PRO-EPANUTIN

  • Name:

    PRO-EPANUTIN

  • Company:
    info
  • Active Ingredients:

    Fosphenytoin Sodium

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/07/19

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Summary of Product Characteristics last updated on medicines.ie: 26/7/2019

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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 26 July 2019 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 26 July 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.4 - Special precautions for storage

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

 

Section 4.2 and 6.4 with editorial changes.

Section 4.4  with sodium content

Updated on 7 February 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 7 February 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: section 4.4 to include pregnancy section, 4.6 to include a statement regarding phenytoin crossing the placenta.

Sections 4.2, 4.5, 4.8, 5.1, 5.2, 6.2, 6.4 and 6.5 editorial changes.

Updated on 22 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 22 March 2018 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

section 4.5 of the SmPC revised to include “disopyramide” as a drug interaction where the serum levels and/or effects of the drug may be altered by phenytoin in line with the latest company Core Data Sheet

Updated on 21 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 March 2018 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 18 August 2017 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 16 August 2017 SmPC

Reasons for updating

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

to update sections 4.2 and 4.4 of the Summary of Product Characteristics (SmPC) to include information regarding elevated unbound concentration of phenytoin in patients with hyperbilirubinaemia, and in addition in line with QRD version 9.1

to update section 4.8 “Undesirable effects” of the Summary of Product Characteristics (SmPC) with the addition of the commonly reported (incidence ≥5% of treated subjects) adverse drug reactions (ADRs) in the fosphenytoin-treated paediatric population in line with the MAH’s latest Core Data Sheet (CDS).

to include information related to the risks of asystole and respiratory depression to section 4.4 “Special warnings and precautions for use”, and to update section 4.8 “Undesirable effects” adverse drug reaction (ADR) frequency category of “asystole” from “Not known” to “Uncommon” in the Fosphenytoin sodium Summary of Product Characteristics (SmPC).

(MRP)

Updated on 26 August 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows
VAR II Update to section 4.2 (and other sections) to include age range for paediatric populations. As part of RMC review; Update in section 4.2 to specify that parenteral fosphenytoin can be substituted for oral phenytoin sodium therapy at the same total daily “phenytoin sodium equivalents (PE)”  dose.

Update to section 4.2 (and other sections) regarding dosing instructions and dosing errors

Updated on 24 August 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to information about drinking alcohol
  • Change to further information section
  • Change to date of revision

Updated on 27 June 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 9 - Date of renewal of authorisation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

update section 4.4 "Special Warnings and Precautions for Use" and section 4.9 "Overdose" of the fosphenytoin sodium Summary of Product Characteristics (SmPC) by adding information relating to cerebellar atrophy.

additional editorial and formatting changes to sections 4.2 and 9 of the SmPC.

Updated on 8 March 2016 SmPC

Reasons for updating

  • 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 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: sections 4.3, 4.4, 4.5 and 4.8 and editorial changes

Updated on 3 March 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions

Updated on 13 August 2015 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows.

 

Update section 4.6 and 5.3 of the SPC by adding information relating to fertility in line with the latest company Core Data Sheet. SPC section 6.5 has been updated to revise container description, and minor editorial amend to section 6.6.

SPC has also been updated to remove UK details from sections 7, 8, 9 & 10.

Updated on 5 September 2013 PIL

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 6 August 2013 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

An update to sections 4.4 & 4.8 of SmPC and PIL to include PGS and DRESS  following a revision to the CDS

Updated on 5 August 2013 PIL

Reasons for updating

  • Change to side-effects

Updated on 3 August 2012 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 23 April 2012 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC update to section 4.8.

Updated on 17 April 2012 PIL

Reasons for updating

  • Change to side-effects

Updated on 7 June 2011 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update section 4.4 of SPC.  

Updated on 6 June 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 7 March 2011 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.8          Undesirable Effects

4.5          Interaction with Other Medicinal Products and Other Forms of Interaction

Updated on 18 November 2010 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Type II variation to update section 4.2 of the SPC to clarify dosing recommendations for adults and children.

Updated on 2 November 2010 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SmPC: Update to Section 4.4 of the SmPC to include the wording on SJS/TEN.

Updated on 29 October 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 16 April 2010 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 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 4.5, 4.8 and 4.4 updated in lione with the changes to the core data sheet.

Updated on 6 April 2010 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 3 September 2009 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition of suicide warnings to Section 4.4

Updated on 24 August 2009 PIL

Reasons for updating

  • Change due to user-testing of patient information
  • Change to warnings or special precautions for use

Updated on 26 March 2008 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 18 March 2008 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 11 January 2006 PIL

Reasons for updating

  • Change of licence holder

Updated on 27 September 2005 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 28 October 2004 PIL

Reasons for updating

  • Change of licence holder

Updated on 10 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 9 August 2004 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 12 July 2004 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 1 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)