Polaro

Leaflet attached to the packaging: information for the user

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

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or 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 the symptoms of their illness 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 Polaro and what is it used for
• 2. Important information before using Polaro
• 3. How to use Polaro
• 4. Possible side effects
• 5. How to store Polaro
• 6. Contents of the pack and other information

1. What is Polaro and what is it used for

Polaro belongs to a group of medicines called corticosteroids. Fluticasone furoate reduces inflammation caused by allergies ( rhinitis) and thus alleviates allergy symptoms.
Polaro, 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 certain 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 Polaro

When not to use Polaro

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

Warnings and precautions

Before starting to use Polaro, you should discuss it with your doctor or pharmacist or nurse.

Children and adolescents

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

• 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 is using the smallest effective dose.
• may cause eye diseases, such as glaucoma (increased pressure in the eye) or cataracts (clouding of the lens of the eye). You should tell your doctor if such changes have occurred in the past or if blurred vision or other vision disturbances occur during the use of fluticasone furoate.

Polaro and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking 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 that 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 Polaro, 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, you should consult your doctor before using this medicine.
You should not use Polaro if you are pregnantor plan to have a child, unless your doctor or pharmacist advises you to.
You should not use Polaro if you are breastfeeding, unless your doctor or pharmacist advises you to.

Driving and using machines

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

Polaro 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.
You should tell your doctor or pharmacist if you experience discomfort during use of the spray.

3. How to use Polaro

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

When to use Polaro

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

How long does Polaro work

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

What dose of Polaro to use

Adults and adolescents over 12 years of age

• The usual starting 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

• The usual starting doseis 1 spray into each nostril once a day.
• If symptoms are very 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

Polaro 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. You should follow this instruction carefully to get the most benefit from using Polaro.
See: Detailed instructions for using the nasal spray,after section 6.

Using a higher dose of Polaro than recommended

You should contact your doctor or pharmacist.

Missing a dose of Polaro

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 during use of the nasal spray, you should consult your doctor or pharmacist or nurse.

4. Possible side effects

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

Allergic reactions: seek medical help immediately

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

• wheezing, coughing, or difficulty breathing
• sudden weakness or dizziness (which may 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. You should be aware that they are potentially serious– so if you experience such symptoms:

You should contact your doctor as soon as possible.

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

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

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

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

Uncommon side effects(affecting less than 1 in 100 people):

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

Rare side effects(affecting less 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.
• Voice disorders, loss of voice.
• Taste disorders, loss of taste, loss of smell.

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, you should 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, tel.: + 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 Polaro

The medicine should be stored out of sight and reach of children.
Polaro 27.5 micrograms/dose, nasal spray, suspension is best 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 stated.
The shelf life after first opening of Polaro is 2 months.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Polaro contains

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

What Polaro looks like and contents of the pack

The medicine is a white suspension for nasal use, placed in a 15 ml glass bottle of type III, equipped with a spray pump, nasal applicator (dosage device) made of PP, and a protective cap made of PP.
Polaro is available in one pack size: 1 bottle containing 120 doses, in a cardboard box.

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: Polaro

Date of last revision of the leaflet: 06/2025

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 placed in a glass bottle of orange glass. It contains 120 doses.

Five important pieces of information about using the nasal spray

• Polaro is contained in a 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, you should shake the bottle vigorouslywith the cap on the dosage device for about 10 seconds. This is important because Polaro is a thick suspension that becomes a liquid after vigorous shaking. The medicine will only spray if it is liquid.
• You should press the pump firmly to release a dose through the dosage device
• see figure a.
• You should always replace the protective capon the dosage device when not in use. The cap prevents dust from entering, maintains the pressure in the spray pump, and prevents the dosage device from clogging.
• Never use a pinor other sharp object to clean the dosage device. This may damage the dosage device mechanism.

Preparing the nasal spray for use

You should prepare the nasal spray:

• 1. before using it for the first time
• 2. after leaving the dosage device 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 a full dose of the medicine. You should follow the instructions below:

• 1. Shake the bottle vigorouslywith the cap on the dosage device for about 10 seconds.
• 2. Remove the cap.
• 3. Hold the nasal spray upright, tilt it, and then point the dosage device 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 ready for use.

Using the nasal spray

• 1. Shakethe nasal spray vigorously.

2. Remove the cap.

• 3. Blow your noseto clear your nostrils, then tilt your head slightly forward.
• 4.Place the tip of the dosage device in one nostril. Point the tip of the dosage device 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 inhaling through the nosepress the pump firmly.
• 6.Remove the dosage device from the nostril and exhale through the mouth.
• 7.If your doctor has recommended using 2 doses in each nostril, repeat the steps described in points 4 to 6.
• 8.To administer the medicine to the other nostril, repeat the steps described in points 4 to 7.
• 9. Replace the capon the nasal spray.

Cleaning the nasal spray

After each use:

1. Wipe the tip of the dosage device with a dry, clean tissue

• 2.Do not use water to clean the tip of the dosage device.
• 3. Never use a pinor other sharp object to unclog the tip of the dosage device.
• 4. After use, always replace the capon the nasal spray.

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 tip of the dosage device is clogged, never use a pinor other sharp object to unclog it.
• Try to restart it by following the instructions in the "Preparing the nasal spray for use" section.
• If the nasal spray still does not work, or if a stream of liquid comes out of it, you should take the nasal spray to a pharmacy for advice.