go to medicines.ie homepage
  • Home  |  
  • About  |  
  • Links  |  
  • Help
Font Size
Search for:  
select
select
  • SPCs and PILs
  • SPCs Only
  • PILs Only
  Advanced Search
  • What's
    New
      
  • Browse
    Medicines
      
  • Browse
    Active Ingredients
      
  • Browse
    Companies
      
  • Codes
    of Practice
      
  • Adverse
    Reaction Reporting

Boehringer Ingelheim Limited

Boehringer Ingelheim Limited
Corrig Court, Corrig Road, Sandyford Industrial Estate, Dublin 18,
Telephone: +353 1 2959620
Fax: +353 1 2959624
Medical Information e-mail: Medinfo@dbl.boehringer-ingelheim.com
Summary of Product Characteristics last updated on medicines.ie: 25/10/2011
SPC Buscopan 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 25/10/2011 and displayed until Current
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

Document Links

 
  View all medicines
from this company
View Document
Bookmark and Share

Active Ingredients

 
   hyoscine butylbromide

Versions

 
25/10/2011 to Current
26/11/2009 to 25/10/2011
26/08/2008 to 26/11/2009
01/08/2006 to 26/08/2008
03/05/2006 to 01/08/2006
13/04/2006 to 03/05/2006
22/10/2004 to 13/04/2006
09/06/2004 to 22/10/2004
03/06/2003 to 09/06/2004
  • Terms & Conditions | 
  • Accessibility | 
  • Privacy Statement | 
  • Contact Us

Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

This website is certified by Health On the Net Foundation. Click to verify.

This site complies with the HONcode standard for trustworthy health information: verify here.

logo