Levocetirizine Glenmark 5 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levocetirizine dihydrochloride

Available from:

Glenmark Pharmaceuticals Europe 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:

Not marketed

Authorization date:

2010-05-28

Patient Information leaflet

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 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 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
prostate), please ask your doctor for advice.
If you suffer from epilepsy or are at risk of convulsions,
please ask

Summary of Product characteristics

Health Products Regulatory Authority
27 November 2020
CRN009HC8
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. 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:
Health Products Regulatory Authority
27 November 2020
CRN009HC8
Page 2 of 9
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 with renal impairment.
_ _
_Hepatic impairment: _
No dose adjustment is needed in patients with solely hepatic
impairment. In patients with hepatic impairment and