Deslodina fast iunior

Package Leaflet: Information for the Patient

Deslodyna fast junior, 2.5 mg, orally 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 or as directed by your doctor, pharmacist, or nurse.

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

Table of Contents of the Package Leaflet

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

1. What is Deslodyna fast junior and what is it used for

What is Deslodyna fast junior

Deslodyna fast junior, an orally disintegrating tablet, contains desloratadine, which is an antihistamine.

How Deslodyna fast junior works

Deslodyna fast junior is an anti-allergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.

When to use Deslodyna fast junior

Deslodyna fast junior 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, adolescents, and children aged 6 and older. Symptoms include: sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes. Deslodyna fast junior is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). Symptoms of this condition include: itchy skin and urticaria. 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, you should contact your doctor.

2. Important information before taking Deslodyna fast junior

When not to take Deslodyna fast junior

• 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 Deslodyna fast junior, you should discuss it with your doctor, pharmacist, or nurse:

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

Children and adolescents

This medicine should not be given to children under 6 years of age.

Deslodyna fast junior with other medicines

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. No interactions with other medicines are known.

Deslodyna fast junior with food, drink, and alcohol

It is not necessary to take Deslodyna fast junior with water or any other liquid. Additionally, Deslodyna fast junior can be taken with or without food. Caution should be exercised when taking Deslodyna fast junior with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine. It is not recommended to take Deslodyna fast junior 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, when taken as recommended, will affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended to refrain from performing tasks that require concentration, such as driving or operating machinery, until you know how you react to this medicine.

Deslodyna fast junior contains mannitol, aspartame (E 951), propylene glycol, benzyl alcohol, and sodium

The medicine contains 1.5 mg of aspartame in each orally 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 0.00281 mg of benzyl alcohol in each orally disintegrating tablet. Benzyl alcohol may cause allergic reactions. Pregnant or breastfeeding women should contact their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis). Patients with liver or kidney disease should contact their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis). The medicine contains less than 1 mmol (23 mg) of sodium in each orally disintegrating tablet, which means the medicine is considered "sodium-free".

3. How to take Deslodyna fast junior

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. The medicine is intended for oral use. Before taking, carefully open the blister by tearing it. Remove the orally disintegrating tablet without crushing it. Place it in your mouth, where it will immediately disintegrate. Water or any other liquid is not needed to swallow the dose. Take the dose immediately after opening the blister. Without consulting your doctor, do not take the medicine for more than 10 days. If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Adults and adolescents over 12 years of age

The recommended dose is two tablets once a day, taken with or without food.

Children from 6 to 11 years of age

The recommended dose is one tablet once a day, taken with or without food.

Taking a higher dose of Deslodyna fast junior than recommended

Deslodyna fast junior should be taken only as described in this package leaflet or as directed by your doctor or pharmacist. In case of accidental overdose, severe disorders should not occur. However, if you take a higher dose of Deslodyna fast junior than recommended, you should immediately tell your doctor, pharmacist, or nurse.

Missing a dose of Deslodyna fast junior

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 Deslodyna fast junior

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

4. Possible side effects

Like all medicines, Deslodyna fast junior 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, urticaria, and swelling) have been reported. If you experience any of these severe side effects, you should stop taking the medicine and immediately see a doctor. In clinical trials in adult patients, side effects were almost the same as after taking a placebo. However, fatigue, dry mouth, and headache were reported more frequently than after taking a placebo. In adolescents, the most commonly reported side effect was headache. In clinical trials of desloratadine, the following side effects were reported:

• fatigue
• dry mouth
• headache

After the marketing of desloratadine, the following side effects have been reported:

• severe allergic reactions
• rash
• palpitations and irregular heartbeat
• rapid heartbeat
• abdominal pain
• nausea
• vomiting
• gastrointestinal disorders
• 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
• jaundice and/or yellowing of the eyes
• increased sensitivity of the skin to the sun,
• changes in heart rhythm
• abnormal behavior
• aggressive behavior
• weight gain, increased appetite
• low mood
• dry eyes

Children

• slow heartbeat
• changes in heart rhythm, even in the case of clouded sun and UV radiation, for example, in a solarium
• abnormal behavior
• aggressive behavior

Reporting side effects

If you experience any side effects, including those not listed in this package 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, tel.: +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 Deslodyna fast junior

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. 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 Deslodyna fast junior contains

• The active substance is desloratadine. One orally disintegrating tablet contains 2.5 mg of desloratadine.
• The other ingredients (excipients) are: polacrilin potassium, citric acid monohydrate (for pH adjustment), potassium hydroxide 50% (for pH adjustment), mannitol, microcrystalline cellulose, sodium croscarmellose, aspartame (E 951), red iron oxide (E 172), Tutti-Frutti SD 0272 flavor (contains, among others, propylene glycol, benzyl alcohol, citral, geraniol, farnesol, linalool, d-limonene), magnesium stearate.

What Deslodyna fast junior looks like and contents of the pack

Deslodyna fast junior is a pink, orally disintegrating tablet with red-pink speckles, round, smooth, biconvex, with a beveled edge, without engraving, approximately 6 mm in diameter. One pack of the medicine contains 10 orally disintegrating tablets in OPA/Aluminum/PVC/Aluminum blisters in a cardboard box.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A., ul. Żmigrodzka 242 E, 51-131 Wrocław

Medicine information

tel.: (22) 742 00 22, email: [email protected]

Date of last revision of the package leaflet: