XYZAL 5 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LEVOCETIRIZINE DIHYDROCHLORIDE

Available from:

B & S Healthcare

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:

Piperazine derivatives

Authorization status:

Authorised

Authorization date:

2009-08-07

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE 
USER 

 XYZAL
®
 5MG FILM-COATED TABLETS 
(levocetirizine dihydrochloride) 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 
START TAKING THIS MEDICINE. 

•  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. Do 
not pass it on to others. It may harm them, 
even if their symptoms are the same as yours. 
•  If any of the side effects gets serious, or if you 
notice any side effects not listed in this leaflet, 
please tell your doctor or pharmacist. 

IN THIS LEAFLET: 

1.  What Xyzal is and what it is used for 
2.  Before you take Xyzal 
3.  How to take Xyzal 
4.  Possible side effects 
5.  How to store Xyzal 
6.  Further 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. BEFORE YOU TAKE XYZAL 

DO NOT TAKE XYZAL 

if you are ALLERGIC (HYPERSENSITIVE) to 
levocetirizine dihydrochloride or to an 
antihistamine or any of the other ingredients of 
Xyzal (see ‘What Xyzal contains’) if you have A 
SEVERE IMPAIRMENT OF KIDNEY FUNCTION 
(severe renal failure with creatinine clearance 
below 10ml/min). 

TAKE SPECIAL CARE WITH XYZAL 

The use of Xyzal is not recommended in children 
less than 6 years since the film-coated tablets do 
not allow for dose adaptation. 

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. 

TAKING OTHER MEDICINES 

Please tell your

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xyzal 5mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg levocetirizine dihydrochloride.
Excipients: lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
_Product imported from the UK_
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 05/02/2015_
_CRN 2157661_
_page number: 1_
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium – OPA/aluminium/PVC blister
Carton containing 30 tablets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
B & S Healthcare
Unit 4, Bradfield Road
Ruislip
Middlesex HA4 0NU
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1328/114/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 7
th
August 2009
10 DATE OF REVISION