Avamys 27.5 micrograms/spray, nasal spray suspension
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Avamys 27.5 micrograms per spray, nasal spray suspension
furoate of fluticasone
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.
Leaflet contents
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 for 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), thereby relieving allergy symptoms.
Avamys nasal spray suspension is used to treat the symptoms of allergic rhinitis, including nasal congestion, increased nasal discharge, nasal itching, sneezing, and eye tearing, itching, or redness in adults and children aged 6 years and older.
Allergic symptoms may occur at certain times of the year due to allergies to pollen from plants or trees (hay fever), or may be present throughout the year due to allergies to animals, house dust mites, or molds, among some of the most common triggers.
2. What you need to know before using 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.
The use of Avamys:
-
may cause growth retardation in children when used for prolonged periods. Your doctor will regularly monitor the child's height and ensure the child receives the lowest effective dose.
-
may cause eye disorders such as glaucoma (increased pressure in the eye) or cataracts (loss of transparency of the lens). Inform your doctor if you have previously had any of these conditions, or if you experience blurred vision or other visual disturbances while using Avamys.
Using Avamys with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
It is especially important that you 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 in the treatment of AIDS
- ketoconazole, used to treat fungal infections
Your doctor will assess whether you should use Avamys together with these medicines. Some medicines may increase the effects of Avamys, so your doctor will carry out careful monitoring if you are taking these medicines.
Avamys should not be used at the same time as other nasal sprays containing steroids.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
Do not use Avamys if you are pregnant, or planning to become pregnant, unless advised by your doctor or pharmacist.
Do not use Avamys while breastfeeding unless advised by your doctor or pharmacist.
Driving and use of 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 inflammation inside the nose, especially when used for long-term treatment. Inform your doctor or pharmacist if you experience discomfort when using the spray.
3. How to use Avamys
Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. Do not exceed the recommended dose. If in doubt, consult your doctor or pharmacist again.
When to use Avamys
- Use once daily.
- Use at the same time each day.
This medicine will treat your symptoms throughout the day and night.
How long it takes for Avamys to work
Some people may not feel the full effects until several days after starting to use Avamys.
However, it is generally effective within 8 to 24 hours after use.
How much to use
Adults and children aged 12 years and older
- The normal starting dose is 2 sprays in each nostril once daily.
- Once symptoms are controlled, the dose may be reduced to 1 spray in each nostril once daily.
Children aged 6 to 11 years
- The normal starting dose is 1 spray in each nostril once daily.
- If symptoms are very severe, your doctor may increase the dose to 2 sprays in each nostril once daily until symptoms are under control. Afterwards, the dose may be reduced to 1 spray in each nostril once daily.
How to use the nasal spray
Avamys has little or no taste or smell. It is sprayed into the nose as a fine mist. Be careful not to spray the medicine into your eyes. If this occurs, rinse your eyes with water.
A step-by-step guide on how to use the nasal spray is located after section 6 of this leaflet. Follow the guide carefully to get the full benefit from using Avamys.
- See thestep-by-step guide for using the nasal spray*, located after section 6.***
If you use more Avamys than you should
Consult 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 almost time for your next dose, wait until then. Do not use a double dose to make up for forgotten doses.
If you have any further questions about the use of this medicine, or if you experience any discomfort when using the nasal spray, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Allergic reactions: seek medical help immediately
Allergic reactions to Avamys are rare and affect fewer than 1 in 1,000 people. In a small number of individuals, allergic reactions may become more severe and can even be life-threatening if not treated. Symptoms include:
- development of wheezing, coughing, or breathing difficulties
- sudden feeling of weakness or dizziness (leading to collapse or loss of consciousness)
- swelling of the face
- skin rash or redness.
In many cases, these symptoms may indicate less serious adverse effects. However, you should be alert as they could potentially be serious – therefore, if you experience any of these symptoms:
- Contact your doctor as soon as possible.
Very common adverse effects (may affect more than 1 in 10 people)
- Nosebleeds (usually mild), especially if you use Avamys continuously for more than 6 weeks.
Common adverse effects (may affect up to 1 in 10 people)
- Nasal ulceration – which may cause irritation or discomfort in your nose. Blood spots may appear when you blow your nose.
- Headache
- Shortness of breath.
Uncommon adverse effects (may affect up to 1 in 100 people)
- Pain, burning, irritation, painful sensation, or dryness inside the nose.
Very rare adverse effects (may affect up to 1 in 10,000 people)
- Small holes (perforations) in the nasal septum separating the nostrils.
Frequency not known (frequency cannot be estimated from available data)
- Slowed growth in children.
- Blurred vision or temporary changes in vision with prolonged use.
- Chest tightness causing difficulty in breathing.
- Voice disorder, loss of voice.
- Taste disturbance, loss of taste, loss of smell.
The use of nasal corticosteroids may affect the normal production of hormones in your body, especially if high doses are used for prolonged periods. In children, these adverse effects may result in slower growth.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Avamys
Keep this medicine out of the sight and reach of children.
It is preferable to store the Avamys nasal spray in an upright position. Always keep the cap on.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated. After first opening, the shelf life of Avamys nasal spray suspension is 2 months.
Do not refrigerate or freeze.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.
6. Contents of the pack and other information
Composition of Avamys
- The active substance is fluticasone furoate. Each spray delivers 27.5 micrograms of fluticasone furoate.
- The other components are anhydrous glucose, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, and purified water (see section 2).
Nature of the product and contents of the container
The medicine is a white, nasal spray suspension contained in an amber glass bottle equipped with a spray pump. The bottle is protected by a white plastic cover with a light blue cap and a side-dosing button. The cover has a viewing window to see the contents of the bottle. Avamys is available in packs containing 30, 60, and 120 sprays. Only certain pack sizes may be marketed.
Marketing Authorization Holder
Marketing Authorization:
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
Any information about this medicine can be requested by contacting the local representative of the marketing authorization holder:
Belgium/Belgium/Belgium GlaxoSmithKline Pharmaceuticals s.a./n.v. Tel/Tel: + 32 (0)10 85 52 00 | Lithuania GlaxoSmithKline Trading Services Limited Tel: + 370 80000334 |
| Luxembourg/Luxembourg GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgium/Belgium Tel/Tel: + 32 (0) 10 85 52 00 |
Czech Republic GlaxoSmithKline s.r.o. Tel: + 420 222 001 111 | Hungary GlaxoSmithKline Trading Services Limited Tel.: + 36 80088309 |
Denmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 | Malta GlaxoSmithKline Trading Services Limited Tel: + 356 80065004 |
Germany GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701 | Netherlands GlaxoSmithKline BV Tel: + 31 (0) 33 2081100 |
Estonia GlaxoSmithKline Trading Services Limited Tel: + 372 8002640 | Norway GlaxoSmithKline AS Tlf: + 47 22 70 20 00 |
Greece GlaxoSmithKline Μονοπρóσωπη A.E.B.E. Tel: + 30 210 68 82 100 | Austria GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 |
Spain GlaxoSmithKline, S.A. Tel: + 34 900 202 700 | Poland GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000 |
France Laboratory GlaxoSmithKline Tel.: + 33 (0)1 39 17 84 44 | Portugal GlaxoSmithKline – Pharmaceutical Products, Lda. Tel: + 351 21 412 95 00 |
Croatia GlaxoSmithKline Trading Services Limited Tel: + 385 800787089 | Romania GlaxoSmithKline Trading Services Limited Tel: + 40 800672524 |
Ireland GlaxoSmithKline Trading Services Limited Tel: + 353 (0)1 4955000 | Slovenia GlaxoSmithKline Trading Services Limited Tel: + 386 80688869 |
Iceland Vistor hf. Sími: + 354 535 7000 | Slovak Republic GlaxoSmithKline Trading Services Limited Tel: + 421 800500589 |
Italy GlaxoSmithKline S.p.A. Tel: + 39 (0)45 7741 111 | Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 |
Cyprus GlaxoSmithKline Trading Services Limited Tel: + 357 80070017 | Sweden GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 |
Latvia GlaxoSmithKline Trading Services Limited Tel: + 371 80205045 |
Date of the most recent review of this leaflet:
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
STEP-BY-STEP GUIDE FOR USING THE NASAL SPRAY
Appearance of the nasal spray
The nasal spray is contained in an amber glass bottle protected by a plastic cover – see picture a. It will contain 30, 60, or 120 sprays, depending on the pack size prescribed for you.
The window in the plastic cover allows you to see how much Avamys remains in the bottle. You will be able to see the liquid level in new 30- or 60-spray bottles, but not in a new 120-spray bottle because the liquid level is above the window.
Six important points you need to know about how to use the nasal spray
- Avamys is contained in an amber glass bottle. If you need to check how much remains, hold the nasal spray upright against the light. This way you will be able to see the level through the window.
- When using the nasal spray for the first time, you need to shake it vigorously with the cap on for 10 seconds. This is important because Avamys is a dense suspension that turns into a liquid when shaken well – see picture b. It will only spray when it becomes liquid.
- The pump must be pressed firmly and completely to release the mist through the nasal applicator – see picture c.
- If you have difficulty pressing the pump with your thumb, you may use both hands – see picture d.
- Always keep the cap on the nasal spray when not in use. The cap prevents dust from entering, seals tightly under pressure, and prevents the nasal applicator from becoming blocked. While the cap is on, the pump cannot be accidentally pressed.
- Never use a pin or any other sharp object to unblock the nasal applicator. This would damage the nasal spray.
Preparing the nasal spray for use
You must prepare the nasal spray:
- before first use
- if you have left it uncovered for 5 days or have not used the intranasal device for 30 days or more.
Preparing the nasal spray helps ensure you always receive the full dose of medication. Follow these steps:
1 Shake the nasal spray vigorously with the cap on for 10 seconds.
2 Remove the cap by pressing firmly on the sides of the cap with your thumb and index finger – see picture e.
3 Hold the nasal spray upright, then tilt and orient the nasal applicator away from you.
4 Press the pump firmly and completely. Do this at least 6 times until a fine spray mist is released into the air – see picture 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 the nasal passages, then tilt your head slightly forward.
4 Insert the nasal applicator into one nostril – see picture g. Slightly orient the tip of the nasal applicator outward, away from the nasal septum. This helps the medication reach the correct area of the nose.
5 Press the pump firmly and completely while inhaling through your nose – see picture h.
6 Remove the nasal applicator and breathe out through your mouth.
7 If your dose is 2 sprays in each nostril, repeat steps 4 to 6.
8 Repeat steps 4 to 7 in the other nostril.
9 Replace the cap on the nasal spray.
Cleaning the nasal spray
After each use:
1 Wipe the applicator and the inside of the cap with a clean, dry tissue – see pictures i and j.
2 Do not use water to clean it.
3 Never use a pin or any other sharp object on the nasal applicator.
4 Always replace the cap after using the nasal spray.
If the nasal spray does not seem to be working:
- Check whether there is still medication left. Look at the level through the window. If the level is very low, there may not be enough to operate the nasal spray.
- Check whether the nasal spray has been damaged.
- If you think the nasal applicator may be blocked, do not use a pin or any other sharp object to unblock it.
- Try re-priming it by following the instructions in “Preparing the nasal spray for use.”
If it still does not work, or if a stream of liquid is released, take the nasal spray to your pharmacy and consult your pharmacist.