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EPANUTIN INFATABS

*
Pharmacy Only: Prescription

  • Company:

    Upjohn EESV

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Phenytoin

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

Updated on 08 August 2024

File name

ie-spc-nl3211-pr3299761-maht-clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 18 July 2024

File name

Epanutin Infatabs - Patient Information Leaflet - clean.pdf

Reasons for updating

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

Updated on 05 April 2023

File name

Reg SPC EP 49_1 Infatab 50mg IE-clean-IE EP 312.pdf

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

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

Updated on 02 August 2022

File name

DEC202208915-V_Reg PIL EP 23_2 Infatab 50mg (UK) IE - clean.pdf

Reasons for updating

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

Updated on 26 January 2022

File name

DEC202200672-V_Reg SPC EP 48_1 Infatab 50mg - clean.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 4.6 - Pregnancy and lactation
  • 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:

Section 4.4 Addition of wording regarding CYP2C9*3 variant

Section 4.4 Women of childbearing potential – Update of wording regarding pregnancy and contraceptives in women of childbearing potential

Section 4.5 Interaction with other medicinal products and other forms of interaction – Addition of anticoagulants and antiplatelets

Section 4.5 Interaction with other medicinal products and other forms of interaction – Addition of wording regarding Hyperammonaemia with Concomitant Use of Valproate

Section 4.6 Fertility, Pregnancy and lactation – Update to wording regarding pregnancy and women of child bearing potential

Section 4.8 Undesirable side effects – Addition of pure red Cell aplasia side effect

Section 4.8 Undesirable side effects – Update to ADR reporting details

 

Updated on 26 January 2022

File name

DEC202200672-V_Reg PIL EP 22_0 Infatab 50mg (UK) IE - clean.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 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 17 May 2021

File name

DEC202106671-V_Reg PIL EP 21_1 Infatab 50mg (UK) IE - clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - manufacturer
  • Correction of spelling/typing errors

Updated on 04 May 2021

File name

DEC202106101-V_Reg SPC EP 47_1 Infatab 50mg - clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 04 May 2021

File name

DEC202106101-V_Reg PIL EP 20_0 Infatab 50mg UK-IE - clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 28 October 2020

File name

DEC202049573-V_Reg SPC EP 46_0 Infatab 50mg-clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

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

Updated on 28 October 2020

File name

DEC202049573-V_Reg PIL EP 19_0 Infatab 50mg IE - clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product contains

Updated on 20 October 2020

File name

DEC202049131-V_Reg SPC EP 45_1 Infatab 50mg clean.pdf

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)

Updated on 20 October 2020

File name

DEC202049131-V_Reg PIL EP 18_0 Infatab 50mg UK-IE clean .pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 19 May 2020

File name

DEC202028579_SmPC EPANUTIN INFATABS clean.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 INFATABS clean.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 43_1 Infatab 50mg cl.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 28 April 2020

File name

DEC202027012_Reg PIL EP 15_1 Infatab 50mg UK-IE cl.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 11 July 2019

File name

DEC201936334_Reg PIL EP 13_2 Infatab 50mg UK-IE-clean.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 6 - date of revision

Updated on 11 July 2019

File name

DEC201936334_Reg SPC EP 40_2 Infatab 50mg-clean.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.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-0822-011-005 clean.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 35_1 Infatab 50mg.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_35_1_infatab_50mg_IE_Clean.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_35_1_infatab_50mg_IE_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

  • New SPC for new product

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

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 02 March 2018

File name

PIL_8706_870.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
  • Change to section 4 - how to report a side effect

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 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 20 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

·      

·      • 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

Addition of information related to the potential need for dose modification in elderly patients on account of a decrease in phenytoin clearance with increasing ageAddition 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 01 December 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 25 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 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 27 September 2012

Reasons for updating

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

Updated on 28 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 24 August 2012

Reasons for updating

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

Updated on 31 May 2012

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • 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 2 (Qualitative and Quantitative Composition) – Update to quantity of sucrose in new formulation and addition of the excipient E110 Sunset Yellow

Section 3 (Pharmaceutical Form) – Update to tablet description to add bevelled edge description and tablet marking of P-D 007

Section 4.4 (Special Warnings and precautions for use) – Update to include warnings on the excipient Sunset Yellow  E110

Section 6.1 (List of Excipients) – Update to include Sunset Yellow E110 and removal of Sucrose Solution in line with the new formulation

Section 6.5 (Nature and contents of container) – Update for the replacement of pack size from 112 tablets to 200 tablets and description of container closure system

Section 10 (Revision Date) – Approval date added

Updated on 30 May 2012

Reasons for updating

  • Change of inactive ingredient
  • Change to packaging
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 28 July 2011

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 6.1 affected.

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 30 September 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
  • Change to MA holder contact details

Updated on 27 July 2010

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6 - Pharmaceutical particulars

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

Free text change information supplied by the pharmaceutical company

Sections 2 (Composition), 3 (Pharmaceutical Form), 6 (Pharmaceutical Particulars)  Sections 4.3 (Contra-Indications), 4.4 (Special Warnings), 4.5 (Interactions) & 5.2 (Pharmacokinetic Properties), 4.7 (Ability to drive and use machines) and 4.8 (Undesirable Effects).

Updated on 22 July 2010

Reasons for updating

  • Change of inactive ingredient
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision
  • Change to appearance of the medicine
  • Change to MA holder contact details
  • Change to improve clarity and readability

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 23 January 2006

Reasons for updating

  • Change of active ingredient
  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to date of revision
  • Change to storage instructions
  • Change of licence holder

Updated on 18 January 2006

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 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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 7 - Marketing authorisation holder
  • 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)

Updated on 30 March 2005

Reasons for updating

  • Improved electronic presentation

Updated on 21 March 2005

Reasons for updating

  • Improved electronic presentation

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 04 February 2005

Reasons for updating

  • Change to marketing authorisation holder
  • Change to drug interactions

Updated on 10 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 01 March 2004

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 16 February 2004

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

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)