Buscopan 10 mg Coated Tablets *
Company:
SANOFIStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive 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_OTC_cropped_1588230040.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 Tablets_1587041865.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Supply through pharmacy only
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)
Updated on 24 October 2018
File name
PIL_8952_815.pdf
Reasons for updating
- XPIL Created
Updated on 18 December 2017
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
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:Supply through pharmacy only
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 14 December 2017
File name
PIL_8952_815.pdf
Reasons for updating
- New PIL for new product
Updated on 14 December 2017
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 6 - date of revision
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:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 8 (Marketing Authorisation Number) has been amended. PA 7/16/1 has been replaced by PA 540/181/2.
Section 10 (Date of Revision of the Text) has been amended from October 2016 to August 2017.
Updated on 11 August 2017
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 24 March 2017
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
- Change to legal category
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
The following changes have been made to enable it to be suitable for OTC supply:
Section 1 - Product name changed to Buscopan 10 mg Coated Tablets
Section 4.1 - Addition of a specific indication for Irritable Bowel Syndrome (IBS) with consequential dosage information added to section 4.2
Section 4.2 - Dosage in children under 12 years of age removed from SPC
Section 4.2 - Warning added about a 2 week treatment period
Section 4.3 - Addition of "10 mg Coated" and "are contraindicated in patients with:" text
Section 4.4 - Addition of warnings (in line with those already registered in the UK) required for OTC supply
Section 4.5 - Addition of "10 mg Coated Tablets" text
Section 4.6 - Addition of "butylbromide" text in Breastfeeding paragraph, addition of "10 mg Coated" text in Breastfeeding paragraph
Section 4.8 - Addition of "hyoscine butylbromide" text in first paragraph, addition of "10 mg Coated Tablets" text in first paragraph
Section 4.9 - Addition of "10 mg Coated Tablets" text in first paragraph of Therapy sub-heading, addition of "should be considered" in second paragraph of Therapy sub-heading
Section 5.1 - Addition of "Hyoscine butylbromide" text at beginning of second paragraph
Section 6.4 - Amendment to storage precautions
Section 6.5 - OTC pack sizes of 20s and 40s added and existing POM pack sizes deleted
Section 10 - Revision date updated from January 2015 to October 2016
Sections 2, 4.2, 4.3, 4.4, 4.6, 5.1 and 5.2 - Minor updates to align with current EU QRD SPC template
The updated SPC has been uploaded to medicines.ie to align with the OTC product launch date.
Updated on 22 March 2017
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to name of medicinal product
Updated on 04 February 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 4.8 Undesirable Effects
The Irish authority name and contact details have been updated in the adverse event reporting statements included in this section following the change from IMB to HPRA.
Section 10 Date of Revision of the Text
The date has been amended from December 2013 to January 2015.
Updated on 03 February 2015
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 19 December 2013
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 4.8 Undesirable Effects
New text regarding the reporting of suspected adverse reactions has been added at the end of this section. In total, two new paragraphs have been added.
Section 10 Date of Revision of the Text
The date has been amended from October 2011 to December 2013.
Updated on 17 December 2013
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 19 November 2012
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 02 November 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to date of revision
- Change to dosage and administration
Updated on 25 October 2011
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 5.1 additional statement has been added.
Section 5.2 has been re-written.
Section 10 has been updated.
Updated on 29 January 2010
Reasons for updating
- Change of manufacturer
Updated on 26 November 2009
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Previous wording: For excipients, see 6.1.
Updated wording:
Excipients: Contains Sucrose 41.2 mg.
For a full list of excipients, see section 6.1.
Section 4.2 – Posology and method of administration
Minor formatting change.
Section 9 – Date of Renewal of the Authorisation
1 April 2009
Section 10: Date of revision of the text
October 2009
Updated on 19 September 2008
Reasons for updating
- Improved electronic presentation
Updated on 26 August 2008
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 4.5 Interaction with other medicinal products and other forms of interaction
The previous
Updated on 18 August 2006
Reasons for updating
- Improved electronic presentation
Updated on 01 August 2006
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 15 May 2006
Reasons for updating
- Improved electronic presentation
Updated on 03 May 2006
Reasons for updating
- Improved electronic presentation
Legal category:Supply through pharmacy only
Updated on 13 April 2006
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 22 October 2004
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 17 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 09 June 2004
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
Legal category:Supply through pharmacy only
Updated on 03 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only