Detrusitol SR 4 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):

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

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