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Detrusitol 1 mg filmcoated tablets *
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 21 April 2021

File name

DEC202105560-V_Reg SPC DT 11_1 1mg Tabs IE-clean_1618991837.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 21 April 2021

File name

DEC202105560-V_REG PIL DT 13_0 1mg and 2mg IE-clean_1618991788.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 02 March 2021

File name

DEC202102853-V_Reg SPC DT 9_1 1mg Tabs IE-clean_1614672215.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 11_1 1mg and 2mg IE-clean_1614671989.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 23 October 2018

File name

REG PIL DT 10_1 1mg 2mg IE-Clean__1539942544.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 19 October 2018

File name

Reg SPC DT 8_1 1mg Tabs IE-Clean_1539945263.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

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

Updated on 30 July 2015

Reasons for updating

  • New SPC for new product

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

Updated on 30 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_8885_124.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 July 2015

Reasons for updating

  • Change to side-effects

Updated on 09 April 2013

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

Addition of :

or PP Child Resistant Squeeze and Turn closures.

Updated on 14 May 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 Limited; Section 8 - updated with new PA number

Updated on 09 May 2012

Reasons for updating

  • Change of licence holder
  • Change to date of revision
  • Change in co-marketing arrangement

Updated on 20 February 2012

Reasons for updating

  • PIL re-instated

Updated on 20 January 2012

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 29 July 2010

Reasons for updating

  • Change of manufacturer

Updated on 10 December 2008

Reasons for updating

  • Change to side-effects

Updated on 09 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 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

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 March 2008

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 06 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 06 December 2007

Reasons for updating

  • Change to marketing authorisation holder address

Updated on 14 June 2007

Reasons for updating

  • Change to side-effects

Updated on 18 May 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 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 4.1 - Therapeutic indications
  • 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

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

Updated on 16 November 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 06 August 2004

Reasons for updating

  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

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

Updated on 03 July 2003

Reasons for updating

  • New SPC for medicines.ie

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