Hitaxa fast kids
Poland
Table of Contents
Package leaflet: Information for the patient
HITAXA FAST KIDS, 0.5 mg/ml, oral solution
Desloratadinum
Please read all of this 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 or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, please contact your pharmacist.
- If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.
- If there is no improvement after 3 days, or if you feel worse, you should consult your doctor.
Leaflet contents:
- What Hitaxa Fast Kids is and what it is used for
- Important information before taking Hitaxa Fast Kids
- How to take Hitaxa Fast Kids
- Possible side effects
- How to store Hitaxa Fast Kids
- Contents of the pack and other information
1. What Hitaxa Fast Kids is and what it is used for
Hitaxa Fast Kids oral solution is an antiallergy 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 allergy, such as hay fever or dust mite allergy). Symptoms of this
condition include: sneezing, runny or itchy nose, itchy palate, and itchy, red, watery eyes.
Hitaxa Fast Kids oral solution is also used to relieve symptoms associated with urticaria (an
allergy-related skin condition). Symptoms of this condition include: itchy skin and hives.
Relief from these symptoms lasts throughout the day, helping patients return to normal daily
activities and sleep normally.
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 you feel worse, you should consult your doctor.
2. Important information before using Hitaxa Fast Kids
When not to use 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 starting treatment with Hitaxa Fast Kids, discuss with a doctor or pharmacist:
- if the patient has impaired kidney function,
- if the patient has a personal or family history of seizures.
Children
This medicine must not be given to children under 2 years of age.
Hitaxa Fast Kids and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
No interactions between Hitaxa Fast Kids and other medicines are known.
Hitaxa Fast Kids with food, drink and alcohol
Hitaxa Fast Kids may be taken with or without food.
Caution should be exercised when taking Hitaxa Fast Kids with alcohol.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
The use of Hitaxa Fast Kids is not recommended during pregnancy or breastfeeding.
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 Kids, when used at the recommended dose, affects the ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended to refrain from activities requiring mental alertness, such as driving or operating machinery, until the individual's response to this medicine is known.
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 (adult or child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot break down fructose, consult a doctor before taking this medicine or giving it to a child.
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, meaning the medicine is considered "sodium-free".
3. How to use Hitaxa Fast Kids
This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor or pharmacist.
Recommended dose:
Adults and adolescents (aged 12 years and older): 10 ml (2 measuring spoons of 5 ml capacity) of oral solution once daily.
Use in children
In cases of underweight or overweight, it is recommended to consult a doctor to adjust the dose.
Children above 2 years to 5 years of age: 2.5 ml (half a 5 ml measuring spoon) of oral solution once daily.
In children aged 2 to 5 years, Hitaxa Fast Kids should be used only after a diagnosis of allergy has been established.
Children aged 6 to 11 years: 5 ml (one 5 ml measuring spoon) of oral solution once daily.
Method of administration:
The dose of oral solution should be swallowed and followed with water. The medicine may be taken with or without food.
An oral syringe or measuring spoon is provided with the bottle of oral solution and may be used interchangeably to measure the appropriate 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, consult a doctor.
Treatment of allergic rhinitis and urticaria with desloratadine without medical consultation should not last longer than 10 days.
Use of a higher than recommended dose of Hitaxa Fast Kids
Hitaxa Fast Kids oral solution should be taken as described in the leaflet. Severe adverse effects following accidental overdose are unlikely.
However, if a higher than recommended dose of Hitaxa Fast Kids oral solution has been taken, consult a doctor or pharmacist.
Missed dose of Hitaxa Fast Kids
If a dose is missed at the scheduled time, 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.
If there are any further doubts concerning the use of this medicine, consult a doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
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,
you must stop using the medicine and contact your doctor immediately.
In clinical trials, in most children and adults, adverse reactions were almost the same as those observed after using a solution or tablet not containing the active substance. However, in adult patients, fatigue, dry mouth, and headache were reported more frequently than after using a tablet not containing the active substance.
The following adverse reactions have been reported in clinical trials:
Common: may occur in up to 1 in 10 patients
- fatigue
- dry mouth
- headache
The following adverse reactions have been reported since the medicine was placed on the market:
Very rare: may occur in up to 1 in 10,000 patients
- severe allergic reactions
- rash
- palpitations and irregular heartbeat
- rapid heartbeat
- abdominal pain
- nausea
- vomiting
- stomach discomfort
- diarrhoea
- dizziness
- somnolence
- insomnia
- muscle pain
- hallucinations
- seizures
- restlessness with increased motor activity
- hepatitis
- abnormal liver function test results
Frequency unknown: 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 (ultraviolet) radiation, for example UV radiation in sunbeds
- changes in heart rhythm
- unusual behaviour
- aggressive behaviour
- weight gain, increased appetite
- low mood
- dry eyes
Children
Frequency unknown: 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 for Monitoring Adverse Drug Reactions of 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.
5. How to store Hitaxa Fast Kids
Keep this medicine out of sight and reach of children.
Do not use Hitaxa Fast Kids after the expiry date stated on the carton and bottle: EXP. The expiry date refers to the last day of the stated month.
No special temperature storage requirements. Store in the original packaging to protect from light.
Do not use this medicine if you notice any change in the appearance of the oral solution.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Contents of the packaging and other information
What Hitaxa Fast Kids contains
- The active substance is desloratadine. One ml of oral solution contains 0.5 mg of desloratadine.
- 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 flavour, liquid (propylene glycol, flavouring substances), purified water.
What Hitaxa Fast Kids looks like and contents of the pack
Hitaxa Fast Kids oral solution is a clear, colourless solution with a fruity odour.
Hitaxa Fast Kids is available in amber glass bottles of type III, closed with a screw cap made of PE or PP, with a PE seal and child-resistant closure, packed in a cardboard box. An oral dosing spoon made of PE with markings at 2.5 ml and 5 ml, or an oral syringe made of PE with markings at 2.5 ml and 5 ml, is included in the pack.
Pack sizes: 30 ml, 50 ml, 60 ml or 100 ml of oral solution.
Not all pack sizes may be marketed.
Marketing Authorisation 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
IASIS Pharmaceuticals Hellas S.A. - Koropi
Archimidous Street
19 400 Koropi Attikis
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