Package leaflet: Information for the user

Aleric Deslo Active, 2.5 mg, orodispersible tablets
Desloratadine
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this patient leaflet or as your doctor or pharmacist has instructed.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please 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.

Contents of the leaflet:

What Aleric Deslo Active is and what it is used for
Important information before taking Aleric Deslo Active
How to take Aleric Deslo Active
Possible side effects
How to store Aleric Deslo Active
Contents of the package and other information

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

What Aleric Deslo Active is
Aleric Deslo Active contains desloratadine, which is an antihistamine medicine.
How Aleric Deslo Active works
Aleric Deslo Active is an antiallergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
When Aleric Deslo Active should be used
Aleric Deslo Active relieves symptoms of allergic rhinitis (inflammation of the nasal mucosa caused by allergy, such as hay fever or dust mite allergy) in adults, adolescents, and children aged 6 years and older. Symptoms of this condition include sneezing, nasal itching or discharge, itching of the palate, and itchy, red or watery eyes.
Aleric Deslo Active is also used to relieve symptoms of urticaria (a skin condition caused by allergy). Symptoms of this condition may include itching, redness, or development of blisters on the skin.
Relief from these symptoms lasts throughout the day, helping patients return to normal daily activities and sleep.
If there is no improvement after 3 days or if you feel worse, consult your doctor.

2. Important information before using Aleric Deslo Active

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When not to use 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 use Aleric Deslo Active, consult your doctor or
pharmacist:

if the patient has kidney function disorders,
if the patient has a history or family history of seizures.

Children and adolescents
Do not use this medicine in children under 6 years of age.
Aleric Deslo Active and other medicines
No interactions with other medicines are known.
You should inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to take.
Taking Aleric Deslo Active with food, drink and alcohol
It is not necessary to take the medicine with water or other liquid. The medicine may be taken with or without food. Caution should be exercised when taking Aleric Deslo Active 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.
Use of Aleric Deslo Active is not recommended during pregnancy or breastfeeding.
Fertility
There are no available data 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 performing activities requiring mental concentration, such as driving or operating machinery, until the individual's response to the medicine is known.
Aleric Deslo Active contains aspartame
The medicine contains 1.5 mg of aspartame per 2.5 mg dose of Aleric Deslo Active in the form of orally disintegrating tablet.
Aspartame is a source of phenylalanine. It may be harmful for people with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Aleric Deslo Active

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults and adolescents aged 12 years and older
The recommended dose is two tablets once daily, taken with or without food.
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Children aged 6 to 11 years
The recommended dose is one tablet once daily, taken with or without food.
Method of administration
This medicine is intended for oral use.
Before use, carefully open the blister pack by tearing it open. Remove the orally disintegrating tablet without crushing it. Place the tablet in the mouth, where it will disintegrate immediately. Water or any other liquid is not required to swallow the dose. Take the dose immediately after opening the blister pack.
Duration of treatment
Consult your doctor or pharmacist.
When starting treatment with desloratadine, treatment should not last longer than 10 days without consulting a doctor.
If the patient has:

intermittent allergic rhinitis (symptoms occurring less than 4 days per week or for less than 4 weeks),
persistent allergic rhinitis (symptoms occurring for 4 or more days per week and for more than 4 weeks),
urticaria (duration of treatment may vary among individual patients),

the doctor will determine the duration of treatment with Aleric Deslo Active, taking into account the type, duration, and course of symptoms.

If there is no improvement after 3 days of treatment with Aleric Deslo Active, or if the patient feels worse, consult a doctor.
If breathing difficulties or swelling of the lips, tongue, or throat occur, seek immediate medical advice.
Taking more than the recommended dose of Aleric Deslo Active
Aleric Deslo Active should be taken in accordance with the instructions provided in the leaflet.
Serious adverse effects are not expected after accidental overdose. However, if an overdose has occurred, inform your doctor, pharmacist, or nurse immediately.
Missing a 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
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Very rarely, severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported since desloratadine was introduced to the market. If any of these severe adverse reactions occur, discontinue use of the medicine immediately and consult a doctor without delay.
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In clinical trials in adult patients, adverse reactions were almost the same as with placebo (tablet without active ingredient). However, fatigue, dry mouth, and headache were reported more frequently than with placebo. In adolescents, the most commonly reported adverse reaction was headache.
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

After desloratadine was introduced to the market, the following adverse reactions have been reported:
Very rare: may occur in up to 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 ● seizures
restlessness with excessive motor activity ● hepatitis ● abnormal liver function tests.

Frequency unknown: 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 on cloudy days, and to UV (ultraviolet) radiation, for example UV radiation in sunbeds
changes in heart rhythm
unusual behaviour
aggressive behaviour
weight gain, increased appetite
low mood
dry eyes

Additional adverse reactions in children and adolescents
Frequency unknown: frequency cannot be estimated from the available data

slow heartbeat
change in heart rhythm
unusual behaviour
aggressive behaviour

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

5. How to store Aleric Deslo Active

Keep this medicine out of 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 the EXP
abbreviation. The expiry date refers to the last day of the stated month.
No special storage conditions apply.
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 packaging and other information

What Aleric Deslo Active contains

The active substance is desloratadine in a dose of 2.5 mg.
Other components of the medicine are: potassium polacrinate, citric acid monohydrate, iron oxide red (E 172), magnesium stearate, sodium croscarmellose, spray-dried mannitol, potassium hydroxide (for pH adjustment), microcrystalline cellulose, aspartame (E 951), and Tutti Frutti flavour (also containing propylene glycol).

What Aleric Deslo Active looks like and contents of the packaging
Aleric Deslo Active 2.5 mg orodispersible tablets are brick-red,
round, flat with bevelled edges, and embossed with the mark “2.5”.
The medicine is packed in containers containing 5, 6, 10 or 20 orodispersible tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
US Pharmacia Sp. z o.o.
Ziębicka 40, 50-507 Wrocław, Poland
Manufacturers:
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 further information, please contact:
USP Zdrowie Sp. z o.o.
Poleczki 35, 02-822 Warszawa, Poland
tel. +48 (22) 543 60 00
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