Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
LEVOCETIRIZINE DIHYDROCHLORIDE
Primecrown 2010 Ltd
R06AE09
LEVOCETIRIZINE DIHYDROCHLORIDE
5 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Piperazine derivatives
Authorised
2010-05-28
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: contains lactose monohydrate (63.5mg per tablet) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from the UK_ White to off-white, oval, film-coated tablet with a Y logo on one side and plain on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and 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. The CLcr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula: Dosing Adjustments for Patients with Impaired Renal Fun Przeczytaj cały dokument