Dordask

Package leaflet: Information for the user

Dordask, 27.5 micrograms/dose, nasal spray, suspension
fluticasone furoate
Please read the entire leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Dordask is and what it is used for
2. Important information before using Dordask
3. How to use Dordask
4. Possible side effects
5. How to store Dordask
6. Contents of the package and other information

1. What Dordask is and what it is used for

Dordask belongs to a group of medicines called glucocorticosteroids. Fluticasone furoate reduces
inflammation caused by allergies ( allergic rhinitis ) and therefore relieves allergy symptoms.
Dordask nasal spray is used to treat symptoms of allergic rhinitis,
including nasal congestion, runny nose, nasal itching, sneezing, watery, itchy or
red eyes in adults, adolescents, and children aged 6 years and older.
Allergy symptoms may occur at specific times of the year and may be caused by sensitivity
to grass or tree pollen (hay fever), or may occur throughout the year, most commonly due to
sensitivity to animals, house dust mites, or moulds.

2. Important information before using Dordask

When not to use Dordask

• if the patient is allergic to fluticasone furoate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Dordask, discuss this with your doctor, pharmacist, or nurse.
Children and adolescents
Do not use in children under 6 years of age.
Use of Dordask:

• may cause slowed growth in children when used long-term. The doctor will regularly monitor the child's growth and ensure that the child uses the lowest effective dose possible.
• may cause eye disorders such as glaucoma (increased pressure in the eye) or cataracts (clouding of the eye lens). Inform your doctor if such conditions occurred previously or if blurred vision or other visual disturbances occur during treatment with fluticasone furoate.

Dordask with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those obtained without a prescription.
It is especially important to inform your doctor if you are currently taking or have recently taken any of the following medicines:

• steroids in tablets or injections
• steroid creams
• medicines used for asthma
• ritonavir or cobicistat used in the treatment of HIV
• ketoconazole used to treat fungal infections.

Your doctor will assess whether it is safe to use fluticasone furoate with these medicines. Some of these medicines may increase the risk of adverse effects of Dordask, and your doctor may wish to monitor your condition closely while taking such medicines.
Fluticasone furoate should not be used at the same time as other intranasal aerosols containing steroids.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor before using this medicine.
Do not use Dordask if you are pregnant or planning to become pregnant unless advised by your doctor or pharmacist.
Do not use Dordask if you are breastfeeding, unless advised by your doctor or pharmacist.
Driving and using machines
It is unlikely that Dordask will affect the 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 per dose.
Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a prolonged period.
Polysorbates may cause allergic reactions.
Inform your doctor or pharmacist if you experience discomfort while using the aerosol.

3. How to use Dordask

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
When to use Dordask

• Use once daily.
• Use at the same time each day. The medicine treats symptoms both during the day and at night.

How long does Dordask take to work
Some people may not notice improvement for several days after first using Dordask.
The effect of the medicine is usually observed within 8 to 24 hours after administration.
What dose to use
Adults and adolescents aged 12 years and older

• The usual starting dose is 2 sprays into each nostril once daily.
• After symptoms are under control, the dose may be reduced to 1 spray into each nostril once daily.

Children aged 6 to 11 years

• The usual starting dose is 1 spray into each nostril once daily.
• If symptoms are severe, your doctor may recommend increasing the dose to 2 sprays into each nostril once daily until symptoms are controlled. Then the dose may be reduced to 1 spray into each nostril once daily.

How to use the nasal spray
Dordask has almost no taste or smell. It is delivered as a fine mist into the nose. Be careful not to
get the spray into the eyes. If this happens, rinse the eyes thoroughly with water.
Detailed instructions for using the nasal spray are provided after section 6 in this leaflet. You should
follow these instructions carefully to achieve the maximum benefit from using Dordask.
See: Detailed instructions for using the nasal spray, after section 6.
Use of more than the recommended dose of Dordask
Contact your doctor or pharmacist.
If you miss a dose of Dordask
If you forget to use a dose, use it as soon as you remember.
However, if it is almost time for your next dose, wait and use the next dose at the scheduled time. Do not
use a double dose to make up for a missed dose.
If you have any further doubts about how to use this medicine, or if you experience any discomfort during
use of the nasal spray, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Allergic reactions: seek medical help immediately
Allergic reactions to Dordask occur rarely and affect fewer than 1 in 1,000 patients.
In a small number of patients, allergic reactions may develop into a serious, even life-threatening condition if not treated. Symptoms include:

• wheezing, 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 of the skin.

In many cases, these symptoms may indicate less serious adverse reactions. However, they could potentially be severe – therefore, if any of these symptoms occur:
Contact a doctor as soon as possible.
Very common adverse reactions (occur in more than 1 in 10 people):

• Nosebleeds (usually mild), particularly if Dordask has been used continuously for longer than 6 weeks.

Common adverse reactions (occur in fewer than 1 in 10 people):

• Nasal mucosal ulceration – which may cause irritation or a sensation of discomfort inside the nose. Blood streaks may also be visible when clearing the nose.
• Headache.
• Shortness of breath.

Uncommon adverse reactions (occur in fewer than 1 in 100 people):

• Pain, burning, irritation, tenderness, or dryness inside the nose.

Rare adverse reactions (occur in fewer than 1 in 10,000 people):

• Small holes (perforations) in the nasal septum separating the nostrils.

Adverse reactions with unknown frequency (frequency cannot be determined from available data):

• Slowed growth in children.
• Blurred vision or transient visual disturbances during prolonged use.
• Chest tightness causing difficulty in breathing.
• Voice disorders, loss of voice.
• Taste disturbances, loss of taste, loss of smell.

Intranasal corticosteroids may affect hormone production in the body, especially when high doses are used over a long period. This adverse reaction may lead to slowed growth in children.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Dordask

Keep the medicine out of the sight and reach of children.
Dordask 27.5 micrograms/dose nasal spray, suspension should be stored in an upright position.
Always replace the protective cap.
Do not use this medicine after the expiry date stated on the label or carton after: EXP. The expiry date refers to the last day of the stated month.
The shelf-life of Dordask after first opening is 2 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Dordask contains

• The active substance is fluticasone furoate. Each dose delivers 27.5 micrograms of fluticasone furoate.
• Other ingredients are: glucose, microcrystalline cellulose and sodium carmellose, polysorbate 80, benzalkonium chloride solution (50%), disodium edetate, purified water (see section 2).

What Dordask looks like and contents of the pack
Dordask is a white nasal suspension contained in a 15 ml amber glass type III bottle equipped with a spray pump, a polypropylene (PP) nasal applicator (dosage device), and a protective PP cap.
Dordask is available in one pack size: 1 bottle containing 120 doses, in a cardboard box.

Marketing Authorisation Holder
Solinea Sp. z o.o.
Elizówka, ul. Szafranowa 6
21-003 Ciecierzyn
Poland
(logo of the marketing authorisation holder)

Manufacturer
CURIDA AS
Solbærvegen 5
Elverum 2409
Norway

This medicinal product is authorised in the European Economic Area member countries under the following names:
Austria: Konika 27.5 Microgram/Spray Nasal Spray, Suspension
Poland: Dordask

Further information
Detailed instructions for use of the nasal spray.

DETAILED INSTRUCTIONS FOR USE OF THE NASAL SPRAY

What the nasal spray looks like
The nasal spray is contained in an amber glass bottle. It contains 120 doses.

Five important points about using the nasal spray

• Dordask is contained in an amber glass bottle. To check how much medicine remains, hold the bottle upright in bright light. The liquid level is visible through the glass.
• When using the nasal spray for the first time, shake the bottle vigorously with the cap on the applicator for about 10 seconds. This is important because Dordask is a thick suspension that becomes liquid after vigorous shaking. The medicine will only spray properly when it is liquid.
• Press the pump firmly and fully to release a dose through the applicator tip.
• see figure a.
• Always replace the protective cap on the applicator when the nasal spray is not in use. The cap prevents dust from entering, maintains pressure in the spray device, and helps prevent blockage of the applicator tip.
• Never use a pin or any other sharp object to clean the applicator tip. This may damage the spray mechanism.

Preparing the nasal spray for use
You must prepare the nasal spray:

1. before first use,
2. after leaving the applicator without the cap for 5 days, or
3. if the device has not been used for 30 days or more.

Preparing the nasal spray ensures that you always receive a full dose of medicine. Follow the steps below:

1. Shake the bottle vigorously with the cap on the applicator for about 10 seconds.
2. Remove the cap.
3. Hold the nasal spray upright, tilt it slightly, and point the applicator away from you.
4. Press the pump firmly and fully – see figure a. Press at least 6 times until a fine mist is released into the air.

a
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 applicator tip into one nostril. Point the tip slightly outward, away from the nasal septum. This helps deliver the medicine to the correct area of the nose – see figure b.

b

5. While inhaling through your nose, press the pump firmly and fully.
6. Remove the applicator from the nostril and breathe out through your mouth.
7. If your doctor has prescribed 2 doses into each nostril, repeat steps 4 to 6.
8. To administer the medicine into the other nostril, repeat steps 4 to 7.
9. Replace the cap on the nasal spray.

Cleaning the nasal spray
After each use:

1. Wipe the applicator tip with a clean, dry tissue.
2. Do not use water to clean the applicator tip.
3. Never use a pin or any other sharp object to unblock the applicator tip.
4. Always replace the cap on the nasal spray after use.

If the nasal spray does not work:

• Check whether there is still medicine left. Look through the glass to see the liquid level. If the medicine is nearly empty, the nasal spray may not work properly.
• Check whether the nasal spray container is damaged.
• If you suspect the applicator tip is blocked, never use a pin or any other sharp object to unblock it.
• Try to prime it again by following the instructions under "Preparing the nasal spray for use".
• If the nasal spray still does not work, or if a stream of liquid comes out, take the nasal spray to a pharmacy for advice.