Leaflet: information for the user

Avancort 27.5 micrograms/dose, nasal spray suspension

fluticasone furoate

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Avancort belongs to a group of medications calledglucocorticoids. Furoate of fluticasone acts by reducing the inflammation caused by allergy (rinitis), and therefore, reduces the symptoms of allergy.

Avancort nasal spray suspension is used for the treatment of symptoms of allergic rhinitis including nasal congestion, increased nasal secretion or nasal itch, sneezing and tearing and eye itch or redness in adults and children 6 years of age or older.

Allergic symptoms can appear at certain times of the year as a result of allergy to plant or tree pollen (hay fever), or they can occur throughout the year as a result of allergy to animals, dust mites or mold, among others.

Do not use Avancort

Warnings and precautions

Consult your doctor,pharmacist or nurse before starting to useAvancort

Children and adolescents

Do not use in children under 6 years.

Using Avancort:

Other medicines and Avancort

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine, including those bought without a prescription.

It is especially important to inform your doctor if you are taking or have taken recently, any of the following medicines:

Your doctor will assess whether you should take fluticasone furoate with these medicines. Your doctor may wish to monitor you closely if you are taking any of these medicines as they may increase the effects of Avancort.

Fluticasone furoate should not be used at the same time as other nasal sprays that contain steroids.

Pregnancy and breastfeeding

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

Do not use Avancort if you are pregnant, or are planning to become pregnant, unless your doctor or pharmacist tells you to.

Do not use Avancort if you are breastfeedingunless your doctor or pharmacist tells you to.

Driving and operating machinery

Avancort is unlikely to affect your ability to drive and use machines.

Avancort contains benzalkonium chloride

This medicine contains 8.25 micrograms of benzalkonium chloride in each spray and 13.75 micrograms of polysorbate in each spray.

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

Polysorbates may cause allergic reactions.

Inform your doctor or pharmacist if you experience any discomfort when using the spray.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

When to use Avancort

• Use once a day.
• Use at the same time every day.

This medication will treat your symptoms throughout the day and night.

How long does it take for Avancort to take effect

Some people may not feel the complete effects until several days after starting to use Avancort.

However, it is generally effective between 8 to 24 hours after use.

How much to use

Adults and children 12 years and older

• Initial normal doseis 2 sprays in each nasal passage once a day.
• Once symptoms are controlled, it may be possible to reduce the dose to 1 spray in each nasal passage, once a day.

Children 6 to 11 years

• Initial normal doseis 1 spray in each nasal passage once a day.
• If symptoms are very severe, your doctor may increase the dose to 2 sprays in each nasal passage once a day, until symptoms are under control. After that, it may be possible to reduce the dose to 1 spray in each nasal passage once a day.

How to use the nasal sprayer

Avancort has almost no taste or smell. It is sprayed into the nose as a fine mist. Be careful not to spray the medication into the eyes. If this happens, rinse the eyes with water.

There is a step-by-step guide on the use of the nasal sprayer following section 6 of this leaflet. Follow the guide carefully to get the most benefit from using Avancort.

SeetheStep-by-Step Guide for the use of the nasal sprayer,following section 6.

If you use more Avancort than you should

Consult your doctor or pharmacist.

If you forgot to use Avancort

If you forgot to administer a dose, do it when you remember.

If it is almost time for the next dose, wait until then. Do not take a double dose to make up for the missed doses.

If you have any other questions about the use of this medication, or if you feel any discomfort when using the nasal sprayer, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Allergic reactions: seek immediate medical help

Allergic reactions to Avancort are rare and affect fewer than 1 in 1,000 people. In a small number of people, allergic reactions can become more severe, even life-threatening if not treated. Symptoms include:

• Appearance of many wheezes (sibilance), cough, or breathing difficulties
• Sudden feeling of weakness or dizziness (leading to collapse or loss of consciousness)
• Swelling in the face
• Skin rash or redness.

In many cases, these symptoms will be signs of less severe side effects.However, you should be aware that they can be potentially serious– therefore, if you notice any of these symptoms:

Contact your doctor as soon as possible.

Very common side effects(can affect more than 1 in 10 people)

• Nasal bleeding (usually of little importance), especially if you use Avancort for more than 6 weeks continuously.

Common side effects(can affect up to 1 in 10 people)

• Nasal ulceration – which can cause irritation or discomfort in your nose. Bleeding may appear when you blow your nose.
• Headache.
• Shortness of breath.

Uncommon side effects(can affect up to 1 in 100 people)

• Pain, burning, irritation, painful or sore nasal sensation, or dryness inside the nose.

Rare side effects(can affect up to 1 in 10,000 people)

• Small holes (perforations) in the nasal septum that separates the nasal passages.

Frequency not known(the frequency cannot be estimated from the available data)

• Slowed growth in children.
• Blurred vision or temporary changes in vision with prolonged use.
• Chest tightness causing breathing difficulties.
• Voice disorder, loss of voice.
• Taste disorder, loss of taste, loss of smell.

The use of nasal corticosteroids can affect the normal production of hormones in your body, especially if high doses are used for prolonged periods of time. In children, these side effects can cause slower growth.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

It is recommended to storeAvancort 27.5 micrograms/pulverization, nasal spray suspension inan upright position.

Always keep the cap closed.

Do not use this medication after the expiration date that appears on the label and the box after “CAD:”. The expiration date is the last day of the month indicated. Avancort should be used within 2 months after the first opening.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines that you no longer need at the SIGRE collection pointof the pharmacy. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Avancort

• The active ingredient is fluticasone furoate. Each spray releases 27.5 micrograms of fluticasone furoate.
• The other components are: glucose, microcrystalline cellulose (E460) and sodium carmellose (E466), polisorbate 80 (E433), benzalkonium chloride, disodium edetate and purified water (see section 2).

Appearance of the product and contents of the container

The medicine is a nasal spray suspension of white color contained in an amber glass bottle type III of 15 ml, equipped with a dosing spray pump, a nasal applicator (sprayer) and a cap.

Avancort is available in a packaging size: 1 bottle of 120 sprays.

Marketing authorization holder and responsible for manufacturing

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Curida AS

Solbærvegen 5,

2409 Elverum,

Norway

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria:Fluticasonfuroat Goibela 27.5 Mikrogramm/Sprühstoß Nasenspray, Suspension

Spain:Avancort 27.5 micrograms/spray, nasal spray suspension

Last review date of this leaflet:March 2025

Other sources of information

Step-by-step guide for using the nasal spray.

STEP-BY-STEP GUIDE FOR USING THE NASAL SPRAY

Appearance of the nasal spray

The nasal spray is contained in an amber glass bottle. It will contain 120 sprays.

Five important things you need to know about using the nasal spray

• Avancort is contained in an amber glass bottle. If you need to check how much is left,hold the nasal spray in a vertical position against the light.This will allow you to see the level through the window.
• Whenyou use the nasal spray for the first timeyou will needto shake it vigorouslywith the cap on for 10 seconds. This is important because Avancort is a dense suspension that becomes liquid when shaken well.It will only spray when it becomes liquid.
• You mustpressthe dosing buttonfirmly and completelyto release the mist through the nasal applicator – see diagrama.
• Always keep the cap on the nasal spraywhen not in use. The cap prevents dust from entering, seals hermetically under pressure and prevents the nasal applicator from becoming blocked.
• Never use a pinor any other sharp object to unclog the nasal applicator. This will damage the nasal spray.

Preparing the nasal spray for use

You must prepare the nasal spray:

1. before using it for the first time
2. if it has been left open for 5 days or you have not used the nasal device for 30 days or more.

Preparing the nasal spray helps to ensure that you always receive the full dose of medicine. Follow these steps:

1. Shake the nasal spray vigorouslywith the cap on for 10 seconds.
2. Remove the cap.
3. Hold the nasal spray in a vertical position, then tilt andorient the nasal applicator away from you.
4. Press the dosing button firmlyand completely – see diagrama.Do this at least 6 timesuntil a fine mist of spray is released into the air.

a

The nasal spray is now ready for use.

Using the nasal spray

1. Shake the nasal sprayvigorously.
2. Remove the cap.
3. Blow your noseto clear your nasal passages, then lean your head slightly forward.
4. Place the nasal applicator in one of your nostrils. Orient the end of the nasal applicator slightly towards the outside, away from the nasal septum. This will help the medicine reach the right part of your nose – see diagramb.

b

1. Pressthe dosing button firmlyand completely,while inhaling through your nose.
2. Remove the nasal applicator andexhale through your mouth.
3. If your dose is 2 sprays in each nostril, repeat steps 4 to 6.
4. Repeat steps 4 to 7 in the other nostril.
5. Replace the capon the nasal spray.

Cleaning the nasal spray

After each use:

1. Clean the nasal applicator with a clean and dry tissue.
2. Do not use water to clean it.
3. Never use a pin or any other sharp object in the nasal applicator.
4. Always replace the caponce you have finished.

If the nasal spray seems not to be working:

• Check if there is still medicine left. Look at the level through the window. If the level is very low it may not be enough for the nasal spray to work.
• Check if the nasal spray has been damaged.
• If you think the nasal applicator may be blocked,do not use a pinor any other sharp object to unclog it.
• Try to restart it by following the instructions mentioned in “Preparing the nasal spray for use”.
• If it still does not work, or if a liquid jet is produced, take the nasal spray to the pharmacy and consult your pharmacist.

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

You can access detailed and updated information about this medicine by scanning the QR code with your smartphone (mobile phone) included in the leaflet and packaging. You can also access this information on the following internet address:https://cima.aemps.es/cima/dochtml/p/89779/P_89779.html

QR code to:https://cima.aemps.es/cima/dochtml/p/89779/P_89779.html