Diamicron MR 30 mg
- Name:
Diamicron MR 30 mg
- Company:
Servier Laboratories Ireland Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
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Servier Laboratories Ireland Ltd
Company Products
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 2 April 2020 PIL
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 SmPC
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 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 9 January 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 9 January 2017 PIL
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 SmPC
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 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 31 May 2016 PIL
Reasons for updating
- Change to side-effects
Updated on 24 May 2016 SmPC
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 SmPC
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 PIL
Reasons for updating
- Change to date of revision
Updated on 2 April 2015 PIL
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 11 September 2012 SmPC
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
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 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 24 November 2011 SmPC
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 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 PIL
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 SmPC
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
Updated on 18 August 2008 SmPC
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
Updated on 18 August 2008 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 22 September 2005 SmPC
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 PIL
Reasons for updating
- Improved electronic presentation
Updated on 20 September 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 4 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)