ALERIC DESLO ACTIVE

Package leaflet: Information for the patient

Aleric Deslo Active, 0.5 mg/ml, oral solution
Desloratadine
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if you feel worse, consult your doctor.

Table of contents

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

What is Aleric Deslo Active
Aleric Deslo Active contains desloratadine, which is an antihistamine medicine.
How Aleric Deslo Active works
Aleric Deslo Active oral solution is an antiallergic 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 allergy, such as hay fever or dust mite allergy). Symptoms of this condition include: sneezing, itching or nasal discharge, itching of the palate, and itchy, red or watery eyes.
Aleric Deslo Active oral solution is also used to relieve symptoms associated with urticaria (a skin condition caused by allergy). Symptoms of this condition include: skin itching, redness or presence of blisters on the skin.
Relief from these symptoms lasts throughout the day, helping you return to normal daily activities and allowing for 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 be used only after a prior diagnosis of allergy has been established.
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If there is no improvement after 3 days or if you feel worse, you should contact your 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 treatment with Aleric Deslo Active, discuss with your doctor or pharmacist:

• if the patient has impaired kidney function,
• if the patient has a history of seizures or a family history of seizures,
• if the child is between 2 and 5 years of age. 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 must not be given to children under 2 years of age.
Aleric Deslo Active and other medicines
No interactions between Aleric Deslo Active and other medicines are known.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Aleric Deslo Active with food, drink and alcohol
Aleric Deslo Active oral solution can be taken with or without food.
Caution is advised when taking this medicine with alcohol.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The use of Aleric Deslo Active is not recommended during pregnancy or breastfeeding.
Fertility
There are no available data on the effect on fertility in men and women.
Driving and operating machinery
It is not expected that this medicine, when used at the recommended dose, affects the ability to drive or operate machinery. Although drowsiness does not occur in most people, it is recommended to refrain from activities requiring mental alertness, such as driving or operating machinery, until the patient's response to the medicine is known.
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, corresponding to 150 mg/ml.
Sorbitol is a source of fructose. If the patient (adult or child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot break down fructose, consult a doctor before taking this medicine or giving it to a 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, corresponding to 150 mg/ml.
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The medicine contains less than 1 mmol (23 mg) of sodium per 5 ml of solution, meaning 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 your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
Adults and adolescents (aged 12 years and older): the recommended dose is 10 ml (two 5 ml measuring spoons) of oral solution once daily.
Use in children
In cases of underweight or overweight, dose adjustment should be discussed with a doctor.
Children aged 6 to 11 years: the recommended dose is 5 ml (one 5 ml measuring spoon) of oral solution once daily.
Children aged over 2 years to 5 years: 2.5 ml (half of a 5 ml measuring spoon) of oral solution once daily.
In children aged 2 to 5 years, Aleric Deslo Active may only be used after a diagnosis of allergy has been confirmed.
If an oral syringe is provided with the bottle of oral solution, it may be used interchangeably to measure the appropriate amount of oral solution.
Method of administration:
This medicine is intended for oral use.
The dose of oral solution should be swallowed and followed with water. The medicine may be taken with or without food.
Duration of treatment:
If there is no improvement after 3 days or if the patient feels worse, consult a doctor.
Do not use Aleric Deslo Active for longer than 10 days without consulting a doctor.
Taking more than the recommended dose of Aleric Deslo Active
Aleric Deslo Active oral solution should only be taken as described in this patient leaflet or as directed by your doctor or pharmacist.
Severe adverse effects are not expected following accidental overdose. However, if more than the recommended dose of Aleric Deslo Active oral solution is taken, contact your doctor or pharmacist immediately.
Missed dose of Aleric Deslo Active
If a dose is missed, take it as soon as possible, then return to the regular dosing schedule. Do not take a double dose to make up for a missed dose.
Stopping Aleric Deslo Active oral solution
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
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4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Since desloratadine has been marketed, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) as well as rash have been reported. If any of these severe adverse reactions occur, you should stop taking the medicine immediately and consult a doctor without delay.

In clinical trials, adverse reactions in most children and adults were almost the same as those observed with placebo solution or tablets containing no active substance. However, in adult patients, fatigue, dry mouth, and headache were reported more frequently than with placebo tablets.

The following adverse reactions have been reported in clinical trials with desloratadine:

Common: may occur in up to 1 in 10 patients

• fatigue ● dry mouth ● headache

Since desloratadine has been marketed, the following reactions have been observed:

Very rare: may occur in less than 1 in 10,000 patients

• severe allergic reactions ● rash ● palpitations and irregular heartbeat
• rapid heartbeat ● abdominal pain ● nausea
• vomiting ● stomach discomfort ● diarrhoea
• dizziness ● somnolence ● insomnia
• muscle pain ● hallucinations ● convulsions
• restlessness with increased motor activity ● hepatitis ● abnormal liver function test results

Frequency not known: frequency cannot be estimated from available data

• unusual weakness ● yellowing of the skin and/or eyes
• increased sensitivity of the skin to sunlight, even on cloudy days, and to UV (ultraviolet) radiation, for example UV radiation in sunbeds
• change in heart rhythm
• unusual behaviour
• aggressive behaviour
• weight gain, increased appetite
• depressed mood
• dry eyes

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

• slow heartbeat
• change in heart rhythm
• unusual behaviour
• aggressive behaviour
• weight gain, increased appetite

Reporting of adverse reactions
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If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Aleric Deslo Active

Keep this medicine out of sight and reach of children.
The shelf life after first opening the immediate packaging is 2 years.
Do not use this medicine after the expiry date stated on the carton and label following: EXP.
The expiry date refers to the last day of the stated month.
No special storage temperature requirements; store in the original immediate packaging.
Inform the pharmacist if the patient notices any change in the appearance of the oral solution.
Medicines must not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Aleric Deslo Active oral solution contains

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

What Aleric Deslo Active oral solution looks like and contents of the pack
Aleric Deslo Active oral solution is a clear, colourless solution with a fruity taste.
It is available in bottles closed with a child-resistant cap.
An oral measuring spoon or oral syringe with markings at 2.5 ml and 5 ml is included in packs containing 30 ml, 50 ml, 60 ml and 100 ml.
Pack sizes: 30 ml, 50 ml, 60 ml, 100 ml of oral solution.

Marketing Authorisation Holder:
US Pharmacia Sp. z o.o.
Ziębicka 40 Street, 50-507 Wrocław, Poland

Manufacturer:
Genepharm S.A.,
18 Km Marathon Avenue,
15351 Pallini, Greece

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

For further information, please contact:
USP Zdrowie Sp. z o.o.
Poleczki 35 Street, 02-822 Warsaw, Poland, Tel. +48 (22) 543 60 00

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