Epanutin 30mg/5ml Oral Suspension
*Company:
Upjohn EESVStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 20 July 2023
File name
Epanutin 30mg_5ml OS - Patient Information Leaflet - 003027738 version 1.0 - MT LENC- clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 05 April 2023
File name
Reg SPC EP 43_1 30mg-5ml Suspension Oral 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 07 April 2022
File name
Reg PIL EP 34_1 Suspension - clean (002).pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
Updated on 23 March 2022
File name
Reg PIL EP 34_1 Suspension - clean.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 42_2 30mg-5ml Suspension Oral IE - 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
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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 33_1 Suspension - 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 30 November 2021
File name
DEC202115438-V_Reg SPC EP 40_1 30mg-5ml Suspension Oral IE - 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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 7 - Pfizer Healthcare Ireland changed to Upjohn EESV as the MAH, with updated address
Section 8 - updated with new PA number for Upjohn EESV
Updated on 30 November 2021
File name
DEC202115438-V_Reg PIL EP 32_1 Suspension - 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 22 January 2021
File name
DEC202101234-V_Reg SPC EP 39_2 30mg-5ml Suspension Oral IE-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 22 January 2021
File name
DEC202101234-V_Reg PIL EP 31_2 Suspension IE-clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 19 May 2020
File name
DEC202028579_SmPC EPANUTIN ORAL SUSPENSION clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 19 May 2020
File name
DEC202028579_PIL EPANUTIN ORAL SUSPENSION clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 28 April 2020
File name
DEC202027012_Reg PIL EP 29_1 Suspension cl.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 28 April 2020
File name
DEC202027012_Reg SPC EP 37_1 30mg-5ml Suspension Oral IE cl.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 February 2020
File name
DEC202009094_Reg SPC EP 35_2 30mg-5ml Suspension Oral IE CLEAN.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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The SPC has been updated as follows: SPC section 1 format change, section 2 excipients and quantity updated, section 4.4 sub section added 'Information about Excipients' & section 6.1 editorial change. |
Updated on 12 February 2020
File name
DEC202009094_Reg PIL EP 27_1 Suspension. CLEANdoc.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 09 December 2019
File name
DEC201968793_PIL-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 11 July 2019
File name
DEC201936334_Reg PIL EP 22_2 Suspension-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 6 - date of revision
Updated on 11 July 2019
File name
DEC201936334_Reg SPC EP 34_2 30 mg-5ml Suspension Oral IE-clean.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-0822-011-007 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 29_1 30 mg-5ml Suspension Oral IE.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Improved presentation of SPC uploaded
Updated on 28 August 2018
File name
Reg_SPC_EP_29_1_30mg-5ml_Suspension_Oral_clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: Updated section 4.6 (Fertility, pregnancy and lactation, Usage in Pregnancy) with the deletion of statements in regarding fetal hydantoin syndrome. In the second sentence of the fourth paragraph the terms " barbiturates, alcohol, or trimethadione" are removed, as well as the last sentence following it, "However, these features are all interrelated and are frequently associated with intrauterine growth retardation from other causes".
Updated on 11 July 2018
File name
Reg_SPC_EP_29_1_30mg-5ml_Suspension_Oral_clean.docx
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: Updated section 4.6 (Fertility, pregnancy and lactation, Usage in Pregnancy) with the deletion of statements in regarding fetal hydantoin syndrome. In the second sentence of the fourth paragraph the terms " barbiturates, alcohol, or trimethadione" are removed, as well as the last sentence following it, "However, these features are all interrelated and are frequently associated with intrauterine growth retardation from other causes".
Updated on 05 March 2018
Reasons for updating
- 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
Updated on 02 March 2018
File name
PIL_8707_72.pdf
Reasons for updating
- New PIL for new product
Updated on 02 March 2018
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 19 September 2017
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 19 September 2017
Reasons for updating
- Change to section 4 - possible side effects
Updated on 11 July 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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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. |
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The PIL is not affected. |
Updated on 19 June 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows
Section 4.2 Posology and method of administration of the Pfizer Phenytoin Sodium capsule and Phenytoin oral Core Data Sheets updated to clarify the information relating to dosing with different indications.Updated on 16 January 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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The SPC has been updated as follows: · Addition of information regarding the potential need for dose modification and/or measurement of unbound phenytoin levels due to the potential for the elevated concentrations of unbound phenytoin in patients with renal or hepatic diseases, hypoalbuminemia, and/or hyperbilirubinemia · Addition of information related to the potential need for dose modification in elderly patients on account of a decrease in phenytoin clearance with increasing age |
Updated on 13 January 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 25 November 2016
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows; Section 4.6 of the SmPCs have been updated with information on the active substance crossing the placenta.
Updated on 24 November 2016
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 22 August 2016
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 24 December 2015
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.3 Contraindications Co-administration of phenytoin is contraindicated with delavirdine
Section 4.4 Special warnings and precautions for use: Subsections – General warning section updated to include new warnings, Serious skin reactions updated with DRESS.
Section 4.5 has been updated to provide a clearer overview of the different types of drug interaction with phenytoin and include information on P450 induction effect.
Section 4.6 has been updated to add information on fertility.
Section 4.8 Undesirable effects: updates improve the clarity of the information relating to adverse reactions associated with possible hypersensitivity reactions and to include new potential manifestations of hypersensitivity (DRESS).
Section 5.3 has been updated with information on carcinogenic potential,
Updated on 21 December 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to improve clarity and readability
Updated on 02 November 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows
Section 4.4 Special warnings and precautions for use “PHT may precipitate or aggravate absence seizures and myoclonic seizures.” Section 4.8 Undesirable effects “Paediatric population The adverse event profile of phenytoin is generally similar between children and adults. Gingival hyperplasia occurs more frequently in paediatric patients and in patients with poor oral hygiene.”Updated on 03 July 2015
Reasons for updating
- Change of manufacturer
Updated on 21 October 2013
Reasons for updating
- Improved electronic presentation
Updated on 17 December 2012
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 Special warnings and precautions for use
Section 4.5 Interactions with other medicinal products and other forms of interaction
Section 4.8 Undesirable effects
Updated on 12 December 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
Updated on 31 August 2012
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.8 has been updated to include PhVWP wording on bone related side-effects
Sections 4.4 and 4.8 have been updated to include PhVWP wording on Stevens-Johnson-Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)
Sections 9 and 10 have also been updated
Updated on 28 August 2012
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 25 October 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 30 September 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 27 August 2009
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 12 June 2009
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2 Qualitative and Quantitative Composition: Line wrt composition added
Updated on 10 June 2009
Reasons for updating
- Change of inactive ingredient
- Change to date of revision
Updated on 10 March 2009
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Change due to user-testing of patient information
- Change to improve clarity and readability
Updated on 21 January 2009
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Addition of suicide warnings to Section 4.4
Updated on 31 July 2008
Reasons for updating
- Correction of spelling/typing errors
Updated on 26 February 2008
Reasons for updating
- Change to name of manufacturer
Updated on 13 October 2005
Reasons for updating
- Change of active ingredient
- Change of inactive ingredient
- Change to marketing authorisation holder
- Change to drug interactions
- Change to dosage and administration
- Change to side-effects
- Change to storage instructions
- Change to date of revision
- Change to warnings or special precautions for use
- Change to, or new use for medicine
Updated on 12 October 2005
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 March 2005
Reasons for updating
- Change to marketing authorisation holder
Updated on 17 March 2005
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 10 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 27 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)