Avamys 27.5 micrograms/spray, nasal spray suspension

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Never pass it on to others. It may harm them, even if their signs of illness seem the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4

1. What Avamys is and what it is used for
2. What you need to know before you use 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 to using the nasal spray

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

Children and adolescents

Do not use in children under 6 years old.

Taking Avamys:

• may when taken for a long time cause children to grow more slowly. The doctor will check your child’s height regularly, and make sure he or she is taking the lowest possible effective dose.
• may cause eye conditions such as glaucoma (increase in pressure in the eye) or cataracts (clouding of the lens of the eye). Tell your doctor if you had these conditions in the past, or if you notice blurred vision or other visual disturbances while you are taking Avamys.

Tell your doctor or pharmacist if you are taking, or have recently taken, or might take any other medicines, including medicines obtained without a prescription.

It is especially important to tell your doctor if you are taking, or have recently taken any of the following medicines:

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

Your doctor will assess whether you should take Avamys with these medicines. Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Avamys.

Avamys should not be used at the same time with other nasal sprays containing steroids.

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.

Avamys is unlikely to affect your ability to drive and use machines.

This medicine contains 8.25 micrograms of benzalkonium chloride per spray (27.5 micrograms).

Benzalkonium chloride may cause irritation or swelling inside of the nose, especially if used for a long time. Tell your doctor or pharmacist if you feel discomfort when using the spray.

• Use once a day
• Use at the same time each day.

This will treat your symptoms throughout the day and night.

Some people will not feel the full effects until several days after first using Avamys.

However, it is usually effective within 8 to 24 hours of use.

Adults and children 12 years and over

• The usual starting dose is 2 sprays in each nostril once every day.
• Once symptoms are controlled you may be able to decrease your dose to 1 spray in each nostril, once every day.

Children 6 to 11 years

• The usual starting dose is 1 spray in each nostril once a day.
• If symptoms are very bad your doctor may increase the dose to 2 sprays in each nostril once every day until the symptoms are under control. It may then be possible for the dose to be reduced to 1 spray in each nostril once every day.

Avamys has virtually no taste or smell. It is sprayed into the nose as a fine mist. Be careful not to get any spray into your eyes. If you do, rinse your eyes with water.

There is a step-by-step guide to using the nasal spray after Section 6 of this leaflet. Follow the guide carefully to get full benefit from using Avamys

• See Step-by-step guide to using the nasal spray, after Section 6.

Talk to your doctor or pharmacist.

If you miss a dose, take it when you remember.

If it is nearly the time for your next dose, wait until then. Do not take a double dose to make up for a forgotten dose.

Allergic reactions to Avamys are rare and affect less than 1 person in 1,000. In a small number of people, allergic reactions can develop into a more serious, even life-threatening problem if not treated. Symptoms include:

• becoming very wheezy, coughing or having difficulty with breathing
• suddenly feeling weak or light-headed (which may lead to collapse or loss of consciousness)
• swelling around the face
• skin rashes or redness.

In many cases, these symptoms will be signs of less serious side effects. But you must be aware that they are potentially serious — so, if you notice any of these symptoms:

Contact a doctor as soon as possible.

Very common side effects (may affect more than 1 in 10 people)

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

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

• Nasal ulceration – which may cause irritation or discomfort in your nose. You may also get 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, soreness or dryness in the inside of the nose.

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

• Small holes (perforations) in the ridge inside the nose that separates the nostrils.

Not known (frequency cannot be estimated from the available data)

• Slowing of growth in children.
• Blurred vision or temporary changes to vision with long term use.
• Chest tightness causing difficulty in breathing.

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

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store

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

The medicine is a white nasal spray suspension contained in an amber glass bottle, fitted with a pump. The bottle is in an off-white plastic casing with a light blue cap and side-actuated lever. The casing has a window for viewing the bottle contents. Avamys is available in pack sizes 30, 60 and 120 sprays. Not all pack sizes may be marketed.

Marketing authorisation:

The nasal spray comes in an amber glass bottle inside a plastic casing - see picture a. It will contain either 30, 60 or 120 sprays, depending on the pack size that has been prescribed for you.

Your leaflet has a picture in this location, labelled a. This picture shows the front and back views of the nasal spray. In the front view, the cap is fitted to the nasal spray, and in the back view, the cap is removed exposing the nozzle. The nasal spray is labelled with the following details:

cap

nozzle

mist-release button

window

FRONT

BACK

The window in the plastic casing lets you see how much Avamys is left in the bottle. You will be able to see the liquid level for a new 30 or 60 spray bottle, but not in a new 120 spray bottle because the liquid level is above the window.

• Avamys comes in an amber glass bottle. If you need to check how much is left hold the nasal spray upright against a bright light. You will then be able to see the level through the window.
• When you first use the nasal spray you will need to shake it vigorously with the cap on for about 10 seconds. This is important as Avamys is a thick suspension that becomes liquid when you shake it well see picture b. It will only spray when it becomes liquid.

Your leaflet has a picture in this location, labelled b. This picture shows the nasal spray being shaken vigorously by wrapping 3 fingers around the spray, putting thumb at the top and little finger at the bottom

• The mist-release button must be pressed firmly all the way in, to release the mist through the nozzle - see picture c.

Your leaflet has a picture in this location, labelled c. This picture shows the mist-release button being pressed firmly all the way in and the mist being released through the nozzle.

• If you have difficulty pressing the button with your thumb, you can use two hands – see picture d

Your leaflet has a picture in this location, labelled d. This picture shows the nasal spray being held in two hands with two thumbs pressing firmly on the mist-release button.

• Always keep the cap on the nasal spray when you are not using it. The cap keeps the dust out, seals in the pressure and stops the nozzle from blocking up. When the cap is in place the mist-release button cannot be pressed accidentally.
• Never use a pin or anything sharp to clear the nozzle. It will damage the nasal spray

You must prepare the nasal spray:

• before you use it for the first time
• if you have left the cap off for 5 days or the intranasal device has not been used for 30 days or more.

Preparing the nasal spray helps to make sure you always get the full dose of medicine. Follow these steps:

1 Shake the nasal spray vigorously with the cap on for about 10 seconds.
2 Remove the cap by squeezing firmly on the sides of the cap with your thumb and forefinger– see picture e.

Your leaflet has a picture in this location, labelled e. This picture shows the nasal spray being held in one hand and the cap being removed by the other hand with the thumb and forefinger squeezing firmly on the sides of the cap.

3 Hold the nasal spray upright, then tilt and point the nozzle away from you.
4 Press the button firmly all the way in. Do this at least 6 times until it releases a fine mist of spray into the air – see picture f.

Your leaflet has a picture in this location, labelled f. This picture shows the mist-release button being pressed firmly all the way in and the mist being released through the nozzle.

The nasal spray is now ready for use.

1 Shake the nasal spray vigorously.
2 Remove the cap.
3 Blow your nose to clear your nostrils, then tilt your head forward a little bit.
4 Place the nozzle in one of your nostrils – see picture g. Point the end of the nozzle slightly outwards, away from the centre ridge of your nose. This helps to get the medicine to the correct part of your nose.
5 Press the button firmly all the way in, while you breathe in through your nose – see picture h.

Your leaflet has two pictures in this location, labelled g and h respectively. Picture g shows the nasal spray nozzle being placed in a nostril and picture h shows the mist-release button being pressed firmly all the way in while the nozzle remains in the nostril.

6 Take the nozzle out 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 to treat the other nostril.
9 Replace the cap on the nasal spray.

After each use:

1 Wipe the nozzle and inside of the cap with a clean, dry tissue – see pictures i and j.

Your leaflet has two pictures in this location, labelled i and j respectively. Picture i shows the nasal spray nozzle being being wiped with a clean, dry tissue. Picture j shows the inside of the cap being wiped with a clean, dry tissue.

2 Do not use water to clean it.
3 Never use a pin or anything sharp on the nozzle.
4 Always replace the cap once you have finished.

• Check you still have medicine left. Look at the level through the window. If the level is very low there may not be enough left to work the nasal spray.
• Check the nasal spray for damage
• If you think the nozzle may be blocked, don’t use a pin or anything sharp to clear it.
• Try to reset it by following the instructions under ‘Preparing the nasal spray for use’.
• If it is still not working, or if it produces a jet of liquid, take the nasal spray back to the pharmacy to get advice.