Package leaflet: information for the patient

Aleric Deslo Pro, 2.5 mg, orodispersible tablets
Desloratadine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Always take this medicine exactly as described in this 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if your condition worsens, contact your doctor.

Contents of the leaflet:

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.
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, for example hay fever or allergy to house dust mites) in adults, adolescents, and children aged 6 years and older. Symptoms of this condition include: sneezing, nasal itching or watery nasal discharge, itching of the palate, and eye itching, redness or watering.
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 of these symptoms lasts throughout the day, helping patients return to normal daily activities and sleep normally.
If there is no improvement after 3 days, or if your condition worsens, consult your doctor.

2. Important 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.

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 should not be used in children under 6 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 all 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 another 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 have a baby, she should consult a doctor or pharmacist before using this medicine.
The 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. In most people, drowsiness does not occur; however, it is recommended to refrain from activities requiring concentration, such as driving or operating machinery, until the patient's response to this medicine is known.
Aleric Deslo Pro contains aspartame, sulphites (flavouring ingredient Tutti Frutti), glucose (component of maltodextrin), and sodium.
The medicine contains 1.5 mg of aspartame per Aleric Deslo Pro tablet and 2.5 mg per orodispersible tablet. Aspartame is a source of phenylalanine. It may be harmful for 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 take Aleric Deslo Pro

Always take this medicine exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Children aged 6 to 11 years: one tablet once daily.
Adults and adolescents aged 12 years and over: two tablets once daily.
This medicine is for oral use.
Before taking, carefully open the blister by tearing it. Remove the tablet without crushing it. Place it in the mouth, where it disintegrates immediately. Water or any other liquid is not required to swallow the dose.
The dose should be taken immediately after removal from the blister. Tablets may be taken with or without food.
Do not take 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 according to the instructions in the leaflet. Severe symptoms are unlikely to occur after accidental overdose. However, if you have taken more than the recommended dose of Aleric Deslo Pro, contact your doctor or pharmacist.
If you forget to take Aleric Deslo Pro
If you miss a dose, take it as soon as possible and 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 they do not occur in everyone.
After desloratadine was placed on the market, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) and skin rash have been reported. If any of these severe adverse reactions occur, you must stop taking the medicine and consult a doctor immediately.

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

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

Common: may occur in less 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 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 ● seizures
restlessness with excessive motor activity ● hepatitis ● abnormal liver function test results.

Frequency unknown: frequency cannot be estimated from the available data:

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

Children
Frequency unknown: frequency cannot be estimated from the available data:

slow heartbeat
change in heartbeat rhythm
unusual behaviour
aggressive behaviour.

Reporting of adverse reactions
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 for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 this medicine.

5. How to store Aleric Deslo Pro

Keep this medicine out of the 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.
No special storage instructions apply to this medicine.
Do not use this medicine if you notice any changes in the appearance of the tablets.
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 Pro contains

The active substance is desloratadine. One orodispersible tablet contains 2.5 mg of desloratadine.
The other components are: potassium polyacrylate, citric acid monohydrate, iron oxide red (E 172), magnesium stearate, sodium croscarmellose, Tutti Frutti flavour (containing 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 2.5 mg orodispersible tablets are brick-red, round, flat with bevelled edges, and embossed with the mark "2.5" measuring 6.4 mm x 2.4 mm.
Aleric Deslo Pro is available in packaging containing 5, 6 or 10 orodispersible tablets.
Marketing Authorisation Holder:
US Pharmacia Sp. z o.o.
Ziębicka 40,
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,
Poland
Tel. +48 (22) 543 60 00