Hitaxa fast iunior

Package Leaflet: Information for the Patient

Hitaxa 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 the package leaflet or as directed by the 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 any 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 Hitaxa fast junior and what is it used for
• 2. Important information before taking Hitaxa fast junior
• 3. How to take Hitaxa fast junior
• 4. Possible side effects
• 5. How to store Hitaxa fast junior
• 6. Contents of the pack and other information

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

What is Hitaxa fast junior

Hitaxa fast junior contains desloratadine, which is an antihistamine.

How does Hitaxa fast junior work

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

When to use Hitaxa fast junior

Hitaxa 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. The symptoms of this condition include: sneezing, itching or runny nose, itching of the palate, and itching, redness, or tearing of the eyes.
Hitaxa fast junior, orally disintegrating tablets, are also used to relieve symptoms associated with hives (a skin condition caused by an allergy). The symptoms of this condition include: skin itching and hives.
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 Hitaxa fast junior

When not to take Hitaxa 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 Hitaxa fast junior, 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

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

Hitaxa fast junior and 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 for Hitaxa fast junior.

Hitaxa fast junior with food, drink, and alcohol

Taking Hitaxa fast junior does not require drinking water or any other liquid. Additionally, Hitaxa fast junior can be taken with or without food. Be cautious when taking Hitaxa 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, consult your doctor or pharmacist before taking this medicine.
It is not recommended to take Hitaxa fast junior during pregnancy or breastfeeding.

Fertility

There is no available data on the effect on fertility in men and women.

Driving and using machines

It is unlikely that Hitaxa fast junior, when taken as recommended, 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 you react to this medicine.

Hitaxa fast junior in the form of orally disintegrating tablets contains aspartame.

The medicine contains 1.5 mg of aspartame in each 2.5 mg dose of the medicinal product. 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.

Hitaxa fast junior in the form of orally disintegrating tablets contains sodium.

The medicine contains less than 1 mmol (23 mg) of sodium per orally disintegrating tablet, which means the medicine is considered "sodium-free".

3. How to take Hitaxa fast junior

This medicine should always be taken exactly as described in the package leaflet or as directed by the doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The recommended dose is:

• Adults and adolescents (12 years and older):two 2.5 mg orally disintegrating tablets of Hitaxa fast junior once a day. The dose should be taken immediately after opening the blister.

Children:

• Children aged 6 to 11 years:one 2.5 mg orally disintegrating tablet of Hitaxa fast junior once a day. The dose should be taken immediately after opening the blister.

This medicine is intended for oral use.
Before taking, carefully open the blister and remove the orally disintegrating tablet without crushing it. Place it in the mouth, where it will immediately disintegrate. Water or any other liquid is not needed to swallow the dose. The dose should be taken immediately after opening the blister.

Duration of treatment

Treatment of allergic rhinitis and hives with desloratadine without medical supervision should not last longer than 10 days.

Taking a higher dose of Hitaxa fast junior than recommended

Hitaxa fast junior should only be taken as described in this leaflet or as directed by the doctor or pharmacist. If you accidentally take more than the recommended dose of Hitaxa fast junior, you should contact a doctor or pharmacist immediately.

Missing a dose of Hitaxa 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 the missed dose.

Stopping treatment with Hitaxa fast junior

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.
Very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported after the medicine was placed on the market. If you experience any of these severe side effects, stop taking the medicine and seek medical attention immediately.
In adults, side effects were almost the same as after taking a placebo. However, fatigue, dry mouth, and headache were reported more often than after taking a placebo.
In adolescents, the most commonly reported side effect was headache.
The following side effects have been reported in clinical trials:

Common (may affect up to 1 in 10 people):

• fatigue
• dry mouth
• headache

The following side effects have been reported after desloratadine was placed on the market.

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
• hepatitis
• abnormal liver function test results

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

• unusual weakness
• weight gain, increased appetite
• increased skin sensitivity to the sun, physical activity
• jaundice of the skin and/or eyes
• aggressive behavior
• low mood
• dry eyes even in cloudy weather and to UV (ultraviolet) radiation, for example, to UV radiation in a solarium
• unusual behavior
• changes in heart rhythm

Additional side effects in children and adolescents

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

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 to gather more information on the safety of this medicine.

5. How to store Hitaxa 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 carton and blister after: EXP.
The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
Do not use this 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Hitaxa fast junior contains

• The active substance is desloratadine in a dose of 2.5 mg.
• The other ingredients are: polacrilin potassium, citric acid monohydrate, iron oxide red (E 172), magnesium stearate, croscarmellose sodium, Tutti Frutti flavor liquid (also contains propylene glycol), aspartame (E 951), microcrystalline cellulose, mannitol (spray-dried), potassium hydroxide (to adjust pH).

What Hitaxa fast junior looks like and contents of the pack

Hitaxa fast junior, 2.5 mg, orally disintegrating tablets are reddish-brown, round, flat tablets with beveled edges, with the engraving "2.5".
Hitaxa fast junior is packaged in packs containing 10 or 20 orally disintegrating tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer:

Genepharm S.A.
18km Marathon Avenue
15351 Pallini
Greece
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
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

Date of last revision of the leaflet: 01.2025