Aleric Deslo Pro

Package Leaflet: Information for the Patient

Aleric Deslo Pro, 2.5 mg, Oral Disintegrating Tablets

Desloratadine

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

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, consult a doctor.

Table of Contents of the Leaflet:

• 1. What is Aleric Deslo Pro and what is it used for
• 2. Important information before taking Aleric Deslo Pro
• 3. How to take Aleric Deslo Pro
• 4. Possible side effects
• 5. How to store Aleric Deslo Pro
• 6. Contents of the pack and other information

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

Aleric Deslo Pro contains desloratadine, which is an antihistamine.
Aleric Deslo Pro is an anti-allergic medicine that does not cause drowsiness. It facilitates the control of allergic reactions and their symptoms.
Aleric Deslo Pro relieves symptoms associated with allergic rhinitis (rhinitis caused by an allergy, such as hay fever or allergy to dust mites) in adults, adolescents, and children aged 6 and older. These symptoms include: sneezing, nasal itching or watery discharge, itching of the palate, and itching, redness, or tearing of the eyes.
Aleric Deslo Pro is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include: skin itching and urticaria.
The relief of these symptoms lasts throughout the day, making it easier to return to normal daily activities and normal sleep.
If after 3 days there is no improvement or you feel worse, consult a doctor.

2. Important information before taking Aleric Deslo Pro

When not to take Aleric Deslo Pro

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

Warnings and precautions

Before taking Aleric Deslo Pro, discuss it with your doctor or pharmacist if you have:

• kidney function disorders,
• a history of seizures or a family history of seizures.

Children and adolescents

Do not give this medicine to children under 6 years of age.

Aleric Deslo Pro with other medicines

No interactions with other medicines are known.
Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan 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 can be taken with or without food.

Caution should be exercised when taking Aleric Deslo Pro with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Aleric Deslo Pro should not be taken 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. Most people do not experience drowsiness, but it is recommended to avoid activities that require concentration, such as driving or using machines, until it is known how you react to this medicine.
Aleric Deslo Pro contains aspartame, sulfites(Tutti Frutti flavor ingredient),glucose
(maltodextrin ingredient),sodium.
The medicine contains 1.5 mg of aspartame per Aleric Deslo Pro 2.5 mg tablet, an oral disintegrating tablet. 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 its improper excretion.
The medicine contains sulfites and may rarely cause severe hypersensitivity reactions and bronchospasm.
The medicine contains glucose. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Aleric Deslo Pro

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Children aged 6 to 11 years:one tablet once a day.
Adults and adolescents aged 12 and over:two tablets once a day.
This medicine is intended for oral use.
Before taking, carefully open the blister by tearing it. Remove the tablet without crushing. Place it in the mouth, where it will disintegrate immediately. Water or another liquid is not needed to swallow the dose.
The dose should be taken immediately after removal from the blister. The tablets can be taken with or without food.

Do not take Aleric Deslo Pro for more than 10 days without consulting a doctor.

Taking a higher dose of Aleric Deslo Pro than recommended

Aleric Deslo Pro should be taken as directed in the package leaflet. No serious disorders are expected after accidental overdose of the medicine. However, if you take more than the recommended dose of Aleric Deslo Pro, consult your doctor or pharmacist.

Missing a dose of 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 the missed dose.

Stopping treatment with Aleric Deslo Pro

If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After the introduction of desloratadine to the market, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, urticaria, and swelling) and rash have been reported. If you experience any of these severe side effects, stop taking the medicine and consult your doctor immediately.
In clinical trials in adult patients, side effects were almost the same as after taking a placebo tablet. However, fatigue, dry mouth, and headache were reported more frequently than after taking a placebo tablet. In adolescents, the most commonly reported side effect was headache.
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 the introduction of desloratadine to the market, the following side effects have been reported:
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
• gastrointestinal upset
• diarrhea
• dizziness
• drowsiness
• 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
• jaundice and/or 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)
• changes 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.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aleric Deslo Pro

Keep the medicine out of the sight and reach of children.
Do not take the medicine after the expiry date stated on the carton and blister after the EXP mark. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Do not take the 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 that are no longer needed.
This will help protect the environment.

6. Contents of the pack and other information

What Aleric Deslo Pro contains

• The active substance of the medicine is desloratadine. One oral disintegrating tablet contains 2.5 mg of desloratadine.
• The other ingredients of the medicine are: polacrilin potassium, citric acid monohydrate, iron oxide red (E 172), magnesium stearate, sodium croscarmellose, Tutti Frutti flavor (containing flavoring substances, propylene glycol, maltodextrin (containing glucose), modified starch, sulfites), aspartame (E 951), microcrystalline cellulose, mannitol, and potassium hydroxide (to adjust pH).

What Aleric Deslo Pro looks like and contents of the pack

Aleric Deslo Pro 2.5 mg oral disintegrating tablets are reddish-brown, round, flat with beveled edges and engraved with "2.5" measuring 6.4 mm x 2.4 mm.
Aleric Deslo Pro is packaged in packs containing 5, 6, or 10 oral disintegrating tablets.

Marketing authorization holder:

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

Manufacturer:

Genepharm S.A.,
18 km Marathonos Avenue,
153 51 Pallini,
Greece
Pharmapath S.A.
28is Oktovriou 1,
Agia Varvara, 123 51,
Greece
To obtain more detailed information, please 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: