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
This leaflet was last approved in {MM/YYYY}.
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.