Aleric Deslo Active

Leaflet attached to the packaging: patient information

Aleric Deslo Active, 5 mg, orally disintegrating tablets

Desloratadine

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

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any possible side effects 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 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.

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 (allergic inflammation of the nasal mucosa, e.g., 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 runny nose, itching of the palate, and itching, redness, or tearing of the eyes.
Aleric Deslo Active is also used to relieve symptoms associated with hives (a skin condition caused by an allergy). The symptoms of this condition may include itching, redness, or the appearance of blisters on the skin.
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 Active

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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.

Warnings and precautions

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

• if you have kidney function disorders,
• 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, have recently taken, or might take.

Taking Aleric Deslo Active with food, drink, and alcohol

It is not necessary to take this medicine with water or any other liquid. The medicine can be taken with or without food.
Be cautious when taking Aleric Deslo Active with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Aleric Deslo Active should not be used during pregnancy or breastfeeding.
Fertility
There is no data on the effect on fertility.

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 using machines, until you know how this medicine affects you.

Aleric Deslo Active contains aspartame

The medicine contains 3 mg of aspartame in a 5 mg dose of Aleric Deslo Active orally disintegrating tablets. Aspartame is a source of phenylalanine. It may be harmful to people with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.
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 Active

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

Adults and adolescents aged 12 years and older

The recommended dose is one tablet once a day, taken with or without food.
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Method of administration
This medicine is intended for oral use.
Before use, carefully open the blister by tearing it. Remove the orally disintegrating tablet without crushing it. Place it in your mouth, where it will dissolve immediately. Water or any other liquid is not needed to swallow the dose. Take the dose immediately after removing it from the blister.
Duration of treatment
Consult your doctor or pharmacist.

When starting treatment with desloratadine, the duration of use should not exceed 10 days without consulting a doctor.

If you:

• have intermittent allergic rhinitis (symptoms occur for less than 4 days a week or for less than 4 weeks),
• have persistent allergic rhinitis (symptoms occur for 4 or more days a week and for more than 4 weeks),
• have hives (the duration of treatment may vary from patient to patient), your doctor or pharmacist will determine the duration of treatment with Aleric Deslo Active, taking into account the type, duration, and course of symptoms.

If after 3 days of taking Aleric Deslo Active there is no improvement or you feel worse, consult a doctor.
If you experience difficulty breathing or swelling of the lips, tongue, or throat, seek medical attention immediately.

Taking a higher dose of Aleric Deslo Active than recommended

Aleric Deslo Active should be taken as directed in the patient leaflet.
In case of accidental overdose, severe disorders are unlikely to occur. However, if you take a higher dose of Aleric Deslo Active than recommended, tell your doctor, pharmacist, or nurse immediately.

Missing a dose of Aleric Deslo Active

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 treatment with Aleric Deslo Active

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

4. Possible side effects

Like all medicines, Aleric Deslo Active can cause side effects, although not everybody gets them.
After the marketing of desloratadine, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If you experience any of these severe side effects, stop taking the medicine and seek medical attention immediately.
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In clinical trials 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 of desloratadine:

• Common: may affect up to 1 in 10 people:
• fatigue
• dry mouth
• headache

After the marketing of desloratadine, 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)
• vomiting
• upset stomach
• diarrhea
• dizziness
• drowsiness
• insomnia
• muscle pain
• hallucinations
• seizures
• restlessness with excessive motor activity
• 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 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

Additional side effects in children and adolescents

• 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 any possible side effects 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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Aleric Deslo Active

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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.
There are no special precautions for storage.
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 in a dose of 5 mg.
• The other ingredients are: polacrilin potassium, citric acid monohydrate, iron oxide red (E 172), magnesium stearate, croscarmellose sodium, Tutti Frutti flavor (also containing propylene glycol), aspartame (E 951), microcrystalline cellulose, spray-dried mannitol, and potassium hydroxide (to adjust pH).

What Aleric Deslo Active looks like and contents of the pack

Aleric Deslo Active 5 mg orally disintegrating tablets are brick-red, round, flat with beveled edges and engraved with "5".
The medicine is packaged in packs containing 5, 6, or 10 orally disintegrating tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

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

Manufacturer:

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
To obtain more detailed information on this medicine, 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:

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