Neurontin 100mg Hard Capsules

  • Name:

    Neurontin 100mg Hard Capsules

  • Company:
    info
  • Active Ingredients:

    Gabapentin

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 14/05/19

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Summary of Product Characteristics last updated on medicines.ie: 14/5/2019

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

Company Products

Medicine NameActive Ingredients
Medicine Name Accupro 10 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 20 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 40 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accuretic 20 mg/12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Quinapril hydrochloride
Medicine Name Aciclovir 25 mg/ml Concentrate for Solution for Infusion. Active Ingredients Aciclovir sodium
Medicine Name Aldactone 100mg film coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 25mg film-coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 50 mg Film-coated tablets. Active Ingredients Spironolactone
Medicine Name Amlodipine Pfizer 10 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Anugesic HC Cream Active Ingredients Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Hydrocortisone Acetate, Pramocaine Hydrochloride, Zinc Oxide
Medicine Name ARICEPT 10 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name ARICEPT 5 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Aromasin 25 mg coated tablets Active Ingredients Exemestane
Medicine Name Arthrotec 50 Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Arthrotec 75 modified-release tablets Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Ativan 1mg Tablets Active Ingredients Lorazepam
Medicine Name ATIVAN INJECTION Active Ingredients Lorazepam
Medicine Name BeneFIX Active Ingredients nonacog alfa
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
Medicine Name Bosulif 100 mg, 400 mg & 500 mg film-coated tablets Active Ingredients Bosutinib monohydrate
Medicine Name Cabaser 1mg Tablet Active Ingredients Cabergoline
Medicine Name Cabaser 2mg Tablet Active Ingredients Cabergoline
Medicine Name CAMPTO 20 mg/ml, concentrate for solution for infusion Active Ingredients Irinotecan hydrochloride trihydrate
1 - 0 of 227 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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 14 May 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 14 May 2019 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 17 January 2018 SmPC

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 PIL

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 December 2017 PIL

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 4 December 2017 SmPC

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 7 September 2017 SmPC

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 7 September 2017 PIL

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 3 March 2017 PIL

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 3 March 2017 SmPC

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 23 May 2016 PIL

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 23 May 2016 SmPC

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 29 April 2016 PIL

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 29 April 2016 SmPC

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 18 February 2016 SmPC

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 PIL

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 PIL

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 SmPC

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 2 June 2015 PIL

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 2 June 2015 SmPC

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 1 May 2015 PIL

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 1 May 2015 SmPC

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 6 November 2014 PIL

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 6 November 2014 SmPC

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 9 July 2014 PIL

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 9 July 2014 SmPC

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 8 May 2013 PIL

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 8 May 2013 SmPC

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 23 July 2012 PIL

Reasons for updating

  • Improved electronic presentation

Free text change information supplied by the pharmaceutical company

Improved electronic presentation

Updated on 23 July 2012 SmPC

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 25 April 2012 PIL

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 25 April 2012 SmPC

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 21 July 2011 PIL

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 21 July 2011 SmPC

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 18 January 2010 PIL

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 18 January 2010 SmPC

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 16 December 2008 PIL

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 16 December 2008 SmPC

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 5 September 2008 PIL

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 5 September 2008 SmPC

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 3 October 2007 PIL

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 3 October 2007 SmPC

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 25 October 2006 SmPC

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 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 13 September 2006 SmPC

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 PIL

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 SmPC

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 PIL

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 SmPC

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 PIL

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 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects

Updated on 15 November 2004 SmPC

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 26 June 2003 SmPC

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 PIL

Reasons for updating

  • New SPC for medicines.ie