Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
desloratadine
Schering-Plough Labo N.V.
R06AX27
desloratadine
5mg
tablets film-coated
(10/1x10/) in blister
Prescription
Registered
2020-12-30
Page 1 of 6 Summary of Product Characteristics Aerius ® tablets SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Aerius tablets 5 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of desloratadine. For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Coated tablets 4. CLINICAL PARTICULARS 4.1 Therapeutic Indications For the relief of symptoms associated with allergic rhinitis such as sneezing, nasal discharge and itching, as well as ocular itching, tearing and redness, and itching of palate. For relief of symptoms associated with urticaria such as itching and rash. 4.2 Posology and Method of Administration For relief of symptoms associated with allergic rhinitis (including intermittent and persistent) and urticaria, Aerius ® is taken with or without meal. Adults and adolescents (12 years of age and over) take one tablet (5 mg) 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. The treatment should 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. Pediatric 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 tablets in children below the age of 12 years have not been established. No data are available. Additional information for special populations Geriatric population: The safety and efficacy of Aerius ® has not been established for geriatric population. Renal impairment: Aerius ® should be used with caution in patients with severe renal failure. Hepatic impairment: There is no data regarding administration of Aerius ® in patients with hepatic impair Read the complete document