Prospect: information for the user

Avamys 27.5micrograms pernasal spray, suspension for nasal spray

fluticasone furoate

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacistor nurse.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

1.What is Avamys and how it is used

2.What you need to know before starting to use Avamys

3.How to use Avamys

4.Possible adverse effects

5.Storage of Avamys

6.Contents of the package and additional information

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

Avamys (furoate of fluticasone) belongs to a group of medicines calledglucocorticoids. Avamys acts by reducing the inflammation caused by an allergy (rhinitis), and therefore, reduces the symptoms of an allergy.

Avamys nasal spray suspension is used for the treatment of symptoms of allergic rhinitis including nasal congestion, increased nasal discharge, and 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 useAvamys

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

Warnings and precautions

Children and adolescents

Do not use in children under 6 years.

Using Avamys:

• may cause a delay in the growth of children when used for prolonged periods of time. Your doctor will regularly monitor the child's height, and ensure the child receives the minimum effective dose.

• may cause eye problems such as glaucoma (increased eye pressure) or cataracts (loss of transparency of the lens). Inform your doctor if you have had any of these problems in the past, or if you experience blurry vision or other visual disturbances while using Avamys.

Using Avamys with other medicines

Inform your doctor or pharmacist if you are using, have used recently or might have to use any other medicine, including those bought without a prescription.

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

• oral or injected steroids
• steroid creams
• asthma medicines
• ritonavir or cobicistat, used in the treatment ofHIV/AIDS
• ketoconazole, used in the treatment offungal infections

Your doctor will evaluate whether you should use Avamys with these medicines. Some medicines may increase the effects of Avamys, so your doctor will perform close monitoring if you are taking these medicines.

Avamys should not be used at the same time as other nasal sprays containing steroids.

Pregnancy, breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant or plan to become pregnant, consult your doctor before using this medicine.

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

Do not use Avamys if you are breastfeeding, unless your doctor or pharmacist tells you to.

Driving and operating machinery

It is unlikely that Avamys will affect your ability to drive and use machines.

Avamys contains benzalkonium chloride

This medicine contains 8.25 micrograms of benzalkonium chloride in each spray (27.5 micrograms). Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for a long treatment. Inform your doctor or pharmacist if you feel discomfort when using the sprayer.

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.

When to use Avamys

• 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 Avamys take to work

Some people may not feel the full effects until several days after starting to use Avamys.

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

How to use

Adults and children 12 years and older

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

Children 6 to 11 years

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

How to use the nasal sprayer

Avamys 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 to using the nasal sprayer following section 6 of this leaflet. Follow the guide carefully to get the most benefit from using Avamys.

• See thestep-by-step guide to using the nasal sprayer, following section 6.

If you use more Avamys than you should

Consult your doctor or pharmacist.

If you forget to use Avamys

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

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

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

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

Allergic reactions: seek immediate medical help

Allergic reactions to Avamys 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 Avamys 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. You may see remnants of blood when you blow your nose.
• Headache
• Shortness of breath.

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

• Pain, burning, irritation,nasal discomfortor 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 of 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 thenational notification system included in theAppendix V. 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 preferable to store the Avamys nasal spray in an upright position. Always keep the cap closed.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated. Once opened, the shelf life of Avamys nasal spray suspension is 2 months.

Do not refrigerate or freeze.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition of Avamys

• The active ingredient is fluticasone furoate. Each spray releases 27.5 micrograms of fluticasone furoate.
• The other components are anhydrous glucose, dispersible cellulose, polisorbate 80, 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 a white color contained in an amber glass bottle with a pump dispenser. The bottle is protected by a white plastic cap with a blue clear lid and a lateral dosing button. The cap has a window to see the contents of the bottle. Avamys is available in containers of 30, 60, and 120 sprays.Only some sizes of containers may be marketed.

Marketing Authorization Holder

Marketing Authorization:

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus

Dublin 24, Ireland

Responsible for manufacturing

Glaxo Wellcome S.A.

Avenida de Extremadura 3

09400 Aranda de Duero

Burgos

Spain

You can request any information about this medicine by contacting the local representative of the marketing authorization holder:

Last update of this leaflet:

The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu

STEP-BY-STEP GUIDE FOR USING THE NASAL SPRAY

Appearance of the nasal spray

The nasal spray is contained in an amber glass bottle with a pump dispenser – see drawinga.It will contain 30, 60, or 120 sprays, depending on the size of the container prescribed.

You will be able to see the level of liquid in the new 30 or 60 spray bottles, but not in a new 120 spray bottle because the level of liquid is above the window.

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

• Avamys 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.You will be able 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 Avamys is a dense suspension that becomes liquid when shaken well – see drawingb.It will only spray when it becomes liquid.

• You mustpressthe dosing buttonfirmly and completelyto release the mist through the nasal applicator – see drawingc.

• If you have difficulty pressing the button with your thumb, you can use both hands – see drawingd.

• Always keep the cap on the nasal spraywhen not in use. The cap prevents dust from entering, seals tightly under pressure, and prevents the nasal applicator from becoming blocked. While the cap is on, the dosing button cannot be pressed accidentally.
• Never use a pinor any other sharp object to clear the nasal applicator. This will damage the nasal spray.

Preparing the nasal spray for use

You must prepare the nasal spray:

• before using it for the first time
• if it has been left uncovered for 5 days or not used for 30 days or more.

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

1Shake the nasal spray vigorouslywith the cap on for 10 seconds.

2Remove the cap by pressing firmly on the sides of the cap with your thumb and index finger – see drawinge.

3Hold the nasal spray in a vertical position, then tilt andorient the nasal applicator away from you.

4Press the dosing button firmlyand completely.Do this at least 6 timesuntil a fine mist of spray is released into the air – see drawingf.

The nasal spray is now ready for use.

Using the nasal spray

1Shake the nasal sprayvigorously.

2Remove the cap.

3Blow your noseto clear your nasal passages, then tilt your head slightly forward.

4Place the nasal applicator in one of your nostrils – see drawingg.Orient the tip of the nasal applicator slightly towards the outside, away from the nasal septum. This will help the medicine reach the correct area of the nose.

5Pressthe dosing buttonfirmlyand completely, while inhaling through your nose –see drawingh.

6Remove the nasal applicator andexhale through your mouth.

7If your dose is 2 sprays in each nostril, repeat steps 4 to 6.

8Repeat steps 4 to 7 in the other nostril.

9Replace the capon the nasal spray.

Cleaning the nasal spray

After each use:

1Clean the nasal applicator and the inside of the cap with a dry and clean tissue – see drawingsiandj.

2Do not use water to clean it.

3Never use a pinor any other sharp object in the nasal applicator.

4Always replace the caponce you have finished using the nasal spray.

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 clear 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.