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Zirtek Oral Solution

*
Pharmacy Only: Non-prescription

Updated on 03 October 2023

File name

ie-pil-zirtek-osl.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 03 October 2023

File name

ie-spc-zirtek-osl.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 08 July 2022

File name

ie-pil-zirtek-osl-en-clean.pdf

Reasons for updating

  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

CCDS.v2.0 - myalgia + renal impairment + excipients wording re-submission - QRD template update + removal of CMS SE

Updated on 08 July 2022

File name

ie-spc-zirtek-osl-en-clean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

CCDS.v2.0 - myalgia + renal impairment + excipients wording re-submission - QRD template update + removal of CMS SE

Updated on 03 July 2019

File name

master-pil-zirtek-osl-ie.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 23 April 2019

File name

ie-osl-spc-clean.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

minor updates to section 4.6 upon clarification with RMS, "Cetirizine is excreted in human milk at concentrations representing 25% to 90% of those measured in plasma depending on sampling time after administration” should remain in section 4.6.

Updated on 18 April 2019

File name

20191804-ie-pil-osl-en-approved-current.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 18 April 2019

File name

SPC Zirtek IE oral sol clean.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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

4.6     Fertility, pregnancy and lactation

 Pregnancy

For cetirizine prospectively collected data on pregnancy outcomes do not suggest potential for maternal or foetal/embryonic toxicity above background rates.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.  Caution should nevertheless be exercised when prescribing to pregnant women.

 Breast-feeding
 

Cetirizine passes into breast milk. A risk of side effects in breastfed infants cannot be excluded.  Cetirizine is excreted in human milk at concentrations representing 25% to 90% of those measured in plasma, depending on sampling time after administration. Therefore, caution should be exercised when prescribing cetirizine to lactating women.

Updated on 27 June 2018

File name

SPC Zirtek IE oral sol.docx

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

Free text change information supplied by the pharmaceutical company

Change to section 4.8- Undesirable effects: Addition of hepatitis
Change to section 10- Date of revision of the text: updated to May 2018

Updated on 27 June 2018

File name

Zirtek PIL IE oral sol.pdf

Reasons for updating

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

Updated on 12 May 2018

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 11 July 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 11 July 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

  • Updates to section 4.8 “Undesirable effects” as follows:

- Addition of ADRs “nightmare” and “arthralgia”

- Addition of ADR “acute generalized exanthematous pustulosis”

  • Updates to sections 4.2 and 5.2, to align some wording with QRD.

Updated on 03 July 2017

File name

PIL_9085_640.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 July 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 20 June 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Heading “Special population” added.
  • Some text added and deleted.

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4.2.        Posology and Method of Administration

  • Heading “Special population” added.

4.4         Special warnings and precautions for use

  • Some text added and deleted.

4.8.        Undesirable Effects

·       Some text added and deleted.

10          DATE OF REVISION OF THE TEXT

·       Date of revision updated.

Updated on 17 June 2016

Reasons for updating

  • Change to how the medicine works

Updated on 20 November 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company


Section 4.2
Method of administration:
The solution can be swallowed as such.
Duration of continuous treatment should not be longer than 30 days, after this period, patients should also consult with their doctor.

Updated on 15 November 2012

Reasons for updating

  • Change of inactive ingredient
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 15 October 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4.4     Special warnings and precautions for use

 

Caution should be taken in patients with predisposition factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as cetirizine may increase the risk of urinary retention.

 

 

4.8         Undesirable effects

 

Metabolism and nutrition disorders:

Not known: increased appetite

 

Psychiatric disorders:

Not known: suicidal ideation

 

Ear and labyrinth disorders:

Not known: vertigo

 

Renal and urinary disorders:

Not known: urinary retention

 

 

Updated on 13 June 2012

Reasons for updating

  • Change to improve clarity and readability

Updated on 02 April 2012

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

 

One ml of solution contains 1 mg cetirizine dihydrochloride

 

Excipients with known effect:    

- one ml of solution contains 450 mg sorbitol (solution at 70 %, non crystallizing)

- one ml of solution contains 1.35 mg methylparahydroxybenzoate

- one ml of solution contains 0.15 mg propylparahydroxybenzoate

 

For the full list of excipients, see section 6.1

 

 

4.2     Posology and method of administration

 

Method of administration:

The solution can be swallowed as such.

 

 

Paediatric population

Due to the amount of some excipients in the formulation, the use of the product is not recommended in children aged less than 2 years.

 

 

4.6     Fertility, pregnancy and lactation

 

Breast-feeding

Cetirizine is excreted in human milk at concentrations representing 25% to 90% of those measured in plasma, depending on sampling time after administration. Therefore, caution should be exercised when prescribing cetirizine to lactating women.

Updated on 18 July 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation

Updated on 10 June 2011

Reasons for updating

  • Change to side-effects
  • Change to further information section

Updated on 13 May 2011

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4.4     Special warnings and precautions for use

 

At therapeutic doses, no clinically significant interactions have been demonstrated with alcohol (for a blood alcohol level of 0.5 g/l).  Nevertheless, precaution is recommended if alcohol is taken concomitantly.

 

Caution in epileptic patients and patients at risk of convulsions is recommended.

 

Due to the amount of some excipients in the formulation, the use of the product is not recommended in children aged less than 2 years.

 

Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).

Allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.

 

 4.6     Fertility, pregnancy and lactation

 

Preagnancy

For cetirizine very rare clinical data on exposed pregnancies are available.  Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.  Caution should be exercised when prescribing to pregnant women.

Lactation

Cetirizine is excreted in human milk at concentrations representing 0.25 to 0.90 those measured in plasma, depending on sampling time after administration. Therefore, caution should be exercised when prescribing cetirizine to lactating women.


4.8       Undesirable effects

Post-marketing experience

 

In addition to the adverse reactions reported during clinical studies and listed above, the following undesirable effects have been reported in post-marketing experience. 

 

Undesirable effects are described according to MedDRA System Organ Class and by estimated

frequency based on post-marketing experience.

 

Frequencies are defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon

(≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be

estimated from the available data)

 

 

Psychiatric disorders:

Uncommon: agitation

Rare: aggression, confusion, depression, hallucination, insomnia

Very rare: tics

 

Nervous system disorders:

Uncommon: paraesthesia

Rare: convulsions

Very rare: dysgeusia, syncope, tremor, dystonia, dyskinesia

Not known: amnesia, memory impairment

 

Updated on 12 January 2011

Reasons for updating

  • Deletion of a pack size

Updated on 13 December 2010

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Removal of 200ml presentation

Updated on 06 May 2009

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 30 April 2009

Reasons for updating

  • Change to section 4 - Clinical particulars
  • Change to section 5 - Pharmacological properties

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

SPC has been updated in line with referral procedure to harmonise SPC within the EU

Updated on 11 June 2008

Reasons for updating

  • Change to marketing authorisation holder
  • Change to storage instructions

Updated on 08 May 2008

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 6.4 - Special precautions for storage

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Change in storage conditions and PA holder name/address and PA number

Updated on 10 August 2007

Reasons for updating

  • Correction of spelling/typing errors

Updated on 18 July 2007

Reasons for updating

  • Change to date of revision

Updated on 17 July 2007

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update SPC following renewal of PA

Updated on 07 February 2006

Reasons for updating

  • Change of manufacturer

Updated on 06 October 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 May 2004

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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