Alisade
fluticasone furoate
Fluticasone furoate
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Never pass it on to others. It may harm them, even if their symptoms seem the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Alisade 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.
Alisade belongs to a group of medicines called glucocorticoids. Alisade works to decrease inflammation caused by allergy (rhinitis).
If you are allergic (hypersensitive) to fluticasone furoate or any of the other ingredients of Alisade.
Taking nasal glucocorticoids (such as Alisade):
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 Alisade
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 Alisade with these medicines.
Ask your doctor for advice before taking any medicine.
Alisade is unlikely to affect your ability to drive and use machines.
Alisade 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 Alisade exactly as your doctor has told you. You should check with your doctor if you are not sure.
Alisade 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.
Use once a day
Use at the same time each day.
This will treat your symptoms throughout the day and night.
Some people will not feel the full effects until several days after first using Alisade. However, it is usually effective within 8 to 24 hours of use.
Once symptoms are controlled you may be able to decrease your dose to 1 spray in each nostril, once every 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.
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 Alisade
�See Step-by-step guide to using the nasal spray, after Section 6.
Talk to your doctor or pharmacist.
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, Alisade can cause side effects, although not everybody gets them.
Allergic reactions to Alisade 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.Nosebleeds (generally minor), particularly if you use Alisade for more than 6 weeks continuously.
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 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 Alisade nasal spray upright. Always keep the cap on.
Do not use Alisade after the expiry date which is stated on the label and carton. The expiry date refers to the last day of the month. Alisade 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.
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.
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. Alisade is available in pack sizes 30, 60 and 120 sprays.
Marketing authorisation: Glaxo Group Ltd
Greenford, Middlesex, UB6 0NN United Kingdom
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:
Tél/Tel: + 32 (0)2 656 21 11
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701
GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900
GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0
GlaxoSmithKline A.E.B.E.
Τηλ: + 30 210 68 82 100
GSK Commercial Sp. z o.o. Tel.: + 48 (0)22 576 9000
GlaxoSmithKline – Produtos Farmacêuticos, Lda. Tel: + 351 21 412 95 00
Laboratoire GlaxoSmithKline Tél.: + 33 (0)1 39 17 84 44
GlaxoSmithKline (GSK) S.R.L. Tel: + 4021 3028 208
GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000
GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
GlaxoSmithKline Cyprus Ltd
Τηλ: + 357 22 39 70 00
GlaxoSmithKline Latvia SIA Tel: + 371 67312687
GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00
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 Alisade 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.
Alisade 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 Alisade 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
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:
Remove the cap by squeezing firmly on the sides of the cap with your thumb and forefinger– see picture e.
Hold the nasal spray upright, then tilt and point the nozzle away from you.
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.
Press the button firmly all the way in, while you breathe in through your nose – see picture
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.
nolon product
Wipe the nozzle and inside of the cap with a clean, dry tissue – see pictures i and j.
Do not use water to clean it.
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.