DEFLUT 27.5 MICROGRAMS Spray do nosa, zawiesina

Treść ulotki

1. Deflut 27.5 micrograms/spray, nasal spray, suspension
   1. What is Deflut and what is it used for
   2. What you need to know before using Deflut
   3. How to use Deflut
   4. Possible side effects
   5. How to store Deflut
   6. Contents of the pack and other information

Deflut 27.5 micrograms/spray, nasal spray, suspension

fluticasone furoate

Equivalent Medicinal Product
Read this leaflet carefully before you start using 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, even if they have the same symptoms as you, as it may be harmful.
• 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 Deflut is and what it is used for
• 2. What you need to know before you use Deflut
• 3. How to use Deflut
• 4. Possible side effects
• 5. How to store Deflut
• 6. Contents of the pack and other information Step-by-step guide to using the nasal spray

1. What is Deflut and what is it used for

Deflut (fluticasone furoate) belongs to a group of medicines called glucocorticoids. Deflut
works by reducing inflammation caused by allergy (rhinitis) and therefore reduces allergy symptoms.
Deflut nasal spray is used to treat the symptoms of allergic rhinitis including nasal congestion, runny
or itchy nose, sneezing, watery eyes, itchy and red eyes, in adults and 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 using Deflut

Do not use Deflut

• if you are allergic to fluticasone furoate or 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 Deflut:

• may cause slower growth in children 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 Deflut.

Other medicines and Deflut
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines 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 to treat HIV
• ketoconazole, used to treat fungal infections

Your doctor will check if you should take Deflut with these medicines. Your doctor may want to carefully monitor you if you are taking any of these medicines as they may
increase the side effects of Deflut.
Deflut 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 use Deflut if you are pregnantor intend to become pregnant, unless your doctor or
pharmacist tells you to take it.

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

Driving and using machines
It is unlikely that Deflut will affect your ability to drive or operate machinery.

Deflut contains benzalkonium chloride
This medicine contains 8.25 micrograms of benzalkonium chloride per actuation (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 use Deflut

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.

When to use Deflut

• Use it once a day
• Use it every day at the same time. This allows you to control your symptoms during the day and night.

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

How much Deflut to use
Adults and children 12 years and over

• The normal starting dose is 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 between 6 and 11 years

• The normal starting dose is 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
Deflut is practically tasteless and odorless. It is sprayed into the nose as a fine mist.
Be careful not to spray it into your eyes. If this should happen, rinse your eyes with
water.
There is a step-by-step guide to using the nasal spray available after paragraph 6 of this leaflet.
Follow the guide carefully to get the most benefit from using Deflut.

Consult the Step-by-step guide to using the nasal spray, after paragraph 6.
If you use more Deflut than you should
Inform your doctor or pharmacist.

If you forget to use Deflut
If you forget a dose, take it when you remember.
If it is close to the time to take your next dose, wait until then. Do not take a
double dose to make up for a forgotten dose.
If you have any doubts about using this medicine or if you have any difficulty using the nasal
spray, ask your doctor, pharmacist or nurse 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 Deflut are rare and affect less than 1 in 1000 people. For a few people, allergic reactions can turn into a more serious problem, even life-threatening, if
not treated. Symptoms include:

• shortness of breath, cough or difficulty breathing
• sudden feeling of weakness or dizziness (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 use Deflut for more than 6 weeks continuously.

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 blood streaks 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 based on available data)

• Delayed growth in children.
• Blurred vision or temporary changes in vision with prolonged use.
• Chest tightness causing difficulty breathing.

Corticosteroids taken by nasal route can alter the normal production of steroid hormones in
your body, particularly if you use high doses for a long period of time. In children, this undesirable effect
may 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. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Deflut

Keep this medicine out of the sight and reach of children.
Always keep the cap on.
Do not use this medicine after the expiry date that is stated on the label and on the package. The
expiry date refers to the last day of the month. After first use, Deflut nasal spray must
be used within two months.
Do not refrigerate or freeze.
Do not dispose of any medicine in wastewater 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 Deflut contains

• The active ingredient is fluticasone furoate. Each actuation delivers 27.5 micrograms of fluticasone furoate.
• The excipients are glucose, microcrystalline cellulose (E460), sodium carboxymethylcellulose (E466), polysorbate 80 (E433), benzalkonium chloride, disodium edetate, water for injections (see section 2).

Description of Deflut 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 spray pump, an applicator and a protective cap. Deflut is available
in a container with 120 actuations.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Day Zero ehf.
Reykjavíkurvegur 62
Hafnarfjörður 220
Iceland

Manufacturer
Teva Czech Industries s.r.o.
Ostravská 305/29
Opava 747 70
Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Netherlands: Deflut
Italy: Deflut
--------------------------------------------------------------------------------------------------------------------------->

STEP-BY-STEP GUIDE ON HOW TO USE THE NASAL SPRAY
What the nasal spray looks like
The nasal spray is presented in an amber glass bottle equipped with a spray pump, an
applicator and a protective cap. It contains 120 actuations.

Five things you need to know about using the nasal spray

• Deflut 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 bottle.
• When you use the nasal spray for the first time, you will need to shake it vigorouslyfor about 10 seconds, with the cap in place. This is important because Deflut is a dense suspension that becomes liquid when shaken well. The medicine will only spray when it becomes liquid.
• The pump must be pressed down fully, so as to release the mist through the nozzle.
• Always keep the cap on the nasal spraywhen you are not using the medicine. The cap keeps out dust, seals under pressure and prevents the nozzle from becoming blocked.
• Do not use a pinor a 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 the off position 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 the
following steps:

• 1. Shake the nasal spray vigorouslywith the cap in place for about 10 seconds.

• 2. Remove the cap – see figure 1.

Figure 1

• 3. Hold the nasal spray upright, then tilt it and point the nozzle away from yourself.
• 4. Prime the pump by placing two fingers on either side of the spray pump and positioning your thumb under the bottle. Press and release the pump. Repeat the operation at least 6 times until you see a fine mist in the air – see figure 2.

Figure 2

• 5. The nasal spray is now ready for use.

Using the nasal spray
1 Shake the nasal sprayvigorously.
2 Remove the cap.
3 Blow your noseto clear your nostrils, then tilt your head slightly forward.
4 Insert the nozzle into one nostril and close the other nostril with a finger – see figure 3. The
nozzle should be positioned inside the nostril towards the outer part of the nose, away from the nasal
septum. This promotes the release of the medicine into the correct part of the nose.

5Pressthe pumpfirmly down while inhaling through your nose.
Figure 3

6 Remove the nozzle and exhale through your mouth.
7 If the prescribed dosage is 2 sprays in each nostril, repeat steps 4 to 6.
8 Repeat steps 4 to 7 to treat the other nostril.
9 Put the cap back on the nasal spray.

Cleaning the nasal spray
After each use:
1 Clean the nozzle and the inside of the cap with a clean, dry cloth.
2 Do not use water to clean the nasal spray.
3 Never use a pin or a sharp object on the nozzle.
4 Always replace the cap on the spray after use.

If the nasal spray seems to be not working:

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