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Servier Laboratories Limited
Rowley, Wexham Springs, Framewood Road, Wexham, Slough, SL3 6PJ
Telephone: +44 (0)1753 662744
Fax: +44 (0)1753 663456
Medical Information Direct Line: +44 (0)1753 666409
Medical Information e-mail: medical.information@uk.netgrs.com

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: 08/03/2012
SPC Diamicron 30 mg MR

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 08/03/2012 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:   01-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


7.            MARKETING AUTHORISATION HOLDER

Les Laboratoires Servier
50, rue Carnot

92284 Suresnes cedex
France

 

10.       DATE OF REVISION OF THE TEXT

11/2011
Updated on 23/09/2011 and displayed until 08/03/2012
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • 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-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


- Removal of the strength and pharmaceutical form of the product in 2 different places from sections 4.4 and 4.8:

4.4        Special warnings and precautions for use

overdose of Diamicron

4.8            Undesirable effects

As for other sulphonylureas, treatment with Diamicron can cause hypoglycaemia, if mealtimes are irregular and, in particular, if meals are skipped.

 

- Addition of Hyponatremia to section 4.8 Undesirable effects

Class attribution effects:

As for other sulphonylureas, the following adverse events have been observed: cases of erythrocytopenia, agranulocytosis, haemolytic anaemia, pancytopenia, allergic vasculitis, hyponatremia, elevated liver enzyme levels and even impairment of liver function (e.g. with cholestasis and jaundice) and hepatitis which regressed after withdrawal of the sulphonylurea or led to life-threatening liver failure in isolated cases.

 

-  Date of revision update : July 2011

 
Updated on 20/05/2010 and displayed until 23/09/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Some administrative changes have been made in Section 2, 6.4 and 6.5.

Please note that the product does not require any special storage conditions (see update of section 6.4).
Updated on 13/02/2009 and displayed until 20/05/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   01-May-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.4 (Special warnings and precautions for use) of the SPC addition of a warning regarding the use of the product in patients with G6PD-deficiency.
Updated on 01/02/2007 and displayed until 13/02/2009
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 5 - Nature and Contents of Container
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   05/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
  • Throughout the SPC the name of "Diamicron 30mg MR" has been changed to "Diamicron 30mg MR Tablets"
  • Throughout the SPC the spelling of Sulphonylurea has been corrected
  • Section 4.2 - "...taken orally, once daily" has been changed to "...taken orally in a single intake at breakfast time"
  • Section 4.8 - This section has been reordered with a subsequential addition of a "class attribution effects" section
  • Section 5.1 - " HYPOGLYCAEMIC SULPHONYLUREA - ORAL BLOOD GLUCOSE LOWERING DRUG (A10BB09: Alimentary tract and metabolism)" has been removed and replaced with " SULFONAMIDES, UREA DERIVATIVES, ATC code: A10BB09)
  • Section 6.5 - "...in blisters (PVC/Aluminium) has been removed and replaced with "Aluminium/Poly(vinylchloride) blister, packed in cardboard boxes".  " Not all pack sizes may be marketed" has also been added.
    • Updated on 08/07/2003 and displayed until 01/02/2007
    Reasons for adding or updating:
    • Change to section 3 - pharmaceutical form
    Updated on 17/07/2001 and displayed until 08/07/2003
    Reasons for adding or updating:
    • Correction of spelling/typing errors
    Updated on 15/05/2001 and displayed until 17/07/2001
    Reasons for adding or updating:
    • No reasons supplied

    Active Ingredients/Generics

     
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