Levocetirizine Glenmark 5 mg Film-coated Tablets

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Levocetirizine dihydrochloride

Prieinama:

Glenmark Arzneimittel GmbH

ATC kodas:

R06AE; R06AE09

INN (Tarptautinis Pavadinimas):

Levocetirizine dihydrochloride

Dozė:

5 milligram(s)

Vaisto forma:

Film-coated tablet

Gydymo sritis:

Piperazine derivatives; levocetirizine

Autorizacija statusas:

Not marketed

Leidimo data:

2010-05-28

Pakuotės lapelis

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Levocetirizine Glenmark 5mg Film-coated tablets
Levocetirizine dihydrochloride
For adults and children aged 6 years and above
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 Glenmark
is and what it is used for
2.
What you need to know before you take Levocetirizine Glenmark
3.
How to take Levocetirizine Glenmark
4.
Possible side effects
5.
How to store Levocetirizine Glenmark
6.
Contents of the pack and other information
1.
WHAT LEVOCETIRIZINE GLENMARK 5MG FILM-COATED TABLETS
IS AND WHAT IT IS USED FOR
Levocetirizine dihydrochloride is the active ingredient of
Levocetirizine Glenmark 5mg film-coated
tablets.
Levocetirizine Glenmark 5mg Film-coated tablets is an antiallergic
medication. For the treatment
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 GLENMARK 5MG
FILM-COATED
TABLETS
DO NOT TAKE LEVOCETIRIZINE GLENMARK 5MG FILM-COATED TABLETS:
•
if you are allergic to levocetirizine dihydrochloride, to cetirizine,
to hydroxuzine or any of the
other ingredients of this medicine (listed in section 6).
•
If you have a severe kidney disease requiring dialysis
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Levocetirizine
Glenmark 5 mg Film-coated tablets.
If you are likely to be unable to empty your bladder (with conditions
such as spinal cord injury or
enlarged prosta

Prekės savybės

Health Products Regulatory Authority
19 October 2023
CRN00DJNV
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levocetirizine Glenmark 5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg levocetirizine dihydrochloride.
Excipients: 60.27 mg lactose per tablet.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White oval film coated biconvex tablets, one side embossed with G
breakline G and the other side plain. The tablet can be
divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levocetirizine Glenmark 5 mg film-coated tablets are 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 Renal impairment
below).
_Renal impairment: _
The dosing intervals must be individualised according to renal
function (eGFR – estimated Glomerular Filtration Rate). Refer to
the following table and adjust the dose as indicated.
Dosing adjustments for patients with impaired renal function:
Group
eGFR (ml/min)
Dosage and frequency
Normal renal function
≥ 90
1 tablet once daily
Mildly decreased renal function
60–< 90
1 tablet once daily
Moderately decreased renal function
30 – < 60
1 tablet once every 2 days
Severely decreased renal function
15 – < 30
(not requiring dialysis)
1 tablet once every 3 days
End-stage renal disease - (ESRD)
< 15(requiring dialysis treatment)
Contra-indicated
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 chi