EPANUTIN Ready Mixed Parenteral * Pharmacy Only: Prescription
Company:
Upjohn EESVStatus:
No Recent UpdateLegal 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 11 August 2023
File name
64d5e513b0452.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 01 August 2023
File name
64c8a48236b0e.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 05 April 2023
File name
642d47ef5800d.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 not be renewed (A)
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
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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
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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
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The SPC has been updated as follows:
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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
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
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
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
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
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
Sections 4.4 and 4.8 have been updated to include PhVWP wording on Stevens-Johnson-Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)
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 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
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)