Fycompa 0.5 mg/ml oral suspension
*Company:
Eisai LtdStatus:
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 16 May 2023
File name
ROI Fycompa oral suspension SmPC Apr 2023.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 be renewed (B)
Updated on 16 May 2023
File name
ROI Fycompa oral suspension PIL Apr 2023.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 15 September 2022
File name
Fycompa oral suspension PIL_ROI Aug 2022.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2: What you need to know before you take Fycompa - Updated the warning information for sorbitol
Included the warning and quantitative information for both sodium benzoate and benzoic acid to align with the excipient guidance for the oral solution
Section 6: Contents of the pack and other information - Updated to 08/2022
Updated on 15 September 2022
File name
Fycompa oral suspension SmPC_ROI Aug 2022.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 4.4: Special warnings and precautions for use - Updated the warning information for sorbitol; Included the warning and quantitative information for both sodium benzoate and benzoic acid to align with the excipient guidance for the oral solution
Section 10: Date of revision of the text - Updated to 08/2022
Updated on 25 May 2022
File name
Fycompa oral suspension PIL_ROI Apr 2022.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 15 May 2022
File name
Fycompa oral suspension PIL_ROI Apr 2022.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 15 May 2022
File name
Fycompa oral suspension SmPC_ROI Apr 2022.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 September 2021
File name
Fycompa oral suspension PIL_ROI Sept 2021.pdf
Reasons for updating
- Change to other sources of information section
Updated on 21 June 2021
File name
Fycompa oral suspension SmPC_ROI June 2021.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.pdf
Reasons for updating
- XPIL Created
Updated on 11 May 2021
File name
Fycompa oral suspension PIL_ROI Apr 2021.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.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.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 12 November 2020
File name
Fycompa OS PIL_ROI Nov 2020.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.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.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.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.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.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.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.pdf
Reasons for updating
- New PIL for new product
Updated on 20 March 2019
File name
Fycompa OS SmPC_ROI.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)