Buscopan Rx 10mg Coated Tablets
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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 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
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 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
Updated on 22 March 2017
Reasons for updating
- New PIL for new product