PRO-EPANUTIN *
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 27 September 2022

File name

633304564ac72.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to other sources of information section
  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

The PIL has been updated for the following reasons:

·    To align with the latest CMDh QRD template for MR/DC procedures, CMDh/201/2005, Rev.12 (based on version 10.2 of the QRD template for CP).

·    To align with the current SmPC wording, including side effects and potential birth defects when using fosphenytoin whilst pregnant. (HPRA query)

·    Brexit-related update to include “United Kingdom (Northern Ireland)”.


Updated on 06 April 2022

File name

RegSPCPJ312IECLEAN_1649237672.pdf

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

The SPC has been updated as follows:

Section 4.5: Anticoagulants (apixaban, dabigatran, edoxaban, rivaroxaban), Antiplatelets (ticagrelor) and Lacosamide added to Drugs whose serum levels and/or effects may be altered by phenytoin listed by likely mechanism sub-section.

Section 4.8: Reference of pharmacokinetic study (982-028) reference to hypotension (5.2%) added to Paediatric Population sub-section

Updated on 06 April 2022

File name

RegPILPJ271IECLEAN_1649237564.pdf

Reasons for updating

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

Updated on 09 July 2021

File name

DEC202146211_IE PIL CLEAN_1625833129.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 09 July 2021

File name

DEC202146211_IE SPC CLEAN_1625833008.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 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

The SPC has been updated as follows:

  • 4.4 Addition of the warning on serious cutaneous adverse reactions and CYP2CP metabolism
  • 4.5 Addition of interactions with Tenofovir alafenmide and afatinib and their mechanism

4.8 Addition of Uriticaria  with unknown frequency

Updated on 11 January 2021

File name

DEC202101375_Reg PIL PJ 25_0 IE_clean_1610355036.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 23 March 2020

File name

DEC202018505_Reg SPC PJ 29_1 IE_clean_1584948558.pdf

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Addition of AGEP and Angioedema to the following sections;

4.4       Special warnings and precautions for use

4.8       Undesirable effects

 

Updated on 23 March 2020

File name

DEC202018505_Reg PIL PJ 24_1 UK & IE_clean_1584948353.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer

Updated on 11 December 2019

File name

DEC201969140_Reg PIL PJ 23_3 UK & IE clean_1576057032.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • 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 - driving and using machines
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to other sources of information section

Updated on 26 July 2019

File name

DEC201930564_Reg PIL PJ 22_2 UK & IE_clean_1564136730.pdf

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

File name

DEC201930564_Reg SPC PJ 28_2 IE_clean_1564136804.pdf

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 07 February 2019

File name

Reg PIL PJ 20_0 UK & IE-clean_1549525846.pdf

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 07 February 2019

File name

Reg SPC PJ 27_1 IE-clean_1549525973.pdf

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

Reasons for updating

  • New SPC for new product

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

Updated on 22 March 2018

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

File name

PIL_8714_555.pdf

Reasons for updating

  • New PIL for new product

Updated on 21 March 2018

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

Reasons for updating

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

Updated on 16 August 2017

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

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

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

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 08 March 2016

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 03 March 2016

Reasons for updating

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

Updated on 13 August 2015

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 05 September 2013

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 06 August 2013

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 05 August 2013

Reasons for updating

  • Change to side-effects

Updated on 03 August 2012

Reasons for updating

  • Change to name of manufacturer

Updated on 23 April 2012

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

Reasons for updating

  • Change to side-effects

Updated on 07 June 2011

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 06 June 2011

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 07 March 2011

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

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 02 November 2010

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

Reasons for updating

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

Updated on 16 April 2010

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 06 April 2010

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 03 September 2009

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

Reasons for updating

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

Updated on 26 March 2008

Reasons for updating

  • Improved electronic presentation

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

Updated on 18 March 2008

Reasons for updating

  • Improved electronic presentation

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

Updated on 11 January 2006

Reasons for updating

  • Change of licence holder

Updated on 27 September 2005

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

Reasons for updating

  • Change of licence holder

Updated on 10 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 09 August 2004

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

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 01 July 2003

Reasons for updating

  • New SPC for medicines.ie

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