Elyzium film-coated tablets 5 mg, pack of 30 pieces

• active ingredient: desloratadine;
• 1 tablet contains 5 mg of desloratadine;
• excipients: microcrystalline cellulose, corn starch, mannitol (E 421), talc, magnesium stearate;
• film coating composition: Opadry Blue 03F20404 (hypromellose, titanium dioxide (E 171), polyethylene glycol (macrogol), indigo carmine aluminum lake (E 132)).

Hypersensitivity to the active substance or to any of the excipients or to loratadine.

Adults and children over 12 years of age: 1 tablet once daily, regardless of meals, for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria.

Treatment of intermittent allergic rhinitis (presence of symptoms less than 4 days per week or less than 4 weeks) should be carried out taking into account the anamnesis: stop after the symptoms disappear and resume after their reappearance.

In case of persistent allergic rhinitis (presence of symptoms more than 4 days a week or more than 4 weeks), treatment should be continued throughout the entire period of contact with the allergen.

Use during pregnancy or breastfeeding

Desloratadine did not demonstrate teratogenic properties in animal studies.

The safety of the drug during pregnancy has not been established, therefore the use of Elyzium during this period is not recommended.

Desloratadine passes into breast milk, so the use of Elyzium in breastfeeding women is not recommended.

Children

There are limited clinical trial data on the efficacy of desloratadine tablets in adolescents aged 12 to 17 years.

The efficacy and safety of Elyzium tablets in children under 12 years of age have not been established.

Ability to influence reaction speed when driving vehicles or other mechanisms

In clinical studies, no impairment of the ability to drive was observed in patients taking desloratadine. Patients should be informed that very rarely, some people experience drowsiness while taking desloratadine, which may affect their ability to drive or operate machinery.

In clinical studies of desloratadine tablets, no clinically significant interactions were observed when erythromycin or ketoconazole were co-administered.

In clinical and pharmacological studies, when the drug was used together with alcohol, no increase in the negative effect of ethanol on psychomotor function was noted. However, in the post-registration period, cases of alcohol intolerance and alcohol intoxication were observed during the use of the drug. Therefore, caution should be exercised when using alcohol during treatment with desloratadine.

In case of overdose, standard measures should be taken to remove unabsorbed active substance. Symptomatic and supportive treatment is recommended. In clinical studies in which desloratadine was administered at doses of 45 mg (9 times the recommended dose), no clinically significant adverse reactions were observed. Desloratadine is not removed by hemodialysis; its removal by peritoneal dialysis has not been established.

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

The most commonly reported side effects 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 common adverse reaction was headache, occurring in 5.9% of patients treated with desloratadine and 6.9% of patients treated with placebo.

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

Store at a temperature not exceeding 25°C. Keep out of the reach of children.

Shelf life 3 years.