Hitaxa

Leaflet attached to the packaging: patient information

Hitaxa, 2.5 mg, orally disintegrating tablets

Desloratadine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Hitaxa and what is it 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 is Hitaxa and what is it used for

What is Hitaxa

Hitaxa contains desloratadine, which is an antihistamine medicine.

How Hitaxa works

Hitaxa is an anti-allergic medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.

When to use Hitaxa

Hitaxa relieves symptoms associated with allergic rhinitis (hay fever or allergy to dust mites) in adults, adolescents, and children aged 6 and older. Symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red, or teary eyes. Hitaxa is also used to relieve symptoms associated with hives (an itchy skin condition caused by an allergy). Symptoms of this condition include itchy skin and hives. Relief of these symptoms lasts all day, making it easier to return to normal daily activities and normal sleep. If there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Hitaxa

When not to take 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 taking Hitaxa, 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 6 years of age.

Hitaxa and other medicines

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

Hitaxa with food, drink, and alcohol

Taking Hitaxa does not require drinking water or any other liquid. Additionally, Hitaxa can be taken with or without food. The patient should be cautious when taking Hitaxa with alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. It is not recommended to take Hitaxa during pregnancy or breastfeeding.

Fertility

There is no available data on the effect on fertility in males and females.

Driving and using machines

It is unlikely that Hitaxa will affect the patient's ability to drive or use machines. Although most people do not experience drowsiness, it is recommended to avoid activities that require concentration, such as driving or using machines, until it is known how the medicine affects them.

Hitaxa orally disintegrating tablets contain aspartame (E951).

The medicine contains 1.5 mg of aspartame in each 2.5 mg dose. Aspartame is a source of phenylalanine. It may be harmful to people with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination.

Hitaxa orally disintegrating tablets contain sodium.

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

3. How to take Hitaxa

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. The recommended dose is:

• Adults and adolescents (12 years and older):two Hitaxa 2.5 mg orally disintegrating tablets; once a day, taken with or without food. The dose should be taken immediately after opening the blister.

This medicine is intended for oral use. Before taking, the blister should be carefully opened and the orally disintegrating tablet removed without crushing. It should be placed in the mouth, where it will dissolve immediately. Water or any other liquid is not needed to swallow the dose.

• Children aged 6 to 11 years:one Hitaxa 2.5 mg orally disintegrating tablet; once a day, taken with or without food.

The duration of treatment with Hitaxa will be determined by the doctor based on the type of allergic rhinitis the patient has. If the patient has seasonal allergic rhinitis (symptoms occur for less than 4 days a week or for less than 4 weeks), the doctor will recommend a treatment schedule based on the patient's medical history. If the patient has perennial allergic rhinitis (symptoms occur for 4 or more days a week and for more than 4 weeks), the doctor may recommend long-term use of the medicine. For hives, the duration of treatment may vary from patient to patient. Therefore, the patient should follow the doctor's recommendations.

Overdose of Hitaxa

Hitaxa should only be taken as prescribed. In case of accidental overdose, no serious disorders are expected to occur. However, if a higher dose of Hitaxa is taken, the patient should immediately tell their doctor or pharmacist.

Missed dose of Hitaxa

If a dose is missed, it should be taken as soon as possible, and then the patient should return to their regular dosing schedule. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Hitaxa

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 can cause side effects, although not everybody gets them. After marketing, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If any of these severe side effects occur, the patient should stop taking the medicine and immediately consult their doctor. In adults, side effects were almost the same as after taking a placebo. However, fatigue, dry mouth, and headache were reported more often than after taking a placebo. In adolescents, the most commonly reported side effect was headache. In clinical trials of desloratadine, the following side effects were reported:

Common: may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

After marketing, 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
• gastrointestinal disorders
• diarrhea
• dizziness
• drowsiness
• insomnia
• muscle pain
• hallucinations
• seizures
• restlessness and hyperactivity
• 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 sun, physical activity
• jaundice
• aggressive behavior
• low mood
• dry eyes
• unusual behavior
• changes in heart rhythm, even in cases of clouded sun and UV radiation (ultraviolet), for example, in a solarium

Additional side effects in children and adolescents

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

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Hitaxa

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month. There are no special precautions for storage. Do not use this medicine if the patient notices any changes in the appearance of the tablets. 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 use. This will help protect the environment.

6. Contents of the pack and other information

What Hitaxa contains

• The active substance is desloratadine in a dose of 2.5 mg.
• The other ingredients are: polacrilin potassium, citric acid monohydrate, iron oxide red (E 172), magnesium stearate, croscarmellose sodium, Tutti Frutti flavor (liquid, also contains propylene glycol), aspartame (E 951), microcrystalline cellulose, mannitol (spray-dried), potassium hydroxide (to adjust pH).

What Hitaxa looks like and contents of the pack

Hitaxa 2.5 mg orally disintegrating tablets are brick-red, round, flat tablets with beveled edges, engraved with "2.5". Hitaxa is packaged in packs containing 10, 30, and 60 orally disintegrating tablets. Not all pack sizes may be marketed.

Marketing authorization holder:

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

Manufacturer:

Genepharm S.A., 18km Marathon Avenue, 15351 Pallini, Greece, Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów, 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

Date of last revision of the leaflet: 12.2023