Xyzal 5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levocetirizine dihydrochloride

Available from:

Imbat Limited

ATC code:

R06AE; R06AE09

INN (International Name):

Levocetirizine dihydrochloride

Dosage:

5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Piperazine derivatives; levocetirizine

Authorization status:

Authorised

Authorization date:

2007-12-19

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XYZAL
® 5 MG FILM-COATED TABLETS
For adults and children aged 6 years and above
(levocetirizine dihydrochloride)
Your medicine is available using the above name but will be
referred to as Xyzal throughout this leaflet.
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

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(s) with known effect
Lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from the UK & Czech Republic_
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
Microcrystalline cellulose
Lactose monohydrate
Colloidal anhydrous silica
Magnesium stearate
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 shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
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6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer containing blister strips. Pack size: 28 or 30.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISAT