Aleric Deslo Active

Package Leaflet: Information for the Patient

Aleric Deslo Active, 5 mg, Film-Coated 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 the package leaflet 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 doctor or pharmacist.
• If you experience any side effects, including those not listed in the 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 Active and what is it 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 is Aleric Deslo Active and what is it 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 is an anti-allergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.

When to use Aleric Deslo Active

Aleric Deslo Active relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by an allergy, such as hay fever or allergy to dust mites) in adults and adolescents aged 12 years and older. The symptoms of this condition include: sneezing, itching or discharge from the nose, itching of the palate, and itching, redness, or tearing of the eyes.
Aleric Deslo Active is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). The symptoms of this condition include: skin itching and urticaria.
The relief of these symptoms persists 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 Active

When not to take Aleric Deslo Active

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

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Warnings and precautions

Before taking Aleric Deslo Active, discuss it with your doctor or pharmacist:

• if you have kidney problems;
• if you have a history of seizures or a family history of seizures.

Children and adolescents

Do not give this medicine to children under 12 years of age.

Aleric Deslo Active and other medicines

No interactions with other medicines are known.
Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any you plan to take.

Taking Aleric Deslo Active with food, drink, and alcohol

Aleric Deslo Active can be taken with or without food.
Be cautious when taking this medicine with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.
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 using machines

It is unlikely that this medicine will affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended to avoid activities that require concentration, such as driving or operating machinery, until you know how this medicine affects you.

3. How to take Aleric Deslo Active

Always take this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Adults and adolescents (12 years and older)

The recommended dose is one tablet once daily, taken with water, with or without food.
This medicine is for oral use only.
Swallow the tablet whole.

Do not take this medicine for more than 10 days without consulting a doctor.

If after 3 days there is no improvement or you feel worse, consult a doctor.

Taking a higher dose of Aleric Deslo Active than recommended

Aleric Deslo Active should be taken as directed in the package leaflet.
If you accidentally take more than the recommended dose, you may not experience severe problems. However, if you take more than the recommended dose of Aleric Deslo Active, consult your doctor or pharmacist immediately.
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Missing a dose of Aleric Deslo Active

If you miss a dose, take it as soon as possible, and then continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping treatment with Aleric Deslo Active

If you have any further questions on the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Aleric Deslo Active can cause side effects, although not everybody gets them.
After desloratadine was made available, 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 adult patients, side effects were almost the same as with a placebo. However, fatigue, dry mouth, and headache were reported more frequently than with a placebo.
In adolescents, the most commonly reported side effect was headache.
The following side effects have been reported in clinical trials with desloratadine:
Common:may affect up to 1 in 10 people

• fatigue
• headache
• dry mouth

After desloratadine was made available, 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 movement
• hepatitis
• abnormal liver function tests.

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 the sun, even in cloudy weather, and to UV (ultraviolet) radiation, such as in a solarium
• change in heartbeat
• 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 heartbeat
• abnormal behavior

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• aggressive behavior
• weight gain
• increased appetite

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje 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 Active

Keep the 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 month.
Store in the original package to protect from light.
Do not use this medicine if you notice any change 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 pack and other information

What Aleric Deslo Active contains

• The active substance is desloratadine, 5 mg.
• The other ingredients are: tablet core: microcrystalline cellulose, maize starch, magnesium stearate, and silica colloidal anhydrous. coating Opadry blue 03A30735 (containing: hypromellose 6 cP, titanium dioxide (E 171), microcrystalline cellulose, stearic acid, and indigo carmine (E 132)).

What Aleric Deslo Active looks like and contents of the pack

Aleric Deslo Active 5 mg film-coated tablets are blue, round, and biconvex.
Aleric Deslo Active is available in packs containing 1, 2, 3, 5, 7, 10 film-coated tablets.

Marketing authorization holder:

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

Genepharm S.A.,
18 km Marathon Avenue,
15351 Pallini,
Greece
For more information, 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: December 2022

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