Hitaxa

Package leaflet: Information for the patient

Hitaxa, 5 mg, orodispersible tablets
Desloratadinum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Hitaxa is and what it is used for
2. Important information before taking Hitaxa
3. How to take Hitaxa
4. Possible side effects
5. How to store Hitaxa
6. 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 is a non-sedating antiallergic medicine. It helps control allergic reactions and their symptoms.
When Hitaxa should be used
Hitaxa 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 and adolescents aged 12 years and older. Symptoms include: sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.
Hitaxa is also used to relieve symptoms associated with urticaria (an allergic skin condition). Symptoms of this condition include: skin itching and hives.
Relief of 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 using Hitaxa

When not to use Hitaxa

• if the patient is allergic to desloratadine or to any of the other ingredients of the medicine (listed in section 6), or to loratadine.

Warnings and precautions
Before starting to use Hitaxa, consult a doctor or pharmacist:

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

Children and adolescents
This medicine should not be given to children under 12 years of age.
Interaction of Hitaxa with other medicines
No interactions between Hitaxa and other medicines are known.
Inform 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.
Hitaxa with food, drink and alcohol
Hitaxa does not need to be taken with water or any other liquid. Moreover, Hitaxa may be taken with or without food. Caution should be exercised when taking Hitaxa 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 a doctor or pharmacist before using this medicine.
The use of Hitaxa 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, 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 concentration, such as driving or operating machinery, until the patient knows how they react to this medicine.
Hitaxa orally disintegrating tablets contain aspartame (E951).
The medicine contains 3 mg of aspartame in each 5 mg dose. 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 improper excretion.
Hitaxa 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

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

The recommended dose is:

• Adults and adolescents (aged 12 years and older): one 5 mg orally disintegrating tablet of Hitaxa once daily, taken with or without food. 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 any other liquid is not required to swallow the dose. The dose should be taken immediately after opening the blister.

The duration of treatment with Hitaxa will be determined by the prescribing doctor based on the type of allergic rhinitis present in the patient.

If the patient has intermittent allergic rhinitis (symptoms occurring for less than 4 days per week or for less than 4 weeks), the prescribing doctor will recommend a treatment regimen taking into account the previous course of the disease.

If the patient has persistent allergic rhinitis (symptoms occurring for 4 or more days per week and for more than 4 weeks), the prescribing doctor may recommend long-term use of the medicine.

In the case of urticaria, the duration of treatment may vary among individual patients. Therefore, the patient should follow the prescribing doctor's instructions.

Taking more Hitaxa than recommended
Hitaxa should only be taken as prescribed. Severe adverse effects are not expected after accidental overdose.
However, if a larger than recommended dose of Hitaxa is taken, inform a doctor or pharmacist immediately.

Missing a dose of Hitaxa
If a dose of Hitaxa 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 treatment
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Since desloratadine has been marketed, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives and swelling) have been reported. If any of these severe adverse reactions occur, the medicine should be discontinued immediately and medical advice should be sought without delay.
In adults, adverse reactions were almost the same as with placebo tablets (tablets without active ingredient). However, fatigue, dry mouth and headache occurred more frequently than with placebo tablets.
In adolescents, the most commonly reported adverse reaction was headache.
The following adverse reactions have been reported in clinical trials with desloratadine:
Common: may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

Since desloratadine has been marketed, the following adverse reactions have been observed:
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, and in response to • aggressive behaviour UV (ultraviolet) radiation, for example UV radiation in sunbeds • low mood
• dry eyes
• 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 not listed in this leaflet, inform a 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.: +48 22 49-21-301, fax: +48 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 safety of this medicine.

5. How to store the medicine Hitaxa

The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
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 package and other information

What Hitaxa contains

• The active substance is desloratadine in a dose of 5 mg.
• Other components of the medicine 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 Hitaxa looks like and contents of the pack

Hitaxa 5 mg orodispersible tablets are brick-red, round, flat tablets with bevelled edges, embossed with the number "5".

Hitaxa is packed in containers containing 10, 30 or 60 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

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

Manufacturers:

Genepharm S.A.
18km Marathon Avenue
15351 Pallini, Greece

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

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