Hitaxa

Leaflet accompanying the packaging: patient information

Hitaxa, 0.5 mg/ml, oral solution

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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. 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 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.

How Hitaxa works

Hitaxa, oral solution is an anti-allergic medicine that does not cause drowsiness. 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 an allergy, such as hay fever or allergy to dust mites) in adults, adolescents, and children over 1 year of age. The symptoms include: sneezing, runny or itchy nose, itchy palate, and itchy, red, or teary eyes. Hitaxa, oral solution is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). The symptoms of this condition include: itchy skin and urticaria. The relief of these symptoms lasts throughout the 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 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 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 and adolescents

This medicine should not be given to children under 1 year 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 might take.

Hitaxa with food, drink, and alcohol

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

Hitaxa is not expected to affect the ability to drive or use machines. Although it does not usually cause drowsiness, the patient should avoid activities that require concentration, such as driving or using machines, until they know how they react to the 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 the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, fructose intolerance, they should consult their doctor before taking this medicine.

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, 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. If the patient is unsure, they should ask their doctor or pharmacist. The recommended dose is: Adults and adolescents (12 years and older):10 ml (2 measuring spoons of 5 ml) of oral solution once a day.

Use in children

The recommended dose is: Children from 1 to 5 years:2.5 ml (½ measuring spoon of 5 ml) of oral solution once a day. Children from 6 to 11 years:5 ml (1 measuring spoon of 5 ml) of oral solution once a day. If a measuring spoon or oral syringe is provided with the bottle, it can be used to measure the correct volume of oral solution. This medicine is for oral use only. The dose of oral solution should be swallowed and then followed by water. The medicine can be taken with or without food. The duration of treatment with Hitaxa will be determined by the doctor, depending 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 chronic 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. In the case of urticaria, the duration of treatment may vary from patient to patient. Therefore, the patient should follow the doctor's recommendations.

Overdose of Hitaxa

Hitaxa, oral solution should only be taken as prescribed. If the patient accidentally takes more than the recommended dose, they should tell their doctor or pharmacist immediately.

Missed dose of Hitaxa

If the patient misses a dose, they should take it as soon as possible and then continue with their regular dosing schedule. They should not take a double dose to make up for a missed dose.

Stopping treatment with Hitaxa

If the patient has any further questions about taking this medicine, they should ask 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, urticaria, and swelling) have been reported. If any of these severe side effects occur, the patient should stop taking the medicine and see a doctor immediately. In most children and adults, side effects were almost the same as with a placebo. However, in children under 2 years of age, common side effects were: diarrhea, fever, and insomnia, while in adults: fatigue, dry mouth, and headache, which were reported more frequently than with a placebo. In clinical trials with desloratadine, the following side effects were reported:

Common in children under 2 years: may affect up to 1 in 10 children

• diarrhea
• fever
• insomnia

Adults:

Common: may affect up to 1 in 10 patients

• fatigue
• dry mouth
• headache

After marketing, the following side effects have been reported:

Very rare: may affect up to 1 in 10,000 patients

• 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 with excessive physical activity
• hepatitis
• abnormal liver function tests

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

• unusual weakness
• increased skin sensitivity to sunlight, even in cloudy weather, and to UV radiation (e.g., in a solarium)
• unusual behavior
• changes in heart rhythm
• weight gain, increased appetite
• jaundice
• aggressive behavior

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

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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, the patient can help provide more information on the safety of this 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 bottle after EXP. The expiry date refers to the last day of the month. There are no special storage precautions for this medicine. Store in the original package. Do not use this medicine if the patient notices any change in the appearance of the oral solution. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Hitaxa contains

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

What Hitaxa looks like and contents of the pack

Hitaxa oral solution is available in bottles with a child-resistant closure. A measuring spoon or oral syringe is provided with packs containing 60 ml, 120 ml, 150 ml. The oral syringe allows for measurement of 2.5 ml and 5 ml of oral solution. The measuring spoon is used to measure 2.5 ml and 5 ml of oral solution. 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, 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

Date of last revision of the leaflet: 04.2021