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Ditropan 2.5mg tablets

  • Name:

    Ditropan 2.5mg tablets

  • Company:
    info
  • Active Ingredients:

    Oxybutynin Hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/07/20

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Summary of Product Characteristics last updated on medicines.ie: 19/12/2016
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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 6 July 2020 PIL

Reasons for updating

  • XPIL Removed

Updated on 19 December 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 19 December 2016 SmPC

Reasons for updating

  • 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 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

Alignment with Oxybutynin CCDSv4

Updated on 29 November 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 November 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 4 - how to report a side effect

Updated on 1 July 2014 SmPC

Reasons for updating

  • 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 4.7 - Effects on ability to drive and use machines
  • 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

Type II.C.I.3.b variation to align our SmPC with the Core Safety Profile for oxybutynin following the completion of PSUR Worksharing Procedure and CCDS v3.

Updated on 25 June 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery

Updated on 9 October 2013 PIL

Reasons for updating

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

Updated on 9 October 2013 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

Type II.C.I.4 CCDS v2 variation to update Sections 4.4 and 4.8 of the SPC for the oxybutynin product range following an update to the Company Core Data Sheet version 2.

Updated on 26 September 2012 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

Section 7 updated to include 'T/A SANOFI'

Updated on 4 April 2011 SmPC

Reasons for updating

  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

User Testing of Patient information leaflets

Updated on 1 April 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 21 March 2011 PIL

Reasons for updating

  • Change to dosage and administration
  • Changes to therapeutic indications

Updated on 21 March 2011 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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

Sections affected / updated

                                    

Section 4.1: Therapeutic indications

Section 4.2: Posology and method of administration.

Updated on 16 August 2010 SmPC

Reasons for updating

  • 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

lactose anyhdrous content udpated

Updated on 3 August 2010 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Ditropan 5mg Tablets shelf life has been amended from 4 years to 3 years

Updated on 26 March 2010 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

Additional statement on excipients

Updated on 24 March 2010 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 8 April 2008 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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

Update
Section 7 - Marketing Authorisation Holder
Section 8 - Marketing Authorisation Number
Section 10 - Date of Revision of Text

Updated on 18 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 28 July 2005 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients

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

Updated on 28 July 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 13 October 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 6 August 2004 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Updated on 4 August 2004 SmPC

Reasons for updating

  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

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

Updated on 26 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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