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Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
Telephone: +44 (0)1635 563 000
Fax: +44 (0)1635 563 393
WWW: http://www.bayer.co.uk

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: 18/05/2012
SPC Glucobay 100 mg tablets

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 18/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   26-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7: MARKETING AUTHORISATION HOLDER The statement 'Trading as Bayer plc, Bayer Schering Pharma' has been removed 
Section 10 : Revision date is now 26 April 2012 
Updated on 25/01/2012 and displayed until 18/05/2012
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 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   14-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The key changes are:

To update sections 4.3 (Contraindications), 4.4 (Special warnings and precautions for use), 4.5 (Interaction with other medicinal products and other forms of interaction), section 4.6 (Pregnancy and Lactation) of the SmPC. 

Updated on 29/06/2010 and displayed until 25/01/2012
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:   18-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 ( Posology & method of administration) -

1. In the event that side-effects persist despite adherence to the diet, Glucobay dose should not be increased and a dose reduction should be considered. Consequentially, a new statement has also been added to the leaflets.
2. When referring to properties of the product (rather than the active substance), the INN "acarbose" has been replaced with the product trade name "Glucobay", in line with the SPC guideline and CCDS.

Section 10 - (Revision date) this is now 18 June 2010
Updated on 26/01/2010 and displayed until 29/06/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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:   12-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 The key changes to the SmPC are:
  • Section 2 (Qualitative and quantitative composition): updated description of the qualitative and quantitative composition
  • Section 3 (Pharmaceutical form): to include a more detailed description of the tablet appearance
  • Section 6.1 (List of excipients): to replace the name of the excipient "Highly dispersed silicon dioxide" with "Silica, colloidal anhydrous" in line with its European monograph
  • Section 10 (Date of revision of the text): updated to 12th January 2010.
Updated on 11/01/2010 and displayed until 26/01/2010
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:   17-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 Following an update to our Company Core Data Sheet (#19), the MHRA have approved the following changes to SmPC section 4.8 "Undesirable effects":

re-format ADR table in line with SmPC guideline, inclusion of ADR frequency description

expansion of terminology used to describe "Hepatobiliary disorders" with specific reference to the increased reporting from Japan

removal of the word "Transient" from the ADR "Transient increase in liver enzymes", in line with MedDRA Preferred Term terminology.

Consequential changes are made to the Patient Information Leaflets. 

Updated on 08/12/2009 and displayed until 11/01/2010
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   25-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 The key change to the SmPC is:
Section 4.5 with regard to an interaction between Glucobay and sucrose. The additional SmPC text is as follows:
"Sucrose (cane sugar) and foods containing sucrose often cause abdominal discomfort or even diarrhoea during treatment with Glucobay tablets as a result of increased carbohydrate fermentation in the colon."
Updated on 19/11/2009 and displayed until 08/12/2009
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 - The name of the product has been updated to include the pharamceutical form and is now Gluboay 100 mg tablets

Section 10 - Revision date is now 09.11.2009 
Updated on 21/07/2008 and displayed until 19/11/2009
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:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Addition of "pneumatosis cystoidis intestinalis" as an undesirable effect of unknown frequency in section 4.8. 

Updated on 09/06/2008 and displayed until 21/07/2008
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   02-May-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 (MA Holder) has been updated with the 'Bayer Schering Pharma' trading sytle.
Section 10 (Date of Revision of the Text) has been updated with the date of approval of the above. 
Updated on 13/08/2007 and displayed until 09/06/2008
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations
  • 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 4.9 - Overdose
  • 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

The Glucobay 50 and 100 mg Tablet SmPCs have been updated in the UK following approval of variations to update the SmPCs in line with CCDS 16 (sections 4.5 and 4.9) and CCDS 17 (MedDRA conversion). 

 

The key changes are:

 

Section 4.4 (Special warnings and precautions for use) - statement on hydrotalcite relocated from section 4.8 to section 4.4 as part of MedDRA conversion update.

 

Section 4.5 (Interactions with other medicinal products and other forms of interaction) - spelling of cholestyramine updated to colestyramine in line with current guidance. 'Simultaneous administration of Glucobay and colestyramine should, therefore, be avoided' has been added for clarity.

 

Section 4.8 (Undesirable effects) - MedDRA conversion

 

Section 4.9 (Overdose) - 'No information on overdosage is available' has been replaced with 'When Glucobay tablets are taken with drinks and/or meals containing carbohydrates overdose may lead to meteorism, flatulence and diarrhoea. If Glucobay tablets are taken in overdose independently of food, excessive intestinal symptoms need not be anticipated'.

 

Section 10 (Date of (partial) revision of the text) – updated to April 2007. 

Active Ingredients/Generics

 
  acarbose