Neurontin 800mg Film-coated Tablets
*Company:
Upjohn EESVStatus:
UpdatedLegal 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 09 April 2024
File name
Summary of Product Characteristics - 800 mg FCT - clean_2024.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 July 2023
File name
Patient Information Leaflet.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 26 July 2023
File name
Summary of Product Characteristics - IE - Neurontin 800mg FCTs.pdf
Reasons for updating
- 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)
Updated on 26 July 2023
File name
Summary of Product Characteristics - IE - Neurontin 800mg FCTs.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 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)
Updated on 17 July 2023
File name
Patient Information Leaflet - IE - Neurontin.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 23 August 2022
File name
Reg SPC NN 30_1 800 mg tablets IE - 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 4.8 – 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)
Updated on 23 August 2022
File name
Reg PIL NN Caps & Tabs 31_1 IE - clean.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 - what the product looks like and pack contents
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 05 August 2021
File name
DEC202110087-V_Reg SPC NN 29_0 800 mg tablets IE - clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 7 - Pfizer Healthcare Ireland changed to Upjohn EESV as the MAH, with updated address
Section 8 - updated with new PA number for Upjohn EESV
Updated on 05 August 2021
File name
DEC202110087-V_Reg PIL NN Caps & Tabs 30_1 IE - clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 26 February 2021
File name
DEC202102969-V_Reg PIL NN Caps & Tabs 29_2 IE - clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 14 May 2019
File name
DEC201923884_Adv PIL NN Caps & Tabs 28_0 IE Clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 May 2019
File name
DEC201923884_Reg SPC NN 26_0 800 mg FCT IE Clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 January 2018
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
- 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
The SPC has been updated as follows:
Section 4.2 – note b in Table 2 updated.
Section 4.6 – Pregnancy- Risk related to gabapentin: Addition of “Gabapentin crosses the human placenta.”
Section 5.3 – Update to Teratogenesis data.Updated on 16 January 2018
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.2 – note b in Table 2 updated.
Section 4.6 – Pregnancy- Risk related to gabapentin: Addition of “Gabapentin crosses the human placenta.”
Section 5.3 – Update to Teratogenesis data.Updated on 15 January 2018
File name
PIL_8712_64.pdf
Reasons for updating
- New PIL for new product
Updated on 07 September 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 07 September 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Free text change information supplied by the pharmaceutical company
Updated on 22 December 2016
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
The SPC has been updated as follows:
Section 4.8: Addition of agitation.Updated on 22 December 2016
Reasons for updating
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.8: Addition of agitation.Updated on 23 May 2016
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
The SPC has been updated as follows:
SPC: Sections 4.4, 4.8 and 5.3:
Changes were made to section 4.4 of the SmPC (addition of anaphylaxis warning (including symptoms of angioedema)) and section 4.8 of the SmPC (Anaphylaxis ADR) + editorial revision to section 5.3 (teratogenicity information)Updated on 23 May 2016
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
SPC: Sections 4.4, 4.8 and 5.3:
Changes were made to section 4.4 of the SmPC (addition of anaphylaxis warning (including symptoms of angioedema)) and section 4.8 of the SmPC (Anaphylaxis ADR) + editorial revision to section 5.3 (teratogenicity information)Updated on 02 June 2015
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Sections 4.4 & 4.5
The labelling language regarding concomitant administration of gabapentin with opioid containing drugs has been be strengthened.
Section 4.6
Statement added stating that there is no effect on fertility in animal studies.
Section 4.8
Replaced existing text related to hyperglycemia and hypoglycaemia.
Section 5.1
Updated information concerning the mechanism of action of gabapentin included.
Updated on 02 June 2015
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Sections 4.4 & 4.5
The labelling language regarding concomitant administration of gabapentin with opioid containing drugs has been be strengthened.
Section 4.6
Statement added stating that there is no effect on fertility in animal studies.
Section 4.8
Replaced existing text related to hyperglycemia and hypoglycaemia.
Section 5.1
Updated information concerning the mechanism of action of gabapentin included.
Updated on 07 May 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
The SPC has been updated as follows:
Section 4.8 Undesirable effects:
Hyponatraemia added.
Updated on 07 May 2015
Reasons for updating
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.8 Undesirable effects:
Hyponatraemia added.
Updated on 09 July 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updates to sections 4.4 & 4.8
Updated on 09 July 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Free text change information supplied by the pharmaceutical company
Updates to sections 4.4 & 4.8
Updated on 08 May 2013
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 4.8 Undesirable effects – rhabdomyolysis and blood creatine phosphokinase increased added
Updated on 08 May 2013
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Free text change information supplied by the pharmaceutical company
Section 4.8 Undesirable effects – rhabdomyolysis and blood creatine phosphokinase increased added