Deslodyna fast junior

Package leaflet: Information for the patient

Deslodyna fast junior, 2.5 mg, orodispersible tablets
Desloratadine
Please read the entire leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor, pharmacist, or nurse.

• 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 side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days, or if you feel worse, contact your doctor.

Table of contents

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

What Deslodyna fast junior is
Deslodyna fast junior orodispersible tablet contains desloratadine, which is an antihistamine medicine.
How Deslodyna fast junior works
Deslodyna fast junior is an antiallergy 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 allergy, such as hay fever or dust mite allergy) in adults, adolescents, and children aged 6 years and older. Symptoms include: sneezing, watery 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 allergy). Symptoms of this condition include: skin itching and hives.
Relief from 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 you feel worse, contact your doctor.

2. Important information before using Deslodyna fast junior

When not to use Deslodyna fast junior

• 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 taking Deslodyna fast junior, consult your doctor, pharmacist,
or nurse:

• if the patient has impaired kidney function,
• if the patient has a history or family history of seizures.

Children and adolescents
This medicine should not be given to children under 6 years of age.
Deslodyna fast junior and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
No interactions between Deslodyna fast junior and 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. Deslodyna fast junior may be taken with or without food. Caution is advised when taking Deslodyna fast junior with alcohol.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The use of Deslodyna fast junior 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
This medicine, when used at the recommended dose, is not expected to affect the ability to drive or operate machinery. Although drowsiness does not occur in most people, it is recommended to refrain from activities requiring mental concentration, such as driving or operating machinery, until the individual's response to this medicine is known.
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 impaired excretion.
The medicine contains 0.00281 mg of benzyl alcohol in each orally disintegrating tablet. Benzyl alcohol may cause allergic reactions. Women who are pregnant or breastfeeding should consult a doctor before using this medicine, as a large amount of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis). Patients with liver or kidney disease should consult a doctor before using this medicine, as a large amount of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).
The medicine contains less than 1 mmol (23 mg) of sodium in each orally disintegrating tablet, meaning the medicine is considered "sodium-free".

3. How to use Deslodyna fast junior

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is intended for oral use.
Before administration, carefully open the blister pack by tearing it along the edge. Remove the orodispersible tablet without crushing it. Place the tablet in the mouth, where it will disintegrate immediately. Water or any other liquid is not required to swallow the dose. The dose should be taken immediately after opening the blister pack.
Do not use this medicine for longer than 10 days without consulting a doctor.
If there is no improvement after 3 days, or if the patient feels worse, contact a doctor.

Adults and adolescents aged 12 years and older
The recommended dose is two tablets once daily, taken with or without food.

Children aged 6 to 11 years
The recommended dose is one tablet once daily, taken with or without food.

Taking more Deslodyna fast junior than recommended
Deslodyna fast junior should only be used as described in this leaflet or as directed by a doctor or pharmacist. Accidental overdose is unlikely to cause serious adverse effects. However, if more than the recommended dose of Deslodyna fast junior has been taken, inform a doctor, pharmacist, or nurse immediately.

If you forget to take Deslodyna fast junior
If a dose is missed, take it as soon as possible, then return to the regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping Deslodyna fast junior
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Since desloratadine has been marketed, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If any of these severe adverse reactions occur, you should stop taking the medicine immediately and consult a doctor without delay.

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

The following adverse reactions have been reported in clinical trials with desloratadine:
Common (may occur in fewer than 1 in 10 patients):

• fatigue
• dry mouth
• headache

After desloratadine was marketed, the following adverse reactions have been reported:
Very rare (may occur in fewer than 1 in 10,000 patients):

• severe allergic reactions – somnolence
• rash – insomnia
• palpitations and irregular heartbeat – muscle pain
• rapid heartbeat – hallucinations
• abdominal pain – convulsions
• nausea – anxiety with excessive motor activity
• vomiting – hepatitis
• gastrointestinal discomfort – abnormal liver function test results
• diarrhoea
• dizziness

Frequency not known (frequency cannot be estimated from the available data):

• unusual weakness – changes in heart rhythm
• jaundice (yellowing of the skin and/or eyes) – unusual behaviour
• increased sensitivity of the skin to sunlight, even on cloudy days – aggressive behaviour
• weight gain, increased appetite for UV (ultraviolet) radiation – depressed mood, for example due to UV radiation exposure in solariums – dry eyes

Children
Frequency not known (frequency cannot be estimated from the available data):

• slow heartbeat
• change in heart rhythm
• unusual behaviour
• aggressive behaviour

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Deslodyna fast junior

Keep this 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 stated month.
No special storage instructions apply.
Medicines must 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 orodispersible tablet contains 2.5 mg of desloratadine.
• The other ingredients (excipients) are: potassium polacrilin, monohydrate citric acid (for pH adjustment), potassium hydroxide 50% (for pH adjustment), mannitol, microcrystalline cellulose, sodium croscarmellose, aspartame (E 951), iron oxide red (E 172), Tutti-Frutti SD 0272 flavour (containing, 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 orodispersible tablet with red-pink specks, round, smooth, biconvex, with bevelled edges, without engraving, approximately 6 mm in diameter.
One pack contains 10 orodispersible tablets in blisters OPA/Aluminium/PVC/Aluminium, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
ul. Żmigrodzka 242 E, 51-131 Wrocław, Poland

Medicinal product information
tel.: (22) 742 00 22
email: [email protected]