Neurontin 100mg Hard Capsules *
Pharmacy Only: Prescription

  • Company:

    Upjohn EESV
  • Status:

    No Recent Update
  • Legal 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 05 August 2021

File name

DEC202110087-V_Reg SPC NN 30_0 100 mg Capsules IE - clean_1628145455.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_1628145392.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_1628145284.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_1614335776.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_1614335708.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_1557833659.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_1557833137.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

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

Free text change information supplied by the pharmaceutical company

update to sections 4.4 and 4.8 with Respiratory Depression.

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 sulfate

Updated 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 sulfate

Updated 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 sulfate

Updated 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 sulfate

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 - 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 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 - 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 included

Updated 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

Improved electronic presentation

Updated on 23 July 2012

Reasons for updating

  • Improved electronic presentation

Free text change information supplied by the pharmaceutical company

Improved electronic presentation

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

Section 5.2 – Updated to include pharmacokinetic study in 24 healthy paediatric subjects

Updated on 25 April 2012

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties

Free text change information supplied by the pharmaceutical company

Section 5.2 – Updated to include pharmacokinetic study in 24 healthy paediatric subjects

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

Section 4.4: Warning Regarding Suicidal ideation and behaviour in patients treated with antiepileptic medication added.

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

Section 4.4: Warning Regarding Suicidal ideation and behaviour in patients treated with antiepileptic medication added.

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

Section 3:
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.
 
Section 4.2:
A statement has been added regarding the discontinuation of Gabapentin for all indications.
 
Section 4.4:
Lactose warning for Neurontin Hard Capsules has been modified.

Section 4.8:
The adverse drug reaction section has been re-formatted to a table format.
Breast hypertrophy, gynaecomastia and myoclonus have been added as adverse drug reactions.
A warning for patients on haemodialysis has also been added.

Section 4.9:
Warning added regarding combinations with other CNS depressants.

Section 6.1:
Excipients have changed due to the Tablets formulation change from printed tablets to scored tablets.
 
Section 6.5:
Nature and contents of container – section was harmonised due to the MRP renewal.

Section 9:
New renewal dates added
 
Section 10:
New revision date added

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

Section 3:
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.
 
Section 4.2:
A statement has been added regarding the discontinuation of Gabapentin for all indications.
 
Section 4.4:
Lactose warning for Neurontin Hard Capsules has been modified.

Section 4.8:
The adverse drug reaction section has been re-formatted to a table format.
Breast hypertrophy, gynaecomastia and myoclonus have been added as adverse drug reactions.
A warning for patients on haemodialysis has also been added.

Section 4.9:
Warning added regarding combinations with other CNS depressants.

Section 6.1:
Excipients have changed due to the Tablets formulation change from printed tablets to scored tablets.
 
Section 6.5:
Nature and contents of container – section was harmonised due to the MRP renewal.

Section 9:
New renewal dates added
 
Section 10:
New revision date added

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

Changes to sections 1, 2, 4.1 - 4.9, 5.1-5.3, 6.5 and consequential changes to the PIL following IMB approval of EU article 30 referral changes 

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

Changes to sections 1, 2, 4.1 - 4.9, 5.1-5.3, 6.5 and consequential changes to the PIL following IMB approval of EU article 30 referral changes 

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