ZOTON FASTAB 15MG
*Company:
Pfizer Healthcare IrelandStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 14 February 2024
File name
Reg SPC ZT 202 15mg 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 15mg tab IE clean.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 15 mg tab IEclean.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
RegSPCZT17115mgtabIEclean.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 15mg 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 15mg 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 15mg 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 02 January 2018
Reasons for updating
- Change to section 4.8 - Undesirable effects
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 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 04 April 2017
Reasons for updating
- Change to section 4.8 - Undesirable effects
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 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 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
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 03 March 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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 03 March 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 9 - Date of first authorisation/renewal of the authorisation
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 13 February 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 February 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Free text change information supplied by the pharmaceutical company
The SPC is updated in section 4.4 and 5.1
Updated on 25 October 2016
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 4.5 - 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
- Change to section 2 - Qualitative and quantitative composition
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 25 October 2016
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 4.5 - 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
- Change to section 2 - Qualitative and quantitative composition
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 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 10Updated 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
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 10Updated on 25 January 2016
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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 25 January 2016
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
Free text change information supplied by the pharmaceutical company
Updated on 06 July 2012
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)
Free text change information supplied by the pharmaceutical company
4.8 – addition of adverse effects: fracture of the hip, wrist or spine; hypomagnesaemia
Updated on 06 July 2012
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
4.8 – addition of adverse effects: fracture of the hip, wrist or spine; hypomagnesaemia
Updated on 14 July 2011
Reasons for updating
- Change to section 8 - MA number
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 7: Marketing Authorisation Holder (John Wyeth & Brother Ltd, Taplow, UK to Pfizer Healthcare Ireland, Dublin).
Section 8: Marketing Authorisation Numbers
Section 9 and 10: approval dates.
Updated on 14 July 2011
Reasons for updating
- Change to section 8 - MA number
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Change to section 7 - Marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Section 7: Marketing Authorisation Holder (John Wyeth & Brother Ltd, Taplow, UK to Pfizer Healthcare Ireland, Dublin).
Section 8: Marketing Authorisation Numbers
Section 9 and 10: approval dates.
Updated on 25 March 2011
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The use of Zoton FasTab is not recommended in children as clinical data are limited (see also section 5.2). Treatment of small children below one year of age should be avoided as available data have not shown beneficial effects in the treatment of gastro-oesophageal reflux disease.”
Updated on 25 March 2011
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Free text change information supplied by the pharmaceutical company
The use of Zoton FasTab is not recommended in children as clinical data are limited (see also section 5.2). Treatment of small children below one year of age should be avoided as available data have not shown beneficial effects in the treatment of gastro-oesophageal reflux disease.”
Updated on 01 July 2008
Reasons for updating
- Change to section 3 - Pharmaceutical form
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 01 July 2008
Reasons for updating
- Change to section 3 - Pharmaceutical form
Free text change information supplied by the pharmaceutical company
Updated on 28 August 2007
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 28 August 2007
Reasons for updating
- Improved electronic presentation
Updated on 12 April 2007
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 12 April 2007
Reasons for updating
- Improved electronic presentation
Free text change information supplied by the pharmaceutical company
Updated on 22 February 2007
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 February 2007
Reasons for updating
- Correction of spelling/typing errors
Updated on 20 February 2007
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 February 2007
Reasons for updating
- New SPC for medicines.ie