Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Desloratidine
Accord Healthcare Ireland Ltd.
R06AX; R06AX27
Desloratidine
5 milligram(s)
Film-coated tablet
Other antihistamines for systemic use; desloratadine
Marketed
2019-09-13
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 IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESLORATADINE TABLETS 3 HOW TO TAKE DESLORATADINE TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE DESLORATADINE TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT DESLORATADINE IS AND WHAT IT IS USED FOR WHAT DESLORATADINE IS Desloratadine contains desloratadine which is an antihistamine. HOW DESLORATADINE WORKS Desloratadine 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 and adolescents 12 years 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 DO NOT TAKE DESLORATADINE • if you are allergic to desloratadine, or 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 De Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 16 August 2023 CRN00DKLC Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Desloratadine 5mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg desloratadine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet). Blue, round shaped, biconvex, film-coated tablets debossed with "J7" on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Desloratadine is indicated in adults and adolescents aged 12 years and older 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 one tablet 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 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 per week and for more than 4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods. _Paediatric population_ There is limited clinical trial efficacy experience with the use of desloratadine in adolescents 12 through 17 years of age (see sections 4.8 and 5.1). The safety and efficacy of Desloratadine 5 mg film-coated tablets in children below the age of 12 years have not been established. Method of administration Oral use. The dose can be taken with or without food. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to loratadine. Health Products Regulatory Authority 16 August 2023 CRN00DKLC Page 2 of 7 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE In the case of severe renal insuffici Olvassa el a teljes dokumentumot