Levocetirizine Krka 5mg film-coated tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Levocetirizine dihydrochloride

Disponible desde:

KRKA, d.d., Novo mesto

Código ATC:

R06AE; R06AE09

Designación común internacional (DCI):

Levocetirizine dihydrochloride

Dosis:

5 milligram(s)

formulario farmacéutico:

Film-coated tablet

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Piperazine derivatives; levocetirizine

Estado de Autorización:

Marketed

Fecha de autorización:

2011-07-15

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVOCETIRIZINE KRKA 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 or 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.
WHAT IS IN THIS LEAFLET:
1.
What Levocetirizine Krka is and what it is used for
2.
What you need to know before you take Levocetirizine Krka
3.
How to take Levocetirizine Krka
4.
Possible side effects
5.
How to store Levocetirizine Krka
6.
Contents of the pack and other information
1.
WHAT LEVOCETIRIZINE KRKA IS AND WHAT IT IS USED FOR
Levocetirizine dihydrochloride is the active ingredient of
Levocetirizine Krka.
Levocetirizine Krka is an antiallergic medicinal product.
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 KRKA
DO NOT TAKE LEVOCETIRIZINE KRKA:
-
if you are allergic to levocetirizine dihydrochloride or to any other
antihistamine or to any of the
other ingredients of this medicine (listed in section 6),
-
if you have 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 Levocetirizine Krka.
The use of Levocetirizne Krka is not recommended for children under 6
years since the film-coated
tablets do not allow dose adaptation.
If you are likely to be unable to empty your bladder (with conditions
such as spinal cord injury or
enlarged prostate), please ask your doctor for adv

Ficha técnica

Health Products Regulatory Authority
11 September 2019
CRN0099LV
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levocetirizine Krka 5mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg levocetirizine dihydrochloride.
Excipient(s) with known effect: 88.63 mg lactose/tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
The tablets are white, round, biconvex film-coated tablets with
bevelled edges.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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 of age and above:_
The recommended daily dose is 5 mg (1 film-coated tablet).
_ _
_Elderly_
Adjustment of the daily dose is recommended in elderly patients with
moderate to severe renal impairment (see Renal
impairment below).
_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:
Dosage adjustments in patients with impaired renal function:
_Group_
_Creatinine clearance (ml/min)_
_Dosage and frequency_
Normal renal function
≥80
1 tablet once daily
Mild renal impairment
50-79
1 tablet once daily
Moderate renal impairment
30-49
1 tablet once every 2 days
Severe renal impairment
<30
1 tablet once every 3 days
End-stage renal disease. – patients undergoing dialysis
<10-
Contraindicated
In paediatric patients suffering from renal impairment, the dose will
have to be adjusted on an individual basis taking into
account the renal clearance of the patient and his body weight. There
are no specific data for children wit