AVAMYS 27.5 micrograms/spraynasal spray suspension

Avamys nasal spray is used to treat symptoms of allergic rhinitis including stuffy, runny or itchy nose, sneezing and watery, itchy or red eyes, in adults and children aged 6 years and over.

Allergy symptoms can occur at specific times of the year and be caused by allergy to pollen from grass or trees (hayfever), or they can occur all year round and be caused by allergy to animals, house-dust mites or moulds.

Avamys belongs to a group of medicines called glucocorticoids. Avamys works to decrease inflammation caused by allergy ( rhinitis).

Do not use Avamys:
If you are allergic ( hypersensitive) to fluticasone furoate or any of the other ingredients of Avamys.

Take special care with Avamys:
If you have any liver problems, tell your doctor or pharmacist. Your doctor may adjust your dose of Avamys.

Taking nasal glucocorticoids (such as Avamys):

• may when taken for a long time cause children to grow more slowly. The doctor will check your child?s height regularly, and make sure he or she is taking the lowest possible effective dose.
• may cause eye conditions such as glaucoma (increase in pressure in the eye) or cataracts (clouding of the lens of the eye). Tell your doctor if you had these conditions in the past, or if you notice any change in your vision while you are taking Avamys.

Taking other medicines

Tell your doctor if you are taking, or have recently taken, any other medicines, including those bought without a prescription.
It is especially important to tell your doctor if you are taking, or have recently taken any of the following medicines:

• steroid tablets or injected steroids
• steroid creams
• medicines for asthma
• ritonavir, used to treat HIV
• ketoconazole, used to treat fungal infections

Your doctor will assess whether you should take Avamys with these medicines.

Pregnancy and breast-feeding

Ask your doctor for advice before taking any medicine.

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

Do not use Avamys if you are breast feeding unless your doctor or pharmacist tells you to.

Driving and using machines

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

Important information about some of the ingredients of Avamys

Avamys contains benzalkonium chloride. In some patients this can cause irritation in the inside of the nose. Tell your doctor or pharmacist if you feel discomfort when using the spray.

Always use Avamys exactly as your doctor has told you. You should check with your doctor if you are not sure.

Avamys has virtually no taste or smell. It is sprayed into the nose as a fine mist. Be careful not to get any spray into your eyes. If you do, rinse your eyes with water.

When to use Avamys

• Use once a day
• Use at the same time each day. This will treat your symptoms throughout the day and night.

How long Avamys takes to work

Some people will not feel the full effects until several days after first using Avamys.
However, it is usually effective within 8 to 24 hours of use.

How much to use

Adults and children 12 years and over

• The usual starting dose is 2 sprays in each nostril once every day.
• Once symptoms are controlled you may be able to decrease your dose to 1 spray in each nostril, once every day.

Children 6 to 11 years

• The usual starting dose is 1 spray in each nostril once a day. .
• If symptoms are very bad your doctor may increase the dose to 2 sprays in each nostril once every day until the symptoms are under control. It may then be possible for the dose to be reduced to 1 spray in each nostril once every day.
• Do not use in children under 6 years old.

How to use the nasal spray

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

SeeStep-by-step guide to using the nasal spray, after Section 6.

If you use more Avamys than you should

Talk to your doctor or pharmacist.

If you forget to use Avamys

If you miss a dose, take it when you remember.

If it is nearly the time for your next dose, wait until then. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, or if you have any discomfort using the nasal spray ask your doctor or pharmacist.

Like all medicines, Avamys can cause side effects, although not everybody gets them.

Allergic reactions: get a doctor?s help straight away

Allergic reactions to Avamys are rare and affect less than 1 person in 1,000. In a small number of people, allergic reactions can develop into a more serious, even life-threatening problem if not treated. Symptoms include:

• becoming very wheezy, coughing or having difficulty with breathing
• suddenly feeling weak or light-headed (which may lead to collapse or loss of consciousness)
• swelling around the face
• skin rashes or redness.In many cases, these symptoms will be signs of less serious side effects. But you must be aware that they are potentially serious ? so, if you notice any of these symptoms: See a doctor as soon as possible.

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

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

Common side effects (These can affect less than 1 person in 10 and more than 1 person in 100)

• Irritation or discomfort in the inside of the nose ? you may also get streaks of blood when you blow your nose. This may be due to nasal ulceration.

Nasal corticosteroids can affect the normal production of hormones in your body, particularly if you use high doses for a long time. In children this side effect can cause them to grow more slowly than others.

If you get side effects

If any of the side effects gets serious or troublesome, or if you notice any side effects not listed in this leaflet: Tell your doctor or pharmacist.

Keep out of the reach and sight of children.

It is best to store your Avamys nasal spray upright. Always keep the cap on.

Do not use Avamys after the expiry date which is stated on the label and carton. The expiry date refers to the last day of the month. Avamys nasal spray should be used within 2 months after first opening.

Do not refrigerate or freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Avamys contains

The active substance is fluticasone furoate. Each spray delivers 27.5 micrograms of fluticasone furoate. The other ingredients are glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water.

What Avamys looks like and contents of the pack

The medicine is a white nasal spray suspension contained in an amber glass bottle, fitted with a pump. The bottle is in an off-white plastic casing with a light blue cap and side-actuated lever. The casing has a window for viewing the bottle contents. Avamys is available in pack sizes 30, 60 and 120 sprays.

Marketing authorisation holder

Marketing authorisation:
Glaxo Group Ltd
Greenford, Middlesex, UB6 0NN
United Kingdom

Manufacturer:

Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)
Harmire Road
Barnard Castle
County Durham

DL12 8DT
United Kingdom

Glaxo Wellcome S.A.
Avenida de Extremadura 3
09400 Aranda de Duero
Burgos
Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien GlaxoSmithKline s.a.n.v. TélTel 32 02 656 21 11 LuxembourgLuxemburg GlaxoSmithKline s.a.n.v. BelgiqueBelgien TélTel 32 02 656 21 11

Te. 359 2 953 10 34 Magyarország GlaxoSmithKline Kft. Tel. 36 1 225 5300

Malta GlaxoSmithKline Malta Tel 356 21 238131 eská republika GlaxoSmithKline s.r.o. Tel 420 222 001 111 gsk.czmailgsk.com

Danmark GlaxoSmithKline Pharma AS Tlf 45 36 35 91 00 dk-infogsk.com Nederland GlaxoSmithKline BV Tel 31 030 6938100 nlinfogsk.com

Deutschland GlaxoSmithKline GmbH Co. KG Tel. 49 089 36044 8701 produkt.infogsk.com Norge GlaxoSmithKline AS Tlf 47 22 70 20 00 firmapostgsk.no

Eesti GlaxoSmithKline Eesti OÜ Tel 372 6676 900 estoniagsk.com Österreich GlaxoSmithKline Pharma GmbH Tel 43 01 97075 0 at.infogsk.com

GlaxoSmithKline A.E.B.E. 30 210 68 82 100 Polska GSK Commercial Sp. z o.o. Tel. 48 022 576 9000

España GlaxoSmithKline, S.A. Tel 34 902 202 700 es-cigsk.com Portugal GlaxoSmithKline Produtos Farmacêuticos, Lda. Tel 351 21 412 95 00 FI.PTgsk.com

România GlaxoSmithKline GSK S.R.L. Tel 4021 3028 208 France Laboratoire GlaxoSmithKline Tél. 33 01 39 17 84 44 diamgsk.com

Ireland GlaxoSmithKline Ireland Limited Tel 353 01 4955000 Slovenija GlaxoSmithKline d.o.o. Tel 386 01 280 25 00 medical.x.sigsk.com

Ísland GlaxoSmithKline ehf. Sími 354 530 3700 Slovenská republika GlaxoSmithKline Slovakia s. r. o. Tel 421 02 48 26 11 11 recepcia.skgsk.com

Italia GlaxoSmithKline S.p.A. Tel 39 045 9218 111 SuomiFinland GlaxoSmithKline Oy PuhTel 358 010 30 30 30 Finland.tuoteinfogsk.com

GlaxoSmithKline Cyprus Ltd 357 22 39 70 00 Sverige GlaxoSmithKline AB Tel 46 08 638 93 00 info.produktgsk.com

Latvija GlaxoSmithKline Latvia SIA Tel 371 67312687 lv-epastsgsk.com United Kingdom GlaxoSmithKline UK Tel 44 0800 221441 customercontactukgsk.com

Lietuva

GlaxoSmithKline Lietuva UAB
Tel: + 370 5 264 90 00
info.lt@gsk.com

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STEP-BY-STEP GUIDE TO USING THE NASAL SPRAY

What the nasal spray looks like

The nasal spray comes in a brown glass bottle inside a plastic casing - see picture a. It will contain either 30, 60 or 120 sprays, depending on the pack size that has been prescribed for you.

The window in the plastic casing lets you see how much Avamys is left in the bottle. You will be able to see the liquid level for a new 30 or 60 spray bottle, but not in a new 120 spray bottle because the liquid level is above the window.

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

• Avamys comes in a brown bottle. If you need to check how much is left hold the nasal spray upright against a bright light. You will then be able to see the level through the window.
• When you first use the nasal spray you will need to shake it vigorously with the cap on for about 10 seconds. This is important as Avamys is a thick suspension that becomes liquid when you shake it well - see picture b. It will only spray when it becomes liquid.
• The mist-release button must be pressed firmly all the way in, to release the mist through the nozzle - see picture c.
• If you have difficulty pressing the button with your thumb, you can use two hands ? see picture d
• Alwayskeep the cap on the nasal spray when you are not using it. The cap keeps the dust out, seals in the pressure and stops the nozzle from blocking up. When the cap is in place the mist-release button cannot be pressed accidentally.
• Never use a pin or anything sharp to clear the nozzle. It will damage the nasal spray

Preparing the nasal spray for use

You must preparethe nasal spray:

• before you use it for the first time
• if you have left the cap off

Preparing the nasal spray helps to make sure you always get the full dose of medicine. Follow these steps: 1 Shake the nasal spray vigorously with the cap on for about 10 seconds.

2 Remove the cap by squeezing firmly on the sides of the cap with your thumb and forefinger? see

picture e.

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

4 Press the button firmly all the way in. Do this at least 6 times until it releases a fine mist of spray

into the air ? see picture f.

The nasal spray is now ready for use.

Using the nasal spray Shake the nasal spray vigorously. Remove the cap. Blow your nose to clear your nostrils, then tilt your head forward a little bit. 1 2 3 4 Place the nozzle in one of your nostrils see picture g. Point the end of the nozzle slightly outwards, away from the centre ridge of your nose. This helps to get the medicine to the correct part of your nose. 5 Press the button firmly all the way in, while you breathe in through your nose see picture h.

6 7 8 9 Take the nozzle out and breathe out through your mouth. If your dose is two sprays in each nostril repeat steps 4 to 6. Repeat steps 4 to 7 to treat the other nostril. Replace the cap on the nasal spray.

Cleaning the nasal spray
After each use:
1 Wipe the nozzle and inside of the cap with a clean, dry tissue ? see pictures i and j.

2 3 4 Do not use water to clean it. Never use a pin or anything sharp on the nozzle. Always replace the cap once you have finished.

If the nasal spray does not seem to be working:

• Check you still have medicine left. Look at the level through the window. If the level is very low there may not be enough left to work the nasal spray.
• Check the nasal spray for damage
• If you think the nozzle may be blocked, do not use a pin or anything sharp to clear it.
• Try to reset it by following the instructions under ?Preparing the nasal spray for use?.

If it is still not working, or if it produces a jet of liquid, take the nasal spray back to the pharmacy to get advice.