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EPANUTIN Ready Mixed Parenteral *
Pharmacy Only: Prescription

  • Company:

    Upjohn EESV

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Phenytoin Sodium

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

Updated on 07 April 2022

File name

Reg PIL EP 42_1 - clean_1649349816.pdf

Reasons for updating

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

Updated on 26 January 2022

File name

DEC202200672-V_Reg SPC EP 53_1 250 mg-5ml RMP Solution For Injection IE - clean_1643216162.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 not be renewed (A)

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 41_1 - clean_1643214859.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 04 May 2021

File name

DEC202106101-V_Reg SPC EP 52_1 250 mg-5ml RMP Solution For Injection IE - clean_1620132453.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 not be renewed (A)

Updated on 04 May 2021

File name

DEC202106101-V_Reg PIL EP 40_0 - clean_1620132383.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 30 November 2020

File name

DEC202050982-V_Reg SPC EP 51_1 250 mg-5ml RMP Solution For Injection IE-clean_1606720063.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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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:

  • Section 2 – addition of propylene glycol. Correction of sodium and ethanol quantities.
  • Section 4.2 – propylene glycol warning for neonates and infants
  • Section 4.4 – propylene glycol, sodium and ethanol warnings
  • Section 4.6 – propylene glycol warning
  • Section 4.8 – addition to adverse events
  • Section 10 – Date of revision

Updated on 30 November 2020

File name

DEC202050982-V_Reg PIL EP 39_0-clean_1606719991.pdf

Reasons for updating

  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 19 May 2020

File name

DEC202028579_SmPC EPANUTIN RMP clean_1589901902.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)

Updated on 19 May 2020

File name

DEC202028579_PIL EPANUTIN RMP clean_1589901852.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 19 May 2020

File name

DEC202028579_SmPC EPANUTIN RMP clean_1589901792.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 49_1 250 mg-5ml RMP Solution For Injection IE cl_1588064600.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)

Updated on 28 April 2020

File name

DEC202027012_Reg PIL EP 37_1 RMP cl_1588064543.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 18 February 2020

File name

DEC202010470_Reg PIL EP 34_3 RMP Clean_1582023050.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 22 August 2019

File name

DEC201945069_Reg PIL EP 33_0 RMP-CLEAN_1566486226.pdf

Reasons for updating

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

Updated on 22 August 2019

File name

DEC201945069_Reg SPC EP 46_0 250 mg-5ml RMP Solution For Injection IE-CLEAN_1566486293.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Updated on 11 July 2019

File name

DEC201936334_Reg PIL EP 31_2 RMP-clean_1562841968.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 44_2 250 mg-5ml RMP Solution For Injection IE-clean_1562842015.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 not be renewed (A)

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 31 July 2018

File name

Reg SPC EP 39_0 250 mg-5ml RMP Solution For Injection IE Clean_1533030841.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

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: 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 10 May 2018

File name

Clean_Reg_SPC_EP_38_RMP_IE.docx

Reasons for updating

  • Other

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

Updated on 04 May 2018

File name

Clean_Reg_SPC_EP_38_RMP_IE.docx

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.9 - Overdose
  • Change to section 6.2 - Incompatibilities

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

Free text change information supplied by the pharmaceutical company

The following sections have been updated as per the Dilution instructions-Dextrose incompatibility variation:

  • 4.2 Posology and method of administration; “Epanutin Ready Mixed Parenteral should not be mixed with other drugs nor be added to dextrose or dextrose-containing solutions due to the potential for precipitation of phenytoin acid.”
  • 6.2 Incompatibilities “Epanutin Ready Mixed Parenteral should not be mixed with other drugs nor be added to dextrose or dextrose-containing solutions due to the potential for precipitation of phenytoin acid.
    The following sections have been updated as per addition of Cerebellar Atrophy Variation;
  • 4.1 Therapeutic indications; “Phenytoin has not been shown to enhance survival in patients with ventricular arrhythmias.”
  • 4.4 Special warnings and precautions for use; “Central Nervous System Effect: Serum levels of phenytoin sustained above the optimal range may produce confusional states referred to as "delirium", "psychosis", or "encephalopathy", or rarely irreversible cerebellar dysfunction and/or cerebellar atrophy.”
  • 4.8 Undesirable effects; “Reactions include nystagmus, ataxia, slurred speech, decreased coordination and mental confusion. Cerebellar atrophy has been reported, and appears more likely in settings of elevated phenytoin levels and/or long-term phenytoin use (see section 4.4). Dizziness, insomnia, transient nervousness, motor twitching, taste perversion, headache, paraesthesia, somnolence, drowsiness and vertigo have also been observed.”

4.9. Overdose; “Irreversible cerebellar dysfunction and atrophy have been reported.”

Updated on 16 April 2018

File name

Clean Reg PIL EP 27_1 RMP .pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - how to take/use

Updated on 12 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 12 March 2018

File name

PIL_8709_895.pdf

Reasons for updating

  • New PIL for new product

Updated on 12 March 2018

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

The SPC has been updated as follows; Type II category C.I.4 variation to update section 4.2 & 4.4 of the Epanutin Injection Summary of Product Characteristics (SmPC) to include clarifying dosing information in line with CDS. The Package Leaflet (PL) has also been updated accordingly.

Updated on 12 March 2018

Reasons for updating

  • Change to section 2 - use in children and adolescents

Updated on 12 March 2018

Reasons for updating

  • Change to section 3 - use in children/adolescents

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 not be renewed (A)

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

Reasons for updating

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

Updated on 28 November 2017

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects

Updated on 13 October 2017

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

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 24 July 2017

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

resubmitted

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 not be renewed (A)

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 21 December 2016

Reasons for updating

  • Change to section 5 - how to store or dispose
  • 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 not be renewed (A)

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 15 August 2016

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

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

Free text change information supplied by the pharmaceutical company

Section 4.1 – text regarding treatment of cardiac arrhythmias modified to clarify existing information

Updated on 12 August 2016

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 22 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 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

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 4.8 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).

Updated on 18 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 not be renewed (A)

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 06 August 2015

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data

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 4.6 and 5.3 have been updated, also section 4.8 had been updated re QRD v9 AE reporting to HPRA.

Updated on 17 December 2012

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

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

Free text change information supplied by the pharmaceutical company

Section 4.2 Posology and method of administration

Section 4.4 Special warnings and precautions for use

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

Section 4.6 Fertility, pregnancy and lactation

Section 4.8 Undesirable effects

Updated on 11 December 2012

Reasons for updating

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

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 30 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 not be renewed (A)

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 26 August 2010

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 2 (Composition) & 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 12 August 2010

Reasons for updating

  • 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 information about driving or using machinery
  • Change to further information section
  • Change to date of revision
  • Change to appearance of the medicine
  • Change to marketing authorisation holder
  • Change to MA holder contact details
  • Change to improve clarity and readability
  • Change of special precautions for disposal

Updated on 29 May 2009

Reasons for updating

  • Correction of spelling/typing errors

Updated on 28 May 2009

Reasons for updating

  • Change to name of manufacturer

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition of suicide warnings to Section 4.4

Updated on 18 June 2008

Reasons for updating

  • Change of manufacturer

Updated on 17 June 2008

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Type IB Variation to Reduce the Shelf Life for Epanutin RMP from 36 to 30 months (EP_081) and a type II finished product manufacturing site transfer (EP_063)

Updated on 12 March 2008

Reasons for updating

  • Improved electronic presentation

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

Updated on 23 January 2006

Reasons for updating

  • Change of licence holder
  • 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

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 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 not be renewed (A)

Updated on 30 March 2005

Reasons for updating

  • Improved electronic presentation

Updated on 24 March 2005

Reasons for updating

  • Improved electronic presentation

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

Updated on 10 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 18 March 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 27 June 2003

Reasons for updating

  • New SPC for medicines.ie

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