Aleric Deslo Active

Leaflet attached to the packaging: patient information

Aleric Deslo Active, 0.5 mg/ml, oral solution

Desloratadine

Read the 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 patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should 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 packaging 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 oral solution 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 oral solution relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by an allergy, such as hay fever or allergy to dust mites). These symptoms include: sneezing, itching or runny nose, itching of the palate, and itching, redness, or tearing of the eyes.
Aleric Deslo Active oral solution is also used to relieve symptoms associated with hives (a skin condition caused by an allergy). These symptoms include: skin itching, redness, or the appearance of blisters on the skin.
The relief of these symptoms lasts all day, making it easier to return to normal daily activities and normal sleep.
Aleric Deslo Active oral solution is intended for children over 2 years of age, adolescents, and adults.
In children aged 2 to 5 years, Aleric Deslo Active may only be used after a diagnosis of allergy has been made.
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If after 3 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Aleric Deslo Active

When not to take Aleric Deslo Active

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

Warnings and precautions

Before starting to take Aleric Deslo Active, the patient should discuss it with their doctor or pharmacist,

• if the patient has kidney function disorders,
• if the patient has a history of seizures or a family history of seizures,
• if the child is between 2 and 5 years old. The doctor will decide whether Aleric Deslo Active can be used,
• if the child is underweight or overweight. The doctor will adjust the dose of this medicine.

Children and adolescents

This medicine should not be given to children under 2 years of age.

Aleric Deslo Active and other medicines

No interactions of Aleric Deslo Active with other medicines are known.
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Aleric Deslo Active with food, drink, and alcohol

Aleric Deslo Active oral solution can be taken with or without food.
Care should be taken when taking the medicine with alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Aleric Deslo Active should not be used during pregnancy or breastfeeding.

Fertility

There are no available data on the effect on fertility in men and women.

Driving and using machines

It is not expected that this medicine will affect the ability to drive or use machines at the recommended dose. However, it is recommended to avoid activities that require concentration, such as driving or using machines, until it is known how the medicine affects the patient.

Aleric Deslo Active contains sorbitol, propylene glycol, and sodium.

The medicine contains 375 mg of sorbitol in each 2.5 ml of oral solution, 750 mg in 5 ml of oral solution, and 1500 mg in 10 ml of oral solution, which corresponds to 150 mg/ml.
Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, fructose intolerance, they should consult their doctor before taking the medicine or giving it to their child.
The medicine contains 375 mg of propylene glycol in each 2.5 ml of oral solution, 750 mg in 5 ml of oral solution, and 1500 mg in 10 ml of oral solution, which corresponds to 150 mg/ml
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The medicine contains less than 1 mmol (23 mg) of sodium per 5 ml of solution, which means the medicine is considered "sodium-free".

3. How to take Aleric Deslo Active

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Recommended dose

Adults and adolescents (12 years and older):the recommended dose is 10 ml (two 5 ml measuring spoons) of oral solution once a day.

Use in children

In case of underweight or overweight, the patient should consult their doctor to adjust the dose.
Children aged 6 to 11 years:the recommended dose is 5 ml (one 5 ml measuring spoon) of oral solution once a day.
Children over 2 years to 5 years:2.5 ml (half a 5 ml measuring spoon) of oral solution once a day.
In children aged 2 to 5 years, Aleric Deslo Active may only be used after a diagnosis of allergy has been made.
If a measuring spoon is provided with the oral solution bottle, it can be used interchangeably to measure the correct amount of oral solution.

Method of administration:

This medicine is intended for oral use.
The dose of oral solution should be swallowed and then followed by water. The medicine can be taken with or without food.

Duration of treatment:

If after 3 days there is no improvement or the patient feels worse, they should consult a doctor.

Aleric Deslo Active should not be used for more than 10 days without consulting a doctor.

Using a higher dose of Aleric Deslo Active than recommended

Aleric Deslo Active oral solution should only be taken as described in this patient leaflet or as directed by a doctor or pharmacist.
No serious disorders are expected in case of accidental overdose. However, if a higher dose of Aleric Deslo Active oral solution is taken, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Aleric Deslo Active

If a dose is missed, the patient should take it as soon as possible and then return to their regular dosing schedule. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Aleric Deslo Active oral solution

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.
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4. Possible side effects

Like all medicines, Aleric Deslo Active can cause side effects, although not everybody gets them.
After desloratadine was introduced to the market, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) and rash have been reported. If any of these severe side effects occur, the patient should stop taking the medicine and immediately consult their doctor.
In clinical trials, most children and adults experienced side effects that were almost the same as those experienced with a placebo or a tablet that did not contain the active substance. However, in adult patients, fatigue, dry mouth, and headache were reported more often than with a placebo.
The following side effects have been reported in clinical trials of desloratadine:
Common:may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache.

After desloratadine was introduced to the market, the following reactions have been observed:
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 increased
• hepatitis
• abnormal liver function test results

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 sunlight, even in cloudy weather, and to UV radiation (e.g., in a solarium)
• change in heart rhythm
• abnormal behavior
• aggressive behavior
• weight gain, increased appetite
• low mood
• dry eyes

Children

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

• slow heartbeat
• change in heart rhythm
• abnormal behavior
• aggressive behavior
• weight gain, increased appetite

Reporting side effects

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If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje Jerozolimskie 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Aleric Deslo Active

Keep the medicine out of sight and reach of children.
The shelf life after first opening the packaging is 2 years.
Do not use this medicine after the expiry date stated on the carton and label after: EXP.
The expiry date refers to the last day of the month.
There are no special storage precautions, store in the original packaging.
The patient should inform their pharmacist if they notice any change in the appearance of the oral solution.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Deslo Active contains

• The active substance is desloratadine. Each ml of oral solution contains 0.5 mg of desloratadine.
• The other ingredients are: sodium citrate, liquid sorbitol, sucralose, citric acid, propylene glycol, hypromellose 2910, Tutti frutti liquid flavor, purified water.

What Aleric Deslo Active looks like and what the packaging contains

Aleric Deslo Active oral solution is a clear, colorless solution with a fruity taste.
It is available in bottles with a child-resistant closure.
A measuring spoon or oral syringe with a scale of 2.5 and 5 ml is provided with the 30 ml, 50 ml, 60 ml, and 100 ml packaging.
Available pack sizes: 30 ml, 50 ml, 60 ml, 100 ml of oral solution.

Marketing authorization holder:

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

Manufacturer:

Genepharm S.A.,
18 Km Marathon Avenue,
15351 Pallini, Greece
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Famar A.V.E
49th km National road Athens Lamia
Avlona Attiki, 19011, Greece
IASIS Pharmaceuticals Hellas S.A. - – Koropi
Archimidous Street, Koropi Attikis, 19 400, Greece
To obtain more detailed information, the patient should contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35, 02-822 Warsaw, phone: +48 (22) 543 60 00

Date of last revision of the leaflet: July 2025

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