AVAMYS 27,5 MCG Nasal spray, suspension

Зміст інструкції

1. Avamys 27.5 micrograms per spray, nasal spray, suspension
   1. What Avamys is and what it is used for
   2. What you need to know before you take AVAMYS
   3. How to take Avamys
   4. Possible side effects
   5. Contents of the pack and other information

Avamys 27.5 micrograms per spray, nasal spray, suspension

fluticasone furoate

Read this leaflet carefully before you start to take this medicine as 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. Do not pass it on to others. It may be harmful for people other than you, even if their symptoms are the same as yours.
• If you get any side effects, even 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 you take Avamys
• 3. How to take Avamys
• 4. Possible side effects
• 5. How to store Avamys
• 6. Contents of the pack and other information Step-by-step guide to using 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) and therefore reduces allergy symptoms.
Avamys nasal spray is used to treat the symptoms of allergic rhinitis including nasal congestion, a
runny or itchy nose, sneezing, watery eyes, itchy and red eyes, in adults and in
children starting from 6 years of age.
Allergy symptoms can occur in well-defined periods of the year and can be caused
by allergies to grass or tree pollen (hay fever), or they can occur throughout
the year and be caused by allergies to animals, house dust mites or molds, to name a few
of the most common.

2. What you need to know before you take AVAMYS

Do not use Avamys

• If you are allergicto 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 check your child's height and make sure they are taking the lowest effective dose possible.
• may cause eye diseases such as glaucoma (increased pressure in the eye) or cataracts (clouding of the lens of the eye). Tell your doctor if you have had these diseases in the past or if you notice blurred vision or other visual disturbances while taking Avamys.

Other medicines and Avamys
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine, including medicines you bought without a prescription.
It is particularly important to tell your doctor if you are taking or have recently taken any of the
following medicines:

• steroids in tablet form or steroid injections
• steroid creams
• medicines for asthma
• ritonavir or cobicistat, used for the treatment of HIV
• ketoconazole, used for the treatment of fungal infections

The doctor will check if you need to take Avamys with these medicines. The doctor may want to
carefully monitor you if you are taking any of these medicines because they
can increase the unwanted effects of Avamys.
Avamys must not be used at the same time as other nasal sprays containing steroids.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are
breastfeeding, ask your doctor for advice before taking this medicine.

Do not take Avamys if you are pregnantor intend to become pregnant, unless your doctor or
pharmacist tells you to take it.

Do not take Avamys if you are breastfeedingunless your doctor or pharmacist tells you to
take it.

Driving and using machines
It is unlikely that Avamys will affect your ability to drive 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 long periods. Tell your doctor or pharmacist if you feel 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 doses. If you have any doubts, ask your doctor or pharmacist.

When to use Avamys

• Take it once a day
• Take it every day at the same time. This helps to control your symptoms during the day and night.

How long does it take for Avamys to work
Some people may feel the full effect of Avamys a few days after the first use.
However, it is usually effective within 8-24 hours of the first nasal administration.

How much Avamys to use
Adults and children 12 years of age and over

• The usual starting doseis 2 sprays in each nostril once a day, every day.
• Once your symptoms are under control, you can reduce the dose to 1 spray in each nostril, once a day, every day.

Children aged 6 to 11 years

• The usual starting doseis 1 spray in each nostril once a day.
• If your symptoms are particularly severe, your doctor may increase the dose to 2 sprays in each nostril once a day, every day until your symptoms are under control. It may then be possible to reduce the dose to 1 spray in each nostril, once a day, every day.

How to use the nasal spray
Avamys has practically no taste or smell. It is sprayed into the nose as a fine mist.
Be careful not to spray it into your eyes. If this happens, rinse your eyes with
water.
Follow the guide carefully to get the most benefit from using Avamys
 See theStep-by-step guide to using the nasal spray, after paragraph 6.
If you take more Avamys than you should
Tell your doctor or pharmacist.

If you forget to take Avamys
If you forget a dose, take it when you remember.
If it is close to 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 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: seek medical attention immediately
Allergic reactions to Avamys are rare and affect less than 1 in 1000 people. In a small
number of people, allergic reactions can turn into a more serious problem, even
life-threatening, if not treated. Symptoms include:

• wheezing, coughing or difficulty breathing
• feeling faint or dizzy (which can lead to collapse or loss of consciousness)
• swelling of the face
• skin rashes or redness.

In many cases, these symptoms will be a sign of less serious side effects. But you should be
aware that they can be potentially serious—therefore if you notice any of these symptoms:

See a doctor as soon as possible.
Very common side effects(may affect more than 1 in 10 people)

• Nosebleeds (usually mild), especially if you take Avamys for more than 6 weeks in a row.

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

• Nasal ulceration - which can cause irritation or discomfort in the nose. You may also notice streaks of blood when you blow 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 portion of the nasal septum that separates the nostrils

Side effects with unknown frequency(frequency cannot be estimated from available data)

• Growth retardation 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.

Corticosteroids taken by nasal route can alter the normal production of steroid hormones in
your body, especially if you use high doses for a long period of time. In children, this side effect
may cause them to grow more slowly than others.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist or nurse. You can also report side effects
directly through the national reporting system listed in Annex V. By reporting
side effects you can help provide more information on the safety of this
medicine.

5How to store Avamys
Keep this medicine out of the sight and reach of children.
It is best to store Avamys nasal spray in an upright position. Always keep the cap on.
Do not use this medicine after the expiry date which is stated on the label and the carton. The
expiry date refers to the last day of that month. After first use, Avamys nasal spray
must be used within two months.
Do not store Avamys in the refrigerator or freezer.
Do not dispose of any medicine via water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Avamys contains

• The active ingredient 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 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 dispensing pump. The bottle is contained in a whitish plastic inhaler with a light blue
cap and a side button that activates the spray.
The plastic inhaler has a window to observe the contents of the bottle.
Avamys is available in packs of 30, 60 and 120 sprays.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Marketing Authorisation Holder:
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, contact the local representative of the Marketing Authorisation
Holder:

België/Belgique/Belgien
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Tél/Tel: + 32 (0)10 85 52 00

Lietuva
GlaxoSmithKline Trading Services Limited
Tel: + 370 80000334

България
GlaxoSmithKline Trading Services Limited
Teл.: + 359 80018205

Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Belgique/Belgien
Tél/Tel: + 32 (0)10 85 52 00

Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 222 001 111
[email protected]

Magyarország
GlaxoSmithKline Trading Services Limited
Tel.: + 36 80088309

Danmark
GlaxoSmithKline Pharma A/S
Tlf.: + 45 36 35 91 00
[email protected]

Malta
GlaxoSmithKline Trading Services Limited
Tel: + 356 80065004

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

Nederland
GlaxoSmithKline BV
Tel: + 31 (0) 33 2081100

Eesti
GlaxoSmithKline Trading Services Limited
Tel: + 372 8002640

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100

Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0
[email protected]

España
GlaxoSmithKline, S.A.
Tel: + 34 90 202 700
[email protected]

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (0)22 576 9000

France
Laboratoire GlaxoSmithKline
Tél.: + 33 (0)1 39 17 84 44
[email protected]

Portugal
GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
[email protected]

Hrvatska
GlaxoSmithKline Trading Services Limited
Tel: + 385 800787089

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

România
GlaxoSmithKline Trading Services Limited
Tel: + 40 800672524

Slovenija
GlaxoSmithKline Trading Services Limited
Tel: + 386 80688869

Ísland
Vistor hf.
Sími: + 354 535 7000

Slovenská republika
GlaxoSmithKline Trading Services Limited
Tel: + 421 800500589

Italia
GlaxoSmithKline S.p.A.
Tel: + 39 (0)45 7741 111

Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30

Κύπρος
GlaxoSmithKline Trading Services Limited
Τηλ: + 357 80070017

Sverige
GlaxoSmithKline AB
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 website of the European Medicines
Agency: http://www.ema.europa.eu

STEP-BY-STEP GUIDE TO USING THE NASAL SPRAY
What the nasal spray looks like
The nasal spray is presented in an amber glass bottle inserted into a plastic device –
see figure a. The bottle contains 30, 60 or 120 sprays, depending on the pack that is
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 for a new 30 or 60 spray bottle, but not for
a new 120 spray bottle, as the liquid level is above the
window.

Six things you need to know about using the nasal spray

• Avamys comes in an amber glass bottle. If you need to check how much medicine is left in the bottle hold the nasal spray upright against the light. This will allow you to see the medicine level through the window.
• When using the nasal spray for the first time, you should shake it vigorouslyfor 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 when it becomes liquid.

• The release button must be pressed down firmlywith force, to release the mist through the nozzle - see figure c.

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

• Always keep the cap on the nasal spraywhen not in use. The cap keeps out dust, seals for pressure and prevents the nozzle from becoming blocked. When the cap is in place, the release button cannot be pressed accidentally.
• Do not use a pinor sharp object to clean the nozzle. This would block the nasal spray.

Preparing the nasal spray for use
The nasal spray must be prepared:

• before its first use
• if you have forgotten the cap in place for 5 days or the intranasal device has not been used for 30 days or more

Preparing the nasal spray ensures that the entire dose of medicine is delivered.
Follow these steps:

1Shake the nasal sprayvigorously with the cap in place for about 10 seconds.

2Remove the cap by firmly squeezing the sides of it with your thumb and index finger –
see figure e.

3Hold the nasal spray upright, then tilt it and point the nozzle away from
yourself.
4Pressthe button down firmly. Repeat this operation at least 6 times
until you see a fine mist in the air – see figure 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 nozzle in one nostril – see figure g. The nozzle should be positioned
inside the nostril towards the outside of the nose, away from the nasal septum. This promotes
delivery of the medicine to the correct part of the nose.

5Press the button down firmly, while inhaling through your nose– see
figure h.

6Remove the nozzle and exhale through your mouth.
7If the prescribed dose is 2 sprays in each nostril, repeat steps 4 to 6.

8Repeat steps 4 to 7 to treat the other nostril.

9Put the cap back onthe nasal spray.

Cleaning the nasal spray
After each use:
1Clean the nozzle and the inside of the cap with a clean, dry cloth – see figures iand

j.

2Do not use water to clean the nasal spray.

3Never use a pinor sharp object on the nozzle.

4Always keep the cap on the sprayafter use.

If the nasal spray does not seem to work:

• Check if there is any medicine left. Look at the medicine level through the window. If the medicine level is very low, there may not be enough left to make the nasal spray work.
• Check if the nasal spray is damaged.
• If you think the nozzle may be blocked, do not use a pinor any sharp object to clean it.
• Try to make it work again by following the instructions in the “Preparing the nasal spray for use” section. If the nasal spray continues to not work, or if it produces a jet of liquid solution, return the nasal spray to the pharmacist for advice.