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GlaxoSmithKline (Ireland) Ltd

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 495 5000
Fax: +353 1 4955225
Medical Information Direct Line: 1 800 244 255
Medical Information Facsimile: +353 1 495 5225
Summary of Product Characteristics last updated on medicines.ie: 17/03/2017
SPC Lamictal 5mg chewable/dispersible tablets

When a pharmaceutical company changes an SPC or PIL, 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 17/03/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   05-Mar-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Shelf life stability update:
6.3 Shelf life - bottle pack updated to 3 years
Updated on 14/11/2016 and displayed until 17/03/2017
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   25-Oct-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

This is an update to the 25 October 2016 approved SPC loaded to Medicines.ie on 02 November 2016 with changes to :  Section 4.5 Interaction with other medicinal products and other forms of interaction - Update wording on OCT-2 inhibition in the SMPC.

We are updating the same SPC due to typos found in Section 6.3 and Section 6.5 - no other changes were made.
Updated on 03/11/2016 and displayed until 14/11/2016
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the 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.

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Active Ingredients

 
   Lamotrigine