Epanutin 30mg/5ml Oral Suspension *

  • Company:

    Pfizer Healthcare Ireland
  • 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

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 22 January 2021

File name

DEC202101234-V_Reg SPC EP 39_2 30mg-5ml Suspension Oral IE-clean_1611309381.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

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

Updated on 22 January 2021

File name

DEC202101234-V_Reg PIL EP 31_2 Suspension IE-clean_1611309320.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 19 May 2020

File name

DEC202028579_SmPC EPANUTIN ORAL SUSPENSION clean_1589901049.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 be renewed (B)

Updated on 19 May 2020

File name

DEC202028579_PIL EPANUTIN ORAL SUSPENSION clean_1589900839.pdf

Reasons for updating

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

Updated on 28 April 2020

File name

DEC202027012_Reg PIL EP 29_1 Suspension cl_1588068489.pdf

Reasons for updating

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

Updated on 28 April 2020

File name

DEC202027012_Reg SPC EP 37_1 30mg-5ml Suspension Oral IE cl_1588063923.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 be renewed (B)

Updated on 12 February 2020

File name

DEC202009094_Reg SPC EP 35_2 30mg-5ml Suspension Oral IE CLEAN_1581519913.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • 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: SPC section 1 format change, section 2 excipients and quantity updated, section  4.4 sub section added 'Information about Excipients' & section 6.1 editorial change.

Updated on 12 February 2020

File name

DEC202009094_Reg PIL EP 27_1 Suspension. CLEANdoc_1581519712.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 09 December 2019

File name

DEC201968793_PIL-clean_1575908905.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 11 July 2019

File name

DEC201936334_Reg PIL EP 22_2 Suspension-clean_1562841277.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
  • Change to section 2 - driving and using machines
  • Change to section 6 - date of revision

Updated on 11 July 2019

File name

DEC201936334_Reg SPC EP 34_2 30 mg-5ml Suspension Oral IE-clean_1562841323.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation

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:  SmPC Sections 4.4 & 4.6 wording relating to advice regarding  use of phenytoin in women of child bearing potential and pregnancy.

Updated on 07 June 2019

File name

DEC201929916_Reg PIL EP 12_0 Infatab 50mg UK-IE clean_1559846366.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 06 June 2019

File name

DEC201929916_m1-3-1-spc-0822-011-007 clean_1559846405.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose

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

Updated on 27 November 2018

File name

Reg SPC EP 29_1 30 mg-5ml Suspension Oral IE_1543330960.pdf

Reasons for updating

  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

Improved presentation of SPC uploaded

Updated on 28 August 2018

File name

Reg_SPC_EP_29_1_30mg-5ml_Suspension_Oral_clean_1535449569.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

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: Updated section 4.6 (Fertility, pregnancy and lactation, Usage in Pregnancy) with the deletion of statements in  regarding fetal hydantoin syndrome. In the second sentence of the fourth paragraph the terms " barbiturates, alcohol, or trimethadione" are removed, as well as the last sentence following it, "However, these features are all interrelated and are frequently associated with intrauterine growth retardation from other causes".

Updated on 11 July 2018

File name

Reg_SPC_EP_29_1_30mg-5ml_Suspension_Oral_clean.docx

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

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: Updated section 4.6 (Fertility, pregnancy and lactation, Usage in Pregnancy) with the deletion of statements in  regarding fetal hydantoin syndrome. In the second sentence of the fourth paragraph the terms " barbiturates, alcohol, or trimethadione" are removed, as well as the last sentence following it, "However, these features are all interrelated and are frequently associated with intrauterine growth retardation from other causes".

Updated on 05 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Update to section 4.5 of Phenytoin/Phenytoin sodium Summary of Product Characteristics (SmPC) to include “disopyramide” as a drug interaction where the serum levels and/or effects of the drug may be altered by Phenytoin/Phenytoin Sodium, in line with the latest company Core Data Sheet (CDS). In addition, a statement to clarify that the list of compounds in section 4.5 is not intended to be all-inclusive or comprehensive.

Updated on 05 March 2018

Reasons for updating

  • New SPC for new product

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

Updated on 02 March 2018

File name

PIL_8707_72.pdf

Reasons for updating

  • New PIL for new product

Updated on 02 March 2018

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 19 September 2017

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 MAH has updated section 4.8 of the phenytoin and phenytoin sodium Summary of Product Characteristics (SmPC) to include “thyroid function test abnormal” as an Adverse Drug Reaction (ADR) in line with the latest company Core Data Sheet (CDS.

Updated on 19 September 2017

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 11 July 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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 Posology and method of administration of the Pfizer Phenytoin Sodium capsule and Phenytoin oral Core Data Sheets updated to clarify the information relating to dosing with different indications.

The PIL is not affected.

Updated on 19 June 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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 Posology and method of administration of the Pfizer Phenytoin Sodium capsule and Phenytoin oral Core Data Sheets updated to clarify the information relating to dosing with different indications.

Updated on 16 January 2017

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

The SPC has been updated as follows:

·       Addition of information regarding the potential need for dose modification and/or measurement of unbound phenytoin levels due to the potential for the elevated concentrations of unbound phenytoin in patients with renal or hepatic diseases, hypoalbuminemia, and/or hyperbilirubinemia

·       Addition of information related to the potential need for dose modification in elderly patients on account of a decrease in phenytoin clearance with increasing age

Updated on 13 January 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 25 November 2016

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

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 4.6 of the SmPCs have been updated with information on the active substance crossing the placenta.

Updated on 24 November 2016

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 22 August 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 4.9 - Overdose

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 4.4, 4.8 and 4.9 of the Summary of Product Characteristics in line with the revised CDS (addition of Cerebellar Atrophy).

Updated on 24 December 2015

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 4.6 - Pregnancy and lactation
  • 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

Section 4.3 Contraindications Co-administration of phenytoin is contraindicated with delavirdine

 

Section 4.4 Special warnings and precautions for use: Subsections – General warning section updated to include new warnings, Serious skin reactions  updated with DRESS.

 

Section 4.5 has been updated to provide a clearer overview of the different types of drug interaction with phenytoin and include information on P450 induction effect.

 

Section 4.6 has been updated to add information on fertility.

Section 4.8 Undesirable effects: updates improve the clarity of the information relating to adverse reactions associated with possible hypersensitivity reactions and to include new potential manifestations of hypersensitivity (DRESS).

Section 5.3 has been updated with information on carcinogenic potential,

Updated on 21 December 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to improve clarity and readability

Updated on 02 November 2015

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

The SPC has been updated as follows

Section 4.4 Special warnings and precautions for use “PHT may precipitate or aggravate absence seizures and myoclonic seizures.” Section 4.8 Undesirable effects “Paediatric population The adverse event profile of phenytoin is generally similar between children and adults. Gingival hyperplasia occurs more frequently in paediatric patients and in patients with poor oral hygiene.”

Updated on 03 July 2015

Reasons for updating

  • Change of manufacturer

Updated on 21 October 2013

Reasons for updating

  • Improved electronic presentation

Updated on 17 December 2012

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions for use

Section 4.5 Interactions with other medicinal products and other forms of interaction

Section 4.8 Undesirable effects

Updated on 12 December 2012

Reasons for updating

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

Updated on 31 August 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 4.8 has been updated to include PhVWP wording on bone related side-effects

Sections 4.4 and 4.8 have been updated to include PhVWP wording on Stevens-Johnson-Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)

Sections 9 and 10 have also been updated

Updated on 28 August 2012

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 25 October 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 30 September 2010

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

SmPC: Section 4.4 (Special Warnings)

Updated on 27 August 2009

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

The date of revision of text was incorrect on the published SPC

Updated on 12 June 2009

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

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

Free text change information supplied by the pharmaceutical company



Section 2 Qualitative and Quantitative Composition: Line wrt composition added

Updated on 10 June 2009

Reasons for updating

  • Change of inactive ingredient
  • Change to date of revision

Updated on 10 March 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change due to user-testing of patient information
  • Change to improve clarity and readability

Updated on 21 January 2009

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

Addition of suicide warnings to Section 4.4

Updated on 31 July 2008

Reasons for updating

  • Correction of spelling/typing errors

Updated on 26 February 2008

Reasons for updating

  • Change to name of manufacturer

Updated on 13 October 2005

Reasons for updating

  • Change of active ingredient
  • Change of inactive ingredient
  • Change to marketing authorisation holder
  • Change to drug interactions
  • Change to dosage and administration
  • Change to side-effects
  • Change to storage instructions
  • Change to date of revision
  • Change to warnings or special precautions for use
  • Change to, or new use for medicine

Updated on 12 October 2005

Reasons for updating

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

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

Updated on 18 March 2005

Reasons for updating

  • Change to marketing authorisation holder

Updated on 17 March 2005

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 10 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 June 2003

Reasons for updating

  • New SPC for medicines.ie

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