XYZAL 5 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-01-2015
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Active ingredient:
LEVOCETIRIZINE DIHYDROCHLORIDE
Available from:
Primecrown 2010 Ltd
ATC code:
R06AE09
INN (International Name):
LEVOCETIRIZINE DIHYDROCHLORIDE
Dosage:
5 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Piperazine derivatives
Authorization status:
Authorised
Authorization date:
2010-05-28
Summary of Product characteristics
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
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