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Xyzal 5mg Tablets

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Pharmacy Only: Non-prescription

Updated on 24 November 2022

File name

ie-pil-xyzal-tab-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 3 - dose and frequency
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 24 November 2022

File name

ie-spc-xyzal-fct-clean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 24 November 2022

File name

ie-pil-xyzal-tab-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 3 - dose and frequency
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 27 May 2021

File name

ie-spc-xyzal-fct-clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update to sections 4.4, 4.7, 5.3 and revision date

Updated on 27 May 2021

File name

ie-pil-xyzal-tab-clean.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Change to section 2 - excipient details

Updated on 17 August 2018

File name

ie-pil-fct-h299en-clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 17 August 2018

File name

ie-spc-fct-h299en-clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 27 June 2018

File name

ie-spc-fct-h299en clean.docx

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 12 May 2018

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 23 April 2018

File name

ie-pil-fct-h299en clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 13 November 2017

File name

PIL_10080_299.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 November 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 13 November 2017

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Supply through pharmacy only

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 13 November 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 11 January 2017

Reasons for 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
  • 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.
  • Description of selected adverse reactions. After levocetirizine discontinuation, pruritus has been reported

Legal category:Supply through pharmacy only

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 11 January 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 25 May 2016

Reasons for 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

Legal category:Supply through pharmacy only

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 23 May 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 21 February 2013

Reasons for 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

Legal category:Supply through pharmacy only

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 21 February 2013

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about driving or using machinery

Updated on 04 February 2011

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Increase shelf life to 4 years

Updated on 01 October 2009

Reasons for updating

  • Change to improve clarity and readability

Updated on 27 September 2008

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Supply through pharmacy only

Updated on 28 July 2008

Reasons for updating

  • Improved electronic presentation

Legal category:Supply through pharmacy only

Updated on 02 November 2007

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 15 October 2007

Reasons for updating

  • Change to section 4 - Clinical particulars

Legal category:Supply through pharmacy 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 21 August 2007

Reasons for updating

  • Change to improve clarity and readability

Updated on 10 August 2007

Reasons for updating

  • Change to date of revision

Updated on 10 June 2006

Reasons for 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

Legal category:Supply through pharmacy only

Updated on 07 February 2006

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Supply through pharmacy only

Updated on 19 July 2005

Reasons for updating

  • New PIL for medicines.ie

Updated on 09 June 2005

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

Updated on 20 December 2004

Reasons for 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

Legal category:Supply through pharmacy only

Updated on 27 May 2004

Reasons for 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

Legal category:Supply through pharmacy only

Updated on 01 March 2004

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Supply through pharmacy only

Updated on 23 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only