Aleric Deslo Active

Package Leaflet: Information for the Patient

Aleric Deslo Active, 2.5 mg, Oral Disintegrating Tablets

Desloratadine

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

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, consult a doctor.

Table of Contents of the Leaflet:

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

1. What is Aleric Deslo Active and what is it used for

What is Aleric Deslo Active

Aleric Deslo Active contains desloratadine, which is an antihistamine.

How Aleric Deslo Active works

Aleric Deslo Active is an anti-allergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.

When to use Aleric Deslo Active

Aleric Deslo Active relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by an allergy, such as hay fever or dust mite allergy) in adults, adolescents, and children aged 6 and older. Symptoms of this condition include sneezing, nasal itching or discharge, itching of the palate, and itching, redness, or tearing of the eyes.

Aleric Deslo Active is also used to relieve symptoms associated with hives (a skin condition caused by an allergy). Symptoms of this condition may include itching, redness, or the appearance of blisters on the skin.

Relief of these symptoms persists throughout the day, making it easier to return to normal daily activities and normal sleep.

If after 3 days there is no improvement or you feel worse, consult a doctor.

2. Important information before taking Aleric Deslo Active

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When not to take Aleric Deslo Active

Warnings and precautions

Before taking Aleric Deslo Active, discuss with your doctor or pharmacist:

Children and adolescents

Do not give this medicine to children under 6 years of age.

Aleric Deslo Active and other medicines

No interactions with other medicines are known.

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Taking Aleric Deslo Active with food, drink, and alcohol

It is not necessary to take this medicine with water or another liquid. The medicine can be taken with or without food.

Be cautious when taking Aleric Deslo Active with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Aleric Deslo Active during pregnancy or breastfeeding.

Fertility

There is no available data on fertility in males and females.

Driving and using machines

This medicine is unlikely to affect your ability to drive or use machines at the recommended dose.

Although it does not normally cause drowsiness, it is recommended to avoid activities that require concentration, such as driving or operating machinery, until you know how this medicine affects you.

Aleric Deslo Active contains aspartame

This medicine contains 1.5 mg of aspartame in a 2.5 mg dose of Aleric Deslo Active oral disintegrating tablets.

Aspartame is a source of phenylalanine. It may be harmful to people with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Aleric Deslo Active

Always take this medicine exactly as described in this package leaflet or as directed by your doctor or pharmacist.

If you are unsure, ask your doctor or pharmacist.

Adults and adolescents over 12 years of age

The recommended dose is two tablets once a day, taken with or without food.

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Children from 6 to 11 years of age

The recommended dose is one tablet once a day, taken with or without food.

Method of administration

This medicine is intended for oral use.

Before taking, carefully open the blister by tearing it. Remove the oral disintegrating tablet without crushing it. Place it in your mouth, where it will dissolve immediately. Water or another liquid is not needed to swallow the dose. Take the dose immediately after opening the blister.

Duration of treatment

Ask your doctor or pharmacist.

When starting treatment with desloratadine, the duration of treatment should not exceed 10 days without consulting a doctor.

If you experience:

• seasonal allergic rhinitis (symptoms occur for less than 4 days a week or for less than 4 weeks),
• perennial allergic rhinitis (symptoms occur for 4 or more days a week and for more than 4 weeks),
• hives (the duration of treatment may vary for each patient), your doctor will determine the duration of treatment with Aleric Deslo Active, considering the type, duration, and course of symptoms.

If after 3 days of taking Aleric Deslo Active there is no improvement or you feel worse, consult a doctor.

If you experience difficulty breathing or swelling of the lips, tongue, or throat, seek medical help immediately.

Taking more Aleric Deslo Active than recommended

Aleric Deslo Active should be taken as directed in the package leaflet.

In case of accidental overdose, serious disorders are unlikely to occur. However, if you take more than the recommended dose, tell your doctor, pharmacist, or nurse immediately.

Missing a dose of Aleric Deslo Active

If you miss a dose, take it as soon as possible, and then continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping treatment with Aleric Deslo Active

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aleric Deslo Active can cause side effects, although not everybody gets them.

After desloratadine was marketed, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If you experience any of these severe side effects, stop taking the medicine and seek medical help immediately.

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In clinical studies in adult patients, side effects were almost the same as with a placebo. However, fatigue, dry mouth, and headache were reported more frequently than with a placebo. In adolescents, the most commonly reported side effect was headache.

The following side effects have been reported in clinical studies with desloratadine:

• Common: may affect up to 1 in 10 people:
• fatigue
• dry mouth
• headache

After desloratadine was marketed, the following side effects have been reported:

• Very rare: may affect up to 1 in 10,000 people:
• severe allergic reactions
• rash
• palpitations and irregular heartbeat
• rapid heartbeat
• abdominal pain
• nausea (vomiting)
• vomiting
• upset stomach
• diarrhea
• dizziness
• drowsiness
• insomnia
• muscle pain
• hallucinations
• seizures
• restlessness with excessive physical activity
• hepatitis
• abnormal liver function tests.

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

• unusual weakness
• yellowing of the skin and/or eyes
• increased sensitivity of the skin to the sun, even when cloudy, and to UV (ultraviolet) radiation, such as in a solarium
• changes in heartbeat
• abnormal behavior
• aggressive behavior
• weight gain, increased appetite
• low mood
• dry eyes

Additional side effects in children and adolescents

• Frequency not known: frequency cannot be estimated from the available data
• slow heartbeat
• changes in heartbeat
• abnormal behavior
• aggressive behavior

Reporting side effects

If you experience any side effects, including those not listed in this 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

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 Aleric Deslo Active

Keep this medicine out of the sight and reach of children.

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Do not use this medicine after the expiry date stated on the carton and blister after EXP.

The expiry date refers to the last day of the month.

No special precautions for storage are necessary.

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 pack and other information

What Aleric Deslo Active contains

• The active substance is desloratadine in a dose of 2.5 mg.
• The other ingredients are: polacrilin potassium, citric acid monohydrate, iron oxide red (E 172), magnesium stearate, sodium croscarmellose, Tutti Frutti flavor (also containing propylene glycol), aspartame (E 951), microcrystalline cellulose, spray-dried mannitol, and potassium hydroxide (to adjust pH).

What Aleric Deslo Active looks like and contents of the pack

Aleric Deslo Active 2.5 mg oral disintegrating tablets are reddish-brown, round, flat with beveled edges, and engraved with "2.5".

The medicine is packaged in packs containing 5, 6, or 10 oral disintegrating tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

US Pharmacia Sp. z o.o.

ul. Ziębicka 40, 50-507 Wrocław

Manufacturer:

Genepharm S.A.,

18th km Marathonos Avenue, 15351 Pallini, Greece

Rontis Hellas Medical and Pharmaceutical Products S.A.,

P.O. BOX 3012 Larisa Industrial Area, Larisa, 41004, Greece

Pharmapath S.A.

28is Oktovriou 1, Agia Varvara, 123 51, Greece

For more information, contact:

USP Zdrowie Sp. z o.o.

ul. Poleczki 35, 02-822 Warsaw,

tel.+48 (22) 543 60 00

Date of last revision of the leaflet: June 2025

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