Levocetirizine 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levocetirizine dihydrochloride

Available from:

DE Pharmaceuticals

ATC code:

R06AE09

INN (International Name):

Levocetirizine dihydrochloride

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100

Patient Information leaflet

340 mm
Levocetirizine dihydrochloride
For adults and children aged 6 years and above
SAME SIZE ARTWORK
SIZE: 170 mm x 340 mm
170 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOCETIRIZINE 5 MG FILM-COATED TABLETS
FONT TYPE: TIMES NEW ROMAN
FONT SIZE: 9 PT
DATE: 26-02-2019
VERSION: 01 (UK)
VARIATION NO. : PT/H/0250/001/IB/015
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 5 mg film-coated tablets are
and what they are used for
2. What
you
need
to
know
before
you
take
Levocetirizine 5 mg film-coated tablets
3. How to take Levocetirizine 5 mg film-coated
tablets
4. Possible side effects
5. How to store Levocetirizine 5 mg film-coated
tablets
6. Contents of the pack and other information
1. WHAT LEVOCETIRIZINE 5 MG FILM-COATED TABLETS
ARE AND WHAT THEY ARE USED FOR
Levocetirizine
is
a
type
of
medicine
called
a non-sedating antihistamine. It is used to treat signs
and symptoms of an allergic reaction such as:
●
an itchy rash similar to nettle rash which lasts
a long time (urticaria).
2. WHAT
YOU
NEED
TO
KNOW
BEFORE
YOU
TAKE
LEVOCETIRIZINE 5 MG FILM-COATED TABLETS
DO NOT TAKE LEVOCETIRIZINE 5 MG FILM-COATED
TABLETS
●
if
you
are
allergic
to
l e v o c e t i r i z i n e
dihydrochloride, to cetirizine, to hydroxyzine 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
Levocet

Summary of Product characteristics

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 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 halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of chronic idiopathic urticaria
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Method of administration _
The film-coated tablet must be taken orally, swallowed whole with
liquid and may be
taken with or without food. It is recommended to take the daily dose
in one single
intake.
_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).
_Children aged 2 to 6 years: _
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
_Infants and toddlers aged less than 2 years_ :
The administration of levocetirizine is not recommended
_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:
Dosing Adjustments for Patients with Impaired Renal Function:
Group
Creatinine clearance
(ml/min)
Dosage and frequency
Normal
80
5 mg once daily
Mild
50