Buscopan Rx 10mg Coated Tablets *

  • Company:

    SANOFI
  • 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

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 30 April 2020

File name

IE_Mock_up_Buscopan_10mg_RX_cropped_1588230080.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

- Update on the Possible Side effects Sub-section of 'Other side effects'  (Section 4 - Possible Side Effects effects) 

Updated on 16 April 2020

File name

1.3.1.1 SmPC Rx Tablets_1587042055.pdf

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

Update to reflect update on Company Core Data Sheet (CCDS) - Version 1, which consisted in:

- Update on the Sub-section adverse events frequency presentation (Section 4.8 - Undesirable effects) 

- Update on the Adverse Reactions Sub-section of 'Skin and subcutaneous tissue disorders'  (Section 4.8 - Undesirable effects) 

File name

PI_1060026778_V2 CROPPED_1561741477.pdf

Updated on 01 July 2019

File name

PI_1060026778_V2 CROPPED_1561741477.pdf

Reasons for updating

  • Addition of marketing authorisation holder
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 18 December 2017

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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

Section 4.3 - Contraindications

The sentence regarding hypersensitivity has been relocated from being the last bullet point to the first bullet point.
Two new bullet points have been added (mechanical stenosis in the gastrointestinal tract and paralytical or obstructive ileus).

Section 10 - Date of Revision of the Text

The date has been amended from August 2017 to December 2017.

Updated on 18 December 2017

Reasons for updating

  • New SPC for new product

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

Updated on 14 December 2017

Reasons for updating

  • Change to section 6 - date of revision
  • Change to section 2 - what you need to know - contraindications

Updated on 14 December 2017

File name

PIL_17129_16.pdf

Reasons for updating

  • New PIL for new product

Updated on 15 August 2017

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)

Free text change information supplied by the pharmaceutical company

Section 7 (Marketing Authorisation Holder) has been amended.  Boehringer Ingelheim Limited details have been replaced by sanofi-aventis Ireland Ltd details.

Section 8 (Marketing Authorisation Number) has been amended.  PA 7/67/1 has been replaced by PA 540/190/1.

Section 10 (Date of Revision of the Text) has been amended.  August 2017 has been added.

Updated on 11 August 2017

Reasons for updating

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

Updated on 23 March 2017

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 22 March 2017

Reasons for updating

  • New PIL for new product