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SANOFI

Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 4035600
Fax: +353 1 4035687
Medical Information e-mail: iemedinfo@sanofi.com
Summary of Product Characteristics last updated on medicines.ie: 18/12/2017
SPC Buscopan 10 mg Coated Tablets

When a pharmaceutical company changes an SPC or PIL, 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 18/12/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Dec-2017
Legal Category:   Supply through pharmacy only

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 15/08/2017 and displayed until 18/12/2017
Reasons for adding or 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
Date of revision of text on the SPC:   01-Aug-2017
Legal Category:   Supply through pharmacy only

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  Boehringer Ingelheim Limited details have been replaced by sanofi-aventis Ireland Ltd details.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  PA 7/16/1 has been replaced by PA 540/181/2.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 24/03/2017 and displayed until 15/08/2017
Reasons for adding or 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
Date of revision of text on the SPC:   12-Oct-2016
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

SPC updated following amendment of legal classification from POM to OTC.

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 04/02/2015 and displayed until 24/03/2017
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jan-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

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 19/12/2013 and displayed until 04/02/2015
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Dec-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

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 25/10/2011 and displayed until 19/12/2013
Reasons for adding or 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
Date of revision of text on the SPC:   01-Oct-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4 has been updated to include additional information.
Section 5.1 additional statement has been added.
Section 5.2 has been re-written.
Section 10 has been updated.
Updated on 26/11/2009 and displayed until 25/10/2011
Reasons for adding or 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
Date of revision of text on the SPC:   01-Oct-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 2 - Qualitative and Quantitative Composition

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 26/08/2008 and displayed until 26/11/2009
Reasons for adding or 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
Date of revision of text on the SPC:   07/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

 The main changes are administrative in nature.  

Section 4.5 Interaction with other medicinal products and other forms of interaction

The previous SPC stated that the anticholinergic effect of some drugs may be intensified with Buscopan.  The list of drugs now includes other anticholinergics (e.g. tiotropium, ipratropium).

Updated on 01/08/2006 and displayed until 26/08/2008
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   02/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 5.1 (List of Excipients) has been updated to include the E-number for titanium dioxide.
Other small formatting changes throughout document.
Updated on 03/05/2006 and displayed until 01/08/2006
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 13/04/2006 and displayed until 03/05/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Updated on 22/10/2004 and displayed until 13/04/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Updated on 09/06/2004 and displayed until 22/10/2004
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
Updated on 03/06/2003 and displayed until 09/06/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   hyoscine butylbromide