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Detrusitol 2 mg film coated 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 19 July 2023

File name

Patient Information Leaflet - 003052975 - version 1.0 - Detrusitol 1mg and 2mg FCT - clean - removal of MT details.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 21 April 2021

File name

DEC202105560-V_Reg SPC DT 12_0 2mg Tabs 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 21 April 2021

File name

DEC202105560-V_REG PIL DT 13_0 1mg and 2mg IE-clean.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 10_0 2mg Tabs 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 11_1 1mg and 2mg 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 23 October 2018

File name

REG PIL DT 10_1 1mg 2mg IE-Clean_.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 9_1 2mg Tabs IE-Clean.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 30 July 2015

Reasons for updating

  • 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 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 08 April 2013

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

Addition to section 6.5 of : or PP Child Resistant Squeeze and Turn closures.

Updated on 08 April 2013

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Free text change information supplied by the pharmaceutical company

Addition to section 6.5 of : or PP Child Resistant Squeeze and Turn closures.