AVAMYS 27.5 micrograms/spray, nasal spray suspension

2. What you need to know before using Avamys

Do not use Avamys

• If you are allergicto fluticasone furoate or 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 of age.

The use of Avamys:

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

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

Using Avamys with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

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

• corticosteroids in tablets or injectable corticosteroids
• corticosteroids in creams
• medicines for asthma
• ritonavir or cobicistat, used to treat HIV/AIDS
• ketoconazole, used to treat fungal infections

Your doctor will assess whether you should use Avamys with these medicines. Some medicines may increase the effects of Avamys, so your doctor will monitor you closely 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 may 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 using machines

Avamys is unlikely to affect your ability to drive or use machines.

Avamys contains benzalkonium chloride

This medicine contains 8.25 micrograms of benzalkonium chloride per actuation (27.5 micrograms). Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for long-term treatment. Inform your doctor or pharmacist if you experience discomfort when using the spray.

3. How to use Avamys

Follow the instructions for administering this medicine exactly as indicated by your doctor or pharmacist. Do not exceed the recommended dose. If in doubt, consult your doctor or pharmacist again.

When to use Avamys

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

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

How long it takes Avamys to work

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

However, it is usually effective between 8 and 24 hours after use.

How much to use

Adults and children 12 years and older

• The usual starting 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

• The usual starting 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. Then, it may be possible to reduce the dose to 1 spray in each nostril once a day.

How to use the nasal spray

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

There is a step-by-step guide to using the nasal spray after section 6 of this leaflet. Follow the guide carefully to get the full benefit of using Avamys.

• See thestep-by-step guide to using the nasal spray, after 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 take a dose, do so when you remember.

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

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

4. Possible side effects

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

Allergic reactions: seek medical help immediately

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

• appearance of many wheezes (wheezing), coughing, or breathing difficulties
• sudden feeling of weakness or dizziness (leading to collapse or loss of consciousness)
• swelling of 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– so if you notice any of these symptoms:

• Contact your doctor as soon as possible.

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

• Nosebleeds (usually minor), especially if you use Avamys for more than 6 weeks continuously.

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

• Nasal ulcers – which can cause irritation or discomfort in your nose. You may notice blood when you blow your nose.
• Headache
• Shortness of breath.

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

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

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

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

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

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

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

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Avamys

Keep this medicine out of sight and reach of children.

It is recommended to store the Avamys nasal spray in an upright position. Always keep the cap on.

Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated. Once opened, the validity period of Avamys nasal spray suspension is 2 months.

Do not refrigerate or freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Contents and Additional Information

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, polysorbate 80, benzalkonium chloride, disodium edetate, and purified water (see section 2).

Appearance of the Product and Container Contents

The medication is a white suspension for nasal spray contained in an amber glass bottle with a spray pump. The bottle is protected by a white plastic cover with a light blue cap and a lateral dosing button. The cover has a window to view the contents of the bottle. Avamys is available in containers of 30, 60, and 120 sprays. Only some package sizes may be marketed.

Marketing Authorization Holder

Marketing authorization:

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

D24 YK11

Manufacturer

Glaxo Wellcome S.A.

Avenida de Extremadura 3

09400 Aranda de Duero

Burgos

Spain

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

Date of Last Revision of this Project:

Detailed information on this medication is available on the European Medicines Agency website: http://www.ema.europa.eu

STEP-BY-STEP GUIDE FOR USING THE NASAL SPRAY

Nasal Spray Appearance

The nasal spray is contained in an amber glass bottle protected by a plastic cover - see drawing a.It will contain 30, 60, or 120 sprays, depending on the package size prescribed for you.

The window on the plastic cover allows you to see how much Avamys is left in the bottle. You will be able to see the liquid level in new bottles of 30 or 60 sprays, but not in a new bottle of 120 sprays because the liquid level 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 upright and against a light source.This way, you will be able to see the level through the window.
• When using the nasal spray for the first time, you will need to 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 drawing b.It will only spray when it becomes liquid.

• You must pressthe dosing button firmly and completelyto release the mist through the nasal applicator - see drawing c.

• If you have difficulty pressing the button with your thumb, you can use both hands - see drawing d.

• 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 clogging. With the cap on, the dosing button cannot be pressed accidentally.
• Never use a pinor any other sharp object to unclog the nasal applicator. This would damage the nasal spray.

Preparing the Nasal Spray for Use

You must prepare the nasal spray:

• before using it for the first time
• if you have left it uncapped for 5 days or have not used the intranasal device for 30 days or more.

Preparing the nasal spray helps ensure that you always receive the full dose of medication. 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 drawing e.

3Hold the nasal spray upright, then tilt and point the nasal applicator away from you.

4Press the dosing button firmlyand completely. Do this at least 6 timesuntil a fine spray mist is released into the air - see drawing f.

The nasal spray is now ready for use.

Using the Nasal Spray

1Shake the nasal sprayvigorously.

2Remove the cap.

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

4Place the nasal applicator in one of your nostrils - see drawing g.Point the tip of the applicator slightly outward, away from the nasal septum. This helps the medication reach the right part of the nose.

5Press the dosing buttonfirmlyand completely while breathing in through your nose- see drawing h.

6Remove the applicator and exhale 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 applicator and the inside of the cap with a dry, clean tissue - see drawings iand j.

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 appears not to be working:

• Check that there is still medication 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 clogged, 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 stream of liquid is produced, take the nasal spray to the pharmacy and consult your pharmacist.