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EPANUTIN 50mg Hard Capsules

*
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 Sodium

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

Updated on 31 May 2023

File name

Epanutin 50 mg Hard Capsules - Patient Information Leaflet - 003027462 version 1.0 - MT LENC - clean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 05 April 2023

File name

Reg SPC EP 49_1 Caps 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 26 January 2022

File name

DEC202200672-V_Reg SPC EP 48_2 Caps 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
  • 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 33_2 Caps 50mg - 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 14 October 2021

File name

DEC202113317-V_Reg SPC EP 47_1 Caps 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 14 October 2021

File name

DEC202113317-V_Reg PIL EP 32_1 Caps 50mg - 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 26 March 2021

File name

Reg SPC EP 46_0 Caps 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 09 March 2021

File name

Reg SPC EP 45_0 Caps 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 19 January 2021

File name

DEC202100949-V_Reg SPC EP 43_1 Caps 50mg-clean.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 19 January 2021

File name

DEC202100949-V_Reg PIL EP 31_1 Caps 50mg-clean.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

Updated on 30 July 2020

File name

Reg PIL EP 30_0 Caps 50mg - clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder

Updated on 19 May 2020

File name

DEC202028579_SmPC EPANUTIN CAPs 50mg 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 CAPs 50mg 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 41_1 Caps 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 28_1 Caps 50mg 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 10 January 2020

File name

DEC201936334_Reg PIL EP 26_2 Caps 50mg-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 09 December 2019

File name

DEC201968821_PIL clean.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 26_2 Caps 50mg-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 39_2 Caps 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 25_1 Caps 50mg 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-0822-011-002 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 31 July 2018

File name

Reg SPC EP 34_1 50mg Caps 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 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_14185_450.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 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

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

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 05 April 2013

Reasons for updating

  • Change to name of manufacturer

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 30 August 2012

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

  • 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

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    Updated on 28 August 2012

    Reasons for updating

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

    Updated on 14 October 2011

    Reasons for updating

    • Change to packaging
    • 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

    Updated on 01 July 2011

    Reasons for updating

    • Change to packaging
    • Change to date of revision

    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 13 August 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 information about driving or using machinery
    • Change to date of revision
    • Change to appearance of the medicine
    • Change to MA holder contact details

    Updated on 11 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 10 March 2009

    Reasons for updating

    • New PIL for medicines.ie