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Detrusitol SR 2 mg, prolonged-release, hard;

*
Pharmacy Only: Prescription

  • Company:

    Upjohn EESV

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Tolterodine Tartrate

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

Updated on 19 July 2023

File name

Patient Information Leaflet - English - 002907983 - version 1.0 - Detrusitol SR 2mg and 4mg PR capsules - logo change - clean .pdf

Reasons for updating

  • New PIL for new product

Updated on 20 December 2022

File name

Reg SPC DT 16_1 SR 2mg Capsule IE - clean.pdf

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

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

Updated on 03 November 2022

File name

Reg SPC DT 16_0 SR 2mg Capsule IE - Clean.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Updated on 12 May 2021

File name

Reg SPC DT 14_0 SR 2mg Capsule IE - clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 21 April 2021

File name

DEC202105560-V_Reg SPC DT 13_0 SR 2mg Capsule IE-clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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 7 - Pfizer Healthcare Ireland changed to Upjohn EESV as the MAH, with updated address 

Section 8 - updated with new PA number for Upjohn EESV 

 

Updated on 02 March 2021

File name

DEC202102853-V_Reg SPC DT 12_1 SR 2mg Capsule IE-clean.pdf

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 4.6 - Pregnancy and lactation
  • 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
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 follows:

Capsules

- Section 2: Excipient heading added
- Section 4: Excipient information heading
- Section 10: Date of revision
- Throughout: QRD template updates to sections 2, 4.2, 4.3, 4.4, 4.6, 4.8, 5.1, 5.2, 6.1, 6.6

Tablets

- Section 4: Excipient information for sodium
- Section 10: Date of revision
- Throughout: QRD template updates to sections 2, 4.2, 4.3, 4.4, 4.6, 4.8, 5.1, 5.2, 6.1, 6.6

Updated on 02 March 2021

File name

DEC202102853-V_Reg PIL DT 15_1 2mg and 4mg SR IE-clean.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 15 January 2021

File name

DEC202100623-V_Reg SPC DT 10_2 SR 2mg Capsule IE-clean.pdf

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

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

Updated on 15 January 2021

File name

DEC202100623-V_Reg PIL DT 13_1 2mg and 4mg SR IE-clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 31 July 2015

Reasons for updating

  • New SPC for new product

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

Updated on 31 July 2015

Reasons for updating

  • 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 as follows.

Section 4.8 Reporting of suspected adverse reactions – QRD text added.

Updated on 28 July 2015

File name

PIL_8804_590.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 July 2015

Reasons for updating

  • Change to side-effects

Updated on 17 February 2012

Reasons for updating

  • PIL re-instated

Updated on 23 January 2012

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Sections 7 - updated with Pfizer Healthcare Ireland; Section 8 - updated with new PA number

Updated on 21 October 2011

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

SmPC MAH name change from Pharmacia Ireland Limited to Pharmacia Ireland

Updated on 18 October 2011

Reasons for updating

  • Change to marketing authorisation holder

Updated on 27 September 2011

Reasons for updating

  • Correction of spelling/typing errors

Updated on 10 November 2010

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

SmPC (Section 6.5 Pack size amended to refer number of units instead of number of blisters)

Updated on 08 November 2010

Reasons for updating

  • Change to date of revision
  • Introduction of new pack/pack size

Updated on 29 July 2010

Reasons for updating

  • Change of manufacturer

Updated on 18 February 2009

Reasons for updating

  • Correction of spelling/typing errors

Updated on 11 December 2008

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

Section 4.8 has been updated to include the most common side effects with the tabulated listing.

Updated on 10 December 2008

Reasons for updating

  • Change to side-effects

Updated on 15 July 2008

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Nature of changes:
Section 4.5 has been updated to include an additional CYP2D6 enzyme.
Section 4.8 has been update to add a number of additional side effects.

Updated on 15 July 2008

Reasons for updating

  • Change to drug interactions
  • Change to side-effects

Updated on 07 December 2007

Reasons for updating

  • 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

7.0 – Marketing Authorisation Holder (Address)

Updated on 07 December 2007

Reasons for updating

  • Change to marketing authorisation holder address

Updated on 14 June 2007

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

4.8 – Revision of section to more closely align with the core data sheet

Updated on 14 June 2007

Reasons for updating

  • Change to side-effects

Updated on 20 April 2007

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 17 April 2007

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

 

Section 2 addition of wording to increase clarity

Section 4.2 amended wording regarding paediatric use

Section 4.5 minor grammatical change to text

Section 4.8 inclusion of text on experience with paediatric use

Section 4.9 minor grammatical change to text 

Section 5.1 inclusion of text on experience with paediatric use

Section 5.2 inclusion of text on experience with paediatric use

Section 6.6 Update in line with current EU guidelines

Updated on 28 November 2005

Reasons for updating

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

Updated on 11 November 2005

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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.3 - Preclinical safety data

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

Updated on 12 August 2005

Reasons for updating

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

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

Updated on 22 September 2004

Reasons for updating

  • Improved electronic presentation

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

Updated on 17 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 July 2004

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 01 July 2003

Reasons for updating

  • New SPC for medicines.ie

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