27.5 micrograms per spray dose of nasal spray, suspension 
fluticasone furoate

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read about it.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects , talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In 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 ingredients information

1. What Avamys is and what it is used for

Avamys (fluticasone furoate) belongs to a group of medicines called steroids ( corticosteroid s ). Avamys works to reduce inflammation caused by allergies ( rhinitis) and therefore reduces the symptoms of allergies .

Avamys nasal spray is used to treat symptoms of allergic rhinitis such as nasal congestion, runny nose or itchy nose, sneezing and eyes that tear, itch or are red in adults and children 6 years and older.

Allergy problems can occur at certain times of the year and are caused by allergies to grass or pollen (hay fever) or they can occur all year round and are caused by allergies to animals, house dust mites or mold, to name a few of the most common.

2. What you need to know before using Avamys

Do not use Avamys

  • if you are allergic to fluticasone furoate or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Children and young people

Not used for children under 6 years.

Using Avamys:

  • can when used for a long time cause children to grow more slowly. Your doctor will check your child’s length regularly and make sure he or she uses the lowest possible effective dose .
  • can cause eye diseases such as glaucoma (increased pressure in the eye), or cataracts (the lens of the eye is cloudy). Tell your doctor if you have had these conditions before or if you notice blurred vision or any other visual disturbance while taking 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.

This is especially important if you are taking, or have recently taken, any of the following medicines:

  • cortisone tablets or cortisone injections
  • cortisone cream or ointment
  • medicines for asthma
  • ritonavir or cobicistat used to treat HIV
  • ketoconazole used to treat fungal infections

Your doctor will decide if you can take Avamys with these medicines. Your doctor may want to monitor you closely if you are taking these medicines as they may increase the effects of Avamys.

Avamys should not be used concomitantly with other nasal sprays containing steroids .

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this 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 the ability to drive or use machines.

Avamys contains benzalkonium chloride

This medicine contains 8.25 micrograms of benzalkonium chloride per spray (27.5 micrograms). Benzalkonium chloride can cause irritation or swelling on the inside of the nose, especially if used for a long time. Tell your doctor or pharmacist if you feel unwell when using the spray.

3. How to use Avamys

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

When to use Avamys

  • Once a day.
  • Use it at the same time every day.

Your problems are then treated throughout the day.

How long does it take before Avamys operates

Some do not feel that they get full effect until several days after they start taking Avamys. Usually you get effect within 8 to 24 hours.

How much Avamys to use

Adults and children 12 years and older

  • The usual starting dose is 2 sprays in each nostril once a day.
  • When the symptoms are under control, the dose can be reduced to 1 spray in each nostril once a day.

Children 6 to 11 years

  • The usual starting dose is 1 spray in each nostril once a day.
  • In case of very severe symptoms, the doctor may increase the dose one to 2 sprays in each nostril once a day until the symptoms are under control. Thereafter, the dose can be reduced to 1 spray in each nostril once a day

How to use the nasal spray

Avamys have basically no taste or smell. It is sprayed in the nose like a fine mist. Be careful not to get any spray in your eyes. If you get it, rinse your eyes with water.

There is a step-by-step instruction after section 6 of this leaflet that describes how to use the nasal spray. Follow the instructions carefully for the full use of Avamys.

  • See step-by-step instructions on how to use the nasal spray, after section 6.

If you use more Avamys than you should

Contact your doctor or pharmacist

If you forget to use Avamys

If you forget to take a dose , take it as soon as you remember.

If it is close in time to when you usually take Avamys, then 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 medicine or if you experience any discomfort when using the nasal spray, contact your doctor, pharmacist or nurse.

4. Possible side effects

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

In case of allergic reactions: contact a doctor immediately

Allergic reactions to Avamys are rare and may affect up to 1 in 1,000 people. In a small number of people, allergic reactions can develop into more serious and even life-threatening problems if left untreated. Symptoms include:

  • hissing, coughing or difficulty breathing
  • sudden feeling of weakness or fainting (which may lead to collapse or unconsciousness)
  • facial swelling
  • skin rash or redness .

In many cases, these symptoms are signs of less serious side effects . However, you must be aware that they can be serious – so if you suffer from any of these symptoms;

Contact a doctor as soon as possible.

Very common side effect are (can occur in more than 1 in 10)

  • Nasal bleeding (usually mild) especially if you use Avamys regularly for more than 6 weeks.

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

  • Ulceration of the nose – which can cause irritation or discomfort in the nose. You can also get light blood-mixed secretions when you cheat.
  • Headache.
  • Shortness of breath.

Less common side effects are (may affect up to 1 in 100)

  • Pain, burning, irritation, tenderness or dryness on the inside of the nose.

Very rare  side effects are (may affect up to 1 in 10 000 users)

  • Small holes (perforations) in the nasal septum that separate the nostrils.

Has been reported (occurs in unknown number of users)

  • Inhibited height growth in children.
  • Blurred vision or temporary changes in vision with long-term use.
  • Pressure over the chest that causes difficulty breathing.

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Avamys

Keep this medicine out of the sight and reach of children.

Avamys should be stored upright. The protective cover must be kept on.

Do not use this medicine after the expiry date which is stated on the bottle and carton. The expiration date is the last day of the specified month. Avamys nasal spray should be used within two months of first opening.

Store in a cold place. Do not 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.

6. Contents of the packaging and other information

Content declaration

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

What the medicine looks like and contents of the pack

The medicine is a white nasal spray suspension packaged in an amber glass bottle with a spray pump. The glass bottle is enclosed in an off-white plastic cover with a light blue protective cover and spray button on the side. The plastic cover has a dose window that shows the bottle contents.

The medicine is available in pack sizes of 30, 60 and 120 spray doses. Not all pack sizes may be marketed.

Marketing Authorisation Holder

GlaxoSmithKline (Ireland) Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

Manufacturer

Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)

Harmire Road

Barnard Castle

Durham County

DL12 8DT

UK

Glaxo Wellcome SA

Avenida de Extremadura 3

09400 Aranda de Duero

Burgos

Spain

Contact the representative of the marketing authorization holder to find out more about this medicine:Show larger

Belgium / Belgique / BelgienGlaxoSmithKline Pharmaceuticals sa / nvTel: + 32 (0) 10 85 52 00 LithuaniaGlaxoSmithKline Lithuania UABTel: + 370 5 264 90 00info.lt@gsk.com
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DenmarkGlaxoSmithKline Pharma A / STel: + 45 36 35 91 00dk-info@gsk.com MaltaGlaxoSmithKline (Malta) LimitedTel: + 356 21 238131
GermanyGlaxoSmithKline GmbH & Co. KGTel .: + 49 (0) 89 36044 8701produkt.info@gsk.com The NetherlandsGlaxoSmithKline BVTel: + 31 (0) 33 2081100
EestiGlaxoSmithKline Eesti OÜTel: + 372 6676 900estonia@gsk.com NorwayGlaxoSmithKline ASTel: + 47 22 70 20 00
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ItalyGlaxoSmithKline SpATel: + 39 (0) 45 9218 111 Finland / FinlandGlaxoSmithKline OyPuh / Tel: + 358 (0) 10 30 30 30Finland.tuoteinfo@gsk.com
ΚύπροςGlaxoSmithKline (Cyprus) Ltd:Ηλ: + 357 22 39 70 00gskcyprus@gsk.com SwedenGlaxoSmithKline ABTel: + 46 (0) 8 638 93 00info.produkt@gsk.com
LatviaGlaxoSmithKline Latvia SIATel: + 371 67312687lv-epasts@gsk.com United KingdomGlaxoSmithKline UK LtdTel: + 44 (0) 800 221441customercontactuk@gsk.com

Muhammad Nadeem

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