Hitaxa Fast

Package Leaflet: Information for the Patient

Hitaxa Fast, 5 mg, Oral Disintegrating Tablets

Desloratadine

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

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, consult your doctor.

Table of Contents of the Leaflet:

• 1. What is Hitaxa Fast and what is it used for
• 2. Important information before taking Hitaxa Fast
• 3. How to take Hitaxa Fast
• 4. Possible side effects
• 5. How to store Hitaxa Fast
• 6. Contents of the pack and other information

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

What is Hitaxa Fast

Hitaxa Fast contains desloratadine, which is an antihistamine.

How Hitaxa Fast works

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

When to take Hitaxa Fast

Hitaxa Fast relieves symptoms associated with allergic rhinitis (hay fever or allergy to dust mites) in adults and adolescents aged 12 years and older. Symptoms of this condition include sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes. Hitaxa Fast, oral disintegrating tablets, are also used to relieve symptoms of urticaria (a skin condition caused by an allergy). 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 after 3 days there is no improvement or you feel worse, consult your doctor.

2. Important information before taking Hitaxa Fast

When not to take Hitaxa Fast

• 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 Fast, discuss 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 Fast with other medicines

No interactions with other medicines are known.

Hitaxa Fast with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is not recommended to take Hitaxa Fast during pregnancy or breastfeeding.

Fertility

There are no available data on the effect on fertility in men and women.

Driving and using machines

It is unlikely that Hitaxa Fast, when taken as recommended, will affect your ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended to avoid activities that require concentration, such as driving or operating machinery, until you know how you react to this medicine.

Hitaxa Fast contains aspartame

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, a rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination.

Hitaxa Fast contains sodium

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

3. How to take Hitaxa Fast

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. Recommended dose

• Adults and adolescents (12 years and older):one oral disintegrating tablet of Hitaxa Fast 5 mg once daily. The tablet should be taken immediately after opening the blister.

This medicine is intended for oral use. Before taking, carefully open the blister and remove the oral disintegrating tablet without crushing. Place it in your mouth, where it will dissolve immediately. Water or any other liquid is not needed to swallow the dose. The tablet should be taken immediately after opening the blister.

Duration of treatment

Treatment of allergic rhinitis and urticaria with desloratadine without medical consultation should not exceed 10 days.

Overdose of Hitaxa Fast

Hitaxa Fast should be taken only as described in the package leaflet or as directed by your doctor or pharmacist. In case of accidental overdose, severe disorders should not occur. However, if you take more than the recommended dose of Hitaxa Fast, consult your doctor or pharmacist.

Missed dose of Hitaxa Fast

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 Fast

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

4. Possible side effects

Like all medicines, Hitaxa Fast 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 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 frequently 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:

Frequent (may affect up to 1 in 10 people):

• fatigue
• dry mouth
• headache

The following side effects have been reported after marketing of desloratadine.

Very rare side effects (may affect less than 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

Side effects with unknown frequency (frequency cannot be estimated from available data):

• unusual weakness
• weight gain, increased appetite
• increased skin sensitivity to the sun, physical activity
• jaundice of the skin and/or eyes
• aggressive behavior
• low mood
• dry eyes
• unusual behavior
• changes in heart rhythm

Additional side effects in children:

Unknown frequency: frequency cannot be estimated from available data

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 Fast

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 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 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. This will help protect the environment.

6. Contents of the pack and other information

What Hitaxa Fast contains

• The active substance is desloratadine 5 mg.
• The other ingredients are polacrilin potassium, citric acid monohydrate, iron oxide red (E 172), magnesium stearate, croscarmellose sodium, Tutti Frutti flavor liquid (contains propylene glycol), aspartame (E 951), microcrystalline cellulose, mannitol (spray-dried), potassium hydroxide (for pH adjustment).

What Hitaxa Fast looks like and contents of the pack

Hitaxa Fast 5 mg oral disintegrating tablets are reddish-brown, round, flat tablets with beveled edges, engraved with "5". Hitaxa Fast is packaged in packs containing 10 or 20 oral disintegrating tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

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: 01.2025