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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: 14/02/2012
SPC Diamicron 80mg 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 14/02/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • 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


The changes to SmPC appear in red below.

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.

7. MARKETING AUTHORISATION HOLDER

 

Servier Laboratories Ltd

Rowley, Wexham Springs

Framewood Road, Wexham

Slough

SL3 6PJ

 

 

10. Date of revision of the text

 

11/2011
Updated on 20/06/2011 and displayed until 14/02/2012
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • 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 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
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


Section 1: Alignment with the latest SPC templates (version 7.2, October 2006).

 

Section 2: Alignment with the latest SPC templates (version 7.2, October 2006).

 

Section 3: Alignment with the latest SPC templates (version 7.2, October 2006).

 

Section 4.2: Alignment with the latest SPC templates (version 7.2, October 2006).

 

Section 4.3:

-         Alignment with Diamicron 30 mg MR Tablets SPC
-      Addition of “Treatment of patients with G6PD-deficiency with sulphonylurea agents can lead to haemolytic anaemia. Since gliclazide belongs to the class of sulphonylurea agents, caution should be used in patients with G6PD-deficiency and a non-sulphonylurea alternative should be considered.” 

Section 4.4: Alignment with Diamicron 30 mg MR Tablets SPC

 

Section 4.5: Alignment with Diamicron 30 mg MR Tablets SPC

 

Section 4.6:

-          Alignment with Diamicron 30 mg MR Tablets SPC

-          Substitution of the following statement “Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development” with the following statement from the CHMP Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling:

“Studies in animals have shown reproductive toxicity (see section 5.3)”

 

Section 4.8: Alignment with Diamicron 30 mg MR Tablets SPC

 

Section 4.9: Alignment with Diamicron 30 mg MR Tablets SPC

 

Section 5.1: Alignment with Diamicron 30 mg MR Tablets SPC

 

Section 5.3: Addition of “Preclinical data reveal no special hazards for humans based on conventional studies of repeated dose toxicity and genotoxicity. Long term carcinogenicity studies have not been done. No teratogenic changes have been shown in animal studies, but lower fetal body weight was observed in animals receiving doses 9.4 fold higher than the maximum recommended dose in humans”.

 

Section 6.1: Alignment with the latest SPC templates (version 7.2, October 2006).

 

Section 6.2: Alignment with the latest SPC templates (version 7.2, October 2006).

 

Section 6.4: Alignment with the latest SPC templates (version 7.2, October 2006).

 

Section 6.5: Alignment with the latest SPC templates (version 7.2, October 2006).

 

Section 6.6: Alignment with the latest SPC templates (version 7.2, October 2006).


Section 10 (Date of revision of the text): 09/2010
Updated on 21/09/2005 and displayed until 20/06/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 27/06/2001 and displayed until 21/09/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 31/05/2001 and displayed until 27/06/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 31/05/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  gliclazide