Hitaxa Fast Kids

Leaflet attached to the packaging: patient information

HITAXA FAST KIDS, 0.5 mg/ml, oral solution

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 the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact a doctor.

Table of contents of the leaflet:

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

1. What is Hitaxa Fast Kids and what is it used for

Hitaxa Fast Kids oral solution is an antiallergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
Hitaxa Fast Kids oral solution relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by an allergy, such as hay fever or dust mite allergy). These symptoms include: sneezing, itching or runny nose, itching of the palate, and itching, redness, or tearing of the eyes.
Hitaxa Fast Kids oral solution is also used to relieve symptoms associated with hives (a skin condition caused by an allergy). These symptoms include: skin itching and hives.
The relief of these symptoms lasts all day, making it easier to return to normal daily activities and normal sleep.
Hitaxa Fast Kids oral solution is intended for children over 2 years of age, adolescents, and adults.
If there is no improvement after 3 days or if the patient feels worse, they should contact a doctor.

2. Important information before taking Hitaxa Fast Kids

When not to take Hitaxa Fast Kids

• 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 Hitaxa Fast Kids, the patient should discuss it with their doctor or pharmacist:

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

Children

This medicine should not be given to children under 2 years of age.

Hitaxa Fast Kids and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
No interactions with other medicines are known.

Hitaxa Fast Kids with food, drink, and alcohol

Hitaxa Fast Kids can be taken with or without food.
Care should be taken when taking Hitaxa Fast Kids with alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Hitaxa Fast Kids should not be taken during pregnancy or breastfeeding.
There is no available data on the effect on fertility in males and females.

Driving and using machines

Hitaxa Fast Kids is not expected to affect the ability to drive or use machines when taken at the recommended dose. However, it is recommended to avoid activities that require concentration, such as driving or using machines, until it is known how the medicine affects the patient.

Hitaxa Fast Kids contains sorbitol (E 420)

This medicine contains 150 mg of sorbitol in each ml of oral solution, 375 mg of sorbitol in 2.5 ml of oral solution, 750 mg of sorbitol in 5 ml of oral solution, and 1.5 g of sorbitol in 10 ml of oral solution.
Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder where the body does not break down fructose, they should consult their doctor before taking this medicine.

Hitaxa Fast Kids contains propylene glycol (E 1520)

This medicine contains 150.75 mg of propylene glycol in each ml of oral solution, 376.875 mg of propylene glycol in 2.5 ml of oral solution, 753.75 mg of propylene glycol in 5 ml of oral solution, and 1.5075 g of propylene glycol in 10 ml of oral solution.

Hitaxa Fast Kids contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free".

3. How to take Hitaxa Fast Kids

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

Recommended dose:

Adults and adolescents (12 years and older): 10 ml (2 measuring spoons of 5 ml) of oral solution once a day.

Use in children

In case of underweight or overweight, it is recommended to consult a doctor to adjust the dose.
Children over 2 years to 5 years: 2.5 ml (half a measuring spoon of 5 ml) of oral solution once a day.
In children from 2 to 5 years, Hitaxa Fast Kids should only be used after a diagnosis of allergy has been made.
Children from 6 to 11 years: 5 ml (one measuring spoon of 5 ml) of oral solution once a day.
Method of administration:
The dose of oral solution should be swallowed and then followed by water. The medicine can be taken with or without food.
A measuring spoon or oral syringe is provided with the bottle of oral solution, which can be used interchangeably to measure the correct volume of oral solution.
Duration of treatment with Hitaxa Fast Kids
If there is no improvement after 3 days or if the patient feels worse, they should contact a doctor.

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

Overdose of Hitaxa Fast Kids

Hitaxa Fast Kids oral solution should be taken as described in the leaflet.
No serious disorders are expected in case of accidental overdose of the medicine.
However, if a higher dose of Hitaxa Fast Kids oral solution is taken, the patient should consult their doctor or pharmacist.

Missed dose of Hitaxa Fast Kids

If a dose is missed, it should be taken as soon as possible, and then the regular dosing schedule should be resumed. A double dose should not be taken to make up for a missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Hitaxa Fast Kids 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 any of these severe side effects occur, the patient should stop taking the medicine and see a doctor immediately.
In clinical trials, most children and adults experienced side effects that were almost the same as those experienced with a placebo or a tablet that did not contain the active substance. However, in adult patients, fatigue, dry mouth, and headache were reported more frequently than with a placebo.
The following side effects have been reported in clinical trials:
Common:may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

After the medicine was placed on the market, 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
• upset stomach
• diarrhea
• dizziness
• drowsiness
• insomnia
• muscle pain
• hallucinations
• seizures
• restlessness with increased physical 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 on cloudy days, and to UV radiation, such as in a solarium
• changes in heartbeat
• abnormal behavior
• aggressive behavior
• weight gain, increased appetite
• low mood
• dry eyes

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

• slow heartbeat
• changes in heartbeat
• abnormal behavior
• aggressive behavior

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product 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 the medicine.

5. How to store Hitaxa Fast Kids

The medicine should be stored out of sight and reach of children.
Do not take Hitaxa Fast Kids after the expiry date stated on the carton and bottle after EXP. The expiry date refers to the last day of the month.
There are no special storage precautions for the medicine. Store in the original package to protect from light.
Do not take this medicine if the patient notices any change in the appearance of the oral solution.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Hitaxa Fast Kids contains

• The active substance is desloratadine. One ml of oral solution contains 0.5 mg of desloratadine.
• The other ingredients are: hypromellose type 2910, sucralose (E 955), citric acid anhydrous, sodium citrate, sorbitol liquid non-crystallizing (E 420), propylene glycol (E 1520), Tutti Frutti flavor liquid (propylene glycol, flavoring substances), purified water.

What Hitaxa Fast Kids looks like and contents of the pack

Hitaxa Fast Kids oral solution is a clear, colorless solution with a fruity odor.
Hitaxa Fast Kids is available in brown glass bottles type III, closed with a PE or PP cap, with a PE seal, with a child-resistant closure, in a cardboard box. A measuring spoon or oral syringe is provided with the packaging.
Pack sizes: 30 ml, 50 ml, 60 ml, or 100 ml of oral solution.
Not all pack sizes may be marketed.

Marketing authorization holder:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
Tel.: +48 22 732 77 00

Manufacturer:

Genepharm S.A.
18th km Marathonos Ave
15351 Pallini Attiki
Greece
Famar A.V.E. AVLON PLANT
49th km National Road Athens-Lamia
19011, Avlona Attiki
Greece
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland
Date of last revision of the leaflet: