Zoton Fas Tab 30 mg

  • Name:

    Zoton Fas Tab 30 mg

  • 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 SmPC

Reasons for updating

  • New SmPC for new product

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

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 22 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 22 December 2017 PIL

Reasons for updating

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

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 3 April 2017 PIL

Reasons for updating

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

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 7 March 2017 PIL

Reasons for updating

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

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 - 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 1 March 2017 PIL

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 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 January 2017 PIL

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 SmPC

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 PIL

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 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 19 July 2016 PIL

Reasons for updating

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

Updated on 25 January 2016 SmPC

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 PIL

Reasons for updating

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

Updated on 9 March 2015 PIL

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 3 July 2012 PIL

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 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 13 July 2011 PIL

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 PIL

Reasons for updating

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

Updated on 2 July 2008 PIL

Reasons for updating

  • Change to appearance of the medicine

Updated on 13 April 2007 PIL

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 19 March 2007 PIL

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 7 September 2006 PIL

Reasons for updating

  • Change of manufacturer

Updated on 23 May 2005 PIL

Reasons for updating

  • New PIL for medicines.ie