Levocetirizine 5 mg Film-Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levocetirizine dihydrochloride

Available from:

Imbat Limited

ATC code:

R06AE; R06AE09

INN (International Name):

Levocetirizine dihydrochloride

Dosage:

5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Piperazine derivatives; levocetirizine

Authorization status:

Authorised

Authorization date:

2011-05-03

Summary of Product characteristics

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
<