Hitaxa

Package Leaflet: Information for the Patient

Hitaxa, 5 mg, Oral Disintegrating Tablets

Desloratadine

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

• 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your 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 is a non-sedating antiallergic medicine that helps control allergic reactions and their symptoms.

When to use Hitaxa

Hitaxa relieves the symptoms associated with allergic rhinitis (hay fever or allergy to dust mites) in adults and adolescents aged 12 years and older. Symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red, or teary eyes. Hitaxa is also used to relieve the symptoms of urticaria (hives). Symptoms of this condition include itchy skin and hives. Relief of these symptoms persists throughout the day, making it easier to return to normal daily activities and normal sleep. If there is no improvement or if you feel worse, you should 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 taking Hitaxa, you should discuss it with your doctor or pharmacist:

• if you have kidney problems,
• if you have a history of seizures or a family history of seizures.

Children and adolescents

Do not give this medicine to children under 12 years of age.

Hitaxa and other medicines

No interactions with other medicines are known. However, tell your doctor or pharmacist about all medicines you are taking now or have recently taken, and about medicines you 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. However, be cautious when taking Hitaxa with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice 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 your 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 you know how you react to this medicine.

Hitaxa oral disintegrating tablets contain aspartame (E951).

The medicine contains 3 mg of aspartame in each 5 mg dose of the medicinal product. 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 excretion.

Hitaxa oral disintegrating tablets contain sodium.

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

3. How to take Hitaxa

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose is:

• Adults and adolescents (12 years and older):one 5 mg oral disintegrating tablet of Hitaxa once daily, taken with or without food. Take the dose immediately after opening the blister.

This medicine is for oral use only. Before taking, carefully open the blister and remove the oral disintegrating tablet without crushing it. Place it in your mouth, where it will dissolve immediately. Water or any other liquid is not needed to swallow the dose. Take the dose immediately after opening the blister. The duration of treatment with Hitaxa will be determined by your doctor after establishing the type of allergic rhinitis you have. If you have seasonal allergic rhinitis (symptoms that occur for less than 4 days a week or for less than 4 weeks), your doctor will recommend a treatment schedule based on your medical history. If you have perennial allergic rhinitis (symptoms that occur for 4 or more days a week and for more than 4 weeks), your doctor may recommend long-term use of the medicine. For urticaria, the duration of treatment may vary from patient to patient. Therefore, you should follow your doctor's advice.

If you take more Hitaxa than you should

Hitaxa should be taken only as prescribed. If you accidentally take more than the prescribed dose, no serious disorders should occur. However, if you take more Hitaxa than prescribed, tell your doctor or pharmacist immediately.

If you forget to take Hitaxa

If you miss a dose, take it as soon as possible, and then return to your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping treatment with Hitaxa

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. After desloratadine was made available, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If you experience any of these severe side effects, stop taking the medicine and seek medical help immediately. In adults, side effects were almost the same as with a placebo. However, fatigue, dry mouth, and headache were reported more often than with a placebo. In adolescents, the most commonly reported side effect was headache. The following side effects have been reported in clinical trials with desloratadine:

Common: may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

The following side effects have been reported after desloratadine was made available:

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 with excessive physical 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, physical activity
• jaundice and/or yellowing of the eyes
• aggressive behavior
• low mood
• dry eyes
• abnormal behavior
• changes in heart rhythm

Additional side effects in children and adolescents

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

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

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please tell your 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, you can help provide more information on the safety of this 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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Do not use this medicine if you notice any visible signs of deterioration. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 5 mg.
• The other ingredients are: polacrilin potassium, citric acid monohydrate, iron oxide red (E 172), magnesium stearate, sodium croscarmellose, Tutti Frutti flavor, liquid (contains propylene glycol), aspartame (E 951), microcrystalline cellulose, mannitol (spray-dried), potassium hydroxide (to adjust pH).

Hitaxa, 5 mg, oral disintegrating tablets are reddish-brown, round, flat tablets with beveled edges, with the engraving "5". Hitaxa is packaged in packs containing 10, 30, and 60 oral 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