Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

Boehringer Ingelheim Limited Consumer Healthcare
Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS
Telephone: +44 (0)1344 424 600
Fax: +44 (0)1344 741 399
WWW: http://www.boehringer-ingelheim.co.uk
Medical Information Direct Line: +44 (0)1344 741 286
Medical Information e-mail: medinfo@bra.boehringer-ingelheim.com
Customer Care direct line: +44 (0)1344 741 186
Medical Information Fax: +44 (0)1344 741 298

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 27/03/2012
SPC Buscopan IBS Relief

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 27/03/2012 and displayed until Current
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   01-Mar-2012
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4 Special Warnings and Precautions for Use

A new first paragraph regarding severe, unexplained abdominal pain has been added to this section.

 

Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction

Text has been both added to and deleted from the first paragraph of this section, including addition of the following words: … and tetra, antipsychotics and atropine-like compounds …

 

Section 4.8 Undesirable Effects

The words … listed … and … properties … have been added to the first paragraph of this section.

 

The word … incidence … has been deleted from the last sentence of the second paragraph of this section.

 

The text … (e.g. urticaria, pruritus) … has been added to the end of the Uncommon sentence of the Immune system disorders sub-heading of this section.

 

The words … with episodes of … have been deleted from the Not known sentence of the Immune system disorders sub-heading of this section.

 

The text * and …, rash, erythema, other … have been added to the Not known sentence of the Immune system disorders sub-heading of this section.

 

The text Rare: hypersensitivity has been deleted from the Immune system disorders sub-heading of this section.

 

A new final paragraph (corresponding text relating to the asterisk added as above) has been added to this section.
Updated on 05/03/2012 and displayed until 27/03/2012
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Mar-2012
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2 Posology and Method of Administration

A new, final paragraph has been added to this section regarding not taking Buscopan IBS Relief on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.

 

Section 10 Date of Revision of the Text

The date has been amended from February 2012 to March 2012.
Updated on 13/02/2012 and displayed until 05/03/2012
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Feb-2012
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 5.2 Pharmacokinetic Properties

This section has been re-written with new sub-headings and corresponding text regarding Absorption, Distribution and Metabolism and elimination.

 

Section 10 Date of Revision of the Text

The date has been amended from January 2012 to February 2012.
Updated on 20/01/2012 and displayed until 13/02/2012
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jan-2012
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 5.1 Pharmacodynamic Properties

New second and third sentences (regarding the central nervous system) have been added to this section.

 

Section 10 Date of Revision of the Text

The date has been amended from November 2011 to January 2012.
Updated on 01/12/2011 and displayed until 20/01/2012
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • 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-Nov-2011
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.6 Fertility, Pregnancy and Lactation

The text Fertility, has been added to this section’s header.

 

This section has been completely updated with replacement text added.  It now incorporates three separate sub-headings with associated text (Pregnancy, Lactation and Fertility).

 

Section 5.3 Preclinical Safety Data

This section has been completed updated, with replacement text added.

 

Section 10 Date of Revision of the Text

The date has been amended from July 2008 to November 2011.
Updated on 22/06/2011 and displayed until 01/12/2011
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-May-2011
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.9 Overdose

The words … should be considered have been added after the words … artificial respiration in the first paragraph of the Therapy sub-heading of this section.

 

Section 10 Date of Revision of the Text

The date has been amended from April 2011 to May 2011.
Updated on 16/05/2011 and displayed until 22/06/2011
Reasons for adding or updating:
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Apr-2011
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.7 Effects on Ability to Drive and Use Machines

A new first sentence has been added to this section i.e. No studies on the effects on the ability to drive and use machines have been performed.

 

Section 10 Date of Revision of the Text

The date has been amended from July 2008 to April 2011.

 
Updated on 11/08/2008 and displayed until 16/05/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jul-2008
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.8 – Undesirable effects:

The following text has been added as the first paragraph of this section “Many of the undesirable effects can be assigned to the anticholinergic property of Buscopan IBS Relief”.

 

The text “Not known – incidence cannot be estimated from the available data” has been added to the end of the now second paragraph (beginning “Adverse events have been ranked …”).

 

The words “Rare”, “Not known” and “Uncommon: skin reactions” have been added to the “Immune system disorders” paragraph.

 

The word “Uncommon” has been added to the “Gastrointestinal disorders” paragraph.

 

Section 10 - Revision date:

Revision date updated to July 2008.
Updated on 11/06/2008 and displayed until 11/08/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   30-May-2008
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.3 – Contraindications – change “sensitivity” to “hypersensitivity”

Section 4.4 – Warnings – addition of small amount of sucrose in each tablet

Section 4.4 – Change in heading to align with MHRA template

Section 4.5 – Interactions – Addition of anticholinergic drugs (tiotropium and ipratropium)

Section 6.6 – Change of heading to “Special precautions for disposal”

Section 10 - Revision date up-dated to 30 May 2008
Updated on 18/02/2008 and displayed until 11/06/2008
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:   04/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 6.1 removal of palmitic acid from list of excipients
Updated on 15/08/2007 and displayed until 18/02/2008
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   08/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to date of revision
Updated on 09/02/2005 and displayed until 15/08/2007
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  hyoscine-n-butylbromide