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UCB (Pharma) Ireland Limited

United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland
Telephone: + 353 14637395
Medical Information Direct Line: +353 1 463 2371
Medical Information e-mail: UCBCares.IE@ucb.com
Summary of Product Characteristics last updated on medicines.ie: 13/11/2017
SPC Xyzal 5mg Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 13/11/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   08-Nov-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Changes in section 2: Editorial change introduced.

Changes in section 4.4: Addition of a  precaution of use in patients with epilepsy and patients at risk of convulsion, consistent with the information already contained in Section 4.8 Undesirable effects .

Updated on 11/01/2017 and displayed until 13/11/2017
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   06-Jan-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Change to section 4.4: addition of
  • Response to allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.

 

  • Pruritus may occur when levocetirizine is stopped even if those symptoms were not present before treatment initiation. The symptoms may resolve spontaneously. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.
Change to section 4.8:
  • Description of selected adverse reactions. After levocetirizine discontinuation, pruritus has been reported
In all the other sections: editiorial changes
Updated on 25/05/2016 and displayed until 11/01/2017
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   11-Oct-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Section 2:Changes to be in line with the current QRD template

Section 4.1: Changes to be in line with the current QRD template

Section 4.2: editorial changes

Section 4.3:  addition of the contraindication in patients with hypersensitivity to ‘hydroxyzine’

Section 4.4:Changes to be in line with the current QRD template

Section 4.5:  to include levels of alcohol in blood reached during concurrent administration of cetirizine or levocetirizine and alcohol or other CNS depressants

Section 4.6: re-wording of the whole section

Section 4.8: addition of 2 side effects: arthralgia and diarrhoea and adding the reporting of side effect sub-section

Section 4.9: editorial changes

Section 5.1: editorial changes

Section 5.2: editorial changes

Updated on 21/02/2013 and displayed until 25/05/2016
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   01-Feb-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



4.1: Posology and method of administration

 

Due to the lack of data in this population, the administration of levocetirizine to infants and toddlers aged less than 2 years is not recommended.

 

Adult patients with renal impairment:

The dosing intervals must be individualised according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in ml/min is needed. The CLcr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula:

 

4.2: Contraindications

 

Hypersensitivity to levocetirizine, to other piperazine derivatives, or to any of the excipients.

Patients with severe renal impairment at less than 10 ml/min creatinine clearance.

 

4.3: Special warnings and precautions for use

 

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

 

4.4: Interaction with other medicinal products and other forms of interaction

 

In a multiple dose study of ritonavir (600 mg twice daily) and cetirizine (10 mg daily), the extent of exposure to cetirizine was increased by about 40% while the disposition of ritonavir was slightly altered (-11%) further to concomitant cetirizine administration.

 

4.8: Undesirable effects

 

Post-marketing experience

Not known: palpitations, tachycardia

Not known: nausea, vomiting

 

9.        DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of first authorization: 5 October 2001

Date of latest renewal: 3 January 2012

Updated on 04/02/2011 and displayed until 21/02/2013
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   01-Nov-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Increase shelf life to 4 years
Updated on 27/09/2008 and displayed until 04/02/2011
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 28/07/2008 and displayed until 27/09/2008
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 15/10/2007 and displayed until 28/07/2008
Reasons for adding or updating:
  • Change to section 4 - Clinical particulars
Date of revision of text on the SPC:   09/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Update section 4.2, 4.3, 4.4, 4.8 & 5.1 as per CCDS and harmonisation
Updated on 10/06/2006 and displayed until 15/10/2007
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 9 - Date of renewal of authorisation
Updated on 07/02/2006 and displayed until 10/06/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Updated on 09/06/2005 and displayed until 07/02/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Updated on 20/12/2004 and displayed until 09/06/2005
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 4.2 - Posology and method of administration
Updated on 27/05/2004 and displayed until 20/12/2004
Reasons for adding or updating:
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
Updated on 01/03/2004 and displayed until 27/05/2004
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
Updated on 23/06/2003 and displayed until 01/03/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Levocetirizine dihydrochloride