Polaro

Patient Information Leaflet

Polaro, 27.5 micrograms/dose, nasal spray, suspension
fluticasone furoate
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

1. What Polaro is and what it is used for
2. What you need to know 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 Polaro is and what it is used for

Polaro belongs to a group of medicines called glucocorticoids. Fluticasone furoate reduces inflammation caused by allergies (inflammation of the nasal mucosa) and therefore relieves allergy symptoms.
Polaro nasal spray is used to treat symptoms of allergic rhinitis, including nasal congestion, runny nose, itchy nose, 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 they may occur throughout the year, most commonly due to allergy to animals, house dust mites, or moulds.

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, discuss this with your doctor, pharmacist, or nurse.
Children and adolescents
Do not use in children under 6 years of age.
Use of Polaro:

• may cause slowed growth in children when used for prolonged periods. The doctor will regularly monitor the child's growth and ensure that the child is using the lowest effective dose.
• may cause eye problems such as glaucoma (increased pressure in the eye) or cataracts (clouding of the eye lens). Tell your doctor if you have ever had such conditions in the past, or if you experience blurred vision or other vision disturbances during treatment with fluticasone furoate.

Polaro and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including medicines 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:

• steroid tablets or injections
• steroid creams
• medicines used for asthma
• ritonavir or cobicistat used in the treatment of HIV
• ketoconazole used in the treatment of 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 Polaro, and your doctor may wish to closely monitor your condition if you are 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, 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 Polaro if you are pregnant or planning to become pregnant, unless advised by your doctor or pharmacist.
Do not use Polaro if you are breastfeeding, unless advised by your doctor or pharmacist.
Driving and operating machinery
It is unlikely that Polaro will affect the ability to drive or operate machinery.
Polaro 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 prolonged periods.
Polysorbates may cause allergic reactions.
Tell your doctor or pharmacist if you experience discomfort during use of the aerosol.

3. How to use Polaro

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 Polaro

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

How long does Polaro take to work
Some people may not notice improvement for several days after first using Polaro.
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.
• Once 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
Polaro has almost no taste or smell. It is sprayed into the nose as a fine mist. Take care not to
get the spray into the eyes. If this occurs, rinse the eyes with water.
Detailed instructions for using the nasal spray are provided in this leaflet after section 6. Follow
these instructions carefully to obtain the maximum benefit from using Polaro.
See: Detailed instructions for using the nasal spray, after section 6.
Use of more than the recommended dose of Polaro
Contact your doctor or pharmacist.
Missed 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 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 questions about the use of this medicine or experience any discomfort
while using the nasal spray, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Allergic reactions: seek medical help immediately
Allergic reactions to Polaro occur rarely and affect less than 1 in 1,000 patients.
In a small number of patients, allergic reactions may progress to 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 effects. However, they may potentially be severe – therefore, if any of these symptoms occur:
Contact a doctor as soon as possible.
Very common adverse effects (occurring in more than 1 in 10 people):

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

Common adverse effects (occurring in less than 1 in 10 people):

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

Uncommon adverse effects (occurring in less than 1 in 100 people):

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

Very rare adverse effects (occurring in less than 1 in 10,000 people):

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

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• Slowed growth in children.
• Blurred vision or transient visual disturbances during long-term 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 if high doses are used over a prolonged period. This adverse effect may lead to slowed growth in children.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Polaro medicine

Keep the medicine out of the sight and reach of children.
Polaro 27.5 micrograms/dose nasal aerosol suspension should be stored in an upright position.
Always replace the protective cap after use.
Do not use this medicine after the expiry date stated on the label or carton following: Expiry (EXP). The expiry date refers to the last day of the stated month.
The shelf-life of Polaro medicine after first opening is 2 months.
Medicines must 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 pack and other information

What Polaro contains

• The active substance 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
Polaro is a white nasal suspension contained in a 15 ml amber glass bottle (Type III) fitted with a spray pump, a nasal applicator (dosage device) made of polypropylene (PP), and a protective cap made of polypropylene (PP).
Polaro is available in one pack size: 1 bottle containing 120 doses, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUBSTIPHARM
24 rue Erlanger
75016 Paris
France

Manufacturer
CURIDA AS
Solbærvegen 5
Elverum 2409
Norway

This medicinal product is authorised in the European Economic Area member states under the following names:
Austria: Konika 27,5 Microgram/Spray Nasal Spray, Suspension
Poland: Polaro

Other sources of 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 a glass bottle made of amber glass. It contains 120 doses.

Five important points about using the nasal spray

• Polaro is contained in an amber glass bottle. To check how much medicine is left, hold the bottle upright in bright light. The level of liquid can be seen through the glass.
• When using the nasal spray for the first time, shake the bottle vigorously with the cap placed on the dosage device for about 10 seconds. This is important because Polaro is a thick suspension which becomes liquid after vigorous shaking. The medicine will only spray when it is in liquid form.
• Press the pump firmly and fully down to release a dose through the dosage nozzle
  • see figure a.
• Always replace the protective cap on the dosage device when the nasal spray is not in use. The cap prevents dust from entering, maintains pressure in the spray device, and prevents the nozzle from becoming blocked.
• Never use a pin or any other sharp instrument to clean the dosage nozzle. This may damage the dosage mechanism.

Preparing the nasal spray for use
Prepare the nasal spray:

1. Before first use
2. After leaving the dosage device without the cap for 5 days or if the device has not been used for 30 days or longer.

Preparing the nasal spray helps ensure that you always receive a full dose of the medicine. Follow the instructions below:

1. Shake the bottle vigorously with the cap on the dosage device for about 10 seconds.
2. Remove the cap.
3. Holding the nasal spray upright, tilt it slightly and point the dosage device away from yourself.
4. Press the pump firmly and fully down – 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 dosage nozzle into one nostril. Direct the nozzle slightly towards the outer side of the nose, away from the nasal septum. This will help deliver the medicine to the correct area of the nose – see figure b.

b

5. While breathing in through your nose, press the pump firmly and fully down.
6. Remove the dosage device from the nostril and breathe out through your mouth.
7. If your doctor has instructed you to use 2 doses in 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 dosage nozzle with a dry, clean tissue

2. Do not use water to clean the dosage nozzle.

3. Never use a pin or any other sharp instrument to unblock the dosage nozzle.

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 level of liquid. If there is very little medicine left, the nasal spray may not work properly.
• Check whether the nasal spray container is damaged.
• If you suspect the dosage nozzle is blocked, do not use a pin or any other sharp instrument to unblock it.
• Try to restart it 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 your pharmacist for advice.