Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Desloratidine
Accord Healthcare Ireland Ltd.
R06AX; R06AX27
Desloratidine
0.5 milligram(s)/millilitre
Oral solution
Other antihistamines for systemic use; desloratadine
Marketed
2020-10-30
DESLORATADINE 0.5 MG/ML ORAL SOLUTION desloratadine PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _Continued over page_ _Continued top of next column_ BBBA8815 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. SEE SECTION 4. WHAT IS IN THIS LEAFLET 1 WHAT DESLORATADINE ORAL SOLUTION IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESLORATADINE ORAL SOLUTION 3 HOW TO TAKE DESLORATADINE ORAL SOLUTION 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE DESLORATADINE ORAL SOLUTION 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT DESLORATADINE ORAL SOLUTION IS AND WHAT IT IS USED FOR WHAT DESLORATADINE ORAL SOLUTION IS Desloratadine Oral Solution contains desloratadine which is an antihistamine. HOW DESLORATADINE ORAL SOLUTION WORKS Desloratadine Oral Solution oral solution is an anti-allergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms. WHEN DESLORATADINE ORAL SOLUTION SHOULD BE USED Desloratadine Oral Solution relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults, adolescents and children 1 year of age and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes. Desloratadine Oral Solution is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives. Relief of these symptoms lasts a full day and helps you to resume your no Aqra d-dokument sħiħ
Health Products Regulatory Authority 19 November 2020 CRN008LL0 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Desloratadine 0.5 mg/ml oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral solution contains 0.5 mg desloratadine. Excipient with known effect: Each ml of oral solution contains 148 mg sorbitol (E420) and 103 mg propylene glycol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution Desloratadine is a clear, colourless solution free from foreign matter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Desloratadine is indicated in adults, adolescents and children over the age of 1 year for the relief of symptoms associated with: - allergic rhinitis (see section 5.1) - urticaria (see section 5.1) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and adolescents (12 years of age and over)_ The recommended dose of desloratadine is 10 ml (5 mg) oral solution once a day. _Paediatric population_ The prescriber should be aware that most cases of rhinitis below 2 years of age are of infectious origin (see section 4.4) and there are no data supporting the treatment of infectious rhinitis with desloratadine. Children 1 through 5 years of age: 2.5 ml (1.25 mg) desloratadine oral solution once a day. Children 6 through 11 years of age: 5 ml (2.5 mg) desloratadine oral solution once a day. The safety and efficacy of desloratadine 0.5 mg/ml oral solution in children below the age of 1 year have not been established. No data are available. There is limited clinical trial efficacy experience with the use of desloratadine in children 1 through 11 years of age and adolescents 12 through 17 years of age (see sections 4.8 and 5.1). 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 Aqra d-dokument sħiħ