Package leaflet: Information for the patient

Hitaxa, 0.5 mg/ml, oral solution
Desloratadine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Hitaxa is and what it is used for
What Hitaxa is
Hitaxa contains desloratadine, which is an antihistamine medicine.
How Hitaxa works
Hitaxa oral solution is a non-sedating antiallergy medicine. It helps control allergic reactions and their symptoms.
When to use Hitaxa
Hitaxa oral solution relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by allergy, such as hay fever or allergy to house dust mites) in adults, adolescents, and children above 1 year of age. Symptoms include: sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.
Hitaxa oral solution 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.
If there is no improvement or if the patient feels worse, consult a doctor.

2. Important information before taking Hitaxa

When not to take Hitaxa

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 starting Hitaxa, discuss with your doctor or pharmacist:

if you have kidney function disorders,
if you have a history of seizures or a family history of seizures.

Children and adolescents
This medicine should not be given to children under 1 year of age.
Hitaxa with other medicines
No interactions between Hitaxa and other medicines are known.
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Hitaxa with food, drink and alcohol
Hitaxa may be taken with or without food.
Exercise caution when taking Hitaxa with alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Use of Hitaxa during pregnancy or breastfeeding is not recommended.
Fertility
There is no available data on the effect on fertility in men and women.
Driving and operating machinery
Hitaxa, when used at the recommended dose, is not expected to affect the ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended to refrain from performing tasks requiring mental alertness, such as driving or operating machinery, until you know how you react to this medicine.
Hitaxa contains sorbitol (E420)
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, 1.5 mg of sorbitol in 10 ml of oral solution.
Sorbitol is a source of fructose. If fructose intolerance has previously been diagnosed in you (or your child), or if hereditary fructose intolerance, a rare genetic disorder in which the body cannot break down fructose, has been diagnosed, you should contact your doctor before taking this medicine (or before giving it to your child).
Hitaxa contains propylene glycol (E1520)
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, 1.5075 mg of propylene glycol in 10 ml of oral solution.
Hitaxa contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per ml of oral solution, meaning the medicine is considered "sodium-free".

3. How to take Hitaxa

This medicine should always be taken exactly as directed by your doctor or pharmacist. In case of
doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults and adolescents (aged 12 years and older): 10 ml (2 measuring spoons of 5 ml each) of oral
solution once daily.
Use in children
The recommended dose is:
Children aged 1 to 5 years: 2.5 ml (½ measuring spoon of 5 ml) of oral solution once daily.
Children aged 6 to 11 years: 5 ml (one 5 ml measuring spoon) of oral solution once daily.
If an oral syringe is provided with the bottle of oral solution, it may be used interchangeably to
measure the appropriate volume of oral solution.
This medicine is intended for oral use.
The dose of oral solution should be swallowed with water. The medicine may be taken with or
without food.
The duration of treatment with Hitaxa will be determined by the treating physician based on the
type of allergic rhinitis present in the patient.
If the patient has intermittent allergic rhinitis (symptoms occur for less than 4 days per week or for
less than 4 weeks), the treating physician will recommend a treatment regimen taking into account
the previous course of the disease.
If the patient has persistent allergic rhinitis (symptoms occur for 4 or more days per week and for more
than 4 weeks), the treating physician may recommend long-term treatment.
In the case of urticaria, the duration of treatment may vary among individual patients. Therefore, the
patient should follow the treating physician's instructions.
Taking more than the recommended dose of Hitaxa
Hitaxa oral solution should be taken only as prescribed. No interactions of Hitaxa with other medicines
are known following accidental overdose.
However, if a larger than recommended dose of Hitaxa oral solution is taken, inform your doctor or
pharmacist immediately.
Missing a dose of Hitaxa
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 individual dose.
Stopping Hitaxa treatment
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone experiences them.
Very rarely, severe allergic reactions have been reported after marketing authorization (difficulty breathing, wheezing, itching, hives, and swelling). If any of these severe adverse reactions occur, administration of the medicine must be stopped immediately and medical advice must be sought without delay.

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 children under 2 years of age, common adverse reactions included: diarrhoea, fever, and insomnia. In adult patients, fatigue, dry mouth, and headache were reported more frequently than with placebo tablets.

The following adverse reactions have been reported in clinical trials with desloratadine:

Children:
Common in children under 2 years of age: may occur in up to 1 in 10 children

diarrhoea
fever
insomnia

Adults:
Common: may occur in up to 1 in 10 patients

fatigue
dry mouth
headache

After marketing of desloratadine, the following adverse reactions have been reported:

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 not known: frequency cannot be estimated from available data

unusual weakness
increased sensitivity of the skin to sunlight, even on cloudy days, and to UV (ultraviolet) radiation, for example UV radiation in sunbeds
unusual behaviour
changes in heart rhythm
weight gain, increased appetite
yellowing of the skin and (or) eyes
aggressive behaviour
low mood
dry eyes

Additional adverse reactions in children and adolescents
Frequency not known: frequency cannot be estimated from available data

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

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring 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 provide more information on the safety of this medicine.

5. How to store the medicine Hitaxa

The medicine should be stored in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after: EXP.
The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements for this medicinal product.
Store in the original immediate packaging.
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 required. Such measures will help protect the environment.

6. Contents of the package and other information

What Hitaxa contains

The active substance is desloratadine 0.5 mg in 1 ml.
The other ingredients are: sodium citrate, sucralose, anhydrous citric acid, sorbitol liquid, propylene glycol, hypromellose, Tutti Frutti flavour, liquid, purified water.

What Hitaxa looks like and contents of the pack
Hitaxa oral solution is available in bottles closed with a child-resistant cap.
Oral dosing syringes or measuring spoons are included in the packages containing 60 ml, 120 ml, or 150 ml.
The oral dosing syringe allows measuring 2.5 ml and 5 ml of the solution.
The measuring spoon is used to measure 2.5 ml and 5 ml of the solution.
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
IASIS Pharmaceuticals Hellas S.A. - Koropi
Archimidous Street,
19 400 Koropi Attikis,
Greece
Famar A.V.E.
49th km National Road Athens-Lamia
Avlona Attiki, 19011,
Greece
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów