Fycompa 0.5 mg/ml oral suspension
- Name:
Fycompa 0.5 mg/ml oral suspension
- Company:
Eisai Ltd
- 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: 12/11/20
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Eisai Ltd
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 12 November 2020 PIL
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 SPC
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 PIL
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 9 July 2020 SPC
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 9 July 2020 PIL
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 5 May 2020 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 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 5 May 2020 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 4.6 - 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 PIL
Reasons for updating
- New PIL for new product
Updated on 20 March 2019 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)