Fycompa tablets
*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 tablets 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 tablets 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 08 November 2022
File name
Fycompa tablets PIL_ROI Apr 2022 NtF Update.pdf
Reasons for updating
- Removal/change of distributor
Updated on 25 May 2022
File name
Fycompa tablets PIL_ROI Apr 2022.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 15 May 2022
File name
Fycompa tablets 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 17 March 2022
File name
Fycompa tablets PIL_ROI Mar 2022.pdf
Reasons for updating
- Change to other sources of information section
Updated on 17 March 2022
File name
Fycompa tablets PIL_ROI Mar 2022.pdf
Reasons for updating
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Change to contact details for Hungary
Updated on 20 September 2021
File name
Fycompa tablets PIL_ROI Sept 2021.pdf
Reasons for updating
- Change to other sources of information section
Updated on 19 May 2021
File name
Fycompa tablets PIL_ROI Apr 2021.pdf
Reasons for updating
- XPIL Updated
Updated on 12 May 2021
File name
Fycompa tablets 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 11 May 2021
File name
Fycompa tablets PIL_ROI Apr 2021.pdf
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
Updated on 25 March 2021
File name
ROI fycompa tablets PIL.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 12 November 2020
File name
Fycompa tablets 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 tablets 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 - how to report a side effect
- 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 09 July 2020
File name
Fycompa tablets PIL_ROI May 2020.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
Updated on 06 July 2020
File name
Fycompa tablets 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
Section 7 - address change
Updated on 06 July 2020
File name
Fycompa tablets PIL_ROI May 2020.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Section 6 - address change
Updated on 05 May 2020
File name
Fycompa tablets PIL_UK 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 tablets 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 28 February 2019
File name
Fycompa tablets PIL_ROI(draft).pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 28 February 2019
File name
Fycompa tablets SmPC_ROI(draft).pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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
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Documented changes |
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Sections of the SmPC |
Changes/updates |
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Section 7 |
Marketing Authorisation Holder details have been updated: Eisai GmbH Lyoner Straße 36 60528 Frankfurt am Main Germany E-mail: medinfo_de@eisai.net |
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Section 10 |
The date of revision of text has been updated to 11/2018 |
Updated on 04 April 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 04 April 2018
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
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Document Changes |
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Section of the SmPC |
Changes / Updates |
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4.4 Special warnings and precautions for use
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The following text has been added:
“Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS)
Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported (frequency unknown; see section 4.8) in association with perampanel treatment.
At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. Symptoms of DRESS include typically, although not exclusively, fever, rash associated with other organ system involvement, lymphadenopathy, liver function tests abnormalities and eosinophilia. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If signs and symptoms suggestive of these reactions appear, perampanel should be withdrawn immediately and an alternative treatment considered (as appropriate).”
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4.8 Undesirable effects
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The following text has been added:
“Post-marketing use
Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with perampanel treatment (see section 4.4).”
The text in bold has been added:
The following convention has been used for the classification of adverse reactions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), not known (cannot be estimated from the available data).
A “Not known” column has been added to the tabulated list of adverse reactions
System Organ Class “Skin and subcutaneous tissue disorders” has been added to the tabulated list of adverse reactions, with “Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)*” included as an adverse reaction under the “Not known” column.
The following footnote has been added to the tabulated list of adverse reactions;
“See section 4.4”
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Section 10 Date of Revision of the text |
February 2018 |
Updated on 29 March 2018
File name
PIL_15855_16.pdf
Reasons for updating
- New PIL for new product
Updated on 29 March 2018
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- 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
- Change to other sources of information section
Updated on 05 December 2017
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
- Improved presentation of PIL
Updated on 11 May 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 11 May 2017
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Removal of black triangle
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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Documented changes |
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Sections of the SPC |
Changes/updates |
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REMOVAL OF BLACK TRIANGLE |
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Section 9 |
Date of latest renewal: 6 April 2017
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Section 10 |
Date of Revision: April 2017 |
Updated on 09 May 2017
Reasons for updating
- Change to section 6 - date of revision
- Removal of black triangle
Updated on 29 March 2017
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 8 - Marketing authorisation number(s)
- 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
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Document Changes
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Section of the SmPC
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Changes / Updates |
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· Section 4.5 Interaction with other medicinal products and other forms of interaction
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The following information has changed from:
Some anti‑epileptic drugs known as enzyme inducers (carbamazepine, phenytoin, oxcarbazepine) have been shown to increase perampanel clearance and consequently to decrease plasma concentrations of perampanel.
to:
Some anti‑epileptic drugs known as CYP450 3A enzyme inducers (carbamazepine, phenytoin, oxcarbazepine) have been shown to increase perampanel clearance and consequently to decrease plasma concentrations of perampanel. Conversely, withdrawal of a concomitant CYP450 3A enzyme inducer can be expected to increase plasma concentrations of perampanel and dose reduction may be required.
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· Section 5.1 Pharmacodynamic properties
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The following paragraph in the clinical efficacy and safety section has changed from:
1.7 to 5.8% of the patients on perampanel in the clinical studies became seizure free during the 3 month maintenance period compared with 0%‑1.0% on placebo. There are no data regarding the effects of withdrawal of concomitant anti-epileptic medicinal products to achieve monotherapy with perampanel
to:
1.7 to 5.8% of the patients on perampanel in the clinical studies became seizure free during the 3 month maintenance period compared with 0%‑1.0% on placebo
The following paragraph in Section 5.1 has also changed from:
Conversion to monotherapy There are no data regarding the effects of withdrawal of concomitant anti-epileptic medicinal products to achieve monotherapy with perampanel.
to:
Conversion to monotherapy In a retrospective study of clinical practice, 51 patients with epilepsy who received perampanel as adjunctive treatment converted to perampanel monotherapy. The majority of these patients had a history of partial onset seizures. Of these, 14 patients (27%) reverted to adjunctive therapy in the following months. Thirty four (34) patients were followed up for at least 6 months and, of these, 24 patients (71%) remained on perampanel monotherapy for at least 6 months. Ten (10) patients were followed up for at least 18 months and, of these, 3 patients (30%) remained on perampanel monotherapy for at least 18 months.
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· Section 8 Marketing Authorisation number(s) |
The Marketing Authorsiation number has changed from:
EU/1/12/776/001-0023
to:
EU/1/12/776/001-023
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· Section 10 Date of Revision of the text
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Feb-2017 |
Updated on 31 January 2017
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the 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
The date of the latest renewal of authorisation has been added to section 9 below:
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 23/07/2012
Date of latest renewal: 26 January 2017
The date of the revision of the text has also changed:
10. DATE OF REVISION OF THE TEXT
01/2017
Updated on 30 December 2016
Reasons for updating
- 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
In addition to some formatting changes, the following sections of the Fycompa SmPC have been updated:
· Section 5.1 Pharmacodynamic properties
· Section 5.2 Pharmacokinetic properties
· Section 10 DATE OF REVISION OF THE TEXT
The below summarises the changes to the Fycompa SmPC:
Section 5.1 Pharmacodynamic properties
The following statement has been added in the Cognitive function section:
In a placebo controlled study conducted in adolescent patients, no significant changes in cognition relative to placebo as measured by Cognitive Drug Research (CDR) System Global Cognition Score were observed for perampanel. In the open label extension, no significant changes were observed in global CDR system score after 52 weeks of perampanel treatment (see section 5.1 Paediatric population).
In addition, the following information has been added under the paediatric population subheading of Section 5.1:
A 19-week, randomised, double-blind, placebo-controlled study with an open-label extension phase (Study 235) was performed to assess the short-term effects on cognition of Fycompa (target dose range of 8 to 12 mg once daily) as adjunctive therapy in 133 (Fycompa n=85, placebo n=48) adolescent patients, ages 12 to less than 18 years old, with inadequately controlled partial-onset seizures. Cognitive function was assessed by the Cognitive Drug Research (CDR) System Global Cognition t-Score, which is a composite score derived from 5 domains testing Power of Attention, Continuity of Attention, Quality of Episodic Secondary Memory, Quality of Working Memory, and Speed of Memory. The mean change (SD) from baseline to end of double-blind treatment (19 weeks) in CDR System Global Cognition t-Score was 1.1 (7.14) in the placebo group and (minus) –1.0 (8.86) in the perampanel group, with the difference between the treatment groups in LS means (95% CI) = (minus) ‑2.2 (‑5.2, 0.8). There was no statistically significant difference between the treatment groups (p = 0.145). CDR System Global Cognition t-Scores for placebo and perampanel were 41.2 (10.7) and 40.8 (13.0), respectively at the baseline. For patients with perampanel in the open label extension (n = 112), the mean change (SD) from baseline to end of open-label treatment (52 weeks) in CDR System Global Cognition t-Score was (minus) ‑1.0 (9.91). This was not statistically significant (p = 0.96). After up to 52 weeks of treatment with perampanel (n = 114), no effect on bone growth was observed. No effects on weight, height and sexual development were seen following up to 104 weeks of treatment (n = 114).
Section 5.2 Pharmacokinetic properties
The following information has changed from:
Paediatric population
In a population pharmacokinetic analysis of the adolescent patients in the Phase 3 clinical studies, there were no notable differences between this population and the overall population.
to:
Paediatric population
In a population pharmacokinetic analysis of the adolescent patients pooled from the Phase 2 and 3 clinical studies, there were no notable differences between this population and the overall population.
Section 10 DATE OF REVISION OF THE TEXT
October 2016
Updated on 17 November 2016
Reasons for updating
- 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 6.6 - Special precautions for disposal and other handling
- 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 4.2 Posology and method of administration
The following statement has been changed from:
Withdrawal
When withdrawing Fycompa, the dose should be gradually reduced (see section 4.4).
to:
Withdrawal
It is recommended that discontinuation be undertaken gradually to minimise the potential for rebound seizures. However, due to its long half-life and subsequent slow decline in plasma concentrations, perampanel can be discontinued abruptly if absolutely needed.
The following paragraph has also been changed from:
Method of administration
Fycompa should be taken as single oral dose at bedtime. It may be taken with or without food (see section 5.2). The tablet should be swallowed whole with a glass of water. It should not be chewed, crushed or split. The tablets cannot be split accurately as there is no break line. To ensure the patient receives the entire dose the tablets should be swallowed whole without chewing or crushing
to:
Method of administration
Fycompa should be taken as single oral dose at bedtime. It may be taken with or without food (see section 5.2). The tablet should be swallowed whole with a glass of water. It should not be chewed, crushed or split. The tablets cannot be split accurately as there is no break line.
- Section 4.4 Special warnings and precautions for use
The following information has been removed from Section 4.4:
End of treatment
It is recommended that discontinuation be undertaken gradually to minimise the potential for rebound seizures (see section 4.2). However, due to its long half-life and subsequent slow decline in plasma concentrations, perampanel can be discontinued abruptly if absolutely needed.
Information moved to Section 4.2.
- Section 4.5 Interaction with other medicinal products and other forms of interaction
The following information has changed from:
Effect of cytochrome P450 inducers on perampanel pharmacokinetics
Strong inducers of cytochrome P450, such as rifampicin and hypericum, are expected to decrease perampanel concentrations. Felbamate has been shown to decrease the concentrations of some drugs and may also reduce perampanel concentrations. The potential for higher plasma concentrations of the reactive metabolites in presence of strong cytochrome P450 inducers could not be excluded.
to:
Effect of cytochrome P450 inducers on perampanel pharmacokinetics
Strong inducers of cytochrome P450, such as rifampicin and hypericum, are expected to decrease perampanel concentrations and the potential for higher plasma concentrations of reactive metabolites in their presence has not been excluded. Felbamate has been shown to decrease the concentrations of some medicinal products and may also reduce perampanel concentrations.
- Section 4.8 Undesirable effects
The following has changed from:
Tabulated list of adverse reactions
In the table below, adverse reactions, which were identified based on review of the full Fycompa clinical studies safety database, are listed by System Organ Class and frequency. The initial review was done by considering all treatment emergent adverse events (TEAEs) in the double-blind Phase 3 epilepsy studies that occurred in ≥2% of patients in the total Fycompa group. The following were also considered: incidence rates higher than with placebo; severity, seriousness, and rates of discontinuation due to the events; analyses of exposure and dose-response; and consistency with Fycompa pharmacology. TEAEs that occurred in less frequency and met the same criteria as for the more frequent TEAEs were also considered. The following convention has been used for the classification of adverse reactions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000).
The dose of 2 mg/day was not included in this assessment because it is not considered to be an effective dose, and the rates of TEAEs in that dose group were generally comparable to, or lower than, those in the placebo group.
to:
Tabulated list of adverse reactions
In the table below, adverse reactions, which were identified based on review of the full Fycompa clinical studies safety database, are listed by System Organ Class and frequency. The following convention has been used for the classification of adverse reactions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100).
- Section 5.1 Pharmacodynamic properties
Formatting changes
- Section 5.2 Pharmacokinetic properties
The Absorption section has changed from:
Absorption
Perampanel is readily absorbed after oral administration with no evidence of marked first-pass metabolism. Food does not affect the extent of absorption, but slows the rate of absorption. When administered with food, peak plasma concentrations are reduced and delayed by 2 hours compared with dosing in a fasted state.
To:
Absorption
Perampanel is readily absorbed after oral administration with no evidence of marked first-pass metabolism. Co-administration of perampanel tablets with a high fat meal had no impact on the peak plasma exposure (Cmax) or total exposure (AUC0-inf) of perampanel. The tmax was delayed by approximately 1 hour compared to that under fasted conditions
The wording in the ‘Elimination’ section of Section 5.2 has also changed from:
Following administration of a radiolabeled perampanel dose to 8 healthy elderly subjects, 30% of recovered radioactivity was found in the urine and 70% in the faeces.
to:
Following administration of a radiolabeled perampanel dose to either 8 healthy adults or elderly subjects, approximately 30% of recovered radioactivity was found in the urine and 70% in the faeces.
- Section 6.6 Special precautions for disposal
The following has been added to Section 6.6:
Any unused medicinal product or waste material should be disposed of in accordance with local requirements
- Section 10 Date of Revision of the text
November 2016
Updated on 05 October 2016
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to date of revision
- Change to dosage and administration
Updated on 01 March 2016
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
Wording has been updated in section 4.8:
Paediatric population
Based on the clinical trial database of 196 adolescents exposed to perampanel from double-blind studies for partial onset seizures and primary generalized tonic-clonic seizures, the overall safety profile in adolescents was similar to that of adults, except for aggression, which was observed more frequently in adolescents than in adults.
Updated on 13 January 2016
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
- The sentence 'The potential for higher plasma concentrations of the reactive metabolites in presence of strong cytochrome P450 inducers could not be excluded' has been added to the subsection titled 'Effect of cytochrome P450 inducers on perampanel pharmacokinetics'
- The sentence 'Strong inhibitors of other cytochrome P450 isoforms could potentially also increase perampanel concentrations' has been removed from the subsection titled 'Effect of cytochrome P450 inhibitors on perampanel pharmacokinetics'
Section 5.1: Typos corrected
Section 5.2
- The sentence 'However, the metabolism has not been completely elucidated and other pathways cannot be excluded' has been deleted from the subsection titled 'Biotransformation'
Updated on 26 June 2015
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 4.8 – Undesirable effects - how to report a side effect
- 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 Therapeutic indications
Additional indication:
Fycompa is indicated for the adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy
· Section 4.2 Posology and method of administration
Primary generalised tonic-clonic seizures dosing information added (see SPC)
· Section 4.4 Special warnings and precautions for use
Sentence regarding responder rates with and without enzyme inducing anti-epileptic medicinal products moved to Section 5.1. Sentence regarding no data for conversion to monotherapy moved to section 5.1
· Section 4.5 Interaction with other medicinal products and other forms of interaction
Interaction data updated to include primary generalised tonic-clonic seizures Phase 3 study. Influence of carbamazepine, oxcarbazepine , phenytoin and topiramate on Fycompa concentration adjusted (see table in Section 4.5)
· Section 4.8 Undesirable effects
Addition of information from primary generalised tonic-clonic seizures clinical trial to summary of safety profile
Addition of 'suicidal ideation' and 'suicide attempt' to the table of adverse reactions under 'uncommon' (≥1/1,000 to <1/100)
· Section 5.1 Pharmacodynamic properties
Addition of clinical efficacy and safety information from the primary generalised tonic-clonic seizures trial (Study 332). Multiple text inserts. Please see the SPC
· 5.2 Pharmacokinetic properties
Addition of information from a population pharmacokinetic analysis of patients with primary generalised tonic-clonic seizures
Updated on 26 June 2015
Reasons for updating
- Change to, or new use for medicine
- Change to date of revision
Updated on 27 May 2015
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
In Section 10, date of revision of the text is 13 May 2015
Updated on 29 September 2014
Reasons for updating
- Change to section 6.3 - Shelf life
- 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 6.3
2 and 4 mg tablets - shelf life extended from 4 years to 5 years
6, 8, 10 and 12 mg tablets - shelf life extended from 3 years to 4 years
Updated on 27 November 2013
Reasons for updating
- Addition of black triangle
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 (undesirable effects) - the phone number and fax number to report suspected adverse reactions has been updated
Updated on 25 November 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Addition of information on reporting a side effect.
- Addition of black triangle
Updated on 01 October 2013
Reasons for updating
- New PIL for new product
- New PIL for medicines.ie
Updated on 30 September 2013
Reasons for updating
- New SPC for new product
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)