EPANUTIN INFATABS
- Name:
EPANUTIN INFATABS
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 28/10/20
(Click to Download)Click on this link to Download PDF directly
Pfizer Healthcare Ireland
Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 28 October 2020
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
Updated on 28 October 2020 PIL
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
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Updated on 20 October 2020 PIL
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
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Updated on 19 May 2020 PIL
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
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Updated on 28 April 2020 PIL
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 PIL
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
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
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 7 June 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 6 June 2019
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.9 - Overdose
Updated on 27 November 2018
Reasons for updating
- Improved presentation of SmPC
Free text change information supplied by the pharmaceutical company
Improved presentation of SPC uploaded
Updated on 28 August 2018
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
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
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 5 March 2018
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 5 March 2018 SPC
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 2 March 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 2 March 2018 PIL
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 SPC
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 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 19 June 2017 SPC
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 indicationsUpdated on 20 January 2017 SPC
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 PIL
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 1 December 2016 SPC
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 PIL
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 22 August 2016 SPC
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 SPC
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 PIL
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 2 November 2015 SPC
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 SPC
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 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
Updated on 27 September 2012 PIL
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 SPC
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 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 31 May 2012 SPC
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 PIL
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 SPC
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
Updated on 30 September 2010 SPC
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 PIL
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 SPC
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 PIL
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 PIL
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 SPC
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 PIL
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 SPC
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 PIL
Reasons for updating
- Improved electronic presentation
Updated on 21 March 2005 PIL
Reasons for updating
- Improved electronic presentation
Updated on 17 March 2005 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 4 February 2005 PIL
Reasons for updating
- Change to marketing authorisation holder
- Change to drug interactions
Updated on 10 September 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 1 March 2004 SPC
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 SPC
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 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)