27.5 micrograms per spray dose of nasal spray, suspension
fluticasone furoate
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 |
| BulgariaThe GlaxoSmithKlein ЕООДTel .: + 359 2 953 10 34 | Luxembourg / LuxemburgGlaxoSmithKline Pharmaceuticals sa / nvBelgium / BelgiumTel: + 32 (0) 10 85 52 00 |
| Czech RepublicGlaxoSmithKline sroTel: + 420 222 001 111cz.info@gsk.com | HungaryGlaxoSmithKline Kft.Tel .: + 36 1 225 5300 |
| 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 |
| GreeceGlaxoSmithKline Aονοπρόσωπη AEBE:Ηλ: + 30 210 68 82 100 | AustriaGlaxoSmithKline Pharma GmbHTel: + 43 (0) 1 97075 0at.info@gsk.com |
| SpainGlaxoSmithKline, SATel: + 34 900 202 700es-ci@gsk.com | PolandGSK Services Sp. z ooTel .: + 48 (0) 22 576 9000 |
| FranceGlaxoSmithKline LaboratoryTel .: + 33 (0) 1 39 17 84 44diam@gsk.com | PortugalGlaxoSmithKline – Pharmaceutical Products, Lda.Tel: + 351 21 412 95 00FI.PT@gsk.com |
| CroatiaGlaxoSmithKlineTel: +385 1 6051 999 | RomaniaGlaxoSmithKline (GSK) SRLTel: + 4021 3028 208 |
| IrelandGlaxoSmithKline (Ireland) LimitedTel: + 353 (0) 1 4955000 | SloveniaGlaxoSmithKline dooTel: + 386 (0) 1 280 25 00medical.x.si@gsk.com |
| IcelandVistor hf.Phone: + 354 535 7000 | Slovak RepublicGlaxoSmithKlineSlovakia sroTel: + 421 (0) 2 48 26 11 11recepcia.sk@gsk.com |
| 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 |