XYZAL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LEVOCETIRIZINE DIHYDROCHLORIDE

Available from:

PCO Manufacturing

ATC code:

R06AE09

INN (International Name):

LEVOCETIRIZINE DIHYDROCHLORIDE

Dosage:

5 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

levocetirizine

Authorization status:

Authorised

Authorization date:

2005-11-04

Patient Information leaflet

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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 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 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
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 with known effect: lactose monohydrate
_For a full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Film-coated Tablet
_Product imported from Austria, the United Kingdom, Czech Republic and
the Netherlands:_
White to off-white, oval, film-coated tablet with a Y logo on one side
4 CLINICAL PARTICULARS
As per PA0891/003/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0891/003/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Core:
Microcrystalline cellulose
Lactose monohydrate
Colloidal anhydrous silica
Magnesium stearate
Coating:
Hypromellose (E464)
Titanium dioxide (E 171)
Macrogol 400
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the
market in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
No special precautions for storage.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 28 and 30 tablets contained in an outer cardboard
carton.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALL