Aleric Sprai

Aleric Spray is used to treat symptoms diagnosed by a doctor

of seasonal and year-round allergic rhinitis in adults.

Before using the medicine, read the leaflet and familiarize yourself with the educational materials. This information is available in pharmacies, after scanning the QR code on the packaging with a smartphone, and on the website www.jakstosowacalericspray.pl (see also point

6 of the patient leaflet).

Leaflet attached to the packaging: patient information

ALERIC SPRAY, 50 micrograms/dose, nasal spray, suspension

Mometasone furoate

For use in adults

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

This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or more information, ask your pharmacist.
• If you experience any side effects, including any not listed in the leaflet, tell your doctor, pharmacist, or nurse. See point 4.
• If after 7 daysthere is no improvement or you feel worse, contact your doctor.

Table of contents of the leaflet

• 1. What is Aleric Spray and what is it used for
• 2. Important information before taking Aleric Spray
• 3. How to use Aleric Spray
• 4. Possible side effects
• 5. How to store Aleric Spray
• 6. Contents of the packaging and other information

1. What is Aleric Spray and what is it used for

What is Aleric Spray?

Aleric Spray contains mometasone furoate, which belongs to a group of medicines called corticosteroids. Mometasone furoate, when administered intranasally, relieves the symptoms of inflammation (swelling and irritation of the nasal mucosa), sneezing, itching, and a stuffy nose, and reduces the amount of nasal discharge. Additionally, Aleric Spray may also relieve itching and tearing of the eyes.

What is Aleric Spray used for?

Aleric Spray is indicated for the treatment of symptoms diagnosed by a doctor:

• seasonal allergic rhinitis caused by plant pollen (hay fever) or
• year-round allergic rhinitis caused by increased exposure to other airborne allergens (e.g., dust, mites, animal dander).

Aleric Spray is indicated for use in adults aged 18 and over.
Page 1 8
Seasonal and year-round allergic rhinitis is characterized by symptoms such as: watery, runny nasal discharge and a stuffy nose with irritation and swelling of the nasal mucosa (which may be accompanied by tearing and itching of the eyes), occurring after contact with an allergen or at certain times of the year. This is an allergic reaction caused by inhaling allergens (e.g., tree, grass, or weed pollen, as well as mold and fungal spores, mites, dust, or animal allergens found on fur, in saliva, dander, or excrement) and can last as long as the allergen is present in the environment.
Aleric Spray reduces the swelling and irritation of the nasal mucosa and thus relieves sneezing, itching, stuffy nose, or nasal discharge caused by seasonal and year-round allergic rhinitis.
If after 7 days there is no improvement or you feel worse, contact your doctor.

2. Important information before taking Aleric Spray

When not to use Aleric Spray:

• if you are allergic to mometasone furoate or any of the other ingredients of this medicine (listed in point 6);
• if you have an untreated nasal infection; Using Aleric Spray during an untreated nasal infection, such as herpes, may worsen the symptoms of the infection. You should wait until the infection is treated before using the nasal spray.
• if you have recently had nasal surgery or a nasal injury; You should not use the nasal spray until the wounds have healed.
• in children and adolescents under 18 years of age.

Warnings and precautions

Before starting treatment with Aleric Spray, discuss it with your doctor or pharmacist:

• if you currently have or have had tuberculosis in the past;
• if you have any other infection (fungal, viral, bacterial, or other);
• if you are taking other corticosteroids orally or by injection;
• if you have cystic fibrosis.

During treatment with Aleric Spray, discuss it with your doctor:

• if your immune system is not working properly (you have trouble fighting infections) and you have been in contact with someone with chickenpox or shingles. You should avoid contact with people who have these infections;
• if you have a nasal or throat infection (change in nasal discharge color or sore throat);
• if you have prolonged nasal or throat irritation;
• if you experience eye itching or irritation;
• if you experience blurred vision or other vision disturbances.

If corticosteroids in the form of a nasal spray are used in high doses for a long time, side effects may occur due to the absorption of the medicine into the body.

Aleric Spray and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
Page 2 8
Consult your doctor if you are taking other corticosteroids orally or by injection. To treat allergies, your doctor may advise you to stop taking them when you start using Aleric Spray. In some patients, after stopping oral or injectable corticosteroids, side effects such as joint or muscle pain, weakness, and depression may occur. Other allergic symptoms, such as itching, tearing of the eyes, or red and itchy skin patches, may also appear. Consult your doctor if you experience any of these symptoms.
Some medicines may enhance the effect of Aleric Spray, and your doctor may want to monitor your condition closely if you are taking such medicines (including certain HIV medicines: ritonavir, cobicistat).

Pregnancy and breastfeeding

There is no data or only limited data on the use of mometasone furoate in pregnant women. It is not known whether mometasone furoate passes into breast milk.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before using this medicine.

Driving and using machines

There is no data on the effect of Aleric Spray on the ability to drive and use machines.

Aleric Spray contains benzalkonium chloride

This medicine contains 20 micrograms of benzalkonium chloride per dose of nasal spray. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use Aleric Spray

This medicine should always be used exactly as described in this patient leaflet or as advised by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Do not use a higher dose or use the medicine more often or for a longer period than recommended in this leaflet.
Use in adults(over 18 years of age):

• Usually, two doses of nasal spray are used for each nostril once a day.
• After improvement, the dose can be reduced:use one dose of nasal spray for each nostril once a day. This dose should be effective for maintenance treatment.

In some patients, relief of symptoms occurs within 12 hours of administration of the first dose of Aleric Spray, but the full benefits of treatment may not appear until after 2 days of treatment. Therefore, you should continue to use the medicine regularly to get the full benefits of treatment.

If after a maximum of 7 days of using the medicine you do not feel any improvement or feel worse, contact your doctor.

The maximum duration of use of Aleric Spray without consulting a doctor is 3 months.

Page 3 8
Children and adolescents
Aleric Spray should not be used in children and adolescents under 18 years of age.

Preparing the nasal spray for use

The Aleric Spray nasal spray packaging contains a protective cap that protects the tip of the dispenser and prevents it from getting dirty. Remember to remove it before using the spray and put it back on after use.

Before the first use of the spray, check the pump by pressing it

10 times, until a fine mist is produced:

• 1. Shake the bottle.
• 2. Remove the protective cap from the tip of the dispenser.
• 3. Place your index and middle fingers on either side of the tip of the dispenser, and your thumb under the bottle. Do not puncture the nasal spray dispenser.
• 4. With the tip of the dispenser pointing away from you, press your fingers to release the spray 10 times, until a uniform mist is produced (diagram on the right).

If the nasal spray has not been used for 14 days or more, before the next use, press the pump 2 times, until a uniform mist is produced.

HOW TO USE THE NASAL SPRAY

• 1. Before applying the medicine, clean and clear your nose by gently blowing it. You can use saline solution or seawater for this purpose.
• 2. Shake the bottle and remove the protective cap.
• 3. Hold the bottle in your right hand and close your left nostril with your left hand.

• 4. Insert the tip of the dispenser into your right nostril. Tilt your head slightly forward, keeping the bottle upright.

Page 4 8

• 5. Direct the tip of the dispenser away from the nasal septum (the wall between the nostrils), i.e., in the right nostril towards the right eye.

WARNING! Do not spray the nasal spray directly onto the nasal septum, as this may cause damage to the nasal mucosa.

• 6. Start a gentle and slow inhalation through the nose, during which you should spray the nasal spray, pressing the dispenser ONCE.
• 7. Exhale through the mouth.
• 8. Repeat the actions described in points 6-7 to administer a second dose of nasal spray to the same nostril, if necessary.
• 9. Remove the tip of the dispenser from the nostril.

• 10. Transfer the bottle to your left hand and close your right nostril with your right hand. Repeat the actions described in points 4-8 to properly administer the nasal spray to your left nostril. Remember to insert the tip of the dispenser into your nose, directing it away from the nasal septum, i.e., in the left nostril towards the left eye.

• 11. After use, gently wipe the tip of the dispenser with a clean tissue or cloth and put the protective cap back on to prevent dust from entering.

Cleaning

• It is essential to regularly clean the nasal spray bottle, as it may not work properly otherwise.
• Remove the protective cap and gently pull off the tip of the dispenser.
• Wash the tip of the dispenser and the protective cap in warm water, then rinse under running water.
• - Do not clear the tip of the dispenser by puncturing it with a needle or other sharp

Page 5 8
object, as this will damage the dispenser and the correct dose of the medicine will not be delivered.

• Leave the protective cap and the tip of the dispenser in a warm place to dry.
• Put the tip of the dispenser back on the bottle, then put the protective cap back on.
• After cleaning, check if the dispenser is working correctly and spray the nasal spray 2 times.

Using a higher dose of Aleric Spray than recommended

If you accidentally use a higher dose of the medicine than recommended, consult your doctor.
If steroids are used for a long time or in high doses, they may have an adverse effect on your hormones. In children, they may affect growth and development.

Missing a dose of Aleric Spray

If you forget to use the nasal spray at the right time, use it as soon as you remember, and then continue with your regular schedule. Do not use a double dose to make up for a missed dose.

Stopping treatment with Aleric Spray

In some patients, relief of symptoms occurs after 12 hours of administration of the first dose of Aleric Spray, but the full benefits of treatment may not be visible until after 2 days of treatment. It is crucial to use the nasal spray regularly. Do not stop treatment, even if you feel better, unless your doctor advises you to.
The condition for effective treatment is regular use of the medicine for the entire period of exposure to the allergen.
The maximum duration of use of the medicine without consulting a doctor is 3 months.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aleric Spray can cause side effects, although not everybody gets them.
After using this medicine, immediate hypersensitivity reactions (allergic) of unknown frequency may occur. These reactions can be severe. Stop using Aleric Spray and seek medical help immediately if you experience symptoms such as:

• swelling of the face, tongue, or throat
• difficulty swallowing
• hives
• wheezing or difficulty breathing.

If corticosteroids in the form of a nasal spray are used in high doses for a long time, side effects may occur due to the absorption of the medicine into the body.
Other side effects
Common side effects (may occur in less than 1 in 10 people):

• headache
• sneezing
• nasal bleeding (very common (may occur in more than 1 in 10 people) in patients with nasal polyps who used two doses of the medicine in each nostril twice a day)
• irritated nose or throat, sore throat
• ulceration of the nasal mucosa

Page 6 8

• upper respiratory tract infection.

Frequency not known (frequency cannot be estimated from the available data):

• increased intraocular pressure (glaucoma) and/or cataracts causing vision disturbances
• damage to the nasal septum separating the nostrils
• taste and smell disturbances
• blurred vision.

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 Aleric Spray

Keep the medicine out of the sight and reach of children.
There are no special precautions for storing the medicine.
Do not use Aleric Spray after the expiry date stated on the bottle and carton after EXP. The expiry date refers to the last day of the month.
Shelf life after first opening the bottle: 2 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Aleric Spray contains

• The active substance of the medicineis mometasone furoate. Each delivered dose contains 50 micrograms of mometasone furoate, in the form of mometasone furoate monohydrate.
• Other ingredientsare: benzalkonium chloride, solution, glycerol, polysorbate 80, microcrystalline cellulose, and sodium carmellose, citric acid monohydrate, sodium citrate, purified water.

What Aleric Spray looks like and what the packaging contains

Aleric Spray is a white or almost white thick suspension with a pH between 4.3 and 4.9.
The packaging of the medicine is an HDPE bottle with a dosing pump made of PP and HDPE/LDPE, and a nasal applicator made of PP, with a PP cap, in a cardboard box.
Pack sizes:
60 doses (10 g) - 1 bottle,
120 doses (16 g) - 1 bottle,
Page 7 8
140 doses (18 g) - 1 bottle.

Marketing authorization holder and manufacturer

Marketing authorization holder:

US Pharmacia Sp. z o.o.,
Ziębicka Street 40, 50-507 Wrocław

Manufacturer:

FARMEA
10, rue Bouché Thomas,
Z.A.C d’Orgemont,
49000 ANGERS, France
US Pharmacia Sp. z o.o.,
Ziębicka Street 40, 50-507 Wrocław

For more detailed information, please contact:

USP Zdrowie Sp. z o.o.,
Poleczki Street 35, 02-822 Warsaw,
phone: +48 (22) 543 60 00
Detailed and up-to-date information about this medicine is available after scanning the QR code on the packaging with a smartphone. The same information is also available on the website: www.jakstosowacalericspray.pl

Date of last revision of the leaflet:

Page 8 8