DORDASK 27.5 MICROGRAMS Nasal spray, suspension

Зміст інструкції

1. Dordask 27.5 micrograms/per actuation, nasal spray, suspension
   1. What Dordask is and what it is used for
   2. What you need to know before taking Dordask
   3. How to take Dordask
   4. Possible side effects
   5. Contents of the pack and other information

Dordask 27.5 micrograms/per actuation, nasal spray, suspension

fluticasone furoate
Generic medicine

Read this leaflet carefully before you start to take 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 pass it on to others even if their symptoms are the same as yours because 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 Dordask is and what it is used for
• 2. What you need to know before you take Dordask
• 3. How to take Dordask
• 4. Possible side effects
• 5. How to store Dordask
• 6. Contents of the pack and other information

1. What Dordask is and what it is used for

Dordask (fluticasone furoate) belongs to a group of medicines called glucocorticoids. Fluticasone furoate works by reducing inflammation caused by allergy (rhinitis) and therefore reduces allergy symptoms.
Dordask 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 allergy to grass or tree pollen (hay fever), or they can occur throughout the
year and be caused by allergy to animals, house dust mites or molds, to name a few
of the most common.

2. What you need to know before taking Dordask

Do not use Dordask

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

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Dordask.

Children and adolescents
Do not use in children under 6 years of age.
Taking Dordask:

• may cause children to grow more slowly if it is taken for a long period of time. The doctor will regularly check the child's height and ensure that they are taking the lowest effective dose possible.

time. The doctor will regularly check the child's height and make sure they are
taking the lowest possible effective dose.

• 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 fluticasone furoate.

Other medicines and Dordask
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

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

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

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

Dordask contains benzalkonium chloride
This medicine contains 8.25 micrograms of benzalkonium chloride and 13.75 micrograms of polysorbate
in each spray.
Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for
long periods.
Polysorbates may cause allergic reactions.
Tell your doctor or pharmacist if you feel any discomfort when using the spray.

3. How to take Dordask

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 Dordask

• Take it once a day
• Take 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 Dordask to work
Some people may feel the full effect of Fluticasone Furoate Substipharm a few days
after the first use. However, it is normally effective within 8-24 hours of the first nasal administration.

How much Dordask to use
Adults and children 12 years and older

• The usual starting doseis 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 6 to 11 years

• The usual starting doseis 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
Dordask has practically no taste or smell. It is sprayed into the nose as a fine mist.
Be careful not to spray it into your eyes. If this happens, rinse your eyes with
water.
Follow the guide carefully to get the most benefit from using Dordask.
 Consult theStep-by-step guide to using the nasal spray, after paragraph 6.
If you take more Dordask than you should
Inform your doctor or pharmacist.

If you forget to take Dordask
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 further questions about using this medicine or if you have any difficulty using the nasal
spray, ask your doctor or pharmacist for advice.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest them.

Allergic reactions: seek medical attention immediately
Allergic reactions to Dordask are rare and affect less than 1 in 1000 people. In a small
number of people, allergic reactions can turn into a more serious, even
life-threatening problem if not treated. Symptoms include:

• wheezing, coughing 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. However, 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 take Dordask for more than 6 weeks consecutively.

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

• Nasal ulceration - which can cause irritation or discomfort to the nose. You may also notice 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 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 from 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, especially if you use high doses for a long period of time. In children, this adverse effect may cause them to grow more slowly than others.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist or nurse. You can also report side effects directly through
the website 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.

5How to store Dordask
Keep this medicine out of the sight and reach of children.
The best is to store Dordask 27.5 micrograms per spray, nasal spray suspension in
an upright position.
Always keep the cap inserted.
Do not use this medicine after the expiry date which is stated on the label and the carton after
“Exp”. The expiry date refers to the last day of that month. After first opening, Dordask
must be used within 2 months.
Do not throw away any medicine in the water or in the 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 Dordask 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, purified water (see section 2).

Description of the appearance of Dordask and contents of the pack
The medicine is a nasal spray in the form of a white suspension contained in an amber glass bottle
of type III with a capacity of 15 mL, equipped with a dispensing pump, a nasal applicator (actuator) and a cap.
Dordask is available in a pack: 1 bottle of 120 sprays.

Marketing Authorisation Holder and manufacturer

Marketing Authorisation Holder:
SUBSTIPHARM
24 Rue Erlanger
75016 Paris- France

Manufacturer:
CURIDA AS
Solbærvegen 5
2409 Elverum
Norway

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Austria Konika 27.5 Microgram/ Spray Nasal Spray, Suspension
PL Dordask
Italy Dordask

Other sources of information
Step-by-step guide to using the nasal spray

STEP-BY-STEP GUIDE TO USING THE NASAL SPRAY
What the nasal spray looks like
The nasal spray comes in an amber glass bottle. The bottle contains 120 sprays.

Five things you should know about using the nasal spray

• Dordask 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 level of the medicine through the glass.
• When you use the nasal spray for the first timeyou should shake it vigorouslyfor about 10 seconds, with the cap in place. This is important because Dordask is a dense suspension that becomes liquid when shaken well. The medicine will only be sprayed when it becomes liquid.
• The pump must be pressed down firmly and decisively, so as to release the mist through the nozzle - see figure a.
• 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 sharp object to clean the nozzle. This would block the nasal spray.

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

• 1. before using it for the first time
• 2. if it has been left without the cap for 5 days or if 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 these steps:
• 1. Shake the nasal spray vigorouslywith the cap on for about 10 seconds.
• 2. Remove the cap.
• 3. Hold the nasal spray upright, then tilt it and point the nozzle away fromyourself.
• 4. Pressthe pump down firmly. Repeat the operation at least 6 timesuntil you see a fine mist in the air

a
The nasal spray is now ready for use.
Using the nasal spray
1Shake the nasal sprayvigorously.

2Remove the cap.

3Blow your noseto clear your nostrils, then tilt your head forward slightly.

4Place the nozzle in one of your nostrils. The nozzle should be positioned inside the nostril
towards the outside of the nose, away from the nasal septum. This promotes the release of
the medicine into the correct part of the nose - see figure b.

b
5Press the pump down firmly, while inhaling through your nose.
6Remove the nozzle and exhale through your mouth.
7If the prescribed dose is 2 sprays in each nostril, repeat the operations from 4 to

• 6. 8Repeat the operations from 4 to 7 to treat the other nostril. 9Put the capback on the nasal spray.

Cleaning the nasal spray
After each use:
1Clean the nozzle with a clean, dry cloth.
2 Do not use water to clean the nasal spray.

3Never use a pinor sharp object on the nozzle.

4Always replace the cap on the sprayafter use.

If the nasal spray seems to be not working:

• Check if there is any medicine left. Look at the level of the medicine through the glass. If the level of the medicine 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 pinor any sharp object to clean it.
• Try to make it work again by following the instructions in the “Preparing the nasal spray for use” section.
• 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.