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Pfizer Healthcare Ireland

9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Medical Information Website: http://www.pfizermedicalinformation.ie
Summary of Product Characteristics last updated on medicines.ie: 19/04/2017
SPC Neurontin 300mg Hard Capsules

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 19/04/2017 and displayed until Current
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Date of revision of text on the SPC:   01-Dec-2016
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 20/12/2016 and displayed until 19/04/2017
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Dec-2016
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 23/05/2016 and displayed until 20/12/2016
Reasons for adding or 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
Date of revision of text on the SPC:   01-May-2016
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 29/04/2016 and displayed until 23/05/2016
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   01-Jan-2016
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 18/02/2016 and displayed until 29/04/2016
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   01-Jan-2016
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 18/01/2016 and displayed until 18/02/2016
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   01-Jan-2016
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 02/06/2015 and displayed until 18/01/2016
Reasons for adding or 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
Date of revision of text on the SPC:   01-May-2015
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 01/05/2015 and displayed until 02/06/2015
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Apr-2015
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 06/11/2014 and displayed until 01/05/2015
Reasons for adding or 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
Date of revision of text on the SPC:   01-Oct-2014
Legal Category:   Product subject to restricted prescription (C)

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 08/07/2014 and displayed until 06/11/2014
Reasons for adding or 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
Date of revision of text on the SPC:   01-Jun-2014
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Updates to sections 4.4 & 4.8

Updated on 08/05/2013 and displayed until 08/07/2014
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 restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Gabapentin