Summary of Product Characteristics
last updated on the eMC:
30/09/2010
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 30/09/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 01-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| SmPC (Section 4.4 – Special Warnings and Precautions for Use)
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Updated on 23/07/2009 and displayed until 30/09/2010
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Reasons for adding or updating:
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Change to separate SPCs covering individual presentations
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| Date of revision of text on the SPC: 01-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Minodiab 2.5mg tablets has been discontinued in the UK so the SPC now only covers Minodiab 5
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Updated on 10/09/2008 and displayed until 23/07/2009
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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| Date of revision of text on the SPC: 01-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.1 has been revised to read as follows:
4.1- Glipizide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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Updated on 04/02/2008 and displayed until 10/09/2008
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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| Date of revision of text on the SPC: 10/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.5: update to section 4.5 by adding the following statement:
Voriconazole: Although not studied, voriconazole may increase the plasma levels of sulfonylureas, (e.g. tolbutamide, glipizide and glyburide) and therefore cause hypoglycaemia. Careful monitoring of blood glucose is recommended during co-administration
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Updated on 20/06/2007 and displayed until 04/02/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 Change of MA Holders address
Section 10 Change to date of revision
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Updated on 28/09/2004 and displayed until 20/06/2007
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Reasons for adding or updating:
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Addition of joint SPC covering all presentations
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Updated on 26/03/2003 and displayed until 28/09/2004
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Change to section 10 (date of (partial) revision of the text
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Updated on 04/09/2002 and displayed until 26/03/2003
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 07/08/2002 and displayed until 04/09/2002
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MA number
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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