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Pfizer Healthcare Ireland

9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Medical Information Website: http://www.pfizermedicalinformation.ie
Summary of Product Characteristics last updated on medicines.ie: 19/06/2017
SPC EPANUTIN INFATABS

When a pharmaceutical company changes an SPC or PIL, 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 19/06/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   01-Jun-2017
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 20/01/2017 and displayed until 19/06/2017
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Jan-2017
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 01/12/2016 and displayed until 20/01/2017
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
Date of revision of text on the SPC:   01-Nov-2016
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 22/08/2016 and displayed until 01/12/2016
Reasons for adding or 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
Date of revision of text on the SPC:   01-Aug-2016
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 24/12/2015 and displayed until 22/08/2016
Reasons for adding or 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
Date of revision of text on the SPC:   01-Dec-2015
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 02/11/2015 and displayed until 24/12/2015
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Oct-2015
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 17/12/2012 and displayed until 02/11/2015
Reasons for adding or 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
Date of revision of text on the SPC:   03-Dec-2012
Legal Category:   Product subject to restricted prescription (C)

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 28/08/2012 and displayed until 17/12/2012
Reasons for adding or 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
Date of revision of text on the SPC:   01-Aug-2012
Legal Category:   Product subject to restricted prescription (C)

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 31/05/2012 and displayed until 28/08/2012
Reasons for adding or 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
Date of revision of text on the SPC:   01-May-2012
Legal Category:   Product subject to restricted prescription (C)

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 28/07/2011 and displayed until 31/05/2012
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   01-Jul-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Section 6.1 affected.
Updated on 30/09/2010 and displayed until 28/07/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   01-Sep-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



SmPC: Section 4.4 (Special Warnings)

Updated on 27/07/2010 and displayed until 30/09/2010
Reasons for adding or 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
Date of revision of text on the SPC:   07-Feb-2010
Legal Category:   Product subject to restricted prescription (C)

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 21/01/2009 and displayed until 27/07/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   01/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Addition of suicide warnings to Section 4.4

Updated on 18/01/2006 and displayed until 21/01/2009
Reasons for adding or 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
Updated on 17/03/2005 and displayed until 18/01/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Updated on 01/03/2004 and displayed until 17/03/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 16/02/2004 and displayed until 01/03/2004
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Updated on 27/06/2003 and displayed until 16/02/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Phenytoin