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Zoton Fas Tab 30 mg

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Lansoprazole

    *Additional information is available within the SPC or upon request to the company

Updated on 14 February 2024

File name

Reg SPC ZT 202 30mg tab IE clean.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 14 February 2024

File name

Reg SPC ZT 202 30mg tab IE clean.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 14 February 2024

File name

Reg PIL ZT 201 15mg 30mg tabs IE clean.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 14 February 2024

File name

Reg PIL ZT 201 15mg 30mg tabs IE clean.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 11 August 2023

File name

Reg SPC ZT 19_1 30mgt ab IE.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 11 August 2023

File name

RegPI LZT 19_1 15mg 30mg tabs IE clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 09 June 2023

File name

Reg PIL ZT 18_2 15mg 30mg tabs IE clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 01 December 2022

File name

Reg SPC ZT 18_1 30 mg tab IE clean.pdf

Reasons for updating

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

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 01 December 2022

File name

Reg PIL ZT 17_0 15 mg 30 mg tabs IE clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 28 September 2022

File name

RegSPCZT17130mgtabIEclean (1).pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 28 September 2022

File name

RegPILZT16115mg30mgtabsIEclean.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 23 September 2021

File name

DEC202162685_Reg SPC ZT 16_1 30mg tab IE-clean.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 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 2 and 5.2- Editorial, addition of full stop

Section 4.4- Addition of Hypomagnesaemia may lead to hypocalcaemia and/or hypokalaemia

Section 4.8- Table foot note: hypocalcaemia and/or hypokalaemia

Updated on 23 September 2021

File name

DEC202162685_Reg PIL ZT 15_1 15mg & 30mg tabs IE-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 26 May 2021

File name

DEC202135552_Reg SPC ZT 15_1 30mg tab IE-clean.pdf

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 17 February 2021

File name

DEC202110835_Reg SPC ZT 14_1 30mg tab IE-clean.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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 17 February 2021

File name

DEC202110835_Reg PIL ZT 14_1 15mg & 30mg tabs IE-clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 02 January 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 02 January 2018

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC is updated in section 4.8.

Updated on 22 December 2017

File name

PIL_9753_247.pdf

Reasons for updating

  • New PIL for new product

Updated on 22 December 2017

Reasons for updating

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

Updated on 04 April 2017

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Approved changes are in line with PRAC update

The following changes to the labelling have been approved. Please refer to attached copies of labelling documentation for full details.

The SPC is updated in section 4.8.

The PIL has been updated in section 4. See PIL tick list for sections updated.

The PI is affected.

The packaging (label/carton) are not affected

Implementation Responsibilities – Brand Marketing

SPC     Ireland Brand Marketing

Please implement in line with REG08-WI-IRL02 Generation and update of promotional material with regulatory license change

Affected

 

PI     Ireland Brand Marketing

Please implement in line with REG08-WI-IRL02 Generation and update of promotional material with regulatory license change

Affected

Updated on 03 April 2017

Reasons for updating

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

Updated on 31 March 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC is updated in section 4.4 and 4.8 and editorial section 9.

Updated on 07 March 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 03 March 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC is updated in section 4.4 and 4.8 and editorial section 9.

Updated on 01 March 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 16 January 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC is updated in section 4.4 and 5.1

Updated on 13 January 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 25 October 2016

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated in section 2, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.3, 6.6 and QRD

Updated on 24 October 2016

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 19 July 2016

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as Follow:

The SPC has been updated in section 9 and 10

Updated on 19 July 2016

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 25 January 2016

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated in section 4.4 & 4.8 to update Proton Pump inhibitor information

Updated on 22 January 2016

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability
  • Change of contraindications

Updated on 09 March 2015

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 03 July 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 26 October 2011

Reasons for updating

  • Correction of spelling/typing errors

Updated on 13 July 2011

Reasons for updating

  • Change of licence holder
  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to name of manufacturer

Updated on 24 March 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 02 July 2008

Reasons for updating

  • Change to appearance of the medicine

Updated on 13 April 2007

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 19 March 2007

Reasons for updating

  • Change of active ingredient
  • Change of inactive ingredient
  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change in co-marketing arrangement

Updated on 07 September 2006

Reasons for updating

  • Change of manufacturer

Updated on 23 May 2005

Reasons for updating

  • New PIL for medicines.ie