Presentation and Status in Health Basket
15 X 5 mg
30 X 5 mg
Adults and adolescents (12 years of age and over): The recommended dose of Aerius is one tablet once a day.
Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patient’s disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.
In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods.
Paediatric population: There is limited clinical trial efficacy experience with the use of desloratadine in adolescents 12 through 17 years of age.
The safety and efficacy of Aerius 5 mg film-coated tablets in children below the age of 12 years have not been established. No data are available.
Method of administration: Oral use. The dose can be taken with or without food.
Relief of symptoms associated with allergic rhinitis, urticaria.
Hypersensitivity to the active substance, to any of the excipients, or to loratadine.
Efficacy and safety of Aerius® tablets in children under 12 years of age have not been established. In the case of severe renal insufficiency, Aerius® should be used with caution. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with Aerius® were reported in 3 % of patients in excess of those treated with placebo. The most frequent of adverse events reported in excess of placebo were fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %). Other undesirable effects reported very rarely during the post-marketing period are listed.
For full details see prescribing information.
No clinically relevant interactions were observed in clinical trials in which erythromycin or ketoconazole were co-administered. In a clinical pharmacology trial, tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol.
Pregnancy and Lactation
Pregnancy: Desloratadine was not teratogenic in animal studies. The safe use of the medicinal product during pregnancy has not been established. The use of Aerius® during pregnancy is therefore not recommended.
Lactation: Desloratadine is excreted into breast milk, therefore the use of Aerius® is not recommended in breastfeeding women.
In the event of overdose, consider standard measures to remove unabsorbed active substance. Symptomatic and supportive treatment is recommended. Based on a multiple dose clinical trial, in which up to 45 mg of desloratadine was administered (nine times the clinical dose), no clinically relevant effects were observed.
Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal dialysis.