Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
DESLORATIDINE
Rosemont Pharmaceuticals Ltd
R06AX27
DESLORATIDINE
0.5 Mg/Ml
Oral Solution
Oral use
Bottle holding 150 ml of solution
Product subject to prescription which may be renewed (B)
Rosemont Pharmaceuticals Ltd
Antihistamines – H1 antagonist
Other antihistamines for systemic use
It is indicated in adults, adolescents and children over the age of 1 year for the relief of symptoms associated with: allergic rhinitis, urticaria
Authorised
2015-05-15
DESLORATADINE 0.5MG/ML ORAL SOLUTION 20.03.15 SEVEN 212 1 of 2 0.5MG/ML N/A Rosemont YES - 210 x 300mm (folded 150 x 30mm) 1 Black Keyline 150ML P0723 ■ ■ 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. PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _Continued overleaf_ 1. WHAT DESLORATADINE ORAL SOLUTION IS AND WHAT IT IS USED FOR WHAT DESLORATADINE IS It contains desloratadine which is an antihistamine. HOW DESLORATADINE WORKS It is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms. WHEN DESLORATADINE SHOULD BE USED Desloratadine 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 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 normal daily activities and sleep. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESLORATADINE ORAL SOLUTION DO NOT TAKE DESLORATADINE ORAL SOLUTION ■ ■ if you are allergic to desloratadine, or to any of the other ingredients of this medicine (listed in section 6) or to loratadine. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking desloratadine: ■ ■ if you have poor kidney function. USE IN CHILDREN AND ADOLESCENTS Do not give th Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Desloratadine 0.5 mg/ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 0.5mg desloratadine_._ Excipient(s) with known effect This medicinal product contains 150 mg/ml sorbitol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution A clear colourless solution. 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 oral solution is 10ml (5mg) 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 oral solution. 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 0.5mg/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 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 08/09/2016_ _CRN 2174792_ _page number: 1_ adolescents 12 through 17 years of age (see sections 4.8 and 5.1). Inter Прочетете целия документ