Avamys

Patient Information Leaflet: Information for the User

Avamys 27.5 micrograms per spray, nasal spray, suspension

fluticasone furoate
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Never give it to others. This medicine may be harmful to other people, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Avamys is and what it is used for
2. What you need to know before using Avamys
3. How to use Avamys
4. Possible side effects
5. How to store Avamys
6. Contents of the pack and other information
   Step-by-step guide on how to use the nasal spray

1. What Avamys is and what it is used for

Avamys (fluticasone furoate) belongs to a group of medicines called glucocorticoids. Avamys works by reducing inflammation caused by allergy (rhinitis), thereby relieving allergy symptoms.
Avamys nasal spray is used to treat symptoms of allergic rhinitis, including blocked, runny or itchy nose, sneezing, and watery, itchy or red eyes, in adults and children aged 6 years and older.
Allergy symptoms may occur during specific times of the year and may be caused by allergies to grass or tree pollen (hay fever), or they may occur throughout the year and be caused by allergies to animals, house dust mites or moulds, among some of the more common triggers.

2. What you need to know before taking AVAMYS

Do not use AVAMYS

• If you are allergic to 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 of age.
Taking AVAMYS:

• may cause children to grow more slowly if taken for a long period of time. Your doctor will regularly monitor your child's height and ensure they are receiving the lowest effective dose possible.
• may cause eye disorders such as glaucoma (increased pressure in the eye) or cataract (clouding of the eye's lens). Inform your doctor if you have previously had these conditions or if you notice blurred vision or other visual disturbances while using AVAMYS.

Other medicines and AVAMYS
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
It is especially important to inform your doctor if you are taking or have recently taken any of the following medicines:

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

Your doctor will check whether you can take AVAMYS together with these medicines. Your doctor may need to closely monitor you if you are taking any of these medicines, as they may increase the risk of side effects from AVAMYS.
AVAMYS must not be used at the same time as other steroid-containing nasal sprays.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Do not take AVAMYS if you are pregnant or planning to become pregnant, unless your doctor or pharmacist has advised you to do so.
Do not take AVAMYS if you are breastfeeding, unless your doctor or pharmacist has advised you to do so.
Driving and using machines
It is unlikely that AVAMYS will affect your ability to drive vehicles or operate machinery.
AVAMYS contains benzalkonium chloride
This medicine contains 8.25 micrograms of benzalkonium chloride per spray (27.5 micrograms). Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for prolonged periods. Inform your doctor or pharmacist if you experience discomfort when using the spray.

3. How to take Avamys

Always use this medicine exactly as your doctor or pharmacist has told you. Do not exceed the recommended dose. If you are unsure, consult your doctor or pharmacist.

When to use Avamys

• Take it once daily.
• Take it every day at the same time. This helps control your symptoms throughout the day and night.

How long does it take for Avamys to work?
Some people may not achieve the full effect of Avamys until several days after starting treatment. However, it is usually effective within 8–24 hours after the first nasal dose.

How much Avamys to use

Adults and children aged 12 years and older

• The usual starting dose is 2 sprays in each nostril once daily, every day.
• Once symptoms are under control, the dose may be reduced to 1 spray in each nostril once daily, every day.

Children aged 6 to 11 years

• The usual starting dose is 1 spray in each nostril once daily.
• If symptoms are particularly severe, your doctor may increase the dose to 2 sprays in each nostril once daily, every day, until symptoms are controlled. The dose may then be reduced to 1 spray in each nostril once daily, every day.

How to use the nasal spray
Avamys is practically tasteless and odourless. It is sprayed into the nose as a fine mist. Be careful not to spray it into the eyes. If this happens, rinse the eyes with water.
A step-by-step guide on how to use the nasal spray is provided after section 6 of this leaflet.
Please follow the instructions carefully to get the maximum benefit from Avamys.
 See the Step-by-step guide on how to use the nasal spray after section 6.

If you take more Avamys than you should
Inform your doctor or pharmacist.

If you forget to take Avamys
If you miss a dose, take it as soon as you remember.
If it is almost time for your next dose, wait until then and take your usual dose. Do not take a double dose to make up for the missed one.

If you have any further questions about using this medicine, or if you have any difficulty using the nasal spray, ask your doctor or pharmacist for advice.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions: consult your doctor immediately
Allergic reactions to Avamys are rare and affect fewer than 1 in 1,000 people. In a small number of people, allergic reactions can develop into a more serious, potentially life-threatening problem if not treated. Symptoms include:

• wheezing, coughing or difficulty breathing
• sudden feeling of weakness or dizziness (which may lead to collapse or loss of consciousness)
• swelling of the face
• skin rash or redness.

In many cases, these symptoms may indicate less serious side effects. However, you must be aware that they could potentially be serious — therefore, if you notice any of these symptoms:
Consult a doctor as soon as possible.
Very common side effects (may affect more than 1 in 10 people)

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

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

• Nasal ulceration – which may cause irritation or discomfort in the nose. You may also notice streaks of blood when blowing your nose.
• Headache
• Shortness of breath.

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

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

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

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

Side effects not known (frequency cannot be estimated from the available data)

• Growth retardation in children.
• Blurred vision or temporary changes in vision with prolonged use.
• Chest tightness causing breathing difficulties.
• Voice disorder, loss of voice.
• Taste disturbance, loss of taste, loss of smell.

Nasally administered corticosteroids may alter the normal production of steroid hormones in your body, particularly if used at high doses over a long period of time. In children, this side effect may result in slower growth compared to other children.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Avamys

Keep this medicine out of the sight and reach of children.
The best way to store Avamys nasal spray is in an upright position. Always keep the cap on.
Do not use this medicine after the expiry date stated on the label and the carton. The expiry date refers to the last day of the month. After first use, Avamys nasal spray should be used within two months.
Do not store Avamys in the refrigerator or freezer.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Avamys Contains

• The active substance is fluticasone furoate. Each spray delivers 27.5 micrograms of fluticasone furoate.
• The excipients are anhydrous glucose, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water (see section 2).

Description of the Appearance of Avamys and Contents of the Pack
The medicine is a nasal spray in the form of a white suspension contained in an amber glass bottle equipped with a metering pump. The bottle is housed in a whiteish plastic inhaler with a light blue cap and a side button that activates the spray.
The plastic inhaler has a viewing window to monitor the remaining content in the bottle.
Avamys is available in packs containing 30, 60, and 120 sprays.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Marketing Authorisation:
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

For further information on Avamys, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals s.a./n.v. GlaxoSmithKline Trading Services Limited
Tél/Tel: + 32 (0)10 85 52 00 Tel: + 370 80000334

България Luxembourg/Luxemburg
GlaxoSmithKline Trading Services Limited GlaxoSmithKline Pharmaceuticals s.a./n.v.
Teл.: + 359 80018205 Belgique/Belgien
Tél/Tel: + 32 (0)10 85 52 00

Česká republika Magyarország
GlaxoSmithKline s.r.o. GlaxoSmithKline Trading Services Limited
Tel: + 420 222 001 111 Tel.: + 36 80088309
[email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S GlaxoSmithKline Trading Services Limited
Tlf.: + 45 36 35 91 00 Tel: + 356 80065004
[email protected]

Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel.: + 49 (0)89 36044 8701 Tel: + 31 (0) 33 2081100
[email protected]

Eesti Norge
GlaxoSmithKline Trading Services Limited GlaxoSmithKline AS
Tel: + 372 8002640 Tlf: + 47 22 70 20 00

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Τηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
GlaxoSmithKline, S.A. GSK Services Sp. z o.o.
Tel: + 34 90 202 700 Tel.: + 48 (0)22 576 9000
[email protected]

France Portugal
Laboratoire GlaxoSmithKline GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tél.: + 33 (0)1 39 17 84 44 Tel: + 351 21 412 95 00
[email protected] [email protected]

Hrvatska România
GlaxoSmithKline Trading Services Limited GlaxoSmithKline Trading Services Limited
Tel: + 385 800787089 Tel: + 40 800672524

Slovenija
Ireland GlaxoSmithKline Trading Services Limited
GlaxoSmithKline Trading Services Limited Tel: + 386 80688869
Tel: + 353 (0)1 4955000

Ísland Slovenská republika
Vistor hf. GlaxoSmithKline Trading Services Limited
Sími: + 354 535 7000 Tel: + 421 800500589

Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel: + 39 (0)45 7741 111 Puh/Tel: + 358 (0)10 30 30 30

Κύπρος Sverige
GlaxoSmithKline Trading Services Limited GlaxoSmithKline AB
Τηλ: + 357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
GlaxoSmithKline Trading Services Limited
Tel: + 371 80205045

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

STEP-BY-STEP GUIDE TO USING THE NASAL SPRAY

What the Nasal Spray Looks Like
The nasal spray comes in an amber glass bottle placed inside a plastic device – see figure a. The bottle contains 30, 60, or 120 sprays, depending on the pack prescribed.

The window on the side of the plastic inhaler allows you to see the amount of medicine remaining in the bottle. You can see the liquid level in a new 30- or 60-spray bottle, but not in a new 120-spray bottle, as the liquid level is above the window in the latter.

Six Important Things to Know About Using the Nasal Spray

• Avamys comes in an amber glass bottle. To check how much medicine remains in the bottle, hold the nasal spray upright against the light. This allows you to see the medicine level through the viewing window.
• When using the nasal spray for the first time, you must shake it vigorously for about 10 seconds with the cap in place. This is important because Avamys is a dense suspension that becomes liquid when shaken well – see figure b. The medicine will only spray properly once it has become liquid.

• The release button must be pressed firmly and completely to release the mist through the nozzle – see figure c.

• If you have difficulty pressing the release button with your thumb, you may use both hands – see figure d.

• Always keep the cap on the nasal spray when not in use. The cap protects against dust, seals by pressure, and prevents the nozzle from becoming blocked. When the cap is in place, the release button cannot be accidentally pressed.
• Do not use a pin or any sharp object to clean the nozzle. This could block the nasal spray.

Preparing the Nasal Spray for Use
The nasal spray must be prepared:

• Before first use
• If the cap has been left off for 5 days or more
• If the nasal device has not been used for 30 days or more

Preparing the nasal spray ensures that the full dose of medicine is delivered.
Follow these steps:
1 Shake the nasal spray vigorously with the cap in place for about 10 seconds.
2 Remove the cap by firmly squeezing its sides with your thumb and index finger – see figure e.

3 Hold the nasal spray upright, then tilt it and point the nozzle away from yourself.
4 Press the button firmly and completely. Repeat this at least 6 times until a fine mist is seen in the air – see figure f.

The nasal spray is now ready for use.

Using the Nasal Spray
1 Shake the nasal spray vigorously.
2 Remove the cap.
3 Blow your nose to clear your nostrils, then tilt your head slightly forward.
4 Insert the nozzle into one nostril – see figure g. The nozzle should be placed inside the nostril pointing outward, away from the central nasal septum. This helps deliver the medicine to the correct area of the nose.
5 Press the button firmly and completely while inhaling through your nose – see figure h.

6 Remove the nozzle and breathe out through your mouth.
7 If the prescribed dose is 2 sprays in each nostril, repeat steps 4 to 6.
8 Repeat steps 4 to 7 for the other nostril.
9 Replace the cap on the nasal spray.

Cleaning the Nasal Spray
After each use:
1 Wipe the nozzle and the inside of the cap with a clean, dry cloth – see figures i and j.

2 Do not use water to clean the nasal spray.
3 Never use a pin or any sharp object on the nozzle.
4 Always replace the cap on the spray after use.

If the nasal spray does not seem to work:

• Check whether any medicine remains. Look at the medicine level through the viewing window. If the level is very low, there may not be enough left to operate the spray.
• Check whether the nasal spray has been damaged.
• If you think the nozzle may be blocked, do not use a pin or any sharp object to clean it.
• Try to get it working again by following the instructions in the section “Preparing the Nasal Spray for Use”. If the nasal spray still does not work or delivers a stream of liquid instead of a mist, return it to your pharmacist for advice.