Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Levocetirizine dihydrochloride
Imbat Limited
R06AE; R06AE09
Levocetirizine dihydrochloride
5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Piperazine derivatives; levocetirizine
Authorised
2011-05-03
Health Products Regulatory Authority 18 October 2019 CRN009DT8 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levocetirizine 5 mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5mg of levocetirizine dihydrochloride. Contains lactose. 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, film coated oval shaped tablet; One side of the tablet is debossed with LC5. The other side of the tablet is plain. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levocetirizine is indicated for the symptomatic treatment of perennial allergic rhinitis, seasonal 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. _Adults and adolescents:_ The recommended dose is 5 mg once daily _Children aged between 6 and 12 years:_ The daily recommended dose is 5 mg once daily Levocetirizine is not recommended for use in children below the age of 6 due to insufficient data on safety and efficacy. _The elderly:_ At present there are no data to suggest that the dose needs to be reduced in elderly subjects provided that their renal function is normal. _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 Function: Group Creatinine clearance (ml/min) Dosage and frequency Health Products Regulatory Authority 18 October 2019 CRN009DT8 Page 2 of 7 Normal ≥80 1 tablet once daily Mild 50-79 1 tablet once daily Moderate 30-49 1 tablet once every 2 days Severe < Прочетете целия документ