.

It is essential that you take your dose as indicated by your doctor. You should only use what your doctor recommends, using more or less may worsen your symptoms.

If you forgot to use Flixonase

Do not take a double dose to compensate for the missed doses. If you forget a dose, wait for the next dose when it is due.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Some people may be allergic to this medication, although this occurs rarely.

The systemic effects of nasal corticosteroids may occur mainly when using high doses for prolonged periods.

The following adverse effects are associated with Flixonase:

Very Common Adverse Effects(may affect more than 1 in 10 people)

-Epistaxis (spontaneous nasal bleeding).

Common Adverse Effects(may affect up to 1 in 10 people)

-Headache, unpleasant taste or odor.

- Nasal dryness, nasal irritation, throat dryness, and throat irritation.

Very Rare Adverse Effects(may affect up to 1 in 10,000 people)

- Hypersensitivity reactions, anaphylaxis/anaphylactic reactions (generalized allergic reactions), bronchospasm (spasm in the bronchi that prevents air from reaching the lungs), skin rash, edema (swelling) on the face or tongue.

- Glaucoma (increased intraocular pressure), cataracts.

- Perforation of the nasal septum.

Adverse Effects of Unknown Frequency (cannot be estimated from available data)

- Blurred vision

- Nasal ulcers

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, https://www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 30°C.

Do not usethis medicationafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Flixonase

The active ingredient is fluticasone propionate. Each inhalation releases 50 micrograms of fluticasone propionate.

The other components areanhydrous glucose,microcrystalline cellulose and sodium carmellose, phenylethyl alcohol, benzalkonium chloride, poloxamer 80, diluted hydrochloric acid (for pH adjustment) and purified water.

Appearance of the product and contents of the packaging

The medication is a nasal spray suspension contained in a polypropylene bottle.

Each Flixonase bottle contains approximately 120 inhalations.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Responsible manufacturer:

Glaxo Wellcome, S.A.

Avenida de Extremadura, 3

09400 Aranda de Duero (Burgos)

Date of the last review of this leaflet:February 2018.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/