Hitaxa

Package leaflet: Information for the patient

Hitaxa, 2.5 mg, orodispersible tablets
Desloratadinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine 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:

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 an antiallergic medicine that does not cause drowsiness. 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 dust mite allergy) in adults, adolescents, and children aged 6 years and older. Symptoms include: sneezing, runny or itchy nose, itchy palate, as well as itchy, red or watery eyes.
Hitaxa 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 enabling normal 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 any of the other ingredients of this medicine (listed in section 6), or to loratadine.

Warnings and precautions
Before starting to take 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
This medicine must not be given to children under 6 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 intends to take.
Hitaxa, food, drink and alcohol
Hitaxa does not need to be taken with water or any other liquid. Additionally, 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 become pregnant, she should consult a doctor or pharmacist before using this medicine.
Use of Hitaxa is not recommended during pregnancy or while 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 mental alertness, such as driving or operating machinery, until the individual response to this medicine is known.
Hitaxa orally disintegrating tablets contain aspartame (E951).
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 for people with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired 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 take Hitaxa

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The recommended dose is:

• Adults and adolescents (aged 12 years and older): two Hitaxa 2.5 mg orodispersible tablets once daily, with or without food. Take the dose immediately after opening the blister.

This medicine is intended for oral use.
Before administration, carefully open the blister and remove the orodispersible 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.

• Children aged 6 to 11 years: one Hitaxa 2.5 mg orodispersible tablet once daily, 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 occurring for less than 4 days per week or for less than 4 weeks), the treating physician will recommend a treatment regimen considering 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 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 instructions of the treating physician.

Taking more Hitaxa than recommended
Hitaxa should be taken only as prescribed. Accidental overdose is not expected to cause severe adverse effects. However, if a dose higher than recommended has been taken, inform your doctor or pharmacist immediately.

If you forget to take Hitaxa
If you miss a dose at the scheduled time, take it as soon as possible, then return to your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping Hitaxa
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, stop taking the medicine immediately and consult a doctor without delay.

In adults, adverse reactions were almost the same as those observed with a tablet containing no active substance. However, fatigue, dry mouth, and headache occurred more frequently than with the tablet containing no active substance.

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

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

Common: may occur in up to 1 in 10 patients

• fatigue
• dry mouth
• headache

The following adverse reactions have been reported following marketing authorization of desloratadine:

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 excessive motor activity • hepatitis • abnormal liver function test results

Frequency unknown: frequency cannot be estimated from available data

• unusual weakness • weight gain, increased appetite
• increased skin sensitivity to sunlight,
• yellowing of the skin and (or) eyes even during cloudy weather • aggressive behavior and UV (ultraviolet) radiation sensitivity, • UV radiation exposure in tanning beds • depressive mood
• dry eyes
• unusual behavior
• changes in heart rhythm

Additional adverse reactions in children and adolescents

Frequency unknown: frequency cannot be estimated from available data

• slow heartbeat • changes in heart rhythm
• unusual behavior • aggressive behavior

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 Adverse Drug Reactions, 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 safety of the medicine.

5. How to store Hitaxa

Keep this medicine out of the 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.
No special requirements for storage conditions of the medicinal product.
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 packaging and other information

What Hitaxa contains

• The active substance in Hitaxa is desloratadine 2.5 mg.
• The other ingredients are: potassium polacrylate, citric acid monohydrate, iron oxide red (E 172), magnesium stearate, sodium croscarmellose, Tutti Frutti flavouring (also contains 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 2.5 mg orodispersible tablets are brick-red, round, flat tablets with bevelled edges, embossed with "2.5".
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

Manufacturer:
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