XYZAL TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

GlaxoSmithKline South Africa (Pty) Limited

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

Authorization status:

Registered

Authorization date:

2006-04-05

Patient Information leaflet

Page 1 of 10
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S2
XYZAL
Levocetirizine dihydrochloride 5 mg film-coated tablets
XYZAL tablets contains sugar (63,50 mg lactose monohydrate per tablet)
XYZAL
ORAL SOLUTION
Levocetirizine dihydrochloride 0,5 mg/mL oral solution
XYZAL ORAL SOLUTION contains sugar (0,4 g maltitol per mL)
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
XYZAL is available without a doctor
'
s prescription, for you to treat a mild illness. Nevertheless,
you still need to use XYZAL carefully to get the best results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share XYZAL with any other person.
•
Ask your health care provider or pharmacist if you need more
information or advice.
•
You or your child must see a doctor if your symptoms worsen or do not
improve after 14 to
21 days.
WHAT IS IN THIS LEAFLET:
1. What XYZAL is and what it is used for
2. What you need to know before you use XYZAL
3. How to take XYZAL
4. Possible side effects
5. How to store XYZAL
Page 2 of 10
6. Contents of the pack and other information.
1.
WHAT XYZAL IS AND WHAT IT IS USED FOR
The active ingredient, levocetirizine dihydrochloride, is an
antihistamine for systemic use. It is
used for the treatment of signs of illness (symptoms) associated with:
•
allergic rhinitis (including persistent allergic rhinitis)
•
chronic nettle rash of unknown origin (chronic idiopathic urticaria).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XYZAL
DO NOT TAKE XYZAL:
•
if you or your child are hypersensitive (allergic) to levocetirizine
dihydrochloride, to cetirizine, to hydroxyzine or any other substances
with a similar chemical structure or to one of the other ingredients
of
XYZAL (listed in section 6 ‘What XYZAL contains’
•
if you or your child have a severe impairment of kidney function.
WARNINGS AND PRECAUTIONS:
Take special care if you have predisposing factors of urinary
retention (inability to completely
empty your bladder) (e.g. spinal cord lesions, prostat

Summary of Product characteristics

Page 1 of 15
NCDS07
XYZAL ORAL SOLUTION AND TABLETS
SCHEDULING STATUS:
S2
1.
NAME OF THE MEDICINE:
XYZAL
Levocetirizine dihydrochloride 5 mg film-coated tablets
XYZAL
ORAL SOLUTION
Levocetirizine dihydrochloride 0,5 mg/mL oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
EACH FILM-COATED TABLET CONTAINS 5 MG LEVOCETIRIZINE DIHYDROCHLORIDE.
_Excipient with known effect: _
Contains sugar (63,50 mg lactose monohydrate per tablet).
EACH 1 ML ORAL SOLUTION CONTAINS 0,5 MG LEVOCETIRIZINE
DIHYDROCHLORIDE.
_Excipients with known effect: _
0,675 mg methyl parahydroxybenzoate per mL
0,075 mg propyl parahydroxybenzoate per mL
Contains sugar (0,4 g maltitol per mL).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM:
XYZAL: film-coated tablets.
White to off-white, oval film-coated tablet with a Y logo on one side.
Page 2 of 15
NCDS07
XYZAL ORAL SOLUTION: oral solution.
Clear and colourless solution. 4.
CLINICAL PARTICULARS:
4.1 THERAPEUTIC INDICATIONS:
XYZAL is indicated for the relief of symptoms associated with the
following allergic conditions:
•
seasonal allergic rhinitis
•
perennial allergic rhinitis
•
chronic idiopathic urticaria.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION:
XYZAL FILM-COATED TABLET:
The film-coated tablet must be taken orally, swallowed 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 OF AGE AND OLDER:
The daily recommended dose is one 5 mg tablet.
_ _
ELDERLY:
Adjustment of the dose is recommended in elderly patients with
moderate to severe renal
impairment (see “Patients with renal impairment below”).
CHILDREN:
For children aged 2 – 6 years no adjusted dosage is possible with
the film-coated tablet
formulation. IT IS RECOMMENDED TO USE XYZAL ORAL SOLUTION (see section
4.4).
_Children aged 6 – 12 years: _
Page 3 of 15
NCDS07
The daily recommended dose is one 5 mg tablet.
XYZAL ORAL SOLUTION:
An oral syringe is included in the package. The appropriate volume o