Detrusitol SR 4 mg, prolonged-release, hard

Product Information *

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 12 May 2021

File name

Reg SPC DT 14_0 SR 4mg Capsues IE -clean_1620823134.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 4mg Capsues IE-clean_1618992219.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 16_0 2mg and 4mg SR IE-clean_1618992172.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 12_1 SR 4mg Capsues IE-clean_1614673277.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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_1614673201.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_1 SR 4mg Capsues IE-clean_1610709064.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_1610709034.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 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 28 July 2015

File name

PIL_8804_590.pdf

Reasons for updating

  • New PIL for new product