国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Desloratadine
Actavis UK Ltd
R06AX27
Desloratadine
500microgram/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5012617025036 5012617025043
DESLORATADINE 0.5MG/ML ORAL SOLUTION PACKAGE LEAFLET: INFORMATION FOR THE USER _Continued over page_ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • 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. 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 Desloratadine Oral Solution is an anti-allergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms. 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 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 (hypersensitive) to desloratadine, loratadine, or to any of the other ingredients of Desloratadine Oral Solution (listed in section 6). WARNINGS AND PRECAUTIONS TAKE 完全なドキュメントを読む
OBJECT 1 DESLORATADINE 0.5MG/ML ORAL SOLUTION Summary of Product Characteristics Updated 07-Mar-2018 | Accord-UK Ltd 1. Name of the medicinal product Desloratadine 0.5mg/ml Oral Solution 2. Qualitative and quantitative composition Each ml of oral solution contains 0.5 mg desloratadine. Excipients with known effect Sorbitol (E420) Sodium citrate Disodium edentate Propylene glycol (E1520) For a 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 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 Desloratadine may be taken without regard to mealtime for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1). 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. In adults and adolescents (12 years of age and over): 10 ml (5 mg) Desloratadine oral solution once a day. 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 persistent allergic rhinitis (presence of symptoms for 4 days or more 完全なドキュメントを読む