Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Desloratidine
Glenmark Arzneimittel GmbH
R06AX; R06AX27
Desloratidine
5 milligram(s)
Tablet
Other antihistamines for systemic use; desloratadine
Not marketed
2012-04-20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DESLORATADINE GLENMARK 5 MG TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING/USING 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 Glenmark 5 mg Tablets are and what they are used for 2. What you need to know before you take Desloratadine Glenmark 5 mg Tablets 3. How to take Desloratadine Glenmark 5 mg Tablets 4. Possible side effects 5. How to store Desloratadine Glenmark 5 mg Tablets 6. Contents of the pack and other information 1. WHAT DESLORATADINE GLENMARK 5 MG TABLETS ARE AND WHAT THEY ARE USED FOR WHAT DESLORATADINE 5 MG TABLETS IS Desloratadine 5 mg Tablets contain desloratadine which is an antihistamine. HOW DESLORATADINE 5 MG TABLETS WORKS Desloratadine 5 mg Tablets is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms. WHEN DESLORATADINE 5 MG TABLETS SHOULD BE USED • Desloratadine relieves symptoms associated with ALLERGIC RHINITIS (inflammation of the nasal passages caused by an allergy, 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 symptoms of 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 GLENMA Belgenin tamamını okuyun
Health Products Regulatory Authority 24 August 2022 CRN00D3ND Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Desloratadine Glenmark 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5mg desloratadine. Excipient(s) with known effect: This medicine contains lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Off white to light pink, circular, biconvex with ‘L5’ debossed on one side and plain on the other side. Diameter: approximately 10.5mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Desloratadine Glenmark 5mg Tablets are 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 Glenmark 5mg Tablets 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 Glenmark in children under the age of 12 years have not been established. Method of administration: Oral use. The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water). The dose can be taken with or without food. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance, to any of the excipients Belgenin tamamını okuyun