go to medicines.ie homepage
Font Size
Search for:  
select
  Advanced Search

Gerard Laboratories
Unit 36, Baldoyle Industrial Estate, Grange Road, Baldoyle, Dublin 13,
Telephone: +353 1 832 2250
Fax: +353 1 466 1912
Medical Information Direct Line: +353 1800 272 272
Medical Information e-mail: sales@gerard-laboratories.ie
Summary of Product Characteristics last updated on medicines.ie: 27/05/2011
SPC Diaclide Tablets 80 mg

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 27/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   29-Sep-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 10:Date of revision of text changed from June 2010 to September 2010
Updated on 16/08/2010 and displayed until 27/05/2011
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   30-Jun-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 4.5:
Updated to be inline with the Innovator.

Section 4.8:
Updated to be in line with the Innovator

Section 4.9;
Updated to be in line with the Innovator

Registered symbol r removed from throughout SPC
Updated on 04/09/2009 and displayed until 16/08/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 7 - Marketing authorisation holder
  • 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:   24-Jul-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 2 - Addition of excipient quantity for Lactose Monhydrate.

Section 3 - Addition of flat bevel edged to description, addition of the statement - The scoreline allows the tablets to be divided into equal doses

Section 4.4 - Removal of hte word special before the precautions for use.

Section 5.1 - Addition of ATC code A10BB09

Section 6.1 - Changed excipients format to be on 1 line per excipient

Section 6.4 - Update to storage conditions changed from Store below 25ºC to do not store above 25ºC.

Section 7 - MAH format changed to 1 line per address, addition of Ireland to the address.

Section 9- Update to the dates

Section 10 - Update to the date of revision.
Updated on 22/11/2007 and displayed until 04/09/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   10/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Safety variation approved to update section 4.4 with regard to G6PD deficiency
Updated on 29/08/2006 and displayed until 22/11/2007
Reasons for adding or updating:
  • Improved electronic presentation
Date of revision of text on the SPC:   06/2006
Legal Category:   POM

Free-text change information supplied by the pharmaceutical company
tfrjhnzedhtb\zedhtbzedhb\zewsrhxb
\wrshbg\rwxs\rwxg\rsgt
Updated on 31/03/2006 and displayed until 29/08/2006
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
  • Change to section 4.9 - Overdose
  • Change to section 6.4 - Special precautions for storage
Updated on 14/04/2004 and displayed until 31/03/2006
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Updated on 19/06/2003 and displayed until 14/04/2004
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

 
  Gliclazide