Diamicron MR 30 mg

Product Information *

  • Company:

    Servier Laboratories Ireland Ltd
  • Status:

    No Recent Update
  • Active Ingredients * :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

When a pharmaceutical company changes any document, 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 02 April 2020

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains

Updated on 19 March 2020

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 10 May 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 09 January 2017

Reasons for updating

  • New PIL for new product

Updated on 09 January 2017

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - what you need to know - contraindications

Updated on 30 November 2016

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

-          4.2 Posology and method of administration: format

-          4.3 Contraindications: format

-          4.4 Special warnings and precautions for use: format + Addition of St. John’s Wort (Hypericum perforatum) preparations + Addition of a section Dysglycaemia

-          4.5 Interactions with other medicinal products and other forms of interaction: Format + addition of Saint John’s Wort (Hypericum perforatum) preparations and Fluoroquinolones

-           4.8 Undesirable effects: format

-          4.9 Overdose: format

-          5.1 Pharmacodynamic properties: format

-          6.1 List of excipients: format

Updated on 30 November 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 31 May 2016

Reasons for updating

  • Change to side-effects

Updated on 24 May 2016

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.6          Fertility, pregnancy and lactation

- Update of pregnancy and breast-feeding  data

- Addition of fertility section

 

4.7          Effects on ability to drive and use machines

Update of the section: “DIAMICRON MR 30mg has no or negligible[…]”

 

4.8          Undesirable effects

- Update of the section

- Addition of drug rash with eosinophilia and systemic symptoms (DRESS) as exceptional undesirable effect

 

5.3       Pre-clinical safety data

Update of the section (addition of the sentence “Fertility and reproductive performance were unaffected after gliclazide administration in animal studies.”)

Updated on 22 September 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Updated on 15 June 2015

Reasons for updating

  • Change to date of revision

Updated on 02 April 2015

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 11 September 2012

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Formating Changes have been applied to the following sections:

2, 4.2, 4.3, 4.4, 4.6, 5.1, 5.2, 6.6, 10

Section 4.5: under Combinations requiring precautions for use, the following antidiabetic agents have been added: thiazolidinediones, dipeptidyl peptidase-4 inhibitors, GLP-1 receptor agonists. Clarithromycin has also been added to the list.

Section 4.7: The following sentence has been added: DIAMICRON MR 30mg has no known influence on the ability to drive and use machines.

Section 4.8: "and with other sulphonylureas" has been removed from the first sentence

                    angioedema has been added to the list of undesirable effects which have been more rarely reported
        
                    "(such as Stevens-Johnson syndrome and toxic epidermal necrolysis)" has been specified under bullous reactions

Section 5.2: The following sentence has been removed under Absorption: "The relationship between the dose administered ranging up to 120mg and the area under the concentration time curve is linear."

                    The following sentences have been added under Distribution: " The volume of distribution is around 30 litres. A single daily intake DIAMICRON MR 30mg maintains effective gliclazide plasma concentrations over 24 hours."

                    The following paragraph has been added: 
                    Linearity/ non-linearity
                    The relationship between the dose administered ranging up to 120 mg and the area under the concentration time curve is linear.

Updated on 16 February 2012

Reasons for updating

  • Change to MA holder contact details

Updated on 24 November 2011

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.8 (undesirable effects) the following has been added/removed: As for other sulphonylureas, the following adverse events have been observed: Ccases of erythrocytopenia, agranulocytosis, haemolytic anaemia, pancytopenia and , allergic vasculitis, hyponatraemia,have been described for other sulphonylureas.

In section 7 (Marketing Authorisation Holder) The following has been removed:
Les Laboratoires Servier,
22, rue Garnier
92200 Neuilly-sur-Seine
France

and replaced with
Les Laboratoires Servier
50, rue Carnot

92284 Suresnes cedex – France


Updated on 29 September 2010

Reasons for updating

  • Change of trade or active ingredient name
  • Change to storage instructions
  • Change to further information section
  • Change to date of revision

Updated on 20 September 2010

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Renewal date

Updated on 18 August 2008

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4
add following text: Treatment of patients with G6PD-deficiency with sulfonylurea agents can lead to haemolytic anaemia. Since gliclazide belongs to the chemical class of sulfonylurea drugs, caution should be used in patients with G6PD-deficiency and a non-sulfonylurea alternative should be considered.

Updated on 18 August 2008

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 22 September 2005

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 22 September 2005

Reasons for updating

  • Improved electronic presentation

Updated on 20 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 04 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)