Dordask

Leaflet attached to the packaging: information for the user

Dordask, 27.5 micrograms/dose, nasal spray, suspension
fluticasone furoate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Dordask and what is it 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 packaging and other information

1. What is Dordask and what is it used for

Dordask belongs to a group of medicines called glucocorticosteroids. Fluticasone furoate reduces
inflammatory conditions caused by allergies ( nasal mucosa inflammation) and thus alleviates allergy symptoms.
Dordask, nasal spray is used to treat symptoms of allergic rhinitis,
including stuffy nose, runny nose, and itching of the nose, sneezing, tearing, itching or
redness of the eyes in adults, adolescents, and children aged 6 and older.
Allergy symptoms may occur at a specific time of the year and may be caused by an allergy to grass or tree pollen (hay fever), or may occur throughout the year and are most often caused by an allergy to animals, house dust mites, or fungi.

2. Important information before using Dordask

When not to use Dordask

Warnings and precautions

Before starting to use Dordask, discuss it with your doctor, pharmacist, or nurse.

Children and adolescents

Do not use in children under 6 years of age.
Using Dordask:

• may cause growth retardation in children if used for a long period. The doctor will regularly check the child's growth and ensure that the child uses the smallest effective dose.
• may cause eye diseases, such as glaucoma (increased eye pressure) or cataracts (clouding of the lens). You should tell your doctor if such changes have occurred in the past or if you experience blurred vision or other vision disturbances while using fluticasone furoate.

Dordask and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take, including those that are available without a prescription.
It is especially important to tell your doctor about any of the following medicines you are currently taking or have recently taken:

• corticosteroids in tablets or injections
• corticosteroids in creams
• medicines used in asthma
• ritonavir or cobicistat used in the treatment of HIV
• ketoconazole used in the treatment of fungal infections.

Your doctor will assess whether you can use fluticasone furoate with these medicines. Some of these medicines may enhance the side effects of Dordask, and your doctor may want to closely monitor your condition while taking such medicines.
Fluticasone furoate should not be used at the same time as other nasal sprays containing steroids.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
Do not use Dordask if you are pregnantor plan to have a child, unless your doctor or pharmacist advises you to.
Do not use Dordask if you are breastfeeding, unless your doctor or pharmacist advises you to.

Driving and using machines

It is unlikely that Dordask will affect your ability to drive or use machines.

Dordask contains benzalkonium chloride

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

3. How to use Dordask

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

When to use Dordask

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

How long Dordask works

Some people may not feel an improvement even after a few days of using Dordask.
Usually, the effect of the medicine is observed within 8 to 24 hours of use.

What dose of Dordask to use

Adults and adolescents over 12 years old

• Typically, the initial doseis 2 sprays into each nostril once a day.
• After symptoms are under control, the dose can be reduced to 1 spray into each nostril once a day.

Children aged 6 to 11 years old

• Typically, the initial doseis 1 spray into each nostril once a day.
• If symptoms are severe, the doctor may recommend increasing the dose to 2 sprays into each nostril once a day until symptoms are under control. Then, the dose can be reduced to 1 spray into each nostril once a day.

How to use the nasal spray

Dordask has almost no taste or smell. It is sprayed into the nose in the form of a mist. Be careful not to get the spray into your eyes. If this happens, rinse your eyes with water.
In this leaflet, after section 6, there is a detailed instruction for using the nasal spray. Follow these instructions carefully to get the most benefit from using Dordask.
See: Detailed instructions for using the nasal spray, after section 6.

Using a higher dose of Dordask than recommended

Consult your doctor or pharmacist.

Missing a dose of Dordask

If you miss a dose, take it as soon as you remember.
If it is almost time for your next dose, wait and take it at that time. Do not take a double dose to make up for a missed dose.
If you have any further doubts about using this medicine or experience discomfort while using the nasal spray, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Dordask can cause side effects, although not everybody gets them.

Allergic reactions: seek medical help immediately

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

• wheezing, coughing, or difficulty breathing
• sudden weakness or dizziness (which can lead to fainting or loss of consciousness)
• swelling of the face
• skin rash or redness.

In many cases, these symptoms will be signs of less serious side effects. However, they can be serious– so if you experience such symptoms:

Seek medical help immediately.

Very common side effects(affecting more than 1 in 10 people):

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

Common side effects(affecting less than 1 in 10 people but more than 1 in 100 people)

• Ulcers of the nasal mucosa - which can cause irritation or discomfort inside the nose. There may also be visible blood streaks when blowing your nose.
• Headache.
• Shortness of breath.

Uncommon side effects(affecting less than 1 in 100 people but more than 1 in 1,000 people):

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

Rare side effects(affecting less than 1 in 1,000 people but more than 1 in 10,000 people):

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

Side effects of unknown frequency(frequency cannot be estimated from available data)

• Growth retardation in children.
• Blurred vision or transient vision disturbances during prolonged use.
• Chest tightness causing breathing difficulties.

Nasal corticosteroids may affect the production of hormones in the body, especially if large doses are used for a long time. This side effect may cause growth retardation in children.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301,
fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dordask

Keep the medicine out of 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: Expiry Date (EXP). The expiry date refers to the last day of the month.
The shelf life after first opening of Dordask 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. This will help protect the environment.

6. Contents of the packaging and other information

What Dordask contains

• The active substance of Dordask 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

The medicine is a white suspension for nasal use, contained in a 15 ml glass bottle of type III, fitted with a pump spray, nasal applicator, and protective cap.
Dordask is available in one pack size: 1 bottle containing 120 doses, in a carton.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUBSTIPHARM
24 rue Erlanger
75016 Paris
France

Manufacturer

CURIDA AS
Solbærvegen 5
Elverum 2409
Norway

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria: Konika 27,5 Mikrogramm/Sprühstoß Nasenspray, Suspension
Poland: Dordask

Date of last revision of the leaflet:

Other sources of information

Detailed instructions for using the nasal spray.

DETAILED INSTRUCTIONS FOR USING THE NASAL SPRAY

What the nasal spray looks like

The nasal spray is contained in a glass bottle of orange glass. It contains 120 doses.

Five important points about using the nasal spray

• Dordask is contained in a glass bottle of orange glass. To check how much medicine is left, hold the bottle upright in bright light. The level of the liquid can be seen through the glass.
• When using the nasal spray for the first time, shake the bottle vigorouslywith the cap on the actuator for about 10 seconds. This is important because Dordask is a thick suspension that becomes a liquid after vigorous shaking. The medicine will only spray if it is liquid.
• Press the pump firmlyto release a dose through the actuator tip
• see figure a.
• Always replace the protective capon the actuator when not in use. The cap prevents dust from entering, maintains the pressure in the sprayer, and prevents the actuator tip from clogging.
• Never use a needleor any other sharp object to clean the actuator tip. This can damage the dosing mechanism.

Preparing the nasal spray for use

You need to prepare the nasal spray:

• 1. before using it for the first time
• 2. after leaving the actuator without the cap for 5 days or when the device has not been used for 30 days or longer.

Preparing the nasal spray helps ensure that you always take the full dose of the medicine. Follow these steps:

• 1. Shake the bottle vigorouslywith the cap on the actuator for about 10 seconds.
• 2. Remove the cap.
• 3. Hold the nasal spray upright and tilt it, then point the actuator away from you.
• 4. Press the pump firmly- see figure a. Press at least 6 timesuntil a mist is released into the air.

a

The nasal spray is now ready to use.

Using the nasal spray

• 1. Shake the nasal spray vigorously.

2. Remove the cap.

• 3. Blow your noseto clear your nostrils, then tilt your head slightly forward.
• 4.Place the actuator tip in one nostril. Point the actuator tip slightly towards the outer part of the nose, away from the nasal septum. This will allow the medicine to reach the right part of the nose – see figure b.

b

• 5. While breathing in through your nosepress the pump firmly.
• 6.Remove the actuator from your nostril and breathe out through your mouth.
• 7.If your doctor has prescribed 2 sprays into each nostril, repeat steps 4 to 6.
• 8.To administer the medicine to the other nostril, repeat steps 4 to 7.
• 9. Replace the capon the nasal spray.

Cleaning the nasal spray

After each use:

1. Wipe the actuator tip with a dry, clean tissue

• 2.Do not use water to clean the actuator tip.
• 3. Never use a needleor any other sharp object to unclog the actuator tip.
• 4. Always replace the capon the nasal spray after use.

If the nasal spray does not work:

• Check if there is still medicine left. Look through the glass at the level of the liquid. If there is very little medicine left, the nasal spray may not work properly.
• Check if the nasal spray container is damaged.
• If you suspect that the actuator tip is clogged, never use a needleor any other sharp object to unclog it.
• Try to prime it again by following the instructions in "Preparing the nasal spray for use".
• If the nasal spray still does not work, or if a stream of liquid is released, take the nasal spray to a pharmacy for advice.