Aleric spray

Aleric Spray is used for the treatment of symptoms of seasonal and perennial allergic rhinitis diagnosed by a physician in adults.
Before using the medicine, carefully read the package leaflet and educational materials.
These are available in pharmacies, by scanning the QR code on the packaging with a smartphone, and on the website www.jakstosowacalericspray.pl (see also section 6 of the patient leaflet).
Package leaflet: information for the patient
ALERIC SPRAY, 50 micrograms/dose, nasal aerosol, suspension
Mometasone furoate
For use in adults
Please 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 directed by a physician, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in the leaflet, inform your physician, pharmacist, or nurse. See section 4.
• If there is no improvement after 7 days or if your condition worsens, contact your physician.

Contents of the leaflet

1. What Aleric Spray is and what it is used for
2. What you need to know before using Aleric Spray
3. How to use Aleric Spray
4. Possible side effects
5. How to store Aleric Spray
6. Contents of the pack and other information

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

What is Aleric Spray?
Aleric Spray contains mometasone furoate, which belongs to a group of medicines called corticosteroids. Mometasone furoate administered intranasally reduces inflammation (swelling and irritation of the nasal mucosa), sneezing, itching, nasal congestion, and decreases nasal discharge. Additionally, Aleric Spray may also relieve eye itching and watering.

What is Aleric Spray used for?
Aleric Spray is indicated for the treatment of symptoms of seasonal and perennial allergic rhinitis diagnosed by a physician:

• seasonal allergic rhinitis caused by pollen (hay fever), or
• perennial allergic rhinitis caused by increased exposure to other airborne allergens (e.g. dust, mites, pet dander).

Aleric Spray is indicated for use in adults aged 18 years and older.
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Seasonal and perennial allergic rhinitis are characterized by symptoms such as watery nasal discharge, nasal congestion with irritation and swelling of the nasal mucosa (which may be accompanied by eye watering and itching), occurring after exposure to allergens or during specific times of the year. This is an allergic reaction caused by inhaling allergens (e.g. tree, grass, and weed pollens, mold and fungal spores, dust mites, house dust, and animal allergens such as those found in fur, saliva, shed skin, or animal excreta) and may persist as long as the allergen remains in the environment.
Seasonal allergens appear during similar periods each year, so the onset of allergic rhinitis can be predicted (e.g. based on the pollen calendar or time of year).
Aleric Spray reduces swelling and irritation of the nasal mucosa and thereby relieves sneezing, itching, nasal congestion, and nasal discharge caused by seasonal and perennial allergic rhinitis.
If there is no improvement after 7 days or if your condition worsens, consult your physician.

2. Important information before using Aleric Spray

When not to use Aleric Spray:

• if the patient is allergic to mometasone furoate or any of the other ingredients of this medicine (listed in section 6);
• if the patient has an untreated nasal infection; Using Aleric Spray during an untreated nasal infection, such as herpes, may worsen the symptoms of infection. Nasal spray should not be used until the infection has healed.
• if the patient has recently undergone nasal surgery or nasal trauma; Do not use the nasal spray until wounds have healed.
• in children and adolescents under 18 years of age.

Warnings and precautions
Before starting treatment with Aleric Spray, consult a doctor or pharmacist:

• if the patient currently has or has ever had tuberculosis in the past;
• if the patient has any other infection (fungal, viral, bacterial, or other);
• if the patient is taking other corticosteroids orally or by injection;
• if the patient has cystic fibrosis.

While using Aleric Spray, consult a doctor:

• if the patient's immune system does not function properly (difficulty fighting infections) and the patient has been in contact with someone who has measles or chickenpox. Contact with individuals suffering from these infections should be avoided;
• if the patient develops a nasal or throat infection (change in the color of nasal discharge or sore throat);
• if the patient has persistent irritation of the nose or throat;
• if itching or irritation of the eyes occurs;
• if the patient experiences blurred vision or other visual disturbances.

If nasal corticosteroid sprays are used at high doses for prolonged periods,
adverse effects due to systemic absorption of the drug may occur.
Aleric Spray with other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking,
has recently taken, or plans to take, including those obtained without a prescription.
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Contact a doctor if the patient is taking other corticosteroids orally or by injection.
To treat allergies, the treating physician may recommend that the patient stop taking them when starting Aleric Spray.
Some patients may experience adverse effects after discontinuing oral or injectable corticosteroids, such as joint or muscle pain, weakness, and depression.
Other allergic symptoms may also appear, such as itching, watery eyes, or red, itchy skin rashes. Contact a doctor if any of these symptoms occur.
Some medicines may increase the effect of Aleric Spray, and the doctor may wish to closely monitor the patient taking such medicines (including certain HIV medications: ritonavir, cobicistat).
Pregnancy and breastfeeding
There are no data or only limited data available on the use of mometasone furoate in pregnant women.
It is not known whether mometasone furoate passes into human milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
There is no information available on the influence of Aleric Spray on the ability to drive vehicles
and operate machinery.
Aleric Spray contains benzalkonium chloride
This medicine contains 20 micrograms of benzalkonium chloride per spray dose. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for prolonged periods.

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 in doubt, consult your doctor or pharmacist.
Do not use a higher dose, use the medicine more frequently, or for a longer period than recommended in this leaflet.

Use in adults (aged over 18 years):

• The usual dose is two sprays into each nostril once daily.
• After symptoms improve, the dose may be reduced: one spray into each nostril once daily. This dose should be effective for maintenance treatment.

In some patients, symptom relief may occur within 12 hours of the first dose of Aleric Spray, but full therapeutic benefits may not be evident within the first two days of treatment. Therefore, regular use should be continued to achieve maximum benefit.
If there is no improvement or if symptoms worsen after up to 7 days of treatment, consult your doctor.
The maximum duration of use of Aleric Spray without medical consultation is 3 months.
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Children and adolescents
Aleric Spray must not be used in children and adolescents under 18 years of age.

Preparing the nasal spray for use
The Aleric Spray nasal spray package contains a protective cap that covers the spray nozzle and prevents contamination. Remember to remove it before using the spray and to replace it after use.

Before first use, prime the pump by pressing it 10 times until a fine mist is produced:

1. Shake the bottle.
2. Remove the protective cap from the spray nozzle.
3. Place the index and middle fingers on either side of the spray nozzle, and the thumb underneath the bottle. Do not pierce the nasal spray dispenser.
4. Pointing the nozzle away from you, press down with your fingers 10 times until a uniform mist is produced (see illustration on the right).

If the nasal spray has not been used for 14 days or longer, prime the pump by pressing it 2 times before the next use, until a uniform mist is produced.

HOW TO USE THE NASAL SPRAY

1. Before applying the medicine – clear and unblock the nose by gently blowing it. As an aid, you may use, for example, physiological saline or seawater.
2. Shake the bottle and remove the protective cap.
3. Hold the bottle in the right hand and close the left nostril with the left hand.

4. Insert the spray nozzle into the right nostril. Tilt the head slightly forward, holding the bottle vertically upright.

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5. Direct the spray nozzle away from the nasal septum (the wall between the nostrils), i.e., in the right nostril, point it toward the right eye.

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

6. Begin a gentle and slow inhalation through the nose, while pressing the dispenser once to release the nasal spray.
7. Exhale through the mouth.
8. Repeat steps 6–7 to administer a second spray into the same nostril, if required.
9. Remove the spray nozzle from the nostril.

10. Transfer the bottle to the left hand and close the right nostril with the right hand. Repeat steps 4–8 to correctly administer the spray into the left nostril. Remember to insert the spray nozzle into the nose, directing it away from the nasal septum, i.e., in the left nostril, point it toward the left eye.

11. After using the spray, gently wipe the nozzle with a clean tissue or cloth and replace the protective cap to prevent dust from entering.

Cleaning

• It is important to clean the nasal spray bottle regularly, otherwise it may not work properly.
• Remove the protective cap and gently pull off the spray nozzle.
• Wash the spray nozzle and protective cap with warm water, then rinse thoroughly under running water.
• Do not unblock the spray nozzle by piercing it with a needle or any other sharp object, as this may damage the dispenser and result in incorrect dosing.

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and prevent proper delivery of the medicine.

• Leave the protective cap and spray nozzle in a warm place to dry.
• Reattach the spray nozzle to the bottle, then replace the protective cap.
• After cleaning, check that the dispenser works properly by spraying twice.

Use of more than the recommended dose of Aleric Spray
If you accidentally use more medicine than recommended, consult your doctor.
If steroids are used for a long period or in high doses, they may rarely affect the patient's hormone system. In children, they may affect growth and development.

Missed dose of Aleric Spray
If the patient forgets to use the nasal spray at the scheduled time, they should take it as soon as they remember, then continue treatment at the usual time. Do not use a double dose to make up for a missed dose.

Stopping treatment with Aleric Spray
In some patients, symptom relief may occur within 12 hours of the first dose of Aleric Spray, but full therapeutic benefits may only become evident after 2 days of treatment. It is very important that the patient uses the nasal spray regularly. Do not stop treatment even if the patient feels better, unless advised by a doctor.
Effective treatment depends on regular use throughout the period of allergen exposure.
The maximum duration of use without medical consultation is 3 months.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Immediate allergic (hypersensitivity) reactions may occur after using this medicine, with unknown frequency. These reactions may be severe. You should stop using Aleric Spray and seek immediate medical help if any of the following symptoms occur:

• swelling of the face, tongue or throat
• difficulty swallowing
• hives (urticaria)
• wheezing or breathing difficulties.

If corticosteroids in the form of a nasal aerosol are used in high doses over a long period of time, adverse effects may occur due to systemic absorption of the medicine.

Other adverse effects
Common adverse effects (may occur less frequently than in 1 out of 10 people):

• headache
• sneezing
• nosebleeds (occurred very commonly (may affect more than 1 in 10 people) in patients with nasal polyps who used two doses of the medicine into each nostril twice daily)
• irritated nose or throat, sore throat
• nasal mucosal ulceration

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• upper respiratory tract infection.

Frequency unknown (frequency cannot be estimated from available data):

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 Aleric Spray

Keep the medicine out of the sight and reach of children.
No special storage conditions are required for this 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 specified 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 no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Aleric Spray contains

• The active substance is mometasone furoate. Each delivered dose contains 50 micrograms of mometasone furoate in the form of mometasone furoate monohydrate.
• The other ingredients are: benzalkonium chloride solution, glycerol, polysorbate 80, microcrystalline cellulose and sodium carboxymethylcellulose, citric acid monohydrate, sodium citrate, purified water.

What Aleric Spray looks like and contents of the pack
Aleric Spray is a white or almost white, viscous suspension with a pH between 4.3 and 4.9.
The packaging consists of an HDPE bottle with a metering pump made of PP and HDPE/LDPE, and a nasal applicator made of PP with a PP cap, all contained in a cardboard box.
Pack sizes:
60 doses (10 g) – 1 bottle,
120 doses (16 g) – 1 bottle,
140 doses (18 g) – 1 bottle.
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Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
US Pharmacia Sp. z o.o.,
ul. Ziębicka 40, 50-507 Wrocław, Poland

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

For further information, contact:
USP Zdrowie Sp. z o.o.,
ul. Poleczki 35, 02-822 Warszawa, Poland
{tel.}+48 (22) 543 60 00

Detailed and up-to-date information about this medicinal product is available by scanning the QR code on the packaging using a smartphone. The same information is also available on the website: www.jakstosowacalericspray.pl
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