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Lamictal 50mg Tablets

*
Pharmacy Only: Prescription

  • Company:

    GlaxoSmithKline (Ireland) Ltd

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Lamotrigine

    *Additional information is available within the SPC or upon request to the company

Updated on 13 September 2024

File name

ie-spc-tablets-50mg-issue21+20draft1-Master.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Add adverse reaction - Erythema multiforme

Updated on 13 September 2024

File name

ie-pl-tablets-issue18draft2-Master.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Add adverse reaction - Erythema multiforme

Updated on 27 October 2023

File name

ie-spc-tablets-50mg-issue20draft1-clean.pdf

Reasons for updating

  • 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 10 - Date of revision of the text

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

Updated on 27 October 2023

File name

ie-pl-tablets-issue17draft1-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 27 October 2023

File name

ie-pl-tablets-issue17draft1-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 01 July 2022

File name

ie-pl-tablets-issue16draft1.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to name of manufacturer

Updated on 16 March 2022

File name

ie-pl-tablets-issue15draft1-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 16 March 2022

File name

ie-pl-disp-issue21draft1-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 16 March 2022

File name

ie-spc-tablets-50mg-issue19draft3-clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 4.4 and 4.9: Addition of warning in relation to cardiac sodium channel blocking activity of lamotrigine and potential risk in patients with underlying cardiac disease.
Section 5.1: Addition of information in relation to cardiac sodium channel blocking activity of lamotrigine and potential risk in patients with underlying cardiac disease under Pharmacodynamic effects section
Section 5.3 Addition of information in relation to in vitro studies

Updated on 16 March 2022

File name

ie-spc-tablets-50mg-issue19draft3-clean.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 10 August 2021

File name

ie-spc-tablets-50mg-issue18draft3.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Updates to the SmPC:
• SmPC section 4.2 – Addition of method of administration: For oral use.
• SmPC section 4.4 – Lamictal Tablets only: minor correction to the lactose warning to align the wording to the EU excipients guideline.
• SmPC Section 4.5 - Interaction with other medicinal products and other forms of interaction. Addition of a drug interaction with paracetamol.
• SmPC section 5.3 – Minor correction of existing non-clinical information.
QRD updates across the SPC

Updated on 10 August 2021

File name

ie-pl-tablets-issue14draft3.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 18 January 2021

File name

ie-spc-tablets-50mg-issue17draft1.pdf

Reasons for 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

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

Free text change information supplied by the pharmaceutical company

Section 4.4: Addition of photosensitivity reaction warning
Section 4.8: Addition of photosensitivity reaction undesirable effect to the skin and subcutaneous tissue disorders under frequency uncommon
 

Updated on 18 January 2021

File name

ie-pl-tablets-issue13draft1.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 09 December 2020

File name

ie-spc-tablets-50mg-issue15draft2.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 4.4. Update the wording on hypersensitivity syndrome.
Section 4.8 Removal of duplicate Hypersensitivity syndrome symptoms from the adverse event table
Section 4.8 Minor update – aseptic meningitis under nervous system disorders was moved from the bottom to the middle paragraph.
Section 4.8 Addition of the ADR Tubulointerstitial nephritis (TIN) that may occur in association with uveitis and involvement of the kidney as part of DRESS.
Section 4.8 Update to description of selected adverse reactions: Haematological abnormalities and lymphadenopathy and Rash.
Section 4.8 removal of duplicate statement regarding rash reported as part of hypersensitivity syndrome.
Section 4.8 Update to reporting of side effects details.

Updated on 09 December 2020

File name

ie-pl-tablets-issue10draft2.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 13 March 2020

File name

ie-pl-tablets-issue8draft2.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 13 March 2020

File name

ie-spc-tablets-50mg-issue13draft2-med.ie.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 4.4 - Addition of warning for sodium

Updated on 05 February 2020

File name

ie-spc-tablets-50mg-issue12draft2-medicines.ie.pdf

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

Section 6.5 - addition of child resisitant blister to the nature and contents of container

Updated on 05 November 2018

File name

ie-pl-tablets-issue6draft3clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 05 November 2018

File name

ie-spc-tablets-50mg-issue11draft1clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

To update SmPC Section 4.4, 4.6, 4.8, PIL Section 2 & Section 4 in line with CMDh adopted PRAC recommendation. Inclusion of Brugada syndrome and haemophagocytic lymphohistiocytosis in take special care. Also a note to woman that are breastfeeding to observe if any symptoms are observed in the baby.

Updated on 13 July 2018

File name

ie-spc-tablets-50mg-medsie.docx

Reasons for updating

  • 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 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

  • Update to SmPC Section 4.5 - Interaction with other medicinal products and other forms of interaction – Update wording on Lamictal and Locosomide/Perampanel interaction in the SmPC.
  • Update to SmPC Section 4.6 - Pregnancy and lactation – typographical mistake, removal of the word ‘therefore’

Updated on 26 February 2018

Reasons for updating

  • New SPC for new product

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

Updated on 26 February 2018

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 4.5 - updated with the Lamotrigine and cytochrome P450 interactions. Hepatic drug metabolising replaced with cytochrome P450.

Updated on 03 November 2016

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

4.5 Interaction with other medicinal products and other forms of interaction - Update wording on OCT-2 inhibition in the SMPC.

Please note that the combined SPC for Lamictal Tablets will no longer be used. The SPC for Lamictal Tablets will now be individual SPC documents for each strength - SPC for 25mg, SPC for 50mg, SPC for 100mg and SPC for 200mg (4 individual SPCs in total).

Updated on 14 April 2016

File name

PIL_9867_491.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 April 2016

Reasons for updating

  • Change to instructions about missed dose
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 18 January 2016

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details
  • Change to improve clarity and readability

Updated on 15 July 2015

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 03 March 2015

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 22 October 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 15 May 2014

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 22 January 2014

Reasons for updating

  • Change to instructions about overdose

Updated on 23 September 2013

Reasons for updating

  • Change of manufacturer

Updated on 12 September 2012

Reasons for updating

  • Change to side-effects

Updated on 06 December 2011

Reasons for updating

  • Change of contraindications

Updated on 13 December 2010

Reasons for updating

  • Change to drug interactions
  • Change to dosage and administration

Updated on 26 January 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to dosage and administration

Updated on 27 November 2008

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 22 February 2007

Reasons for updating

  • Change of manufacturer

Updated on 06 December 2006

Reasons for updating

  • Change to information about pregnancy or lactation

Updated on 12 July 2006

Reasons for updating

  • Change of manufacturer
  • Change to warnings or special precautions for use

Updated on 31 January 2006

Reasons for updating

  • Improved electronic presentation

Updated on 11 January 2006

Reasons for updating

  • Improved electronic presentation

Updated on 26 August 2005

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 26 May 2005

Reasons for updating

  • New PIL for medicines.ie