Deflut

Patient Information Leaflet: Information for the User

Deflut 27.5 micrograms/dose, nasal spray, suspension

fluticasone furoate
Generic Medicine
Please read all of this leaflet carefully before you start using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform 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 using 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 on how to use the nasal spray

1. What Deflut is and what it is used for

Deflut (fluticasone furoate) belongs to a group of medicines called glucocorticoids. Deflut works by reducing inflammation caused by allergy (rhinitis) and thereby alleviates allergy symptoms.
Deflut nasal spray is used to treat the symptoms of allergic rhinitis, including blocked, runny or itchy nose, sneezing, watery eyes, and itchy or red eyes, in adults and children aged 6 years and older.
Allergy symptoms may occur during specific times of the year and may be caused by allergies to grass or tree pollen (hay fever), or they may occur throughout the year and be caused by allergies to animals, house dust mites, moulds, among some of the more common triggers.

2. What you need to know before using Deflut

Do not use Deflut

• 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.
Taking Deflut:

• may cause slower growth in children if taken over a long period of time. Your doctor will regularly monitor the child's height and ensure that the lowest effective dose is being used.
• may cause eye disorders such as glaucoma (increased pressure in the eye) or cataract (clouding of the eye's lens). Inform your doctor if you have previously had these conditions 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 obtained without a prescription.
It is especially important to 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 to treat HIV
• ketoconazole, used to treat fungal infections

Your doctor will check whether you should take Deflut with these medicines. Your doctor may want to closely 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, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Do not use Deflut if you are pregnant or planning to become pregnant, unless your doctor or pharmacist tells you to.
Do not use Deflut if you are breastfeeding, unless your doctor or pharmacist tells you to.
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 spray (27.5 micrograms). Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for prolonged periods. Inform your doctor or pharmacist if you experience discomfort when using the spray.

3. How to use Deflut

Use this medicine exactly as directed by your doctor or pharmacist. 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 helps control your symptoms throughout the day and night.

How long does it take for Deflut to work?
Some people may experience the full effect of Deflut several days after first use. However,
it is usually effective within 8–24 hours after the first nasal dose.
How much Deflut to use
Adults and children aged 12 years and older

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

Children aged 6 to 11 years

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

How to use the nasal spray
Deflut is practically tasteless and odourless. It is sprayed into the nose as a fine mist.
Be careful not to spray it into the eyes. If this happens, rinse the eyes with water.
A step-by-step guide on how to use the nasal spray is available after section 6 of this
package leaflet. Follow the instructions carefully to get the maximum benefit from using Deflut.
Please refer to the Step-by-step guide on how to use the nasal spray , after section 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 as soon as you remember.
If it is almost time for your next dose, wait until then. Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use 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 everyone gets them.
Allergic reactions: consult your doctor immediately
Allergic reactions to Deflut are rare and affect fewer than 1 in 1,000 people. For a few individuals, allergic reactions may develop into a more serious, even life-threatening condition if left untreated. Symptoms include:

• sudden shortness of breath, coughing, or difficulty breathing
• sudden weakness or dizziness (which may lead to collapse or loss of consciousness)
• swelling of the face
• skin rash or redness.

In many cases, these symptoms may indicate less serious side effects. However, you must be aware that they could potentially be serious – therefore, if you notice any of these symptoms, consult a doctor as soon as possible.
Very common side effects (may affect more than 1 in 10 people)

• Nosebleeds (generally mild), particularly if you use Deflut for more than 6 consecutive weeks.

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

• Nasal ulceration – which may cause irritation or discomfort in the nose. You may also notice blood streaks when blowing 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 part of the nasal septum that separates the nostrils.

Side effects not known (frequency cannot be determined from available data)

• Growth retardation in children.
• Blurred vision or temporary changes in eyesight with prolonged use.
• Chest tightness causing breathing difficulties.

Nasally administered corticosteroids may interfere with the normal production of steroid hormones in your body, particularly if high doses are used over a long period of time. In children, this side effect may result in slower growth compared to other children.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. You may 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 stated on the label and on the carton. 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Deflut contains

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

Description of the appearance of Deflut and contents of the pack
The medicine is a nasal spray suspension in the form of a white liquid 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 sprays.
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 medicine is authorised in the Member States of the European Economic Area under the
following names:
Netherlands: Deflut
Italy: Deflut
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STEP-BY-STEP GUIDE TO USING THE NASAL SPRAY
What the nasal spray looks like
The nasal spray comes in an amber glass bottle equipped with a spray pump, an applicator, and a
protective cap. It contains 120 sprays.
Five important things to know about using the nasal spray

• Deflut comes in an amber glass bottle. To check how much medicine remains, hold the nasal spray upright against the light. This will allow you to see the level of the medicine through the bottle.
• When using the nasal spray for the first time, you must shake it vigorously for about 10 seconds with the cap in place. This is important because Deflut is a thick suspension that becomes liquid when shaken well. The medicine will only spray when it becomes liquid.
• The pump must be pressed fully down to release the mist through the nozzle.
• Always keep the cap on the nasal spray when not in use. The cap keeps out dust, seals by pressure, and prevents the nozzle from becoming blocked.
• Do not use a pin or any sharp object to clean the nozzle. Doing so may block the nasal spray.

Preparing the nasal spray for use
The nasal spray must be prepared:

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

Preparing the nasal spray ensures that the full dose of medicine is delivered. Follow these steps:

1. Shake the nasal spray vigorously with 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 the sides of the spray pump and your thumb under the bottle. Press and release the pump. Repeat at least 6 times until a fine mist is observed 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 spray vigorously.
2 Remove the cap.
3 Blow your nose to clear the 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 pointing toward the outer side of the nose, away from the central septum. This helps deliver the medicine to the correct area of the nose.
5 Press the pump firmly all the way down while inhaling through the nose.
Figure 3

6 Remove the nozzle and breathe out through the mouth.
7 If the prescribed dose is 2 sprays in each nostril, repeat steps 4 to 6.
8 Repeat steps 4 to 7 for the other nostril.
9 Replace the cap on the nasal spray.
Cleaning the nasal spray
After each use:
1 Wipe the nozzle and the inside of the cap with a clean, dry tissue.
2 Do not use water to clean the nasal spray.
3 Never use a pin or any sharp object on the nozzle.
4 Always replace the cap on the nasal spray after use.
If the nasal spray does not seem to work:

• Check whether any medicine remains. Look at the level of the medicine through the bottle. If the level is very low, there may not be enough medicine left for the nasal spray to function properly.
• Check whether 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 still does not work, or if it produces a stream of liquid instead of a spray, return it to your pharmacist for advice.