Package leaflet: Information for the user

Hitaxa fast junior, 2.5 mg, orodispersible tablets
Desloratadinum
Please read this leaflet carefully before taking the medicine, as it contains important information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

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

Contents of the leaflet:

What Hitaxa fast junior is and what it is used for
Important information before taking Hitaxa fast junior
How to take Hitaxa fast junior
Possible side effects
How to store Hitaxa fast junior
Contents of the pack and other information

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

What Hitaxa fast junior is
Hitaxa fast junior contains desloratadine, which is an antihistamine medicine.
How Hitaxa fast junior works
Hitaxa fast junior is a non-sedating antiallergic medicine. 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 allergy, for example hay fever or dust mite allergy) in adults, adolescents and children aged 6 years and older. Symptoms of this condition include: sneezing, itching or runny nose, itching of the palate, and itchy, red or watery eyes.
Hitaxa fast junior orodispersible tablets are also used to relieve symptoms associated with urticaria (a skin condition caused by allergy). Symptoms of this condition include: skin itching and hives.
Symptom relief 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, consult your doctor.

2. Information before using Hitaxa fast junior

When not to use Hitaxa 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 starting treatment with Hitaxa fast junior, discuss with your doctor or pharmacist:

if the patient has renal function impairment,
if the patient has a history or family history of seizures.

Children
Do not use this medicine in children under 6 years of age.
Hitaxa fast junior and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interactions between Hitaxa fast junior and other medicines are known.
Hitaxa fast junior with food, drink and alcohol
Hitaxa fast junior does not need to be taken with water or any other liquid. Additionally, Hitaxa fast junior may be taken with or without food. Exercise caution when taking Hitaxa 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 baby, she should consult her doctor or pharmacist before using this medicine.
The use of Hitaxa 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
It is not expected that Hitaxa fast junior, when used at the recommended dose, affects the ability to drive or operate machinery. Although drowsiness does not occur in most people, it is recommended to refrain from activities requiring mental alertness, such as driving or operating machinery, until the individual's response to the medicine is known.
Hitaxa fast junior orally disintegrating tablets contain 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 impaired excretion.
Hitaxa fast junior orally disintegrating tablets contain sodium.
The medicine contains less than 1 mmol (23 mg) of sodium per orally disintegrating tablet, meaning the medicine is considered "sodium-free".

3. How to use Hitaxa fast junior

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Recommended dose:

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

Children:

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

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

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

Taking more Hitaxa fast junior than recommended
Hitaxa fast junior should only be taken as described in this leaflet or as directed by a doctor or pharmacist. Serious adverse effects are not expected after accidental overdose. However, if an overdose of Hitaxa fast junior is taken, contact a doctor or pharmacist immediately.

If you forget to take Hitaxa 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 Hitaxa fast junior
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
Very rarely, severe allergic reactions have been reported since the medicine was placed on the market
(difficulty breathing, wheezing, itching, hives, and swelling). If any of these severe adverse reactions occur,
treatment should be discontinued immediately and medical advice should be sought without delay.

In adults, adverse reactions were almost the same as those observed after administration of a tablet
without active ingredient. However, fatigue, dry mouth, and headache were reported more frequently
than with the placebo tablet.

In adolescents, the most commonly reported adverse reaction was headache.

The following adverse reactions have been reported in clinical trials:
Common (may affect up to 1 in 10 people):

fatigue
dry mouth
headache

The following adverse reactions have been reported since 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 • stomach discomfort • diarrhoea
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 • weight gain, increased appetite
increased skin sensitivity to sunlight,
yellowing of the skin and/or eyes even when the sun is obscured • aggressive behaviour and increased sensitivity to UV (ultraviolet) radiation, for example in a solarium • eye dryness • depressed mood
unusual behaviour
changes in heart rhythm

Additional adverse reactions in children and adolescents
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 adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 to provide more information on the safe use of the medicine.

5. How to store Hitaxa fast junior

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister indicated by: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Do not use this medicine if you notice any changes in the appearance of the tablets.
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 Hitaxa fast junior contains

The active substance is desloratadine in a dose of 2.5 mg.
The other ingredients are: potassium polyacrylate, citric acid monohydrate, iron oxide red (E 172), magnesium stearate, sodium croscarmellose, Tutti Frutti flavouring (liquid, containing propylene glycol), aspartame (E 951), microcrystalline cellulose, mannitol (spray-dried), potassium hydroxide (for pH adjustment).

What the medicine looks like and contents of the pack
Hitaxa fast junior, 2.5 mg, orodispersible tablets are brick-red,
round, flat tablets with bevelled edges and embossed with "2.5".
Hitaxa fast junior is packed in packs containing 10 or 20 orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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