ZOTON FASTAB 15MG

  • Name:

    ZOTON FASTAB 15MG

  • Company:
    info
  • Active Ingredients:

    Lansoprazole

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/12/17

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Summary of Product Characteristics last updated on medicines.ie: 2/1/2018
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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

Company Products

Medicine NameActive Ingredients
Medicine Name Zithromax Powder for Oral Suspension 200 mg/5 ml Active Ingredients Azithromycin dihydrate
Medicine Name Zoton Fas Tab 30 mg Active Ingredients Lansoprazole
Medicine Name ZOTON FASTAB 15MG Active Ingredients Lansoprazole
Medicine Name Zyvox 100mg/5ml Granules for Oral Suspension Active Ingredients Linezolid
Medicine Name Zyvox 2 mg/ml Solution for Infusion Active Ingredients Linezolid
Medicine Name Zyvox 600 mg Film-Coated Tablets Active Ingredients Linezolid
226 - 231 of 231 items.Total: 10 pages

When a pharmaceutical company changes any document, 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 2 January 2018 PIL

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 2 January 2018 SmPC

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 2 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 22 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 April 2017 SmPC

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 4 April 2017 PIL

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 PIL

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 31 March 2017 SmPC

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 3 March 2017 PIL

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 3 March 2017 SmPC

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 13 February 2017 SmPC

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 PIL

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 PIL

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 25 October 2016 SmPC

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 19 July 2016 PIL

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 10

Updated on 19 July 2016 SmPC

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 25 January 2016 PIL

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

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

Updated on 25 January 2016 SmPC

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

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

Updated on 6 July 2012 PIL

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

4.4 – addition of hypomagnesaemia text, increased risk of hip, wrist and spine fracture with use of PPIs

4.8 – addition of adverse effects: fracture of the hip, wrist or spine; hypomagnesaemia

Updated on 6 July 2012 SmPC

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

4.4 – addition of hypomagnesaemia text, increased risk of hip, wrist and spine fracture with use of PPIs

4.8 – addition of adverse effects: fracture of the hip, wrist or spine; hypomagnesaemia

Updated on 14 July 2011 PIL

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 14 July 2011 SmPC

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 25 March 2011 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Free text change information supplied by the pharmaceutical company

Section 4.2 – the following text has been added:
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 SmPC

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

Section 4.2 – the following text has been added:
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 1 July 2008 PIL

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Free text change information supplied by the pharmaceutical company

Section 3 - Addition of tablet markings

Updated on 1 July 2008 SmPC

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

Section 3 - Addition of tablet markings

Updated on 28 August 2007 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 28 August 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 12 April 2007 PIL

Reasons for updating

  • Improved electronic presentation

Free text change information supplied by the pharmaceutical company

Changes have been made to the SPC in line with Article 30 referral.

Updated on 12 April 2007 SmPC

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

Changes have been made to the SPC in line with Article 30 referral.

Updated on 22 February 2007 SmPC

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 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 20 February 2007 PIL

Reasons for updating

  • New SPC for medicines.ie

Updated on 20 February 2007 SmPC

Reasons for updating

  • New SPC for medicines.ie

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