Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
EBASTINE
Almirall, S.A.
20mg Milligram
Tablets
2005-04-15
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Kestine 20 mg Film-Coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains ebastine 20 mg For a list of excipients see section 6.1 3 PHARMACEUTICAL FORM Film-Coated tablet. A round white film-coated tablet embossed with E20 on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kestine is indicated for the symptomatic treatment of allergic rhinitis (seasonal and perennial) whether or not associated with allergic conjunctivitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Allergic rhinitis: Kestine at a dose of 10 mg once-a-day is efficacious in the relief of the symptoms of allergic rhinitis; in patients with more severe symptoms including perennial allergic rhinitis, 20 mg once-a-day provides additional benefit. Idiopathic chronic urticaria: The adult dose is one 10 mg tablet once daily. Kestine may be taken with or without food. The safety and efficacy of Kestine in children less than 12 years has not been established. 4.3 CONTRAINDICATIONS Patients with a known hypersensitivity to ebastine or any of the tablet ingredients. Patients with severe liver insufficiency. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Since there is a pharmacokinetic interaction with antimycotics of the imidazol type like ketoconazole or macrolid antibiotics like erythromycin (_see section 4.5, Interaction with other medicinal products and other forms of_ _interactions_) care should be taken when prescribing ebastine with medicines that contain such drugs. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/08/2008_ _CRN 2054294_ _page number: 1_ Ebastine should be used with caution in patients with renal insufficiency Přečtěte si celý dokument