Levocetirizine 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levocetirizine dihydrochloride

Available from:

Phoenix Healthcare Distribution Ltd

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

Levocetirizine dihydrochloride
For adults and children aged 6 years and above
SAME SIZE ARTWORK
SIZE: 170 mm x 300 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOCETIRIZINE 5 MG FILM-COATED TABLETS
FONT TYPE: TIMES NEW ROMAN
FONT SIZE: 9 PT
DATE: 17-12-2019
VERSION: 01 (UK)
variation number: PT/H/0250/001/IB/0016
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. 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 dihydrochloride is the active ingredient of
Levocetirizine 5 mg film-coated tablets.
Levocetirizine 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 5 MG FILM-COATED TABLETS
DO NOT TAKE LEVOCETIRIZINE 5 MG FILM-COATED TABLETS
●
if you are allergic to levocetirizine 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 PRECAUT

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 doses.
4.1
THERAPEUTIC INDICATIONS
Levocetirizine 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 ears 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:
[140-age (years)] x weight (kg)
CLcr (ml/min)
=
-----------------------------------------(x
0.85 for women)
72 x serum creatinine (mg/dl)
Dosing adjustments for patients with impaired renal function:
Group
Creatinine clearance
(ml/min)
Dosage and frequency
Normal
80
1 tablet once daily
Mild
50 – 79
1 tablet once daily
Moderate
30 – 49
1 tablet once every 2 days
Severe
< 30
1 tablet once every 3 days
End-stage renal disease -
Patients undergoing
dialysis
< 10-
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 pat