Neurontin 100mg Hard Capsules
*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 - 100 mg caps -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
Summary of Product Characteristics - IE - Neurontin 100mg Caps.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
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 17 July 2023
File name
Summary of Product Characteristics - IE - Neurontin 100mg Caps.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)
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 31_1 100 mg Capsules 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 30_0 100 mg Capsules 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 05 August 2021
File name
DEC202110079-V_Reg PIL CB 28_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 SPC NN 28_2 100 mg Capsules IE - clean.pdf
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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
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 27_0 100 mg Capsule 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 17 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 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 17 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 04 December 2017
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
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: update to sections 4.4 and 4.8 with Respiratory Depression. |
Updated on 04 December 2017
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
Free text change information supplied by the pharmaceutical company
|
The SPC has been updated as follows: update to sections 4.4 and 4.8 with Respiratory Depression. |
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
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
Free text change information supplied by the pharmaceutical company
Updated on 03 March 2017
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 03 March 2017
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 29 April 2016
Reasons for updating
- 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
The SPC has been updated as follows:
Section 6.1 - sodium lauryl sulphate updated to sodium lauril sulphate
Updated on 29 April 2016
Reasons for updating
- Change to section 6.1 - List of excipients
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 6.1 - sodium lauryl sulphate updated to sodium lauril sulphate
Updated on 18 February 2016
Reasons for updating
- 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
The SPC has been updated as follows:
Section 6.1 - sodium lauryl sulphate updated to sodium lauril sulfateUpdated on 18 February 2016
Reasons for updating
- Change to section 6.1 - List of excipients
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 6.1 - sodium lauryl sulphate updated to sodium lauril sulfateUpdated on 18 January 2016
Reasons for updating
- 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
The SPC has been updated as follows:
Section 6.1 - sodium lauryl sulphate updated to sodium lauril sulfateUpdated on 18 January 2016
Reasons for updating
- Change to section 6.1 - List of excipients
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 6.1 - sodium lauryl sulphate updated to sodium lauril sulfateUpdated 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 - Pharmacological 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 includedUpdated 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 - Pharmacological 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 includedUpdated on 01 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 01 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 06 November 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
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 Special warnings and precautions for use:
A warning has been added regarding Mental Impairment, Loss of consciousness, Fall and the need for patients to exercise caution until they are familiar with the potential effects of the medication.
Section 4.8 Undesirable effects:
Addition of Sexual Dysfunction, Loss of consciousness, and Fall.
Section 4.9 Overdose:
Loss of consciousness has been added to the list of symptoms of overdose.Updated on 06 November 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
- Change to section 4.9 - Overdose
Free text change information supplied by the pharmaceutical company
Section 4.4 Special warnings and precautions for use:
A warning has been added regarding Mental Impairment, Loss of consciousness, Fall and the need for patients to exercise caution until they are familiar with the potential effects of the medication.
Section 4.8 Undesirable effects:
Addition of Sexual Dysfunction, Loss of consciousness, and Fall.
Section 4.9 Overdose:
Loss of consciousness has been added to the list of symptoms of overdose.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
- 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
Section 4.8 Undesirable effects – rhabdomyolysis and blood creatine phosphokinase increased added
Updated on 08 May 2013
Reasons for updating
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
Section 4.8 Undesirable effects – rhabdomyolysis and blood creatine phosphokinase increased added
Updated on 23 July 2012
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 23 July 2012
Reasons for updating
- Improved electronic presentation
Free text change information supplied by the pharmaceutical company
Updated on 25 April 2012
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 25 April 2012
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
Free text change information supplied by the pharmaceutical company
Updated on 21 July 2011
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Update to sections 4.4 and 4.8 to add DRESS (Drug rash with eosinophilia and systemic symptoms),
Updated on 21 July 2011
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
Update to sections 4.4 and 4.8 to add DRESS (Drug rash with eosinophilia and systemic symptoms),
Updated on 18 January 2010
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
Section 4.8 has been updated to include hypersensitivity reactions (
include fever, rash, hepatitis, lymphadenopathy, eosinophilia, and sometimes other signs and symptoms)
Updated on 18 January 2010
Reasons for updating
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
Section 4.8 has been updated to include hypersensitivity reactions (
include fever, rash, hepatitis, lymphadenopathy, eosinophilia, and sometimes other signs and symptoms)
Updated on 16 December 2008
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 16 December 2008
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Free text change information supplied by the pharmaceutical company
Updated on 05 September 2008
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of renewal of authorisation
- 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
Due to Harmonisation of the Module 3 for both Tablets and Capsules the product descriptions have been clarified for Neurontin Capsules. The description for Neurontin Film-Coated Tablets have changed from a printed tablet to a scored tablet.
A statement has been added regarding the discontinuation of Gabapentin for all indications.
Lactose warning for Neurontin Hard Capsules has been modified.
Section 4.8:
Section 4.9:
Section 6.1:
Section 9:
Updated on 05 September 2008
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Due to Harmonisation of the Module 3 for both Tablets and Capsules the product descriptions have been clarified for Neurontin Capsules. The description for Neurontin Film-Coated Tablets have changed from a printed tablet to a scored tablet.
A statement has been added regarding the discontinuation of Gabapentin for all indications.
Lactose warning for Neurontin Hard Capsules has been modified.
Section 4.8:
Section 4.9:
Section 6.1:
Section 9:
Updated on 03 October 2007
Reasons for updating
- 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
6.1 Change in the composition of the printing ink for the 600 mg Tablets
Updated on 03 October 2007
Reasons for updating
- Change to section 6.1 - List of excipients
Free text change information supplied by the pharmaceutical company
6.1 Change in the composition of the printing ink for the 600 mg Tablets
Updated on 25 October 2006
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 October 2006
Reasons for updating
- Correction of spelling/typing errors
Updated on 13 September 2006
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 1 - Name of medicinal product
- Change to section 4.1 - Therapeutic indications
- 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 4.9 - Overdose
- Change to section 5 - Pharmacological properties
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 13 September 2006
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 1 - Name of medicinal product
- Change to section 4.1 - Therapeutic indications
- 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 4.9 - Overdose
- Change to section 5 - Pharmacological properties
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
Updated on 20 February 2006
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 February 2006
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 9 - Date of renewal of authorisation
Updated on 12 August 2005
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 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.5 - Nature and contents of container
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 August 2005
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 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.5 - Nature and contents of container
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - MA number
Updated on 15 November 2004
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 15 November 2004
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
Updated on 26 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 June 2003
Reasons for updating
- New SPC for medicines.ie