Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
EBASTINE
Lindopharm GmbH
EBASTINE
10 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ebastion 10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ebastion 10 mg film-coated tablets: 1 film-coated tablet of Ebastion 10 mg contains: 10 mg ebastine For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Ebastion 10 mg film-coated tablets are white to off-white, round, bevelled film-coated tablets with a score line on one side and a diameter of 7.1 mm. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic treatment of seasonal and perennial allergic rhinitis with or without allergic conjunctivitis. To improve itching and to reduce new weal formation in urticaria of unclear origin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The experience in children under the age of 12 years is limited. ALLERGIC RHINITIS: For children 12 years and above and adults the following dosage recommendations apply: 1 film-coated tablet (10 mg ebastine) once daily. In cases of severe symptoms and for perennial allergic rhinitis the dose may be increased to 2 film-coated tablets (20 mg ebastine) once daily. URTICARIA: For adults above 18 years the following dosage recommendations apply: 1 film-coated tablet (10 mg ebastine) once daily. Special subject groups: In patients with renal insufficiency, no dose adjustment is necessary for treatment up to 5 days. In patients with mild to moderate hepatic insufficiency, no dose adjustment is necessary for treatment up to 7 days. A dosage of 10 mg daily should not be exceeded in patients with severe hepatic insufficiency. Method of administration: The film-coated tablets should be taken unchewed with liquid. Ebastine can be taken at meal times or independently of meals সম্পূর্ণ নথি পড়ুন