País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Desloratidine
Rowex Ltd
R06AX; R06AX27
Desloratidine
0.5 milligram(s)/millilitre
Oral solution
Product subject to prescription which may be renewed (B)
Other antihistamines for systemic use; desloratadine
Marketed
2012-06-22
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DESLOR 0.5 MG/ML ORAL SOLUTION desloratadine 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 Deslor is and what it is used for 2. What you need to know before you take Deslor 3. How to take Deslor 4. Possible side effects 5. How to store Deslor 6. Contents of the pack and other information 1. WHAT DESLOR IS AND WHAT IT IS USED FOR WHAT DESLOR IS Deslor contains desloratadine which is an antihistamine. HOW DESLOR WORKS Deslor oral solution is an anti-allergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms. WHEN DESLOR SHOULD BE USED Deslor 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. Deslor 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 DESLOR DO NOT TAKE DESLOR - 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 nur Llegiu el document complet
Health Products Regulatory Authority 29 June 2022 CRN00CZ8N Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Deslor 0.5 mg/ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral solution contains 0.5 mg of desloratadine. Excipients with known effect Each ml of oral solution contains up to 97.5 mg of sorbitol, 102.30 mg of propylene glycol and 0.167 mmol (3.85 mg) of sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Deslor 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 Deslor 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 Deslor. Children 1 through 5 years of age: 2.5 ml (1.25 mg) Deslor oral solution once a day. Children 6 through 11 years of age: 5 ml (2.5 mg) Deslor oral solution once a day. The safety and efficacy of Deslor 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 persistent allergic rhinitis (presence of symptoms Llegiu el document complet