Xyzal 0.5mg/ml oral solution

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 0.5 mg/ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

LEVOCETIRIZINE DIHYDROCHLORIDE 0.5 mg/ml

Prescription type:

POM

Therapeutic area:

ANTIHISTAMINES FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2007-09-03

Patient Information leaflet

XYZAL 0.5 MG/ML ORAL SOLUTION
Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XYZAL 0.5 MG/ML ORAL SOLUTION
For adults and children aged 2 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.

Summary of Product characteristics

XYZAL 0.5 MG/ML ORAL SOLUTION
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SUMMARY OF PRODUCT CHARACTERISTICS
XYZAL 0.5 MG/ML ORAL SOLUTION
Page 2 of 11
1.
NAME OF THE MEDICINAL PRODUCT
Xyzal 0.5 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of oral solution contains 0.5 mg levocetirizine dihydrochloride.
Excipients with known effect
0.675 mg methyl parahydroxybenzoate/ml
0.075 mg propyl parahydroxybenzoate/ml
0.4 g maltitol liquid/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xyzal 0.5 mg/ml oral solution is indicated for symptomatic treatment
of allergic rhinitis (including persistent
allergic rhinitis) and urticaria in adults and children aged 2 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 (10 ml of solution).
_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
eGRF
(ml/min)
Dosage and frequency
Normal renal function
≥
90
5 mg once daily
Mildly decreased renal function
60 – < 90
5 mg once daily
Moderately decreased renal
function
30 – < 60
5 mg once every 2 days
Severely decreased renal
function
15 – < 30
(not requiring dialysis)
5 mg once every 3 days
End stage renal disease (ESDR)
< 15
(requiring dialysis treatment)
Contra-indicated
XYZAL 0.5 MG/ML ORAL SOLUTION
Page 3 of 11
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