Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
EBASTINE
Almirall, S.A.
10 Milligram
Tablets
2000-07-21
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Kestine 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Ebastine 10 mg For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated Tablet Film-coated, scored, round tablet engraved with E10 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kestine is indicated for the symptomatic treatment of: o Allergic rhinitis (seasonal and perennial) whether or not associated with allergic conjunctivitis. o Idiopathic chronic urticaria. 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. _Special populations:_ No dose adjustment is needed in patients with renal insufficiency, nor in patients with mild to moderate hepatic insufficiency. A dosage of 10 mg should not be exceeded in patients with severe hepatic insufficiency. 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 Kestine or any of its ingredients. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 01/02/2008_ _CRN 2046057_ _page number: 1_ 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 point 4.5, Interaction with other medicinal products and other for Læs hele dokumentet