Actavis LTD Malta #Allergy_and_hay_fever #Antiallergic_preparations #HEALTH_CARE
Product description
Elizium is an antihistamine for systemic use.
Indications for use - elimination of symptoms associated with:
- allergic rhinitis;
- hives.
Compound
active substance: desloratadine;
1 tablet contains 5 mg desloratadine;
auxiliary substances: microcrystalline cellulose, corn starch, beckons (E 421), talc, magnesium stearate;
composition of the film shell: Opadry Blue 03F20404 (hypromellose, titanium dioxide (E 171), polyethylene glycol (macrogol), indigo aluminum varnish (E 132)).
Contraindications
Hypersensitivity to the active substance or to any excipient or to loratadine.
Mode of application
Adults and children over 12 years of age: 1 tablet once a day, regardless of food intake, to eliminate symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria.
Therapy for intermittent allergic rhinitis (the presence of symptoms less than 4 days a week or less than 4 weeks) should be carried out taking into account the history data: stop after the disappearance of symptoms and restore after their recurrence.
For persistent allergic rhinitis (symptoms of more than 4 days a week or more than 4 weeks), treatment should be continued during the entire period of exposure to the allergen.
Application features
Use during pregnancy or lactation
Desloratadine has not been shown to be teratogenic in animal studies.
The safety of using the preparation during pregnancy has not been established, therefore, the use of Elysium during this period is not recommended.
Desloratadine passes into breast milk, so the use of Elysium breastfeeding is not recommended.
Children
There are limited data from clinical studies of the effectiveness of desloratadine tablets in adolescents aged 12 to 17 years.
The efficacy and safety of using Elysium tablets in children under 12 years of age has not been established.
The ability to influence the reaction rate when driving or driving other mechanisms
In clinical studies, no impairment of the ability to drive vehicles was found in patients taking desloratadine. Patients should be advised that it is very rare for some people to experience drowsiness while taking desloratadine, which may affect their ability to drive and difficult equipment.
Interaction with other medicinal products and other forms of interaction
In clinical studies of desloratadine tablets with the combined use of erythromycin or ketoconazole, no clinically significant interactions were observed.
In clinical and pharmacological studies when using the preparation with alcohol, there was no increase in the negative effect of ethanol on psychomotor function. However, in the post-registration period, there were cases of alcohol intolerance and alcohol intoxication when using the preparation. Therefore, care must be taken when using alcohol during the treatment of desloratadine.
Overdose
In case of overdose, apply standard measures to remove the unadsorbed active substance. Symptomatic and supportive treatment is recommended. In clinical studies in which desloratadine was administered at doses of 45 mg (which is 9 times the recommended), clinically significant adverse reactions were not observed. Desloratadine is not removed by hemodialysis; the possibility of its removal during peritoneal dialysis has not been established.
Adverse Reactions
In clinical trials for indications, including allergic rhinitis and chronic idiopathic urticaria, adverse effects were reported 3% more frequently in patients receiving the 5 mg daily dose 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 side effect was headache; it was observed in 5.9% of patients taking desloratadine and 6.9% of patients receiving placebo.
There is a risk of psychomotor hyperactivity (abnormal behavior) associated with desloratadine use (which can manifest as anger and aggression, as well as agitation).
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Shelf life is 3 years.
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