Neurontin 300mg 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_0 300 mg Capsules IE - clean_1628145549.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_1628145511.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_2 300 mg Capsules IE - clean_1614336007.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_1614335918.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_1557833734.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_0 300 mg Capsules IE Clean_1557833270.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 05 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

update to sections 4.4 and 4.8 with Respiratory Depression.

Updated on 05 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

update to sections 4.4 and 4.8 with Respiratory Depression.

Updated on 19 April 2017

Reasons for updating

  • 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

Section 4.8 - agitation ADR:  “unknown” was corrected to “uncommon”

Updated on 19 April 2017

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Free text change information supplied by the pharmaceutical company

Section 4.8 - agitation ADR:  “unknown” was corrected to “uncommon”

Updated on 20 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 20 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 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 sulfate

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 sulfate

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
  • 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
  • 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 08 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 08 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

None provided

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

None provided