Patient Information Leaflet

Aleric Deslo Pro, 5 mg, orodispersible tablets
Desloratadine
Please read this leaflet carefully before using the medicine, as it contains important information for you.
Always take this medicine exactly as described in this patient leaflet or as your doctor or pharmacist has advised.

Keep this leaflet for future reference.
If you need advice or additional information, please consult your pharmacist.
If you experience any side effects, including any 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:

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

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

Aleric Deslo Pro contains desloratadine, which is an antihistamine medicine.
Aleric Deslo Pro is an antiallergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
Aleric Deslo Pro relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by allergy, such as hay fever or dust mite allergy) in adults and adolescents aged 12 years and older. Symptoms of this condition include: sneezing, nasal itching or watery nasal discharge, itching of the palate, and itching, redness or watering of the eyes.
Aleric Deslo Pro is also used to relieve symptoms associated with urticaria (a skin condition caused by allergy). Symptoms of this condition include: skin itching and hives.
Relief from these symptoms lasts throughout the day, helping you return to normal daily activities and sleep normally.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Information before using Aleric Deslo Pro

When not to use Aleric Deslo Pro

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

Page 1 of 5
Warnings and precautions
Before starting treatment with Aleric Deslo Pro, consult a doctor or pharmacist if the patient:

has impaired kidney function,
has a history of seizures or a family history of seizures.

Children and adolescents
This medicine must not be used in children under 12 years of age.
Aleric Deslo Pro and other medicines
No interactions between Aleric Deslo Pro and other medicines are known.
Tell your doctor or pharmacist about any other medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Aleric Deslo Pro with food, drink and alcohol
It is not necessary to take the medicine with water or any other liquid. The medicine may be taken with or without food.
Caution is advised when taking Aleric Deslo Pro with alcohol.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Use of Aleric Deslo Pro 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. Most people do not experience drowsiness; however, patients are advised to refrain from activities requiring mental alertness, such as driving or operating machinery, until they know how they react to this medicine.
Aleric Deslo Pro contains aspartame, sulphites (from the Tutti Frutti flavouring), glucose (from maltodextrin), and sodium.
The medicine contains 3 mg of aspartame in 1 tablet of Aleric Deslo Pro, 5 mg in orally disintegrating tablets. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.
The medicine contains sulphites and may rarely cause severe hypersensitivity reactions and bronchospasm.
The medicine contains glucose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
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 Pro

Always take this medicine exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Page 2 of 5
Adults and adolescents aged 12 years and older: one tablet once daily.
This medicine is intended for oral use.
Before administration, carefully open the blister pack by tearing it. Remove the 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.
The dose should be taken immediately after removal from the blister. The tablets may be taken with or without food.
Do not use Aleric Deslo Pro for longer than 10 days without consulting a doctor.
Taking more Aleric Deslo Pro than recommended
Aleric Deslo Pro should be taken only as directed in the leaflet. Serious adverse effects following accidental overdose are unlikely. However, if you take more than the recommended dose of Aleric Deslo Pro, contact your doctor or pharmacist.
If you miss a dose of Aleric Deslo Pro
If you forget to take your dose at the scheduled time, take it as soon as possible, then return to your regular dosing schedule. Do not take a double dose to make up for a missed dose.
Stopping Aleric Deslo Pro
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Very rarely, severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) and skin rash have been reported after desloratadine was placed on the market. If any of these severe adverse reactions occur, treatment should be discontinued and medical advice should be sought immediately.

In clinical studies in adult patients, adverse reactions were almost the same as with placebo tablets (tablets without active substance). However, fatigue, dry mouth, and headache were reported more frequently than with placebo tablets. In adolescents, the most commonly reported adverse reaction was headache.

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

Common: may occur in fewer than 1 in 10 patients:

fatigue ● dry mouth ● headache

After desloratadine was placed on the market, the following adverse reactions have been observed and reported:

Very rare: may occur in fewer 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 ● seizures
restlessness with excessive motor activity ● 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 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

Children
Frequency not known: 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 a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Aleric Deslo Pro

Keep this medicine out of sight and reach of children.
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 stated month.
There are no special storage instructions for this medicine.
Do not use this medicine if you notice any changes in the appearance of the tablets.
Medicines must 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.
Page 4 of 5

6. Contents of the pack and other information

What Aleric Deslo Pro contains

The active substance is desloratadine. One orodispersible tablet contains 5 mg of desloratadine.
The other ingredients are: potassium polyacrylate, citric acid monohydrate, iron oxide red (E 172), magnesium stearate, sodium croscarmellose, tutti frutti flavour (contains flavouring substances, propylene glycol, maltodextrin (contains glucose), modified starch, sulphites), aspartame (E 951), microcrystalline cellulose, mannitol and potassium hydroxide (for pH adjustment).

What Aleric Deslo Pro looks like and contents of the pack
Aleric Deslo Pro 5 mg orodispersible tablets are brick-red, round, flat tablets with bevelled edges and embossed with the number "5", measuring 8.1 mm x 3.2 mm.
Aleric Deslo Pro is packed in blister packs containing 5, 6 or 10 orodispersible tablets.

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

Manufacturer:
Genepharm S.A.,
18 km Marathonos Avenue,
153 51 Pallini,
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 Warsaw,
tel. +48 (22) 543 60 00
Page 5 of 5