Hitaxa

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Hitaxa (Hitaxa)

Composition:

Active substance: desloratadine;

1 orodispersible tablet contains 2.5 mg or 5 mg of desloratadine;

Excipients: potassium polacrilin; citric acid, monohydrate; purified water; iron oxide red (E 172); magnesium stearate; sodium croscarmellose, flavoring agent, aspartame (E 951), microcrystalline cellulose, mannitol (E 421).

Medicinal form. Orodispersible tablets.

Main physicochemical properties:

orodispersible tablets of 2.5 mg: round, flat, reddish-brown tablets, with a score line and imprint "2.5" on one side;

orodispersible tablets of 5 mg: round, flat, reddish-brown tablets, with a score line and imprint "5" on one side.

Pharmacotherapeutic group.

Antihistamines for systemic use. ATC code R06AX27.

Pharmacological properties.

Pharmacodynamics.

Desloratadine is a non-sedating, long-acting antihistamine that exerts a selective antagonistic effect on peripheral H1-receptors. After oral administration, desloratadine selectively blocks peripheral histamine H1-receptors. In vitro studies have demonstrated anti-allergic properties of desloratadine on endothelial cells. These properties were manifested by inhibition of pro-inflammatory cytokine release, such as IL-4, IL-6, IL-8, and IL-13, from human mast cells/basophils, as well as by suppression of adhesion molecule expression, including P-selectin. The clinical significance of these observations has yet to be confirmed.

Studies have shown that, in addition to its antihistaminic activity, the medicinal product Hitaxa exerts anti-allergic and anti-inflammatory effects.

Desloratadine does not penetrate the central nervous system and does not affect psychomotor function.

In patients with allergic rhinitis, the medicinal product Hitaxa effectively relieved symptoms such as sneezing, rhinorrhea, itching, eye irritation, lacrimation, redness, and itching of the palate for up to 24 hours.

Pharmacokinetics.

Absorption

Desloratadine plasma concentration can be detected within 30 minutes after administration.

Desloratadine is well absorbed, with peak concentration reached approximately within 3 hours.

Elimination

The elimination half-life is approximately 27 hours. The extent of desloratadine accumulation corresponds to its half-life (approximately 27 hours) and the dosing frequency of once daily.

Linearity and non-linearity

Desloratadine bioavailability was proportional to dose over the range of 5 mg to 20 mg. Desloratadine is moderately bound to plasma proteins (83–87%). No evidence of clinically significant drug accumulation was observed after administration of doses ranging from 5 mg to 20 mg once daily for 14 days.

Food (high-fat, high-calorie meal) does not affect the pharmacokinetics of desloratadine. Grapefruit juice has also been shown not to affect desloratadine pharmacokinetics.

Clinical characteristics.

Indications.

Relief of symptoms associated with:

• allergic rhinitis;
• urticaria.

Contraindications.

Hypersensitivity to the active substance, to any excipient, or to loratadine.

Interaction with other medicinal products and other forms of interaction.

No clinically significant interactions were observed when desloratadine tablets were co-administered with erythromycin or ketoconazole.

Desloratadine administered together with alcohol did not enhance the negative effect of ethanol on psychomotor function. However, cases of alcohol intolerance and alcohol intoxication have been reported in the post-marketing period during the use of the drug. Therefore, caution is advised when consuming alcohol during treatment with desloratadine.

Special precautions for use.

The medicinal product Hitaksa should be used with caution and under medical supervision in cases of severe renal impairment.

The medicinal product contains aspartame (a phenylalanine derivative) and therefore may be harmful to individuals with phenylketonuria.

Caution is advised when administering this medicinal product to patients with a medical or family history of seizures, particularly in younger children who are more susceptible to developing seizures during treatment with desloratadine. Healthcare professionals may consider discontinuing desloratadine in patients who experience seizure episodes during treatment.

This medicinal product contains 3/6 mg/dose of sodium. Caution should be exercised when administering it to patients on a sodium-restricted diet.

Use during pregnancy or breastfeeding.

The safety of using Hitaksa during pregnancy has not been established; therefore, its use is not recommended during this period.

Desloratadine passes into breast milk; hence, the medicinal product Hitaksa should not be taken by women who are breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

No reduction in performance has been reported in patients taking desloratadine. However, patients should be informed that, very rarely, somnolence may occur in some individuals, which could affect their ability to drive or operate machinery.

Dosage and Administration

2.5 mg orally disintegrating tablets

Adults and children (aged 12 years and older): 2 tablets once daily, regardless of food intake, to relieve symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria.

Children aged 6 to 12 years: 1 tablet once daily, regardless of food intake, to relieve symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria.

Treatment of intermittent allergic rhinitis (symptoms present less than 4 days per week or less than 4 weeks) should be based on patient history: discontinue after symptoms resolve and resume upon their recurrence. For persistent allergic rhinitis (symptoms present more than 4 days per week or more than 4 weeks), treatment should continue throughout the entire period of allergen exposure.

5 mg orally disintegrating tablets

Adults and adolescents (aged 12 years and older): 1 tablet once daily, regardless of food intake, to relieve symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria.

Treatment of intermittent allergic rhinitis (symptoms present less than 4 days per week or less than 4 weeks) should be based on patient history: discontinue after symptoms resolve and resume upon their recurrence. For persistent allergic rhinitis (symptoms present more than 4 days per week or more than 4 weeks), treatment should continue throughout the entire period of allergen exposure.

Administration method

Immediately before administration, carefully open the blister pack and remove the orally disintegrating tablet without crushing it, ensuring it remains intact. Place the tablet in the mouth, where it will disintegrate immediately. No water or other liquid is required to swallow the tablet. The dose should be taken immediately after opening the blister.

Children

2.5 mg orally disintegrating tablets

This pharmaceutical form is indicated for use in children aged 6 years and older.

The efficacy and safety of Hitaxa orally disintegrating tablets in children under 6 years of age have not been established.

5 mg orally disintegrating tablets

This pharmaceutical form is indicated for use in children aged 12 years and older.

Overdose

In case of overdose, standard measures aimed at removing the unabsorbed active substance are recommended. Symptomatic and supportive therapy is advised. During clinical studies using multiple higher doses administered to adults and adolescents (up to 45 mg of desloratadine, which is 9 times the therapeutic dose), no clinically significant effects were observed.

Desloratadine is not removed by hemodialysis; it is unknown whether it is removed by peritoneal dialysis.

Adverse reactions.

In clinical trials for the approved indications, including allergic rhinitis and chronic idiopathic urticaria, adverse reactions were reported 3% more frequently in patients receiving a 5 mg daily dose than in those receiving placebo.

The most commonly reported adverse reactions compared to placebo were fatigue (1.2%), dry mouth (0.8%), and headache (0.6%).

Children. In clinical trials involving 578 adolescents aged 12 to 17 years, the most commonly reported adverse reaction was headache, occurring in 5.9% of patients taking desloratadine and in 6.9% of patients receiving placebo.

In the post-marketing period, the following have been observed (frequency unknown): QT interval prolongation, arrhythmia, and bradycardia.

There is a risk of psychomotor hyperactivity (abnormal behavior) associated with the use of desloratadine (which may manifest as irritability and aggression, as well as excitation).

The frequency of adverse reactions is classified as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), frequency not known (cannot be estimated from available data).

Psychiatric disorders: very rare – hallucinations; frequency not known – abnormal behavior, aggression, depression.

Nervous system disorders: common – headache; very rare – dizziness, somnolence, insomnia, psychomotor hyperactivity, convulsions.

Eye disorders: not known – dry eyes.

Cardiac disorders: very rare – tachycardia, palpitations; frequency not known – QT interval prolongation, supraventricular tachyarrhythmia.

Gastrointestinal disorders: common – dry mouth; very rare – abdominal pain, nausea, vomiting, dyspepsia, diarrhea.

Hepatobiliary disorders: very rare – increased liver enzyme levels, increased bilirubin, hepatitis; frequency not known – jaundice.

Musculoskeletal and connective tissue disorders: very rare – myalgia.

Skin and subcutaneous tissue disorders: frequency not known – photosensitivity.

General disorders and administration site conditions: common – increased fatigue; very rare – hypersensitivity reactions (anaphylaxis, Quincke's edema, dyspnea, pruritus, rash, urticaria); frequency not known – asthenia.

Metabolism and nutrition disorders: increased appetite.

Investigations: weight gain.

Shelf life.

3 years.

Storage conditions.

No special storage conditions required.

Packaging.

Orodispersible tablets 2.5 mg: 10 tablets in a blister, 1 or 3 blisters in a cardboard box.

Orodispersible tablets 5 mg: 10 tablets in a blister, 1 blister in a cardboard box.

Classification of supply.

Over-the-counter.

Manufacturers responsible for batch release:

Genepharm S.A.

AT "Adamed Pharma", Poland.

Manufacturer's address and place of business.

1. 18 km Marathona Ave, Pallini Attiki, 15351, Greece.
2. ul. Marsz. J. Piłsudskiego 5, 95–200, Pabianice, Poland.