Fycompa 0.5 mg/ml oral suspension *

  • Company:

    Eisai Ltd
  • Status:

    No Recent Update
  • Legal 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

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 21 June 2021

File name

Fycompa oral suspension SmPC_ROI June 2021_1624275015.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 19 May 2021

File name

Fycompa oral suspension PIL_ROI Apr 2021_1620745236.pdf

Reasons for updating

  • XPIL Created

Updated on 11 May 2021

File name

Fycompa oral suspension PIL_ROI Apr 2021_1620745236.pdf

Reasons for updating

  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - date of revision

Updated on 11 May 2021

File name

Fycompa oral suspension SmPC_ROI Apr 2021_1620745125.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 25 March 2021

File name

ROI fycompa suspension PIL_1616665122.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 12 November 2020

File name

Fycompa OS PIL_ROI Nov 2020_1605202839.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - dose and frequency
  • Change to section 6 - date of revision

Updated on 12 November 2020

File name

Fycompa OS SmPC_ROI Nov 2020_1605202733.pdf

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 4.1: new paediatric indications

Section 4.2: new paediatric dosing recommendations

Section 4.4: Updated warnings/precautions re. absence and myoclonic seizures; homicidal ideation included within aggression

Section 4.5: Additional interaction study data, including paediatric data, and update to antiepileptic drugs table of interactions

Section 4.8: Addition of summary of paediatric study data

Section 5.1: Addition of cognitive data from paediatric studies, and summary of paediatric study data

Section 5.2: Updated linearity/non-linearity and paediatric populations sections

Section 10: Updated date of revision of text

Minor formatting changes throughout

Updated on 27 July 2020

File name

Fycompa oral suspension PIL_ROI July 2020_1595852678.pdf

Reasons for updating

  • Change to section 3 - how to take/use

Free text change information supplied by the pharmaceutical company

How to use Fycompa - Method of administration - Revision of the syringe cleaning instructions: addition of points 8 to 11

Updated on 09 July 2020

File name

Fycompa oral suspension SmPC_ROI May 2020_1594300507.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to address of MAH

Updated on 09 July 2020

File name

Fycompa oral suspension PIL_ROI May 2020_1594300408.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

Address change for MAH and manufacturer

Updated on 05 May 2020

File name

Fycompa oral suspension PIL_ROI Apr 2020_1588699157.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 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Section 2: Raised liver enzymes added; Stevens-Johnson syndrome added as potential serious skin reaction; “oral” contraceptives – changed to “hormonal” contraceptives

Section 4: Stevens-Johnson syndrome added as potential serious skin reaction

Updated on 05 May 2020

File name

Fycompa oral suspension SmPC_ROI Apr 2020_1588699015.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 - 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

Section 4.4: Addition of hepatotoxicity warning; Amendment of “oral” contraceptive to “hormonal” contraceptive; Addition of Stevens-Johnson syndrome as potential severe cutaneous adverse reaction.

Section 4.5: Amendment of “oral” contraceptive to “hormonal” contraceptive (interactions section)

Section 4.6: Amendment of “oral” contraceptive to “hormonal” contraceptive (section on women of childbearing potential and contraception)

Section 4.8: Addition of Stevens-Johnson syndrome as skin adverse reaction (frequency = not known)

Updated on 20 March 2019

File name

Fycompa OS PIL_ROI_1553082600.pdf

Reasons for updating

  • New PIL for new product

Updated on 20 March 2019

File name

Fycompa OS SmPC_ROI_1553082695.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)