Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
LEVOCETIRIZINE DIHYDROCHLORIDE
IPS Healthcare Limited
5 Milligram
Film Coated Tablet
2011-07-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xyzal 5mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg levocetirizine dihydrochloride. Excipients: 63.50 mg lactose monohydrate / tablet For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablets _Product imported from the UK:_ White to off-white, oval, film-coated tablet with a Y logo on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and chronic idiopathic urticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The film-coated tablet must be taken orally, swallowed whole with liquid and may be taken with or without food. It is recommended to take the daily dose in one single intake. _Adults and adolescents 12 years and above:_ The daily recommended dose is 5 mg (1 film-coated tablet). _Elderly:_ Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Patients with renal impairment below). _Children aged 6 to 12 years:_ The daily recommended dose is 5 mg (1 film-coated tablet). For children aged 2 to 6 years no adjusted dosage is yet possible with the film-coated tablet formulation. It is recommended to use a paediatric formulation of levocetirine. _Patients with renal impairment:_ The dosing intervals must be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in ml/min is needed. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 11/07/2011_ _CRN 2099607_ _page numb Lire le document complet