Xyzal 5mg Film-Coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LEVOCETIRIZINE DIHYDROCHLORIDE

Available from:

UCB Pharma SA 60 Allee de la Recherche, B-1070 Brussels, Belgium

ATC code:

R06AE09

INN (International Name):

LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

Prescription type:

POM

Therapeutic area:

ANTIHISTAMINES FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2005-10-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XYZAL 5 MG FILM-COATED TABLETS
For adults and children aged 6 years and above
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 Xyzal is and what it is used for
2.
What you need to know before you take Xyzal
3.
How to take Xyzal
4.
Possible side effects
5.
How to store Xyzal
6.
Contents of the pack and other information
1.
WHAT XYZAL IS AND WHAT IT IS USED FOR
Levocetirizine dihydrochloride is the active ingredient of Xyzal.
Xyzal 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 XYZAL
DO NOT TAKE XYZAL
-
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 kidney disease requiring dialysis.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Xyzal.
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
your doctor for advice as
use of Xyzal may cause seizure aggravation.
If you are scheduled for allergy testing, ask your doctor if you
should stop taking Xyzal for
several days before testing. This medicine may affect your allergy
tes

Summary of Product characteristics

PAGE 1 OF 12
1.
NAME OF THE MEDICINAL PRODUCT
Xyzal 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg levocetirizine dihydrochloride.
Excipient(s) with known effect
63.50 mg lactose monohydrate/tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, oval, film-coated tablet with a Y logo on one
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xyzal 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.
PAGE 2 OF 12
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 children with renal impairment.
_Hepatic impairment_
No dose adjustment is needed in patients with solely hepatic
impairment. In patients with hepatic
impairment and rena