Lamictal 50mg chewable/dispersible tablets
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 13 September 2024
File name
ie-spc-disp-50mg-issue27+26draft1-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-disp-issue25draft2-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 10 July 2024
File name
ie-spc-disp-50mg-issue26draft1-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-spc-disp-25mg-issue26draft1-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-disp-issue24draft1-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-disp-issue24draft1-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-disp-issue24draft1-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 24 July 2023
File name
ie-pl-disp-issue23draft1-clean - no header.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Update section 3 on how to take Lamictal.
Updated on 01 July 2022
File name
ie-pl-disp-issue22draft1.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-spc-disp-50mg-issue25draft3-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-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 13 October 2021
File name
ie-spc-disp-50mg-issue24draft1.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 4.2: Addition of a statement that partial dosing should not be performed when using the dispersible/chewable tablets (applicable to all dispersible/chewable tablet strengths).
- Section 4.2: Update the SmPC concerning posology and administration in children co-administered with valproate where the 2 mg dispersible/chewable tablets are the lowest marketed strength.
Updated on 13 October 2021
File name
ie-pl-disp-issue20draft1-medicines.ie.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - manufacturer
Updated on 10 August 2021
File name
ie-spc-disp-50mg-issue22draft3.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 4.5 - 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-disp-issue19draft1 for medicines.ie.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 03 March 2021
File name
ie-spc-disp-50mg-issue17draft2-clean.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 or child resistant PVC/PVdC/aluminium foil/paper blister.
25 mg Dispersible/Chewable Tablets: removal of 21 and 42 tablets Starter Packs
50 mg Dispersible/Chewable Tablets: removal of 21 tablets Starter Packs
Updated on 03 March 2021
File name
ie-pl-disp-issue13draft2 for medicines.ie.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 18 January 2021
File name
ie-spc-disp-50mg-issue20draft1.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-disp-issue16draft1.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
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 09 December 2020
File name
ie-spc-disp-50mg-issue16draft2.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-disp-issue12draft2.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-disp-issue10draft2-med.ie.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-disp-50mg-issue14draft2-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 content
Updated on 05 November 2018
File name
ie-pl-disp-issue9draft1clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
Updated on 05 November 2018
File name
ie-spc-disp-50mg-issue13draft1clean.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-disp-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
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
Section 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 chewable/dispersible tablets will no longer be used. The SPC for Lamictal chewable/dispersible tablets will now be individual SPC documents for each strength - SPC for 2mg, SPC for 5mg, SPC for 25mg, SPC for 50mg, SPC for 100mg and SPC for 200mg (6 individual SPCs in total).
The history of the Combined Lamictal chewable/dispersible tablet SPC is attached to the Lamictal chewable/dispersible 200mg Tablets, so the trail of changes remains intact for future perusal. The SPC for 2mg, SPC for 5mg, SPC for 25mg, SPC for 50mg, and SPC for 100mg will be added to Medicines.IE as 'new' documents.
Updated on 14 April 2016
File name
PIL_10396_266.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 14 May 2015
Reasons for updating
- Change to date of revision
- Introduction of new pack/pack size
Updated on 03 March 2015
Reasons for updating
- Change to date of revision
- Change to side-effects
Updated on 22 October 2014
Reasons for updating
- Change of trade or active ingredient name
- 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 24 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 drug interactions
- Change to dosage and administration
- Change to side-effects
Updated on 27 November 2008
Reasons for updating
- Change due to harmonisation of patient information leaflet
Updated on 08 July 2008
Reasons for updating
- Change to name of manufacturer
Updated on 11 April 2007
Reasons for updating
- Change of manufacturer
Updated on 15 November 2006
Reasons for updating
- Change to warnings or special precautions for use
Updated on 08 June 2006
Reasons for updating
- Change to warnings or special precautions for use
Updated on 17 January 2006
Reasons for updating
- Improved electronic presentation
Updated on 09 January 2006
Reasons for updating
- Improved electronic presentation
Updated on 26 August 2005
Reasons for updating
- New PIL for medicines.ie