Levocetirizine dihydrochloride 5 mg Film-Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levocetirizine dihydrochloride

Available from:

Bristol Laboratories 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:

Marketed

Authorization date:

2012-09-07

Patient Information leaflet

SAME SIZE ARTWORK
240 x 160 mm
Front
24 mm
160 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG
FILM-COATED TABLETS
LEVOCETIRIZINE DIHYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor
o r
pharmacist.
-
This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
THE NAME OF YOUR MEDICINE IS LEVOCETIRIZINE
DIHYDROCHLORIDE 5 MG FILM-COATED TABLETS. HERE
AFTER IT WILL BE REFERRED TO AS LEVOCETIRIZINE
TABLETS THROUGHOUT THE LEAFLET.
WHAT IS IN THIS LEAFLET:
1 .
What Levocetirizine Tablets are and what they
are used for
2 .
What you need to know before you take
Levocetirizine Tablets
3 .
How to take Levocetirizine Tablets
4 .
Possible side-effects
5 .
How to store Levocetirizine Tablets
6 .
Contents of the pack and other information
1. WHAT LEVOCETIRIZINE TABLETS ARE AND WHAT THEY
ARE USED FOR
The name of your medicine is Levocetirizine 5 mg
Film-coated Tablets and the active substance is
Levocetirizine dihydrochloride.
Levocetirizine Tablets is an antiallergic medication.
For the treatment of signs of illness (symptoms)
associated with:
•
Allergic rhinitis (including persistent allergic rhinitis)
•
Nettle rash (urticaria).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LEVOCETIRIZINE TABLETS
DO NOT TAKE LEVOCETIRIZINE TABLETS:
•
If you are allergic to levocetirizine dihydrochloride
or to an antihistamine or any of the other ingredients
of this medicine (listed in section 6)
•
If you have a severe impairment of kidney function
(severe renal failure with creatinine clearance below
10 ml/min).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking

Summary of Product characteristics

Health Products Regulatory Authority
25 April 2019
CRN008J8V
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levocetirizine dihydrochloride 5 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of levocetirizine
dihydrochloride.
Excipient with known effect: Also contains, Lactose Monohydrate 70.0mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated Tablet (Tablet)
White to off white, oval, biconvex film coated tablets with ‘BL’
embossed on one side and ‘5’ embossed on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levocetirizine is indicated in the symptomatic treatment of allergic
rhinitis (including persistent allergic rhinitis) and urticaria in
adults and children aged 6 years and above.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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 possible with the
film-coated tablet formulation. It is recommended to
use a paediatric formulation of levocetirizine.
ADULT PATIENTS WITH RENAL IMPAIRMENT:
The dosing intervals must be individualised 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:
Health Products Regulatory Authority
25 April 2019
CRN008J8V
Page 2 of 9
DOSING ADJUSTMENTS FOR PATIENTS WITH IMPAIRED RENAL FUNCTION:
GROUP
CREATININE CLEARANCE (ML/MIN)
DOSAGE AND FREQUENCY
Normal
80
5 mg once daily
Mild
50 – 79
5 mg once daily
Moder