Fycompa

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



 2 

 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fycompa 2 mg film-coated tablets 
Fycompa 4 mg film-coated tablets 
Fycompa 6 mg film-coated tablets 
Fycompa 8 mg film-coated tablets 
Fycompa 10 mg film-coated tablets 
Fycompa 12 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Fycompa 2 mg film-coated tablets 
 
Each film-coated tablet contains 2 mg perampanel. 
 
Excipient with known effect: Each 2 mg tablet contains 78.5 mg of lactose (as monohydrate). 
For the full list of excipients, see section 6.1. 
 
Fycompa 4 mg film-coated tablets 
 
Each film-coated tablet contains 4 mg perampanel. 
 
Excipient with known effect: Each 4 mg tablet contains 157.0 mg of lactose (as monohydrate). 
For the full list of excipients, see section 6.1. 
 
Fycompa 6 mg film-coated tablets 
 
Each film-coated tablet contains 6 mg perampanel. 
 
Excipient with known effect: Each 6 mg tablet contains 151.0 mg of lactose (as monohydrate). 
For the full list of excipients, see section 6.1. 
 
Fycompa 8 mg film-coated tablets 
 
Each film-coated tablet contains 8 mg perampanel. 
 
Excipient with known effect: Each 8 mg tablet contains 149.0 mg of lactose (as monohydrate). 
For the full list of excipients, see section 6.1. 
 
Fycompa 10 mg film-coated tablets 
 
Each film-coated tablet contains 10 mg perampanel. 
 
Excipient with known effect: Each 10 mg tablet contains 147.0 mg of lactose (as monohydrate). 
For the full list of excipients, see section 6.1. 
 
Fycompa 12 mg film-coated tablets 
 
Each film-coated tablet contains 12 mg perampanel. 
 
Excipient with known effect: Each 12 mg tablet contains 145.0 mg of lactose (as monohydrate). 
For the full list of excipients, see section 6.1. 
 
 



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3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet) 
 
Fycompa 2 mg film-coated tablets 
 
Orange, round, biconvex tablet, engraved with E275 on one side and ‘2’ on other side 
 
Fycompa 4 mg film-coated tablets 
 
Red, round, biconvex tablet, engraved with E277 on one side and ‘4’ on other side 
 
Fycompa 6 mg film-coated tablets 
 
Pink, round, biconvex tablet, engraved with E294 on one side and ‘6’ on other side 
 
Fycompa 8 mg film-coated tablets 
 
Purple, round, biconvex tablet, engraved with E295 on one side and ‘8’ on other side 
 
Fycompa 10 mg film-coated tablets 
 
Green, round, biconvex tablet, engraved with E296 on one side and ‘10’ on other side 
 
Fycompa 12 mg film-coated tablets 
 
Blue, round, biconvex tablet, engraved with E297 on one side and ‘12’ on other side 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Fycompa (perampanel) is indicated for the adjunctive treatment of  
- partial-onset seizures (POS) with or without secondarily generalised seizures in patients from 
4 years of age and older. 
- primary generalised tonic-clonic (PGTC) seizures in patients from 7 years of age and older with 
idiopathic generalised epilepsy (IGE). 
 
4.2 Posology and method of administration 
 
Posology 
 
Fycompa must be titrated, according to individual patient response, in order to optimise the balance 
between efficacy and tolerability. 
Perampanel should be taken orally once daily at bedtime. 
The physician should prescribe the most appropriate formulation and strength according to weight and 
dose.  Alternate formulations of perampanel are available, including oral suspension 
 
Partial-Onset Seizures 
Perampanel at doses of 4 mg/day to 12 mg/day has been shown to be effective therapy in partial-onset 
seizures. 
 
The following table summarises the recommended posology for adults, adolescents and children from 
4 years of age. More details are provided below the table. 
 



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 Adult/adolescent 
(12 years and older) 

Children (4 – 11 years); weighing: 
≥ 30 kg 20 - < 30 kg < 20 kg 

Recommended 
starting dose 2 mg/day 2 mg/day 1 mg/day 1 mg/day 

Titration 
(incremental 
steps) 

2 mg/day 
(no more frequently 
than weekly 
intervals) 

2 mg/day 
(no more 
frequently than 
weekly intervals) 

1 mg/day 
(no more 
frequently than 
weekly intervals) 

1 mg/day 
(no more 
frequently than 
weekly 
intervals) 

Recommended 
maintenance dose 4 – 8 mg/day 4 – 8 mg/day 4 – 6 mg/day 2 – 4 mg/day 

Titration 
(incremental 
steps) 

2 mg/day 
(no more frequently 
than weekly 
intervals) 

2 mg/day 
(no more 
frequently than 
weekly intervals) 

1 mg/day 
(no more 
frequently than 
weekly intervals) 

0.5 mg/day 
(no more 
frequently than 
weekly 
intervals) 

Recommended 
maximum dose 12 mg/day 12 mg/day 8 mg/day 6 mg/day 

 
Adults, adolescents age ≥ 12 years 
Treatment with Fycompa should be initiated with a dose of 2 mg/day. The dose may be increased 
based on clinical response and tolerability by increments of 2 mg (either weekly or every 2 weeks as 
per half-life considerations described below) to a maintenance dose of 4 mg/day to 8 mg/day. 
Depending upon individual clinical response and tolerability at a dose of 8 mg/day, the dose may be 
increased by increments of 2 mg/day to 12 mg/day. Patients who are taking concomitant medicinal 
products that do not shorten the half-life of perampanel (see section 4.5) should be titrated no more 
frequently than at 2-week intervals. Patients who are taking concomitant medicinal products that 
shorten the half-life of perampanel (see section 4.5) should be titrated no more frequently than at 
1-week intervals. 
 
Children (from 4 to 11 years) weighing ≥ 30 kg 
Treatment with Fycompa should be initiated with a dose of 2 mg/day. The dose may be increased 
based on clinical response and tolerability by increments of 2 mg (either weekly or every 2 weeks as 
per half-life considerations described below) to a maintenance dose of 4 mg/day to 8 mg/day. 
Depending upon individual clinical response and tolerability at a dose of 8 mg/day, the dose may be 
increased by increments of 2 mg/day to 12 mg/day. Patients who are taking concomitant medicinal 
products that do not shorten the half-life of perampanel (see section 4.5) should be titrated no more 
frequently than at 2-week intervals. Patients who are taking concomitant medicinal products that 
shorten the half-life of perampanel (see section 4.5) should be titrated no more frequently than at 
1-week intervals. 
 
Children (from 4 to 11 years of age) weighing 20 kg and < 30 kg 
Treatment with Fycompa should be initiated with a dose of 1 mg/day. The dose may be increased 
based on clinical response and tolerability by increments of 1 mg (either weekly or every 2 weeks as 
per half-life considerations described below) to a maintenance dose of 4 mg/day to 6 mg/day.  
Depending upon individual clinical response and tolerability at a dose of 6 mg/day, the dose may be 
increased by increments of 1 mg/day to 8 mg/day. Patients who are taking concomitant medicinal 
products that do not shorten the half-life of perampanel (see section 4.5) should be titrated no more 
frequently than at 2-week intervals. Patients who are taking concomitant medicinal products that 
shorten the half-life of perampanel (see section 4.5) should be titrated no more frequently than at 
1-week intervals. 
 
Children (from 4 to 11 years of age) weighing < 20 kg 
Treatment with Fycompa should be initiated with a dose of 1 mg/day. The dose may be increased 
based on clinical response and tolerability by increments of 1 mg (either weekly or every 2 weeks as 



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per half-life considerations described below) to a maintenance dose of 2 mg/day to 4 mg/day. 
Depending upon individual clinical response and tolerability at a dose of 4 mg/day, the dose may be 
increased by increments of 0.5 mg/day to 6 mg/day. Patients who are taking concomitant medicinal 
products that do not shorten the half-life of perampanel (see section 4.5) should be titrated no more 
frequently than at 2-week intervals. Patients who are taking concomitant medicinal products that 
shorten the half-life of perampanel (see section 4.5) should be titrated no more frequently than at 
1-week intervals. 
 
Primary Generalised Tonic-Clonic Seizures 
Perampanel at a dose up to 8 mg/day has been shown to be effective in primary generalised 
tonic-clonic seizures. 
 
The following table summarises the recommended posology for adults, adolescents and children from 
7 years of age. More details are provided below the table. 
 

 Adult/adolescent 
(12 years and older) 

Children (7 – 11 years); weighing: 
≥ 30 kg 20 - < 30 kg < 20 kg 

Recommended 
starting dose 2 mg/day 2 mg/day 1 mg/day 1 mg/day 

Titration 
(incremental 
steps) 

2 mg/day 
(no more frequently 
than weekly 
intervals) 

2 mg/day 
(no more 
frequently than 
weekly intervals) 

1 mg/day 
(no more 
frequently than 
weekly intervals) 

1 mg/day 
(no more 
frequently than 
weekly 
intervals) 

Recommended 
maintenance dose Up to 8 mg/day 4 – 8 mg/day 4 – 6 mg/day 2 – 4 mg/day 

Titration 
(incremental 
steps) 

2 mg/day 
(no more frequently 
than weekly 
intervals) 

2 mg/day 
(no more 
frequently than 
weekly intervals) 

1 mg/day 
(no more 
frequently than 
weekly intervals) 

0.5 mg/day 
(no more 
frequently than 
weekly 
intervals) 

Recommended 
maximum dose 12 mg/day 12 mg/day 8 mg/day 6 mg/day 

 
Adults, adolescents age ≥ 12 years 
Treatment with Fycompa should be initiated at a dose of 2 mg/day. The dose may be increased based 
on clinical response and tolerability by increments of 2 mg (either weekly or every 2 weeks, as per 
half-life considerations described below) to a maintenance dose of up to 8 mg/day. Depending upon 
individual clinical response and tolerability at a dose of 8 mg/day, the dose may be increased up to 
12 mg/day, which may be effective in some patients (see section 4.4). Patients who are taking 
concomitant medicinal products that do not shorten the half-life of perampanel (see section 4.5) should 
be titrated no more frequently than at 2-week intervals. Patients who are taking concomitant medicinal 
products that shorten the half-life of perampanel (see section 4.5) should be titrated no more frequently 
than at 1-week intervals. 
 
Children (from 7 to 11 years) weighing ≥ 30 kg 
Treatment with Fycompa should be initiated with a dose of 2 mg/day. The dose may be increased 
based on clinical response and tolerability by increments of 2 mg (either weekly or every 2 weeks as 
per half-life considerations described below) to a maintenance dose of 4 mg/day to 8 mg/day. 
Depending upon individual clinical response and tolerability at a dose of 8 mg/day, the dose may be 
increased by increments of 2 mg/day to 12 mg/day. Patients who are taking concomitant medicinal 
products that do not shorten the half-life of perampanel (see section 4.5) should be titrated no more 
frequently than at 2-week intervals. Patients who are taking concomitant medicinal products that 
shorten the half-life of perampanel (see section 4.5) should be titrated no more frequently than at 
1-week intervals. 



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Children (from 7 to 11 years of age) weighing 20 kg and < 30 kg 
Treatment with Fycompa should be initiated with a dose of 1 mg/day. The dose may be increased 
based on clinical response and tolerability by increments of 1 mg (either weekly or every 2 weeks as 
per half-life considerations described below) to a maintenance dose of 4 mg/day to 6 mg/day.  
Depending upon individual clinical response and tolerability at a dose of 6 mg/day, the dose may be 
increased by increments of 1 mg/day to 8 mg/day. Patients who are taking concomitant medicinal 
products that do not shorten the half-life of perampanel (see section 4.5) should be titrated no more 
frequently than at 2-week intervals. Patients who are taking concomitant medicinal products that 
shorten the half-life of perampanel (see section 4.5) should be titrated no more frequently than at 
1-week intervals. 
 
Children (from 7 to 11 years of age) weighing < 20 kg 
Treatment with Fycompa should be initiated with a dose of 1 mg/day. The dose may be increased 
based on clinical response and tolerability by increments of 1 mg (either weekly or every 2 weeks as 
per half-life considerations described below) to a maintenance dose of 2 mg/day to 4 mg/day. 
Depending upon individual clinical response and tolerability at a dose of 4 mg/day, the dose may be 
increased by increments of 0.5 mg/day to 6 mg/day. Patients who are taking concomitant medicinal 
products that do not shorten the half-life of perampanel (see section 4.5) should be titrated no more 
frequently than at 2-week intervals. Patients who are taking concomitant medicinal products that 
shorten the half-life of perampanel (see section 4.5) should be titrated no more frequently than at 
1-week intervals. 
 
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. 
 
Missed doses 
Single missed dose: As perampanel has a long half-life, the patient should wait and take their next 
dose as scheduled. 
 
If more than 1 dose has been missed, for a continuous period of less than 5 half-lives (3 weeks for 
patients not taking perampanel metabolism-inducing anti-epileptic drugs (AED), 1 week for patients 
taking perampanel metabolism-inducing AEDs (see section 4.5)), consideration should be given to 
re-start treatment from the last dose level. 
 
If a patient has discontinued perampanel for a continuous period of more than 5 half-lives, it is 
recommended that initial dosing recommendations given above should be followed. 
 
Elderly (65 years of age and above) 
Clinical studies of Fycompa in epilepsy did not include sufficient numbers of patients aged 65 and 
over to determine whether they respond differently from younger patients. Analysis of safety 
information in 905 perampanel-treated elderly patients (in double-blind studies conducted in 
non-epilepsy indications) revealed no age-related differences in the safety profile. In combination with 
the lack of age-related difference in perampanel exposure, the results indicate that dose-adjustment in 
the elderly is not required. Perampanel should be used with caution in elderly taking into account the 
drug interaction potential in polymedicated patients (see section 4.4). 
 
Renal impairment 
Dose adjustment is not required in patients with mild renal impairment. Use in patients with moderate 
or severe renal impairment or patients undergoing haemodialysis is not recommended. 
 
Hepatic impairment 
Dose increases in patients with mild and moderate hepatic impairment should be based on clinical 
response and tolerability. For patients with mild or moderate hepatic impairment, dosing can be 



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initiated at 2 mg. Patients should be up-titrated using 2 mg doses no faster than every 2 weeks based 
on tolerability and effectiveness. 
Perampanel dosing for patients with mild and moderate impairment should not exceed 8 mg. 
Use in patients with severe hepatic impairment is not recommended. 
 
Paediatric population 
The safety and efficacy of perampanel have not yet been established  in children below 4 years of age 
in the POS indication or in children below 7 years of age in the PGTCS indication. 
 
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. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Suicidal ideation 
 
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic medicinal 
products in several indications. A meta-analysis of randomised placebo-controlled trials of 
anti-epileptic medicinal products has also shown a small increased risk of suicidal ideation and 
behaviour. The mechanism of this risk is not known and the available data do not exclude the 
possibility of an increased risk for perampanel. 
Therefore, patients (children, adolescents, and adults) should be monitored for signs of suicidal 
ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of 
patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour 
emerge. 
 
Severe cutaneous adverse reactions (SCARs) 
 
Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic 
symptoms (DRESS) and Stevens - Johnson Syndrome (SJS), 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. 
 
Symptoms of SJS include typically although not exclusively, skin detachment (epidermal 
necrosis/blister) < 10%, erythematous skin (confluent), rapid progression, painful atypical target-like 
lesions and/or purpuric macules in wide dissemination or large erythema (confluent), bullous/erosive 
involvement of more than 2 mucous membranes. 
 
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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If the patient has developed a serious reaction such as SJS or DRESS with the use of perampanel, 
treatment with perampanel must not be restarted in this patient at any time. 
 
Absence and myoclonic seizures 
 
Absence and myoclonic seizures are two common generalised seizure types that frequently occur in 
IGE patients. Other AEDs are known to induce or aggravate these seizure types. Patients with 
myoclonic seizures and absence seizures should be monitored while on Fycompa. 
 
Nervous system disorders 
 
Perampanel may cause dizziness and somnolence and therefore may influence the ability to drive or 
use machines (see section 4.7). 
 
Hormonal contraceptives 
 
At doses of 12 mg/day Fycompa may decrease the effectiveness of progestative-containing hormonal 
contraceptives; in this circumstance additional non-hormonal forms of contraception are recommended 
when using Fycompa (see sections 4.5 and 4.6). 
 
Falls 
 
There appears to be an increased risk of falls, particularly in the elderly; the underlying reason is 
unclear. 
 
Aggression 
 
Aggressive and hostile behaviour has been reported in patients receiving perampanel therapy. In 
perampanel-treated patients in clinical trials, aggression, anger and irritability were reported more 
frequently at higher doses. Most of the reported events were either mild or moderate and patients 
recovered either spontaneously or with dose adjustment. However, thoughts of harming others, 
physical assault or threatening behaviour were observed in some patients (<1% in perampanel clinical 
studies). Homicidal ideation has been reported in patients. Patients and caregivers should be 
counselled to alert a healthcare professional immediately if significant changes in mood or patterns of 
behaviour are noted. The dosage of perampanel should be reduced if such symptoms occur and should 
be discontinued immediately if symptoms are severe. 
 
Abuse potential 
 
Caution should be exercised in patients with a history of substance abuse and the patient should be 
monitored for symptoms of perampanel abuse. 
 
Concomitant CYP 3A inducing anti-epileptic medicinal products 
 
Response rates after addition of perampanel at fixed doses were less when patients received 
concomitant CYP3A enzyme-inducing anti-epileptic medicinal products (carbamazepine, phenytoin, 
oxcarbazepine) as compared to response rates in patient who received concomitant 
non-enzyme-inducing anti-epileptic medicinal products. Patients’ response should be monitored when 
they are switching from concomitant non-inducer anti-epileptic medicinal products to enzyme 
inducing medicinal products and vice versa. Depending upon individual clinical response and 
tolerability, the dose may be increased or decreased 2 mg at a time (see section 4.2). 
 



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Other concomitant (non- anti-epileptic) cytochrome P450 inducing or inhibiting medicinal products 
 
Patients should be closely monitored for tolerability and clinical response when adding or removing 
cytochrome P450 inducers or inhibitors, since perampanel plasma levels can be decreased or 
increased; the dose of perampanel may need to be adjusted accordingly. 
 
Hepatotoxicity 
 
Cases of hepatotoxicity (mainly hepatic enzyme increased) with perampanel in combination with other 
antiepileptic drugs have been reported. If hepatic enzymes elevation is observed, monitoring of liver 
function should be considered. 
 
Excipients 
 
Lactose intolerance 
Fycompa tablets contains lactose, therefore patients with rare hereditary problems of galactose 
intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this 
medicine. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Fycompa is not considered a strong inducer or inhibitor of cytochrome P450 or UGT enzymes (see 
section 5.2). 
 
Hormonal contraceptives 
 
In healthy women receiving 12 mg (but not 4 or 8 mg/day) for 21 days concomitantly with a combined 
oral contraceptive, Fycompa was shown to decrease the levonorgestrel exposure (mean Cmax and AUC 
values were each decreased by 40%). Ethinylestradiol AUC was not affected by Fycompa 12 mg 
whereas Cmax was decreased by 18%. Therefore, the possibility of decreased efficacy of hormonal 
progestative-containing contraceptives should be considered for women needing Fycompa 12 mg/day 
and an additional reliable method (intra-uterine device (IUD), condom) is to be used (see section 4.4). 
 
Interactions between Fycompa and other anti-epileptic medicinal products 
 
Potential interactions between Fycompa and other anti-epileptic drugs (AEDs) were assessed in 
clinical studies. A population PK analysis of three pooled Phase 3 studies in adolescent and adult 
patients with partial-onset seizures evaluated the effect of Fycompa (up to 12 mg once daily) on the 
PK of other AEDs. In another population PK analysis of pooled data from twenty Phase 1 studies in 
healthy subjects, with Fycompa up to 36 mg, and one Phase 2 and six Phase 3 studies in paediatric, 
adolescent, and adult patients with partial-onset seizures or primary generalised tonic-clonic seizures, 
with Fycompa up to 16 mg once daily, evaluated the effect of concomitant AEDs of perampanel 
clearance. The effect of these interactions on average steady state concentration is summarised in the 
following table. 
 



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AED 
coadministered 

Influence of AED on Fycompa 
concentration 

Influence of Fycompa on AED 
concentration 

Carbamazepine 3 fold decrease <10% decrease 
Clobazam No influence <10% decrease 
Clonazepam No influence No influence 
Lamotrigine No influence <10% decrease 
Levetiracetam No influence No influence 
Oxcarbazepine 2 fold decrease 35% increase 1) 
Phenobarbital 20% decrease No influence 
Phenytoin 2 fold decrease No influence 
Topiramate 20% decrease No influence 
Valproic Acid No influence <10% decrease 
Zonisamide No influence No influence 

1) Active metabolite monohydroxycarbazepine was not assessed. 
 
Based on the results from the population pharmacokinetic analysis of patients with partial-onset 
seizures and patients with primary generalised tonic-clonic seizures the total clearance of Fycompa 
was increased when co-administered with carbamazepine (3-fold), and phenytoin or  oxcarbazepine 
(2-fold), which are known inducers of enzymes of metabolism (see section 5.2). This effect should be 
taken into account and managed when adding or withdrawing these anti-epileptic drugs from a 
patient’s treatment regimen. Clonazepam, levetiracetam, phenobarbital, topiramate, zonisamide, 
clobazam, lamotrigine and valproic acid did not affect to a clinically relevant manner the clearance of 
Fycompa. 
 
In a population pharmacokinetic analysis of patients with partial-onset seizures, Fycompa did not 
affect to a clinically relevant manner the clearance of clonazepam, levetiracetam, phenobarbital, 
phenytoin, topiramate, zonisamide, carbamazepine, clobazam, lamotrigine and valproic acid, at the 
highest perampanel dose evaluated (12 mg/day). 
 
Perampanel was found to decrease the clearance of oxcarbazepine by 26%. Oxcarbazepine is rapidly 
metabolised by cytosolic reductase enzyme to the active metabolite, monohydroxycarbazepine. The 
effect of perampanel on monohydroxycarbazepine concentrations is not known. 
 
Perampanel is dosed to clinical effect regardless of other AEDs. 
 
Effect of perampanel on CYP3A substrates 
 
In healthy subjects, Fycompa (6 mg once daily for 20 days) decreased midazolam AUC by 13%. A 
larger decrease in exposure of midazolam (or other sensitive CYP3A substrates) at higher Fycompa 
doses cannot be excluded. 
 
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. 
 
Effect of cytochrome P450 inhibitors on perampanel pharmacokinetics 
 
In healthy subjects, the CYP3A4 inhibitor ketoconazole (400 mg once daily for 10 days) increased 
perampanel AUC by 20% and prolonged perampanel half--life by 15% (67.8 h vs 58.4 h). Larger 
effects cannot be excluded when perampanel is combined with a CYP3A inhibitor with longer half-life 
than ketoconazole or when the inhibitor is given for a longer treatment duration. 
 



 11 

Levodopa 
In healthy subjects, Fycompa (4 mg once daily for 19 days) had no effect on Cmax or AUC of levodopa. 
 
Alcohol 
 
The effects of perampanel on tasks involving alertness and vigilance such as driving ability were 
additive or supra-additive to the effects of alcohol itself, as found in a pharmacodynamic interaction 
study in healthy subjects. Multiple dosing of perampanel 12 mg/day increased levels of anger, 
confusion, and depression as assessed using the Profile of Mood State 5-point rating scale (see 
section 5.1). These effects may also be seen when Fycompa is used in combination with other central 
nervous system (CNS) depressants. 
 
Paediatric population 
 
Interaction studies have only been performed in adults. 
In a population pharmacokinetic analysis of  adolescent patients age ≥ 12 years and children age 4 to 
11 years, there were no notable differences compared to the adult population. 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential and contraception in males and females 
 
Fycompa is not recommended in women of childbearing potential not using contraception unless 
clearly necessary. Fycompa may decrease the effectiveness of progestative-containing hormonal 
contraceptives. An additional non-hormonal form of contraception is, therefore recommended (see 
sections 4.4 and 4.5). 
 
Pregnancy 
 
There are limited amounts of data (less than 300 pregnancy outcomes) from the use of perampanel in 
pregnant women. Studies in animals did not indicate any teratogenic effects in rats or rabbits, but 
embryotoxicity was observed in rats at maternally toxic doses (see section 5.3). Fycompa is not 
recommended during pregnancy. 
 
Breast-feeding 
 
Studies in lactating rats have shown excretion of perampanel and/or its metabolites in milk (for details 
see section 5.3). It is not known whether perampanel is excreted in human milk. A risk to the 
newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding 
or to discontinue/abstain from Fycompa therapy taking into account the benefit of breast--feeding for 
the child and the benefit of therapy for the woman. 
 
Fertility 
 
In the fertility study in rats, prolonged and irregular oestrous cycles were observed at high-dose 
(30 mg/kg) in females; however, these changes did not affect the fertility and early embryonic 
development. There were no effects on male fertility (see section 5.3). The effect of perampanel on 
human fertility has not been established. 
 
4.7 Effects on ability to drive and use machines 
 
Fycompa has moderate influence on the ability to drive and use machines. 
Perampanel may cause dizziness and somnolence and, therefore, may influence the ability to drive or 
use machines. Patients are advised not to drive a vehicle, operate complex machinery or engage in 
other potentially hazardous activities until it is known whether perampanel affects their ability to 
perform these tasks (see sections 4.4 and 4.5). 



 12 

 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
In all controlled and uncontrolled trials in patients with partial-onset seizures, 1,639 patients have 
received perampanel of whom 1,147 have been treated for 6 months and 703 for longer than 
12 months. 
 
In the controlled and uncontrolled study in patients with primary generalised tonic-clonic seizures, 
114 patients have received perampanel of whom 68 have been treated for 6 months and 36 for longer 
than 12 months. 
 
Adverse reactions leading to discontinuation: 
In the controlled Phase 3 partial-onset seizures clinical trials, the rate of discontinuation as a result of 
an adverse reaction was 1.7% (3/172), 4.2% (18/431) and 13.7% (35/255) in patients randomised to 
receive perampanel at the recommended doses of 4 mg, 8 mg and 12 mg/day, respectively, and 
1.4% (6/442) in patients randomised to receive placebo. The adverse reactions most commonly (≥ 1% 
in the total perampanel group and greater than placebo) leading to discontinuation were dizziness and 
somnolence. 
 
In the controlled Phase 3 primary generalised tonic-clonic seizures clinical trial, the rate of 
discontinuation as a result of an adverse reaction was 4.9% (4/81) in patients randomised to receive 
perampanel 8 mg, and 1.2% (1/82) in patients randomised to receive placebo. The adverse reaction 
most commonly leading to discontinuation (≥ 2% in the perampanel group and greater than placebo) 
was dizziness. 
 
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). 
 
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), not known (cannot be estimated from the 
available data). 
 
Within each frequency category, adverse reactions are presented in order of decreasing seriousness. 
 



 13 

System Organ Class Very common Common Uncommon Not known 
Metabolism and 
nutrition disorders 

 Decreased appetite 
Increased appetite 

  

Psychiatric disorders  Aggression 
Anger 
Anxiety 
Confusional state 

Suicidal 
ideation 
Suicide attempt 

 

Nervous system 
disorders 

Dizziness 
Somnolence 

Ataxia 
Dysarthria 
Balance disorder 
Irritability 

  

Eye disorders  Diplopia 
Vision blurred 

  

Ear and labyrinth 
disorders 

 Vertigo   

Gastrointestinal 
disorders 

 Nausea   

Skin and 
subcutaneous tissue 
disorders 

   Drug Reaction 
with 
Eosinophilia and 
Systemic 
Symptoms 
(DRESS)* 
Stevens - Johnso
n Syndrome 
(SJS)* 

Musculoskeletal and 
connective tissue 
disorders 

 Back pain   

General disorders  Gait disturbance 
Fatigue 

  

Investigations  Weight increased   
Injury, poisoning 
and procedural 
complications 

 Fall   

* See section 4.4 
 
Paediatric population 
 
Based on the clinical trial database of 196 adolescents exposed to perampanel from double-blind 
studies for partial-onset seizures and primary generalised 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. 
 
Based on the clinical trial database of 180 paediatric patients exposed to perampanel from a 
multicentre, open label study, the overall safety profile in children was similar to that established for 
adolescents and adults, except for somnolence, irritability, aggression, and agitation which were 
observed more frequently in the paediatric study compared to studies in adolescents and adults. 
 
Available data in children did not suggest any clinically significant effects of perampanel on growth 
and development parameters including body weight, height, thyroid function, insulin-like growth 
factor-1 (IGF-1) level, cognition (as assessed by Aldenkamp-Baker neuropsychological assessment 
schedule [ABNAS]), behaviour (as assessed by Child Behavior Checklist [CBCL]), and dexterity (as 
assessed by Lafayette Grooved Pegboard Test [LGPT]). However, long term effects [greater than 
1 year] on learning, intelligence, growth, endocrine function, and puberty in children remain unknown. 
 



 14 

Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
There is limited clinical experience with perampanel overdose in humans. In a report of an intentional 
overdose that could have resulted in a dose up to 264 mg, the patient experienced events of altered 
mental status, agitation and aggressive behaviour and recovered without sequelae. There is no 
available specific antidote to the effects of perampanel. General supportive care of the patient is 
indicated including monitoring of vital signs and observation of the clinical status of the patient. In 
view of its long half-life, the effects caused by perampanel could be prolonged. Because of low renal 
clearance special interventions such as forced diuresis, dialysis or haemoperfusion are unlikely to be of 
value. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX22 
 
Mechanism of action 
 
Perampanel is a first-in-class selective, non-competitive antagonist of the ionotropic α-amino-3-
hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on post-synaptic neurons. 
Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in 
a number of neurological disorders caused by neuronal overexcitation. Activation of AMPA receptors 
by glutamate is thought to be responsible for most fast excitatory synaptic transmission in the brain. In 
in vitro studies, perampanel did not compete with AMPA for binding to the AMPA receptor, but 
perampanel binding was displaced by noncompetitive AMPA receptor antagonists, indicating that 
perampanel is a noncompetitive AMPA receptor antagonist. In vitro, perampanel inhibited 
AMPA-induced (but not NMDA-induced) increase in intracellular calcium. In vivo, perampanel 
significantly prolonged seizure latency in an AMPA-induced seizure model. 
 
The precise mechanism by which perampanel exerts its antiepileptic effects in humans remains to be 
fully elucidated. 
 
Pharmacodynamic effects 
 
A pharmacokinetic-pharmacodynamic (efficacy) analysis was performed based on the pooled data 
from the 3 efficacy trials for partial-onset seizures. In addition, a pharmacokinetic-pharmacodynamic 
(efficacy) analysis was performed in one efficacy trial for primary generalised tonic-clonic seizures. In 
both analyses, perampanel exposure is correlated with reduction in seizure frequency. 
 
Psychomotor performance 
Single and multiple doses of 8 mg and 12 mg impaired psychomotor performance in healthy 
volunteers in a dose-related manner. The effects of perampanel on complex tasks such as driving 
ability were additive or supra-additive to the impairment effects of alcohol. Psychomotor performance 
testing returned to baseline within 2 weeks of cessation of perampanel dosing. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 15 

Cognitive function 
In a healthy volunteer study to assess the effects of perampanel on alertness, and memory using a 
standard battery of assessments, no effects of perampanel were found following single and multiple 
doses of perampanel up to 12 mg/day. 
 
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 an open-label uncontrolled study conducted in paediatric patients, no clinically important changes 
in cognition relative to baseline as measured by ABNAS were observed following adjunctive 
perampanel therapy (see section 5.1 Paediatric population). 
 
Alertness and mood 
Levels of alertness (arousal) decreased in a dose-related manner in healthy subjects dosed with 
perampanel from 4 to 12 mg/day. Mood deteriorated following dosing of 12 mg/day only; the changes 
in mood were small and reflected a general lowering of alertness. Multiple dosing of perampanel 
12 mg/day also enhanced the effects of alcohol on vigilance and alertness, and increased levels of 
anger, confusion and depression as assessed using the Profile of Mood State 5-point rating scale. 
 
Cardiac electrophysiology 
Perampanel did not prolong the QTc interval when administered in daily doses up to 12 mg/day, and 
did not have a dose-related or clinically important effect on QRS duration. 
 
Clinical efficacy and safety 
 
Partial-Onset Seizures 
The efficacy of perampanel in partial-onset seizures was established in three adjunctive therapy 
19 week, randomised, double-blind, placebo-controlled, multicentre trials in adult and adolescent 
patients. Patients had partial-onset seizures with or without secondary generalisation and were not 
adequately controlled with one to three concomitant AEDs. During a 6-week baseline period, patients 
were required to have more than five seizures with no seizure-free period exceeding 25 days. In these 
three trials, patients had a mean duration of epilepsy of approximately 21.06 years. Between 85.3% 
and 89.1% of patients were taking two to three concomitant AEDs with or without concurrent vagal 
nerve stimulation. 
 
Two studies (studies 304 and 305) compared doses of perampanel 8 and 12 mg/day with placebo and 
the third study (study 306) compared doses of perampanel 2, 4 and 8 mg/day with placebo. In all three 
trials, following a 6-week Baseline Phase to establish baseline seizure frequency prior to 
randomisation, patients were randomised and titrated to the randomised dose. During the Titration 
Phase in all three trials, treatment was initiated at 2 mg/day and increased in weekly increments of 
2 mg/day to the target dose. Patients experiencing intolerable adverse events could remain on the same 
dose or have their dose decreased to the previously tolerated dose. In all three trials, the Titration 
Phase was followed by a Maintenance Phase that lasted 13 weeks, during which patients were to 
remain on a stable dose of perampanel. 
 
The pooled 50% responder rates were placebo 19%, 4 mg 29%, 8 mg 35% and 12 mg 35%. A 
statistically significant effect on the reduction in 28-day seizure frequency (Baseline to Treatment 
Phase) as compared to the placebo group was observed with perampanel treatment at doses of 
4 mg/day (Study 306), 8 mg/day (Studies 304, 305 and 306), and 12 mg/day (Studies 304 and 305). 
The 50% responder rates in the 4 mg, 8 mg and 12 mg groups were respectively 23.0%, 31.5%, and 
30.0% in combination with enzyme-inducing anti-epileptic medicinal products and were 33.3%, 
46.5% and 50.0% when perampanel was given in combination with non-enzyme-inducing 
anti-epileptic medicinal products. These studies show that once-daily administration of perampanel at 



 16 

doses of 4 mg to 12 mg was significantly more efficacious than placebo as adjunctive treatment in this 
population. 
 
Data from placebo-controlled studies demonstrate that improvement in seizure control is observed 
with a once-daily perampanel dose of 4 mg and this benefit is enhanced as the dose is increased to 
8 mg/day. No efficacy benefit was observed at the dose of 12 mg as compared to the dose of 8 mg in 
the overall population. Benefit at the dose of 12 mg was observed in some patients who tolerate the 
dose of 8 mg and when the clinical response to that dose was insufficient. A clinically meaningful 
reduction in seizure frequency relative to placebo was achieved as early as the second week of dosing 
when patients reached a daily dose of 4 mg. 
 
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 
 
Open label extension study 
Ninety-seven percent of the patients who completed the randomised trials in patients with partial-onset 
seizures were enrolled in the open label extension study (n = 1186). Patients from the randomised trial 
were converted to perampanel over 16 weeks followed by a long-term maintenance period (≥ 1 year). 
The mean average daily dose was 10.05 mg. 
 
Primary Generalised Tonic-Clonic Seizures 
Perampanel as adjunctive therapy in patients 12 years of age and older with idiopathic generalised 
epilepsy experiencing primary generalised tonic-clonic seizures was established in a multicentre, 
randomised, double-blind, placebo-controlled study (Study 332). Eligible patients on a stable dose of 1 
to 3 AEDs experiencing at least 3 primary generalised tonic-clonic seizures during the 8-week baseline 
period were randomised to either perampanel or placebo. The population included 164 patients 
(perampanel N = 82, placebo N = 82). Patients were titrated over four weeks to a target dose of 8 mg 
per day or the highest tolerated dose and treated for an additional 13 weeks on the last dose level 
achieved at the end of the titration period. The total treatment period was 17 weeks. Study drug was 
given once per day. 
 
The 50% primary generalised tonic-clonic seizures responder rate during the Maintenance Period was 
significantly higher in the perampanel group (58.0%) than in the placebo group (35.8%), P = 0.0059. 
The 50% responder rate was 22.2% in combination with enzyme-inducing anti-epileptic medicinal 
products and was 69.4% when perampanel was given in combination with non-enzyme-inducing 
anti-epileptic medicinal products. The number of perampanel patients taking enzyme-inducing 
anti-epileptic medicinal products was small (n = 9). The median percent change in primary generalised 
tonic-clonic seizure frequency per 28 days during the Titration and Maintenance Periods (combined) 
relative to Prerandomisation was greater with perampanel (-76.5%) than with placebo (-38.4%), 
P < 0.0001. During the 3 months maintenance period, 30.9% (25/81) of the patients on perampanel in 
the clinical studies became free of PGTC seizures compared with 12.3% (10/81) on placebo. 
 
Other subtypes of idiopathic generalised seizure 
The efficacy and safety of perampanel in patients with myoclonic seizures have not been established. 
The available data are insufficient to reach any conclusions. 
The efficacy of perampanel in the treatment of absence seizures has not been demonstrated. 
In Study 332, in patients with PGTC seizures who also had concomitant myoclonic seizures, freedom 
from seizures was achieved in 16.7% (4/24) on perampanel compared to 13.0% (3/23) in those on 
placebo. In patients with concomitant absence seizures, freedom from seizures was achieved in 22.2% 
(6/27) on perampanel compared to 12.1% (4/33) on placebo. Freedom from all seizures was achieved 
in 23.5% (19/81) of patients on perampanel compared to 4.9% (4/81) of patients on placebo. 
 
Open label extension phase 
Of the 140 patients who completed the Study 332, 114 patients (81.4%) had entered the Extension 
phase. Patients from the randomised trial were converted to perampanel over 6 weeks followed by a 
long-term maintenance period (≥ 1 year). In the Extension Phase, 73.7% (84/114) of patients have a 



 17 

modal daily perampanel dose of greater than 4 to 8 mg/day and 16.7% (19/114) had a modal daily 
dose of greater than 8 to 12 mg/day. A decrease in PGTC seizure frequency of at least 50% was seen 
in 65.9% (29/44) of patients after 1 year of treatment during the Extension Phase (relative to their 
pre-perampanel baseline seizure frequency). These data were consistent with those for percent change 
in seizure frequency and showed that the PGTC 50% responder rate was generally stable across time 
from about week 26 through the end of year 2. Similar results were seen when all seizures and absence 
vs. myoclonic seizures were evaluated over time. 
 
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. 
 
Paediatric population 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Fycompa in one or more subsets of the paediatric population in treatment-resistant epilepsies 
(localisation-related and age-related epilepsy syndromes) (see section 4.2 for information on 
adolescent and paediatric use). 
 
The three pivotal double-blind placebo-controlled phase 3 studies included 143 adolescents between 
the ages of 12 and 18. The results in these adolescents were similar to those seen in the adult 
population. 
 
Study 332 included 22 adolescents between the ages of 12 and 18. The results in these adolescents 
were similar to those seen in the adult population. 
 
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, aged 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). 
 
An open-label, uncontrolled study (Study 311) was performed to assess the exposure-efficacy 
relationship of perampanel as adjunctive therapy in 180 paediatric patients (aged 4 to 11 years old) 
with inadequately controlled partial-onset seizures or primary generalised tonic-clonic seizures. 
Patients were titrated over 11 weeks to a target dose of 8 mg/day or the maximum tolerated dose (not 
to exceed 12 mg/day) for patients not taking concomitant CYP3A-inducing antiepileptic drugs 
(carbamazepine, oxcarbazepine, eslicarbazepine and phenytoin) or 12 mg/day or the maximum 



 18 

tolerated dose (not to exceed 16 mg/day) for patients taking a concomitant CYP3A-inducing 
antiepileptic drug.  Perampanel dose achieved at the end of titration was maintained for 12 weeks (for 
a total of 23 weeks of exposure) at the completion of the core study. Patients who entered into 
Extension Phase were treated for an additional 29 weeks for a total exposure duration of 52 weeks. 
 
In patients with partial-onset seizures (n = 148 patients), the median change in seizure frequency per 
28 days, the 50% or greater responder rate, and seizure-free rate following 23 weeks of perampanel 
treatment were -40.1%, 46.6% (n = 69/148), and 11.5% (n = 17/148), respectively, for total 
partial-onset seizures. The treatment effects on the median reduction in seizure frequency 
(Weeks 40-52: n = 108 patients, -69.4%), 50% responder rate (Weeks 40-52: 62.0%, n = 67/108), and 
seizure-free rate (Weeks 40-52: 13.0%, n = 14/108) were sustained following 52 weeks of perampanel 
treatment. 
 
In a subset of partial-onset seizure patients with secondarily generalised seizures (n = 54 patients), the 
corresponding values were -58.7%, 64.8% (n = 35/54), and 18.5% (n = 10/54), respectively, for 
secondarily generalised tonic-clonic seizures. The treatment effects on the median reduction in seizure 
frequency (Weeks 40-52: n = 41 patients, -73.8%), 50% responder rate (Weeks 40-52: 80.5%, 
n = 33/41), and seizure-free rate (Weeks 40-52: 24.4%, n = 10/41) were sustained following 52 weeks 
of perampanel treatment. 
 
In patients with primary generalised tonic-clonic seizures (n = 22 patients, with 19 patients aged 
7-<12 years and 3 patients aged 4-<7 years), the median change in seizure frequency per 28 days, the 
50% or greater responder rate, and seizure-free rate were -69.2%, 63.6% (n = 14/22), and 
54.5% (n = 12/22), respectively. The treatment effects on the median reduction in seizure frequency 
(Weeks 40-52: n = 13 patients, -100.0%), 50% responder rate (Weeks 40-52: 61.5%, n = 8/13), and 
seizure-free rate (Weeks 40-52: 38.5%, n = 5/13) were sustained following 52 weeks of perampanel 
treatment. These results should be considered cautiously as the number of patients is very small. 
 
Similar results were obtained in a subset of patients with primary generalised tonic-clonic seizures of 
idiopathic generalised epilepsy (IGE) (n = 19 patients, with 17 patients aged 7-<12 years and 
2 patients aged 4-<7 years; the corresponding values were -56.5%, 63.2% (n = 12/19), and 
52.6% (n = 10/19), respectively. The treatment effects on the median reduction in seizure frequency 
(Weeks 40-52: n = 11 patients, -100.0%), 50% responder rate (Weeks 40-52: 54.5%, n = 6/11), and 
seizure-free rate (Weeks 40-52: 36.4%, n = 4/11) were sustained following 52 weeks of perampanel 
treatment. These results should be considered cautiously as the number of patients is very small. 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetics of perampanel have been studied in healthy adult subjects (age range 18 to 79), 
adults,  adolescents, and paediatric patients with partial-onset seizures and primary generalised 
tonic-clonic seizures, adults with Parkinson’s disease, adults with diabetic neuropathy, adults with 
multiple sclerosis, and patients with hepatic impairment. 
 
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. 
 
Distribution 
 
Data from in vitro studies indicate that perampanel is approximately 95% bound to plasma proteins. 
 
In vitro studies show that perampanel is not a substrate or significant inhibitor of organic anion 
transporting polypeptides (OATP) 1B1 and 1B3, organic anion transporters (OAT) 1, 2, 3, and 4, 



 19 

organic cation transporters (OCT) 1, 2, and 3, and the efflux transporters P-glycoprotein and Breast 
Cancer Resistance Protein (BCRP). 
 
Biotransformation 
 
Perampanel is extensively metabolised via primary oxidation and sequential glucuronidation. The 
metabolism of perampanel is mediated primarily by CYP3A based on clinical study results in healthy 
subjects administered radiolabelled perampanel and supported by in vitro studies using recombinant 
human CYPs and human liver microsomes. 
 
Following administration of radiolabelled perampanel, only trace amounts of perampanel metabolites 
were observed in plasma. 
 
Elimination 
 
Following administration of a radiolabelled 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. 
In urine and faeces, recovered radioactivity was primarily composed of a mixture of oxidative and 
conjugated metabolites. In a population pharmacokinetic analysis of pooled data from 19 Phase 1 
studies, the average t½ of perampanel was 105 hours. When dosed in combination with the strong 
CYP3A inducer carbamazepine, the average t½was 25 hours. 
 
Linearity/non-linearity 
 
In a population PK analysis on pooled data from twenty Phase 1 studies in healthy subjects receiving 
perampanel between 0.2 and 36 mg either as single or multiple doses, one Phase 2 and five Phase 3 
studies in patients with partial-onset seizure receiving perampanel between 2 and 16 mg/day and two 
Phase 3 studies in patients with primary generalised tonic-clonic seizures receiving perampanel 
between 2 and 14 mg/day a linear relationship was found between dose and perampanel plasma 
concentrations. 
 
Special populations 
 
Hepatic impairment 
The pharmacokinetics of perampanel following a single 1 mg dose were evaluated in 12 patients with 
mild and moderate hepatic impairment (Child-Pugh A and B, respectively) compared with 12 healthy, 
demographically matched subjects. The mean apparent clearance of unbound perampanel in mildly 
impaired patients was 188 ml/min vs. 338 ml/min in matched controls, and in moderately impaired 
patients was 120 ml/min vs. 392 ml/min in matched controls. The t½ was longer in mildly impaired 
(306 h vs. 125 h) and moderately impaired (295 h vs. 139 h) patients compared to matched healthy 
subjects. 
 
Renal impairment 
The pharmacokinetics of perampanel have not been formally evaluated in patients with renal 
impairment. Perampanel is eliminated almost exclusively by metabolism followed by rapid excretion 
of metabolites; only trace amounts of perampanel metabolites are observed in plasma. In a population 
pharmacokinetic analysis of patients with partial-onset seizures having creatinine clearances ranging 
from 39 to 160 mL/min and receiving perampanel up to 12 mg/day in placebo-controlled clinical 
trials, perampanel clearance was not influenced by creatinine clearance. In a population 
pharmacokinetic analysis of patients with primary generalised tonic-clonic seizures receiving 
perampanel up to 8 mg/day in a placebo-controlled clinical study, perampanel clearance was not 
influenced by baseline creatinine clearance. 
 
Gender 
In a population pharmacokinetic analysis of patients with partial-onset seizures receiving perampanel 
up to 12 mg/day and patients with primary generalised tonic-clonic seizures receiving perampanel up 



 20 

to 8 mg/day in placebo-controlled clinical trials, perampanel clearance in females (0.54 l/h) was 18% 
lower than in males (0.66 l/h). 
 
Elderly (65 years of age and above) 
In a population pharmacokinetic analysis of patients with partial-onset seizures (age range 12 to 
74 years) and primary generalised tonic-clonic seizures (age range 12 to 58 years), and receiving 
perampanel up to 8 or 12 mg/day in placebo-controlled clinical trials, no significant effect of age on 
perampanel clearance was found. A dose adjustment in the elderly is not considered to be necessary 
(see section 4.2). 
 
Paediatric population 
In a population pharmacokinetic analysis on pooled data from children aged 4 to 11 years, adolescent 
patients aged ≥12 years, and adults, perampanel clearance increased with an increase in body weight.  
Hence, dose adjustment in children aged 4 to 11 years with a body weight < 30 kg is necessary (see 
section 4.2). 
 
Drug interaction studies 
 
In vitro assessment of drug interactions 
 
Drug metabolising enzyme inhibition 
In human liver microsomes, perampanel (30 µmol/l) had a weak inhibitory effect on CYP2C8 and 
UGT1A9 among major hepatic CYPs and UGTs. 
 
Drug metabolising enzyme induction 
Compared with positive controls (including phenobarbital, rifampicin), perampanel was found to 
weakly induce CYP2B6 (30 µmol/l) and CYP3A4/5 (≥ 3 µmol/l) among major hepatic CYPs and 
UGTs in cultured human hepatocytes. 
 
5.3 Preclinical safety data 
 
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to 
clinical exposure levels and with possible relevance to clinical use were as follows: 
 
In the fertility study in rats, prolonged and irregular oestrous cycles were observed at the maximum 
tolerated dose (30 mg/kg) in females; however, these changes did not affect fertility and early 
embryonic development. There were no effects on male fertility. 
 
The excretion into breast milk was measured in rats at 10 days post-partum. Levels peaked at one hour 
and were 3.65 times the levels in plasma. 
 
In a pre- and postnatal development toxicity study in rats, abnormal delivery and nursing conditions 
were observed at maternally toxic doses, and the number of stillbirths was increased in offspring. 
Behavioural and reproductive development of the offspring was not affected, but some parameters of 
physical development showed some delay, which is probably secondary to the pharmacology-based 
CNS effects of perampanel. The placental transfer was relatively low; 0.09% or less of administered 
dose was detected in the foetus. 
 
Nonclinical data reveal that perampanel was not genotoxic and had no carcinogenic potential. The 
administration of maximum tolerated doses to rats and monkeys resulted in pharmacologically-based 
CNS clinical signs and decreased terminal body weight. There were no changes directly attributable to 
perampanel in clinical pathology or histopathology. 
 
 



 21 

6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Fycompa 2 mg, 4 mg film-coated tablets 
 
Core 
Lactose monohydrate 
Low-substituted hydroxypropyl cellulose 
Povidone K-29/32 
Magnesium stearate (E470b) 
 
Fycompa 6 mg, 8 mg, 10 mg, 12 mg film-coated tablets 
 
Core 
Lactose monohydrate 
Low-substituted hydroxypropyl cellulose 
Povidone K-29/32 
Microcrystalline cellulose 
Magnesium stearate (E470b) 
 
Fycompa 2 mg film-coated tablets 
 
Film coating 
Hypromellose 2910 
Talc 
Macrogol 8000 
Titanium dioxide (E171) 
Ferric oxide, yellow (E172) 
Ferric oxide, red (E172) 
 
Fycompa 4 mg film-coated tablets 
 
Film coating 
Hypromellose 2910 
Talc 
Macrogol 8000 
Titanium dioxide (E171) 
Ferric oxide, red (E172) 
 
Fycompa 6 mg film-coated tablets 
 
Film coating 
Hypromellose 2910 
Talc 
Macrogol 8000 
Titanium dioxide (E171) 
Ferric oxide, red (E172) 
 
Fycompa 8 mg film-coated tablets 
 
Film coating 
Hypromellose 2910 
Talc 
Macrogol 8000 
Titanium dioxide (E171) 



 22 

Ferric oxide, red (E172) 
Ferric oxide, black (E172) 
 
Fycompa 10 mg film-coated tablets 
 
Film coating 
Hypromellose 2910 
Talc 
Macrogol 8000 
Titanium dioxide (E171) 
Ferric oxide, yellow (E172) 
FD&C Blue #2 Indigo carmine aluminium lake (E132) 
 
Fycompa 12 mg film-coated tablets 
 
Film coating 
Hypromellose 2910 
Talc 
Macrogol 8000 
Titanium dioxide (E171) 
FD&C Blue #2 Indigo carmine aluminium lake (E132) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
5 years 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
PVC/aluminium blisters 
 
Fycompa 2 mg film-coated tablets 
Pack of 7 only for first week of dosing, 28 and 98 
 
Fycompa 4 mg film-coated tablets 
4 mg – packs of 7, 28, 84 and 98 
 
Fycompa 6 mg film-coated tablets 
6 mg – packs of 7, 28, 84 and 98 
 
Fycompa 8 mg film-coated tablets 
8 mg – packs of 7, 28, 84 and 98 
 
Fycompa 10 mg film-coated tablets 
10 mg – packs of 7, 28, 84 and 98 
 
Fycompa 12 mg film-coated tablets 
12 mg – packs of 7, 28, 84 and 98 
 



 23 

Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Eisai GmbH 
Edmund-Rumpler-Straße 3 
60549 Frankfurt am Main 
Germany 
e-mail: medinfo_de@eisai.net 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/12/776/001-023 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 23 July 2012 
Date of latest renewal: 6 April 2017 
 
 
10. DATE OF REVISION OF THE TEXT 
 
{MM/YYYY} 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 



 24 

1. NAME OF THE MEDICINAL PRODUCT 
 
Fycompa 0.5 mg/ml oral suspension 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each ml of oral suspension contains 0.5 mg perampanel 
 
Each bottle of 340 ml contains 170 mg perampanel 
 
Excipient with known effect: 
Each ml of oral suspension contains 175 mg sorbitol (E420). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Oral suspension 
White to off-white suspension 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Fycompa (perampanel) is indicated for the adjunctive treatment of 
- partial-onset seizures (POS) with or without secondarily generalised seizures in patients from 
4 years of age and older. 
- primary generalised tonic-clonic (PGTC) seizures in patients from 7 years of age and older with 
idiopathic generalised epilepsy (IGE). 
 
4.2 Posology and method of administration 
 
Posology 
 
Fycompa must be titrated, according to individual patient response, in order to optimise the balance 
between efficacy and tolerability. 
Perampanel suspension should be taken orally once daily at bedtime. 
It may be taken with or without food, but preferably always under the same conditions. Switching 
between the tablet and suspension formulation should be done with caution (see section 5.2). 
The physician should prescribe the most appropriate formulation and strength according to weight and 
dose. 
 
Partial-Onset Seizures 
Perampanel at doses of 4 mg/day to 12 mg/day has been shown to be effective therapy in partial-onset 
seizures. 
 
The following table summarises the recommended posology for adults, adolescents and children from 
4 years of age. More details are provided below the table. 
 



 25 

 Adult/adolescent 
(12 years and older) 

Children (4 – 11 years); weighing: 
≥ 30 kg 20 - < 30 kg < 20 kg 

Recommended 
starting dose 

2 mg/day 
(4 ml/day) 

2 mg/day 
(4 ml/day) 

1 mg/day 
(2 ml/day) 

1 mg/day 
(2 ml/day) 

Titration 
(incremental 
steps) 

2 mg/day 
(4 ml/day) 
(no more frequently 
than weekly 
intervals) 

2 mg/day 
(4 ml/day) 
(no more 
frequently than 
weekly intervals) 

1 mg/day 
(2 ml/day) 
(no more 
frequently than 
weekly intervals) 

1 mg/day 
(2 ml/day) 
(no more 
frequently than 
weekly 
intervals) 

Recommended 
maintenance dose 

4 – 8 mg/day 
(8 – 16 ml/day) 

4 – 8 mg/day 
(8 – 16 ml/day) 

4 – 6 mg/day 
(8 – 12 ml/day) 

2 – 4 mg/day 
(4 – 8 ml/day) 

Titration 
(incremental 
steps) 

2 mg/day 
(4 ml/day) 
(no more frequently 
than weekly 
intervals) 

2 mg/day 
(4 ml/day) 
(no more 
frequently than 
weekly intervals) 

1 mg/day 
(2 ml/day) 
(no more 
frequently than 
weekly intervals) 

0.5 mg/day 
(1 ml/day) 
(no more 
frequently than 
weekly 
intervals) 

Recommended 
maximum dose 

12 mg/day 
(24 ml/day) 

12 mg/day 
(24 ml/day) 

8 mg/day 
(16 ml/day) 

6 mg/day 
(12 ml/day) 

 
Adults, adolescents age ≥ 12 years 
Treatment with Fycompa should be initiated with a dose of 2 mg/day (4 ml/day). The dose may be 
increased based on clinical response and tolerability by increments of 2 mg (4 ml) (either weekly or 
every 2 weeks as per half-life considerations described below) to a maintenance dose of 4 mg/day 
(8 ml/day) to 8 mg/day (16 ml/day). Depending upon individual clinical response and tolerability at a 
dose of 8 mg/day (16 ml/day), the dose may be increased by increments of 2 mg/day (4 ml/day) to 
12 mg/day (24 ml/day). Patients who are taking concomitant medicinal products that do not shorten 
the half-life of perampanel (see section 4.5) should be titrated no more frequently than at 2-week 
intervals. Patients who are taking concomitant medicinal products that shorten the half-life of 
perampanel (see section 4.5) should be titrated no more frequently than at 1-week intervals. 
 
Children (from 4 to 11 years) weighing ≥ 30 kg 
Treatment with Fycompa should be initiated with a dose of 2 mg/day (4 ml/day). The dose may be 
increased based on clinical response and tolerability by increments of 2 mg (4 ml/day) (either weekly 
or every 2 weeks as per half-life considerations described below) to a maintenance dose of 4 mg/day 
(8 ml/day) to 8 mg/day (16 ml/day). Depending upon individual clinical response and tolerability at a 
dose of 8 mg/day (16 ml/day), the dose may be increased by increments of 2 mg/day (4 ml/day) to 
12 mg/day (24 ml/day). Patients who are taking concomitant medicinal products that do not shorten 
the half-life of perampanel (see section 4.5) should be titrated no more frequently than at 2-week 
intervals. Patients who are taking concomitant medicinal products that shorten the half-life of 
perampanel (see section 4.5) should be titrated no more frequently than at 1-week intervals. 
 
Children (from 4 to 11 years of age) weighing 20 kg and < 30 kg 
Treatment with Fycompa should be initiated with a dose of 1 mg/day (2 ml/day). The dose may be 
increased based on clinical response and tolerability by increments of 1 mg (2 ml/day) (either weekly 
or every 2 weeks as per half-life considerations described below) to a maintenance dose of 4 mg/day 
(8 ml/day) to 6 mg/day (12 ml/day). Depending upon individual clinical response and tolerability at a 
dose of 6 mg/day (12 ml/day), the dose may be increased by increments of 1 mg/day (2 ml/day) to 
8 mg/day (16 ml/day). Patients who are taking concomitant medicinal products that do not shorten the 
half-life of perampanel (see section 4.5) should be titrated no more frequently than at 2-week intervals. 
Patients who are taking concomitant medicinal products that shorten the half-life of perampanel (see 
section 4.5) should be titrated no more frequently than at 1-week intervals. 
 



 26 

Children (from 4 to 11 years of age) weighing < 20 kg 
Treatment with Fycompa should be initiated with a dose of 1 mg/day (2 ml/day). The dose may be 
increased based on clinical response and tolerability by increments of 1 mg (2 ml/day) (either weekly 
or every 2 weeks as per half-life considerations described below) to a maintenance dose of 2 mg/day 
(4 ml/day) to 4 mg/day (8 ml/day). Depending upon individual clinical response and tolerability at a 
dose of 4 mg/day (8 ml/day), the dose may be increased by increments of 0.5 mg/day (1 ml/day) to 
6 mg/day (12 ml/day). Patients who are taking concomitant medicinal products that do not shorten the 
half-life of perampanel (see section 4.5) should be titrated no more frequently than at 2-week intervals. 
Patients who are taking concomitant medicinal products that shorten the half-life of perampanel (see 
section 4.5) should be titrated no more frequently than at 1-week intervals. 
 
Primary Generalised Tonic-Clonic Seizures 
Perampanel at a dose up to 8 mg/day has been shown to be effective in primary generalised 
tonic-clonic seizures. 
 
The following table summarises the recommended posology for adults, adolescents and children from 
7 years of age. More details are provided below the table. 
 

 
Adult/adolescent 

(12 years and 
older) 

Children (7 – 11 years); weighing: 

≥ 30 kg 20 - < 30 kg < 20 kg 

Recommended 
starting dose 

2 mg/day 
(4 ml/day) 

2 mg/day 
(4 ml/day) 

1 mg/day 
(2 ml/day) 

1 mg/day 
(2 ml/day) 

Titration 
(incremental 
steps) 

2 mg/day 
(4 ml/day) 
(no more 
frequently than 
weekly intervals) 

2 mg/day 
(4 ml/day) 
(no more 
frequently than 
weekly intervals) 

1 mg/day 
(2 ml/day) 
(no more 
frequently than 
weekly intervals) 

1 mg/day 
(2 ml/day) 
(no more 
frequently than 
weekly intervals) 

Recommended 
maintenance dose 

Up to 8 mg/day 
(Up to 16 ml/day) 

4 – 8 mg/day 
(8 – 16 ml/day) 

4 – 6 mg/day 
(8 – 12 ml/day) 

2 – 4 mg/day 
(4 – 8 ml/day) 

Titration 
(incremental 
steps) 

2 mg/day 
(4 ml/day) 
(no more 
frequently than 
weekly intervals) 

2 mg/day 
(4 ml/day) 
(no more 
frequently than 
weekly intervals) 

1 mg/day 
(2 ml/day) 
(no more 
frequently than 
weekly intervals) 

0.5 mg/day 
(1 ml/day) 
(no more 
frequently than 
weekly intervals) 

Recommended 
maximum dose 

12 mg/day 
(24 ml/day) 

12 mg/day 
(24 ml/day) 

8 mg/day 
(16 ml/day) 

6 mg/day 
(12 ml/day) 

 
Adults, adolescents age ≥ 12 years 
Treatment with Fycompa should be initiated at a dose of 2 mg/day (4 ml/day). The dose may be 
increased based on clinical response and tolerability by increments of 2 mg (4 ml/day) (either weekly 
or every 2 weeks, as per half-life considerations described below) to a maintenance dose of up to 
8 mg/day (16 ml/day). Depending upon individual clinical response and tolerability at a dose of 
8 mg/day (16 ml/day), the dose may be increased up to 12 mg/day (24 ml/day), which may be 
effective in some patients (see section 4.4). Patients who are taking concomitant medicinal products 
that do not shorten the half-life of perampanel (see section 4.5) should be titrated no more frequently 
than at 2-week intervals. Patients who are taking concomitant medicinal products that shorten the 
half-life of perampanel (see section 4.5) should be titrated no more frequently than at 1-week intervals. 
 
Children (from 7 to 11 years) weighing ≥ 30 kg 
Treatment with Fycompa should be initiated with a dose of 2 mg/day (4 ml/day). The dose may be 
increased based on clinical response and tolerability by increments of 2 mg (4 ml) (either weekly or 
every 2 weeks as per half-life considerations described below) to a maintenance dose of 4 mg/day 
(8 ml/day) to 8 mg/day (16 ml/day). Depending upon individual clinical response and tolerability at a 
dose of 8 mg/day (16 ml/day), the dose may be increased by increments of 2 mg/day (4 ml/day) to 



 27 

12 mg/day (24 ml/day). Patients who are taking concomitant medicinal products that do not shorten 
the half-life of perampanel (see section 4.5) should be titrated no more frequently than at 2-week 
intervals. Patients who are taking concomitant medicinal products that shorten the half-life of 
perampanel (see section 4.5) should be titrated no more frequently than at 1-week intervals. 
 
Children (from 7 to 11 years of age) weighing 20 kg and < 30 kg 
Treatment with Fycompa should be initiated with a dose of 1 mg/day (2 ml/day). The dose may be 
increased based on clinical response and tolerability by increments of 1 mg (2 ml) (either weekly or 
every 2 weeks as per half-life considerations described below) to a maintenance dose of 4 mg/day 
(8 ml/day) to 6 mg/day (12 ml/day). Depending upon individual clinical response and tolerability at a 
dose of 6 mg/day, the dose may be increased by increments of 1 mg/day (2 ml/day) to 8 mg/day 
(16 ml/day). Patients who are taking concomitant medicinal products that do not shorten the half-life 
of perampanel (see section 4.5) should be titrated no more frequently than at 2-week intervals. Patients 
who are taking concomitant medicinal products that shorten the half-life of perampanel (see 
section 4.5) should be titrated no more frequently than at 1-week intervals. 
 
Children (from 7 to 11 years of age) weighing < 20 kg 
Treatment with Fycompa should be initiated with a dose of 1 mg/day (2 ml/day). The dose may be 
increased based on clinical response and tolerability by increments of 1 mg (2 ml) (either weekly or 
every 2 weeks as per half-life considerations described below) to a maintenance dose of 2 mg/day 
(4 ml/day) to 4 mg/day (8 ml/day). Depending upon individual clinical response and tolerability at a 
dose of 4 mg/day (8 ml/day), the dose may be increased by increments of 0.5 mg/day (1 ml/day) to 
6 mg/day (12 ml/day). Patients who are taking concomitant medicinal products that do not shorten the 
half-life of perampanel (see section 4.5) should be titrated no more frequently than at 2-week intervals. 
Patients who are taking concomitant medicinal products that shorten the half-life of perampanel (see 
section 4.5) should be titrated no more frequently than at 1-week intervals. 
 
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. 
 
Missed doses 
Single missed dose: As perampanel has a long half-life, the patient should wait and take their next 
dose as scheduled. 
 
If more than 1 dose has been missed, for a continuous period of less than 5 half-lives (3 weeks for 
patients not taking perampanel metabolism-inducing anti-epileptic drugs (AED), 1 week for patients 
taking perampanel metabolism-inducing AEDs (see section 4.5)), consideration should be given to 
re-start treatment from the last dose level. 
 
If a patient has discontinued perampanel for a continuous period of more than 5 half-lives, it is 
recommended that initial dosing recommendations given above should be followed. 
 
Elderly (65 years of age and above) 
Clinical studies of Fycompa in epilepsy did not include sufficient numbers of patients aged 65 and 
over to determine whether they respond differently from younger patients. Analysis of safety 
information in 905 perampanel-treated elderly patients (in double-blind studies conducted in 
non-epilepsy indications) revealed no age-related differences in the safety profile. In combination with 
the lack of age-related difference in perampanel exposure, the results indicate that dose-adjustment in 
the elderly is not required. Perampanel should be used with caution in elderly taking into account the 
drug interaction potential in polymedicated patients (see section 4.4). 
 
Renal impairment 
Dose adjustment is not required in patients with mild renal impairment. Use in patients with moderate 
or severe renal impairment or patients undergoing haemodialysis is not recommended. 



 28 

 
Hepatic impairment 
Dose increases in patients with mild and moderate hepatic impairment should be based on clinical 
response and tolerability. For patients with mild or moderate hepatic impairment, dosing can be 
initiated at 2 mg (4 ml). Patients should be up-titrated using 2 mg (4 ml) doses no faster than every 
2 weeks based on tolerability and effectiveness. 
Perampanel dosing for patients with mild and moderate impairment should not exceed 8 mg. 
Use in patients with severe hepatic impairment is not recommended. 
 
Paediatric population 
The safety and efficacy of perampanel have not yet been established in children below 4 years of age 
in the POS indication or in children below 7 years of age in the PGTCS indication.  
 
Method of administration 
 
Fycompa is for oral use. 
 
Preparation: The press-in-bottle adapter (PIBA) which is supplied in the product carton should be 
inserted firmly into the neck of the bottle before use and remain in place for the duration of the usage 
of the bottle. The oral syringe should be inserted into the PIBA and the dose withdrawn from the 
inverted bottle. The cap should be replaced after each use. The cap fits properly when the PIBA is in 
place. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Suicidal ideation 
 
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic medicinal 
products in several indications. A meta-analysis of randomised placebo-controlled trials of 
anti-epileptic medicinal products has also shown a small increased risk of suicidal ideation and 
behaviour. The mechanism of this risk is not known and the available data do not exclude the 
possibility of an increased risk for perampanel. 
Therefore, patients (children, adolescents, and adults) should be monitored for signs of suicidal 
ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of 
patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour 
emerge. 
 
Severe cutaneous adverse reactions (SCARs) 
 
Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic 
symptoms (DRESS) and Stevens - Johnson Syndrome (SJS), 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. 
 



 29 

Symptoms of SJS include typically although not exclusively, skin detachment (epidermal 
necrosis/blister) < 10%, erythematous skin (confluent), rapid progression, painful atypical target-like 
lesions and/or purpuric macules in wide dissemination or large erythema (confluent), bullous/erosive 
involvement of more than 2 mucous membranes. 
 
If signs and symptoms suggestive of these reactions appear, perampanel should be withdrawn 
immediately and an alternative treatment considered (as appropriate). 
 
If the patient has developed a serious reaction such as SJS or DRESS with the use of perampanel, 
treatment with perampanel must not be restarted in this patient at any time. 
 
Absence and myoclonic seizures 
 
Absence and myoclonic seizures are two common generalised seizure types that frequently occur in 
IGE patients. Other AEDs are known to induce or aggravate these seizure types. Patients with 
myoclonic seizures and absence seizures should be monitored while on Fycompa. 
 
Nervous system disorders 
 
Perampanel may cause dizziness and somnolence and therefore may influence the ability to drive or 
use machines (see section 4.7). 
 
Hormonal contraceptives 
 
At doses of 12 mg/day Fycompa may decrease the effectiveness of progestative-containing hormonal 
contraceptives; in this circumstance additional non-hormonal forms of contraception are recommended 
when using Fycompa (see sections 4.5 and 4.6). 
 
Falls 
 
There appears to be an increased risk of falls, particularly in the elderly; the underlying reason is 
unclear. 
 
Aggression 
 
Aggressive and hostile behaviour has been reported in patients receiving perampanel therapy. In 
perampanel-treated patients in clinical trials, aggression, anger and irritability were reported more 
frequently at higher doses. Most of the reported events were either mild or moderate and patients 
recovered either spontaneously or with dose adjustment. However, thoughts of harming others, 
physical assault or threatening behaviour were observed in some patients (<1% in perampanel clinical 
studies). Homicidal ideation has been reported in patients. Patients and caregivers should be 
counselled to alert a healthcare professional immediately if significant changes in mood or patterns of 
behaviour are noted. The dosage of perampanel should be reduced if such symptoms occur and should 
be discontinued immediately if symptoms are severe. 
 
Abuse potential 
 
Caution should be exercised in patients with a history of substance abuse and the patient should be 
monitored for symptoms of perampanel abuse. 
 
Concomitant CYP 3A inducing anti-epileptic medicinal products 
 
Response rates after addition of perampanel at fixed doses were less when patients received 
concomitant CYP3A enzyme-inducing anti-epileptic medicinal products (carbamazepine, phenytoin, 
oxcarbazepine) as compared to response rates in patient who received concomitant 
non-enzyme-inducing anti-epileptic medicinal products. Patients’ response should be monitored when 



 30 

they are switching from concomitant non-inducer anti-epileptic medicinal products to enzyme 
inducing medicinal products and vice versa. Depending upon individual clinical response and 
tolerability, the dose may be increased or decreased 2 mg at a time (see section 4.2). 
 
Other concomitant (non- anti-epileptic) cytochrome P450 inducing or inhibiting medicinal products 
 
Patients should be closely monitored for tolerability and clinical response when adding or removing 
cytochrome P450 inducers or inhibitors, since perampanel plasma levels can be decreased or 
increased; the dose of perampanel may need to be adjusted accordingly. 
 
Hepatotoxicity 
 
Cases of hepatotoxicity (mainly hepatic enzyme increased) with perampanel in combination with other 
antiepileptic drugs have been reported. If hepatic enzymes elevation is observed, monitoring of liver 
function should be considered. 
 
Excipients 
 
Fructose intolerance 
Fycompa contains sorbitol (E420); therefore, patients with rare hereditary problems of fructose 
intolerance should not take this medicinal product. 
 
Caution should be exercised when combining Fycompa oral suspension with other antiepileptic 
medications containing sorbitol, since a combined intake of over 1 gram of sorbitol may affect 
absorption of some drugs. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Fycompa is not considered a strong inducer or inhibitor of cytochrome P450 or UGT enzymes (see 
section 5.2). 
 
Hormonal contraceptives 
 
In healthy women receiving 12 mg (but not 4 or 8 mg/day) for 21 days concomitantly with a combined 
oral contraceptive, Fycompa was shown to decrease the levonorgestrel exposure (mean Cmax and AUC 
values were each decreased by 40%). Ethinylestradiol AUC was not affected by Fycompa 12 mg 
whereas Cmax was decreased by 18%. Therefore, the possibility of decreased efficacy of hormonal 
progestative-containing contraceptives should be considered for women needing Fycompa 12 mg/day 
and an additional reliable method (intra-uterine device (IUD), condom) is to be used (see section 4.4). 
 
Interactions between Fycompa and other anti-epileptic medicinal products 
 
Potential interactions between Fycompa and other anti-epileptic drugs (AEDs) were assessed in 
clinical studies. A population PK analysis of three pooled Phase 3 studies in adolescent and adult 
patients with partial-onset seizures evaluated the effect of Fycompa (up to 12 mg once daily) on the 
PK of other AEDs. In another population PK analysis of pooled data from twenty Phase 1 studies in 
healthy subjects, with Fycompa up to 36 mg, and one Phase 2 and six Phase 3 studies in  paediatric, 
adolescent and adult patients with partial-onset seizures or primary generalised tonic-clonic seizures, 
with Fycompa up to 16 mg once daily, evaluated the effect of concomitant AEDs of perampanel 
clearance. The effect of these interactions on average steady state concentration is summarised in the 
following table. 
 



 31 

AED 
coadministered 

Influence of AED on Fycompa 
concentration 

Influence of Fycompa on AED 
concentration 

Carbamazepine 3 fold decrease <10% decrease 
Clobazam No influence <10% decrease 
Clonazepam No influence No influence 
Lamotrigine No influence <10% decrease 
Levetiracetam No influence No influence 
Oxcarbazepine 2 fold decrease 35% increase 1) 
Phenobarbital 20% decrease No influence 
Phenytoin 2 fold decrease No influence 
Topiramate 20% decrease No influence 
Valproic Acid No influence <10% decrease 
Zonisamide No influence No influence 

1) Active metabolite monohydroxycarbazepine was not assessed. 
 
Based on the results from the  population pharmacokinetic analysis of patients with partial-onset 
seizures and patients with primary generalised tonic-clonic seizures the total clearance of Fycompa 
was increased when co-administered with carbamazepine (3-fold), and phenytoin or oxcarbazepine 
(2-fold), which are known inducers of enzymes of metabolism (see section 5.2). This effect should be 
taken into account and managed when adding or withdrawing these anti-epileptic drugs from a 
patient’s treatment regimen. Clonazepam, levetiracetam, phenobarbital, topiramate, zonisamide, 
clobazam, lamotrigine and valproic acid did not affect to a clinically relevant manner the clearance of 
Fycompa. 
 
In a population pharmacokinetic analysis of patients with partial-onset seizures, Fycompa did not 
affect to a clinically relevant manner the clearance of clonazepam, levetiracetam, phenobarbital, 
phenytoin, topiramate, zonisamide, carbamazepine, clobazam, lamotrigine and valproic acid, at the 
highest perampanel dose evaluated (12 mg/day). 
 
Perampanel was found to decrease the clearance of oxcarbazepine by 26%. Oxcarbazepine is rapidly 
metabolised by cytosolic reductase enzyme to the active metabolite, monohydroxycarbazepine. The 
effect of perampanel on monohydroxycarbazepine concentrations is not known. 
 
Perampanel is dosed to clinical effect regardless of other AEDs. 
 
Effect of perampanel on CYP3A substrates 
 
In healthy subjects, Fycompa (6 mg once daily for 20 days) decreased midazolam AUC by 13%. A 
larger decrease in exposure of midazolam (or other sensitive CYP3A substrates) at higher Fycompa 
doses cannot be excluded. 
 
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. 
 
Effect of cytochrome P450 inhibitors on perampanel pharmacokinetics 
 
In healthy subjects, the CYP3A4 inhibitor ketoconazole (400 mg once daily for 10 days) increased 
perampanel AUC by 20% and prolonged perampanel half--life by 15% (67.8 h vs 58.4 h). Larger 
effects cannot be excluded when perampanel is combined with a CYP3A inhibitor with longer half-life 
than ketoconazole or when the inhibitor is given for a longer treatment duration. 
 



 32 

Levodopa 
In healthy subjects, Fycompa (4 mg once daily for 19 days) had no effect on Cmax or AUC of levodopa. 
 
Alcohol 
 
The effects of perampanel on tasks involving alertness and vigilance such as driving ability were 
additive or supra-additive to the effects of alcohol itself, as found in a pharmacodynamic interaction 
study in healthy subjects. Multiple dosing of perampanel 12 mg/day increased levels of anger, 
confusion, and depression as assessed using the Profile of Mood State 5-point rating scale (see 
section 5.1). These effects may also be seen when Fycompa is used in combination with other central 
nervous system (CNS) depressants. 
 
Paediatric population 
 
Interaction studies have only been performed in adults. 
In a population pharmacokinetic analysis of  adolescent patients age ≥ 12 years and children age 4 to 
11 years, there were no notable differences compared to the adult population. 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential and contraception in males and females 
 
Fycompa is not recommended in women of childbearing potential not using contraception unless 
clearly necessary. Fycompa may decrease the effectiveness of progestative-containing hormonal 
contraceptives. An additional non-hormonal form of contraception is, therefore recommended (see 
sections 4.4 and 4.5). 
 
Pregnancy 
 
There are limited amounts of data (less than 300 pregnancy outcomes) from the use of perampanel in 
pregnant women. Studies in animals did not indicate any teratogenic effects in rats or rabbits, but 
embryotoxicity was observed in rats at maternally toxic doses (see section 5.3). Fycompa is not 
recommended during pregnancy. 
 
Breast-feeding 
 
Studies in lactating rats have shown excretion of perampanel and/or its metabolites in milk (for details 
see section 5.3). It is not known whether perampanel is excreted in human milk. A risk to the 
newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding 
or to discontinue/abstain from Fycompa therapy taking into account the benefit of breast--feeding for 
the child and the benefit of therapy for the woman. 
 
Fertility 
 
In the fertility study in rats, prolonged and irregular oestrous cycles were observed at high-dose 
(30 mg/kg) in females; however, these changes did not affect the fertility and early embryonic 
development. There were no effects on male fertility (see section 5.3). The effect of perampanel on 
human fertility has not been established. 
 
4.7 Effects on ability to drive and use machines 
 
Fycompa has moderate influence on the ability to drive and use machines. 
Perampanel may cause dizziness and somnolence and, therefore, may influence the ability to drive or 
use machines. Patients are advised not to drive a vehicle, operate complex machinery or engage in 
other potentially hazardous activities until it is known whether perampanel affects their ability to 
perform these tasks (see sections 4.4 and 4.5). 



 33 

 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
In all controlled and uncontrolled trials in patients with partial-onset seizures, 1,639 patients have 
received perampanel of whom 1,147 have been treated for 6 months and 703 for longer than 
12 months. 
 
In the controlled and uncontrolled study in patients with primary generalised tonic-clonic seizures, 
114 patients have received perampanel of whom 68 have been treated for 6 months and 36 for longer 
than 12 months. 
 
Adverse reactions leading to discontinuation: 
In the controlled Phase 3 partial-onset seizures clinical trials, the rate of discontinuation as a result of 
an adverse reaction was 1.7% (3/172), 4.2% (18/431) and 13.7% (35/255) in patients randomised to 
receive perampanel at the recommended doses of 4 mg, 8 mg and 12 mg/day, respectively, and 
1.4% (6/442) in patients randomised to receive placebo. The adverse reactions most commonly (≥ 1% 
in the total perampanel group and greater than placebo) leading to discontinuation were dizziness and 
somnolence. 
 
In the controlled Phase 3 primary generalised tonic-clonic seizures clinical trial, the rate of 
discontinuation as a result of an adverse reaction was 4.9% (4/81) in patients randomised to receive 
perampanel 8 mg, and 1.2% (1/82) in patients randomised to receive placebo. The adverse reaction 
most commonly leading to discontinuation (≥ 2% in the perampanel group and greater than placebo) 
was dizziness. 
 
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). 
 
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), not known (cannot be estimated from the 
available data). 
 
Within each frequency category, adverse reactions are presented in order of decreasing seriousness. 
 



 34 

System Organ Class Very common Common Uncommon Not known 
Metabolism and 
nutrition disorders 

 Decreased appetite 
Increased appetite 

  

Psychiatric disorders  Aggression 
Anger 
Anxiety 
Confusional state 

Suicidal 
ideation 
Suicide attempt 

 

Nervous system 
disorders 

Dizziness 
Somnolence 

Ataxia 
Dysarthria 
Balance disorder 
Irritability 

  

Eye disorders  Diplopia 
Vision blurred 

  

Ear and labyrinth 
disorders 

 Vertigo   

Gastrointestinal 
disorders 

 Nausea   

Skin and 
subcutaneous tissue 
disorders 

   Drug Reaction 
with 
Eosinophilia and 
Systemic 
Symptoms 
(DRESS)* 
Stevens - Johnso
n Syndrome 
(SJS)* 

Musculoskeletal and 
connective tissue 
disorders 

 Back pain   

General disorders  Gait disturbance 
Fatigue 

  

Investigations  Weight increased   
Injury, poisoning 
and procedural 
complications 

 Fall   

* See section 4.4 
 
Paediatric population 
 
Based on the clinical trial database of 196 adolescents exposed to perampanel from double-blind 
studies for partial-onset seizures and primary generalised 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. 
 
Based on the clinical trial database of 180 paediatric patients exposed to perampanel from a 
multicentre, open label study, the overall safety profile in children was similar to that established for  
adolescents and adults, except for somnolence, irritability, aggression, and agitation, which were 
observed more frequently in the paediatric study compared to studies in adolescents and adults. 
 
Available data in children did not suggest any clinically significant effects of perampanel on growth 
and development parameters including body weight, height, thyroid function, insulin-like growth 
factor-1 (IGF-1) level, cognition (as assessed by Aldenkamp-Baker neuropsychological assessment 
schedule [ABNAS]), behaviour (as assessed by Child Behavior Checklist [CBCL]), and  dexterity (as 
assessed by Lafayette Grooved Pegboard Test [LGPT]). However, long term effects [greater than 
1 year] on learning, intelligence, growth, endocrine function, and puberty in children remain unknown. 
 



 35 

Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
There is limited clinical experience with perampanel overdose in humans. In a report of an intentional 
overdose that could have resulted in a dose up to 264 mg, the patient experienced events of altered 
mental status, agitation and aggressive behaviour and recovered without sequelae. There is no 
available specific antidote to the effects of perampanel. General supportive care of the patient is 
indicated including monitoring of vital signs and observation of the clinical status of the patient. In 
view of its long half-life, the effects caused by perampanel could be prolonged. Because of low renal 
clearance special interventions such as forced diuresis, dialysis or haemoperfusion are unlikely to be of 
value. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX22 
 
Mechanism of action 
 
Perampanel is a first-in-class selective, non-competitive antagonist of the ionotropic α-amino-3-
hydroxy-5-methyl-4-isoxazolepopionic acid (AMPA) glutamate receptor on post-synaptic neurons. 
Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in 
a number of neurological disorders caused by neuronal overexcitation. Activation of AMPA receptors 
by glutamate is thought to be responsible for most fast excitatory synaptic transmission in the brain. In 
in vitro studies, perampanel did not compete with AMPA for binding to the AMPA receptor, but 
perampanel binding was displaced by noncompetitive AMPA receptor antagonists, indicating that 
perampanel is a noncompetitive AMPA receptor antagonist. In vitro, perampanel inhibited 
AMPA-induced (but not NMDA-induced) increase in intracellular calcium. In vivo, perampanel 
significantly prolonged seizure latency in an AMPA-induced seizure model. 
 
The precise mechanism by which perampanel exerts its antiepileptic effects in humans remains to be 
fully elucidated. 
 
Pharmacodynamic effects 
 
A pharmacokinetic-pharmacodynamic (efficacy) analysis was performed based on the pooled data 
from the 3 efficacy trials for partial-onset seizures. In addition, a pharmacokinetic-pharmacodynamic 
(efficacy) analysis was performed in one efficacy trial for primary generalised tonic-clonic seizures. In 
both analyses, perampanel exposure is correlated with reduction in seizure frequency. 
 
Psychomotor performance 
Single and multiple doses of 8 mg and 12 mg impaired psychomotor performance in healthy 
volunteers in a dose-related manner. The effects of perampanel on complex tasks such as driving 
ability were additive or supra-additive to the impairment effects of alcohol. Psychomotor performance 
testing returned to baseline within 2 weeks of cessation of perampanel dosing. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 36 

Cognitive function 
In a healthy volunteer study to assess the effects of perampanel on alertness, and memory using a 
standard battery of assessments, no effects of perampanel were found following single and multiple 
doses of perampanel up to 12 mg/day. 
 
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 an open-label uncontrolled study conducted in paediatric patients, no clinically important changes 
in cognition relative to baseline as measured by ABNAS were observed following adjunctive 
perampanel (see section 5.1 Paediatric population). 
 
Alertness and mood 
Levels of alertness (arousal) decreased in a dose-related manner in healthy subjects dosed with 
perampanel from 4 to 12 mg/day. Mood deteriorated following dosing of 12 mg/day only; the changes 
in mood were small and reflected a general lowering of alertness. Multiple dosing of perampanel 
12 mg/day also enhanced the effects of alcohol on vigilance and alertness, and increased levels of 
anger, confusion and depression as assessed using the Profile of Mood State 5-point rating scale. 
 
Cardiac electrophysiology 
Perampanel did not prolong the QTc interval when administered in daily doses up to 12 mg/day, and 
did not have a dose-related or clinically important effect on QRS duration. 
 
Clinical efficacy and safety 
 
Partial-Onset Seizures 
The efficacy of perampanel in partial-onset seizures was established in three adjunctive therapy 
19 week, randomised, double-blind, placebo-controlled, multicentre trials in adult and adolescent 
patients. Patients had partial-onset seizures with or without secondary generalisation and were not 
adequately controlled with one to three concomitant AEDs. During a 6-week baseline period, patients 
were required to have more than five seizures with no seizure-free period exceeding 25 days. In these 
three trials, patients had a mean duration of epilepsy of approximately 21.06 years. Between 85.3% 
and 89.1% of patients were taking two to three concomitant AEDs with or without concurrent vagal 
nerve stimulation. 
 
Two studies (studies 304 and 305) compared doses of perampanel 8 and 12 mg/day with placebo and 
the third study (study 306) compared doses of perampanel 2, 4 and 8 mg/day with placebo. In all three 
trials, following a 6-week Baseline Phase to establish baseline seizure frequency prior to 
randomisation, patients were randomised and titrated to the randomised dose. During the Titration 
Phase in all three trials, treatment was initiated at 2 mg/day and increased in weekly increments of 
2 mg/day to the target dose. Patients experiencing intolerable adverse events could remain on the same 
dose or have their dose decreased to the previously tolerated dose. In all three trials, the Titration 
Phase was followed by a Maintenance Phase that lasted 13 weeks, during which patients were to 
remain on a stable dose of perampanel. 
 
The pooled 50% responder rates were placebo 19%, 4 mg 29%, 8 mg 35% and 12 mg 35%. A 
statistically significant effect on the reduction in 28-day seizure frequency (Baseline to Treatment 
Phase) as compared to the placebo group was observed with perampanel treatment at doses of 
4 mg/day (Study 306), 8 mg/day (Studies 304, 305 and 306), and 12 mg/day (Studies 304 and 305). 
The 50% responder rates in the 4 mg, 8 mg and 12 mg groups were respectively 23.0%, 31.5%, and 
30.0% in combination with enzyme-inducing anti-epileptic medicinal products and were 33.3%, 
46.5% and 50.0% when perampanel was given in combination with non-enzyme-inducing 
anti-epileptic medicinal products. These studies show that once-daily administration of perampanel at 



 37 

doses of 4 mg to 12 mg was significantly more efficacious than placebo as adjunctive treatment in this 
population. 
 
Data from placebo-controlled studies demonstrate that improvement in seizure control is observed 
with a once-daily perampanel dose of 4 mg and this benefit is enhanced as the dose is increased to 
8 mg/day. No efficacy benefit was observed at the dose of 12 mg as compared to the dose of 8 mg in 
the overall population. Benefit at the dose of 12 mg was observed in some patients who tolerate the 
dose of 8 mg and when the clinical response to that dose was insufficient. A clinically meaningful 
reduction in seizure frequency relative to placebo was achieved as early as the second week of dosing 
when patients reached a daily dose of 4 mg. 
 
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. 
 
Open label extension study 
Ninety-seven percent of the patients who completed the randomised trials in patients with partial-onset 
seizures were enrolled in the open label extension study (n = 1186). Patients from the randomised trial 
were converted to perampanel over 16 weeks followed by a long-term maintenance period (≥ 1 year). 
The mean average daily dose was 10.05 mg. 
 
Primary Generalised Tonic-Clonic Seizures 
Perampanel as adjunctive therapy in patients 12 years of age and older with idiopathic generalised 
epilepsy experiencing primary generalised tonic-clonic seizures was established in a multicentre, 
randomised, double-blind, placebo-controlled study (Study 332). Eligible patients on a stable dose of 1 
to 3 AEDs experiencing at least 3 primary generalised tonic-clonic seizures during the 8-week baseline 
period were randomised to either perampanel or placebo. The population included 164 patients 
(perampanel N = 82, placebo N = 82). Patients were titrated over four weeks to a target dose of 8 mg 
per day or the highest tolerated dose and treated for an additional 13 weeks on the last dose level 
achieved at the end of the titration period. The total treatment period was 17 weeks. Study drug was 
given once per day. 
 
The 50% primary generalised tonic-clonic seizures responder rate during the Maintenance Period was 
significantly higher in the perampanel group (58.0%) than in the placebo group (35.8%), P = 0.0059. 
The 50% responder rate was 22.2% in combination with enzyme-inducing anti-epileptic medicinal 
products and was 69.4% when perampanel was given in combination with non-enzyme-inducing 
anti-epileptic medicinal products. The number of perampanel patients taking enzyme-inducing 
anti-epileptic medicinal products was small (n = 9). The median percent change in primary generalised 
tonic-clonic seizure frequency per 28 days during the Titration and Maintenance Periods (combined) 
relative to Prerandomisation was greater with perampanel (-76.5%) than with placebo (-38.4%), 
P < 0.0001. During the 3 months maintenance period, 30.9% (25/81) of the patients on perampanel in 
the clinical studies became free of PGTC seizures compared with 12.3% (10/81) on placebo. 
 
Other subtypes of idiopathic generalised seizure 
The efficacy and safety of perampanel in patients with myoclonic seizures have not been established. 
The available data are insufficient to reach any conclusions. 
The efficacy of perampanel in the treatment of absence seizures has not been demonstrated. 
In Study 332, in patients with PGTC seizures who also had concomitant myoclonic seizures, freedom 
from seizures was achieved in 16.7% (4/24) on perampanel compared to 13.0% (3/23) in those on 
placebo. In patients with concomitant absence seizures, freedom from seizures was achieved in 22.2% 
(6/27) on perampanel compared to 12.1% (4/33) on placebo. Freedom from all seizures was achieved 
in 23.5% (19/81) of patients on perampanel compared to 4.9% (4/81) of patients on placebo. 
 
Open label extension phase 
Of the 140 patients who completed the Study 332, 114 patients (81.4%) had entered the Extension 
phase. Patients from the randomised trial were converted to perampanel over 6 weeks followed by a 
long-term maintenance period (≥ 1 year). In the Extension Phase, 73.7% (84/114) of patients have a 



 38 

modal daily perampanel dose of greater than 4 to 8 mg/day and 16.7% (19/114) had a modal daily 
dose of greater than 8 to 12 mg/day. A decrease in PGTC seizure frequency of at least 50% was seen 
in 65.9% (29/44) of patients after 1 year of treatment during the Extension Phase (relative to their 
pre-perampanel baseline seizure frequency). These data were consistent with those for percent change 
in seizure frequency and showed that the PGTC 50% responder rate was generally stable across time 
from about week 26 through the end of year 2. Similar results were seen when all seizures and absence 
vs. myoclonic seizures were evaluated over time. 
 
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. 
 
Paediatric population 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Fycompa in one or more subsets of the paediatric population in treatment-resistant epilepsies 
(localisation-related and age-related epilepsy syndromes) (see section 4.2 for information on 
adolescent and paediatric use). 
 
The three pivotal double-blind placebo-controlled phase 3 studies included 143 adolescents between 
the ages of 12 and 18. The results in these adolescents were similar to those seen in the adult 
population. 
 
Study 332 included 22 adolescents between the ages of 12 and 18. The results in these adolescents 
were similar to those seen in the adult population. 
 
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, aged 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). 
 
An open-label, uncontrolled study (Study 311) was performed to assess the exposure-efficacy 
relationship of perampanel as adjunctive therapy in 180 paediatric patients (aged 4 to 11 years old) 
with inadequately controlled partial-onset seizures or primary generalised tonic-clonic seizures. 
Patients were titrated over 11 weeks to a target dose of 8 mg/day or the maximum tolerated dose (not 
to exceed 12 mg/day) for patients not taking concomitant CYP3A-inducing antiepileptic drugs 
(carbamazepine, oxcarbazepine, eslicarbazepine and phenytoin) or 12 mg/day or the maximum 



 39 

tolerated dose (not to exceed 16 mg/day) for patients taking a concomitant CYP3A-inducing 
antiepileptic drug. Perampanel dose achieved at the end of titration was maintained for 12 weeks (for a 
total of 23 weeks of exposure) at the completion of the core study. Patients who entered into Extension 
Phase were treated for an additional 29 weeks for a total exposure duration of 52 weeks. 
 
In patients with partial-onset seizures (n = 148 patients), the median change in seizure frequency per 
28 days, the 50% or greater responder rate, and seizure-free rate following 23 weeks of perampanel 
treatment were -40.1%, 46.6% (n = 69/148), and 11.5% (n = 17/148), respectively, for total 
partial-onset seizures. The treatment effects on the median reduction in seizure frequency 
(Weeks 40-52: n = 108 patients, -69.4%), 50% responder rate (Weeks 40-52: 62.0%, n = 67/108), and 
seizure-free rate (Weeks 40-52: 13.0%, n = 14/108) were sustained following 52 weeks of perampanel 
treatment. 
 
In a subset of partial-onset seizure patients with secondarily generalised seizures, the corresponding 
values were -58.7%, 64.8% (n = 35/54), and 18.5% (n = 10/54), respectively, for secondarily 
generalised tonic-clonic seizures. The treatment effects on the median reduction in seizure frequency 
(Weeks 40-52: n = 41 patients, -73.8%), 50% responder rate (Weeks 40-52: 80.5%, n = 33/41), and 
seizure-free rate (Weeks 40-52: 24.4%, n = 10/41) were sustained following 52 weeks of perampanel 
treatment. 
 
In patients with primary generalised tonic-clonic seizures (n = 22 patients, with 19 patients aged 
7-<12 years and 3 patients aged 4-<7 years), the median change in seizure frequency per 28 days, the 
50% or greater responder rate, and seizure-free rate were -69.2%, 63.6% ( n = 14/22), and 
54.5% (n = 12/22), respectively. The treatment effects on the median reduction in seizure frequency 
(Weeks 40-52: n = 13 patients, -100.0%), 50% responder rate (Weeks 40-52: 61.5%, n = 8/13), and 
seizure-free rate (Weeks 40-52: 38.5%, n = 5/13) were sustained following 52 weeks of perampanel 
treatment. These results should be considered cautiously as the number of patients is very small. 
 
Similar results were obtained in a subset of patients with primary generalised tonic-clonic seizures of 
idiopathic generalised epilepsy (IGE) (n = 19 patients, with 17 patients aged 7-<12 years and 
2 patients aged 4-<7 years; the corresponding values were -56.5%, 63.2% (n = 12/19), and 
52.6% (n = 10/19), respectively. The treatment effects on the median reduction in seizure frequency 
(Weeks 40-52: n = 11 patients, -100.0%), 50% responder rate (Weeks 40-52: 54.5%, n = 6/11), and 
seizure-free rate (Weeks 40-52: 36.4%, n = 4/11) were sustained following 52 weeks of perampanel 
treatment. These results should be considered cautiously as the number of patients is very small. 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetics of perampanel have been studied in healthy adult subjects (age range 18 to 79), 
adults,  adolescents, and paediatric patients with partial-onset seizures and primary generalised 
tonic-clonic seizures, adults with Parkinson’s disease, adults with diabetic neuropathy, adults with 
multiple sclerosis, and patients with hepatic impairment. 
 
Absorption 
 
Perampanel is readily absorbed after oral administration with no evidence of marked first-pass 
metabolism. 
 
Perampanel oral suspension is bioequivalent on a mg per mg basis to perampanel tablets under fasted 
conditions. When a single 12-mg dose of both formulations was administered with a high fat meal, 
perampanel oral suspension achieves equivalent AUC0-inf  and approximately 23 % lower Cmax and 
2 hours delay in time to peak exposure (tmax) compared to the tablet formulation. However, population 
pharmacokinetic analysis demonstrated that under simulated steady state exposure conditions, Cmax 
and AUC, of perampanel oral suspension were bioequivalent to the tablet formulation under both 
fasted and fed conditions. 
 



 40 

When coadministered with a high fat meal, Cmax and AUC0-inf of a single 12-mg dose of perampanel 
oral suspension were approximately 22% and 13%, respectively, lower compared to fasted conditions. 
 
Distribution 
 
Data from in vitro studies indicate that perampanel is approximately 95% bound to plasma proteins. 
 
In vitro studies show that perampanel is not a substrate or significant inhibitor of organic anion 
transporting polypeptides (OATP) 1B1 and 1B3, organic anion transporters (OAT) 1, 2, 3, and 4, 
organic cation transporters (OCT) 1, 2, and 3, and the efflux transporters P-glycoprotein and Breast 
Cancer Resistance Protein (BCRP). 
 
Biotransformation 
 
Perampanel is extensively metabolised via primary oxidation and sequential glucuronidation. The 
metabolism of perampanel is mediated primarily by CYP3A based on clinical study results in healthy 
subjects administered radiolabelled perampanel and supported by in vitro studies using recombinant 
human CYPs and human liver microsomes. 
 
Following administration of radiolabelled perampanel, only trace amounts of perampanel metabolites 
were observed in plasma. 
 
Elimination 
 
Following administration of a radiolabelled 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. 
In urine and faeces, recovered radioactivity was primarily composed of a mixture of oxidative and 
conjugated metabolites. In a population pharmacokinetic analysis of pooled data from 19 Phase 1 
studies, the average t½ of perampanel was 105 hours. When dosed in combination with the strong 
CYP3A inducer carbamazepine, the average t½was 25 hours. 
 
Linearity/non-linearity 
 
In a population PK analysis on pooled data from twenty Phase 1 studies in healthy subjects receiving 
perampanel between 0.2 and 36 mg either as single or multiple doses, one Phase 2 and five Phase 3 
studies in patients with partial-onset seizure receiving perampanel between 2 and 16 mg/day and two 
Phase 3 studies in patients with primary generalised tonic-clonic seizures receiving perampanel 
between 2 and 14 mg/day a linear relationship was found between dose and perampanel plasma 
concentrations. 
 
Special populations 
 
Hepatic impairment 
The pharmacokinetics of perampanel following a single 1 mg dose were evaluated in 12 patients with 
mild and moderate hepatic impairment (Child-Pugh A and B, respectively) compared with 12 healthy, 
demographically matched subjects. The mean apparent clearance of unbound perampanel in mildly 
impaired patients was 188 ml/min vs. 338 ml/min in matched controls, and in moderately impaired 
patients was 120 ml/min vs. 392 ml/min in matched controls. The t½ was longer in mildly impaired 
(306 h vs. 125 h) and moderately impaired (295 h vs. 139 h) patients compared to matched healthy 
subjects. 
 
Renal impairment 
The pharmacokinetics of perampanel have not been formally evaluated in patients with renal 
impairment. Perampanel is eliminated almost exclusively by metabolism followed by rapid excretion 
of metabolites; only trace amounts of perampanel metabolites are observed in plasma. In a population 
pharmacokinetic analysis of patients with partial-onset seizures having creatinine clearances ranging 



 41 

from 39 to 160 mL/min and receiving perampanel up to 12 mg/day in placebo-controlled clinical 
trials, perampanel clearance was not influenced by creatinine clearance. In a population 
pharmacokinetic analysis of patients with primary generalised tonic-clonic seizures receiving 
perampanel up to 8 mg/day in a placebo-controlled clinical study, perampanel clearance was not 
influenced by baseline creatinine clearance. 
 
Gender 
In a population pharmacokinetic analysis of patients with partial-onset seizures receiving perampanel 
up to 12 mg/day and patients with primary generalised tonic-clonic seizures receiving perampanel up 
to 8 mg/day in placebo-controlled clinical trials, perampanel clearance in females (0.54 l/h) was 18% 
lower than in males (0.66 l/h). 
 
Elderly (65 years of age and above) 
In a population pharmacokinetic analysis of patients with partial-onset seizures (age range 12 to 
74 years) and primary generalised tonic-clonic seizures (age range 12 to 58 years), and receiving 
perampanel up to 8 or 12 mg/day in placebo-controlled clinical trials, no significant effect of age on 
perampanel clearance was found. A dose adjustment in the elderly is not considered to be necessary 
(see section 4.2). 
 
Paediatric population 
In a population pharmacokinetic analysis on pooled data from children aged 4 to 11 years, adolescent 
patients aged ≥12 years, and adults, perampanel clearance increased with an increase in body weight.  
Hence, dose adjustment in children aged 4 to 11 years with a body weight < 30 kg is necessary (see 
section 4.2). 
 
Drug interaction studies 
 
In vitro assessment of drug interactions 
 
Drug metabolising enzyme inhibition 
In human liver microsomes, perampanel (30 µmol/l) had a weak inhibitory effect on CYP2C8 and 
UGT1A9 among major hepatic CYPs and UGTs. 
 
Drug metabolising enzyme induction 
Compared with positive controls (including phenobarbital, rifampicin), perampanel was found to 
weakly induce CYP2B6 (30 µmol/l) and CYP3A4/5 (≥ 3 µmol/l) among major hepatic CYPs and 
UGTs in cultured human hepatocytes. 
 
5.3 Preclinical safety data 
 
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to 
clinical exposure levels and with possible relevance to clinical use were as follows: 
 
In the fertility study in rats, prolonged and irregular oestrous cycles were observed at the maximum 
tolerated dose (30 mg/kg) in females; however, these changes did not affect fertility and early 
embryonic development. There were no effects on male fertility. 
 
The excretion into breast milk was measured in rats at 10 days post-partum. Levels peaked at one hour 
and were 3.65 times the levels in plasma. 
 
In a pre- and postnatal development toxicity study in rats, abnormal delivery and nursing conditions 
were observed at maternally toxic doses, and the number of stillbirths was increased in offspring. 
Behavioural and reproductive development of the offspring was not affected, but some parameters of 
physical development showed some delay, which is probably secondary to the pharmacology-based 
CNS effects of perampanel. The placental transfer was relatively low; 0.09% or less of administered 
dose was detected in the foetus. 



 42 

 
Nonclinical data reveal that perampanel was not genotoxic and had no carcinogenic potential. The 
administration of maximum tolerated doses to rats and monkeys resulted in pharmacologically-based 
CNS clinical signs and decreased terminal body weight. There were no changes directly attributable to 
perampanel in clinical pathology or histopathology. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sorbitol (E420) liquid (crystallising) 
Microcrystalline cellulose (E460) 
Carmellose sodium (E466) 
Poloxamer 188 
Simethicone emulsion 30%, containing purified water, silicone oil, polysorbate 65, methylcellulose, 
silica gel, macrogol stearate, sorbic acid, benzoic acid and sulfuric acid 
Citric acid, anhydrous (E330) 
Sodium benzoate (E211) 
Purified water 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
2 years 
 
After first opening: 90 days. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
Polyethylene terephthalate (PET) bottle with a child-resistant (CR) polypropylene (PP) closure; each 
bottle contains 340 ml of suspension in an outer cardboard carton. 
 
Each carton contains one bottle, two 20 mL graduated oral dosing syringes and an LDPE press-in 
bottle adapter (PIBA). The oral dosing syringes are graduated in 0.5 ml increments. 
 
6.6 Special precautions for disposal 
 
No special requirements for disposal. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 



 43 

7. MARKETING AUTHORISATION HOLDER 
 
Eisai GmbH 
Edmund-Rumpler-Straße 3 
60549 Frankfurt am Main 
Germany 
e-mail: medinfo_de@eisai.net 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/12/776/024 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 23 July 2012 
Date of latest renewal: 6 April 2017 
 
 
10. DATE OF REVISION OF THE TEXT 
 
{MM/YYYY} 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 



 44 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH 
RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 



 45 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Eisai Manufacturing Ltd. 
European Knowledge Centre 
Mosquito Way 
Hatfield, Herts AL10 9SN 
United Kingdom 
 
Or 
 
Eisai GmbH 
Edmund-Rumpler-Straße 3 
60549 Frankfurt am Main 
Germany 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic Safety Update Reports 
 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 
updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
 



 46 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



 47 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 



 48 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton of 7, 28 and 98 tablets 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fycompa 2 mg film-coated tablets 
Perampanel 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 2 mg perampanel. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose: see leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 film-coated tablets 
28 film-coated tablets 
98 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 49 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eisai GmbH 
Edmund-Rumpler-Straße 3 
60549 Frankfurt am Main 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/12/776/001 
EU/1/12/776/017 
EU/1/12/776/018 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Fycompa 2 mg 
 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 



 50 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister Pack (PVC/Aluminium blister) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fycompa 2 mg tablets 
Perampanel 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Eisai 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



 51 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Cartons of 7, 28, 84 and 98 tablets 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fycompa 4 mg film-coated tablets 
Perampanel 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 4 mg perampanel. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose: see leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 film-coated tablets 
28 film-coated tablets 
84 film-coated tablets 
98 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 52 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eisai GmbH 
Edmund-Rumpler-Straße 3 
60549 Frankfurt am Main 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/12/776/002 
EU/1/12/776/003 
EU/1/12/776/004 
EU/1/12/776/019 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Fycompa 4 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 



 53 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister Pack (PVC/Aluminium blister) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fycompa 4 mg tablets 
Perampanel 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Eisai 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



 54 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Cartons of 7, 28,84 and 98 tablets 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fycompa 6 mg film-coated tablets 
Perampanel 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 6 mg perampanel. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose: see leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 film-coated tablets 
28 film-coated tablets 
84 film-coated tablets 
98 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 55 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eisai GmbH 
Edmund-Rumpler-Straße 3 
60549 Frankfurt am Main 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/12/776/005 
EU/1/12/776/006 
EU/1/12/776/007 
EU/1/12/776/020 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Fycompa 6 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 



 56 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister Pack (PVC/Aluminium blister) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fycompa 6 mg tablets 
Perampanel 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Eisai 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



 57 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Cartons of 7, 28,84 and 98 tablets 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fycompa 8 mg film-coated tablets 
Perampanel 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 8 mg perampanel. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose: see leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 film-coated tablets 
28 film-coated tablets 
84 film-coated tablets 
98 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 58 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eisai GmbH 
Edmund-Rumpler-Straße 3 
60549 Frankfurt am Main 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/12/776/008 
EU/1/12/776/009 
EU/1/12/776/010 
EU/1/12/776/021 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Fycompa 8 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 



 59 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister Pack (PVC/Aluminium blister) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fycompa 8 mg tablets 
Perampanel 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Eisai 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



 60 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Cartons of 7, 28, 84 and 98 tablets 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fycompa 10 mg film-coated tablets 
Perampanel 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 10 mg perampanel. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose: see leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 film-coated tablets 
28 film-coated tablets 
84 film-coated tablets 
98 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 61 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eisai GmbH 
Edmund-Rumpler-Straße 3 
60549 Frankfurt am Main 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/12/776/011 
EU/1/12/776/012 
EU/1/12/776/013 
EU/1/12/776/022 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Fycompa 10 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 



 62 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister Pack (PVC/Aluminium blister) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fycompa 10 mg tablets 
Perampanel 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Eisai 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



 63 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Cartons of 7, 28,84 and 98 tablets 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fycompa 12 mg film-coated tablets 
Perampanel 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 12 mg perampanel. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose: see leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 film-coated tablets 
28 film-coated tablets 
84 film-coated tablets 
98 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 64 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eisai GmbH 
Edmund-Rumpler-Straße 3 
60549 Frankfurt am Main 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/12/776/014 
EU/1/12/776/015 
EU/1/12/776/016 
EU/1/12/776/023 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Fycompa 12 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 



 65 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister Pack (PVC/Aluminium blister) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fycompa 12 mg tablets 
Perampanel 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Eisai 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



 66 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fycompa 0.5 mg/ml oral suspension 
perampanel 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each ml contains 0.5 mg perampanel. 
1 bottle (340 ml) contains 170 mg perampanel. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains sorbitol: see leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Oral suspension 340 ml. 
1 bottle 
2 oral syringes 
1 press-in-bottle adapter (PIBA) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Shake for at least 5 seconds before use. 
 
Oral use 
 
Open date: 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 



 67 

8. EXPIRY DATE 
 
EXP 
After first opening: use within 90 days. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eisai GmbH 
Edmund-Rumpler-Straße 3 
60549 Frankfurt am Main 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/12/776/024 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Fycompa 0.5 mg/ml 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 



 68 

 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 



 69 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



 70 

Package Leaflet: Information for the patient 
 

Fycompa 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg film-coated tablets 
Perampanel 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet: 
 
1. What Fycompa is and what it is used for 
2. What you need to know before you take Fycompa 
3. How to take Fycompa 
4. Possible side effects 
5. How to store Fycompa 
6. Contents of the pack and other information 
 
 
1. What Fycompa is and what it is used for 
 
Fycompa contains a medicine called perampanel. It belongs to a group of medicines called 
anti epileptics. These medicines are used to treat epilepsy - where someone has repeated fits (seizures). 
It has been given to you by your doctor to reduce the number of fits that you have. 
 
Fycompa is used in association with other antiepileptic drugs to treat certain forms of epilepsy:  
In adults, adolescents (aged 12 years and older), and children (from 4 to 11 years) 
- It is used to treat fits that affect one part of your brain (called a “partial seizure”). 
- These partial seizures may or may not then be followed by a fit affecting all of your brain 

(called a “secondary generalisation”). 
In adults and adolescents (aged 12 years and older), and children (from 7 to 11 years) 
- It is also used to treat certain fits that affect all of your brain from the start (called “generalised 

seizures”) and cause convulsions or staring spells. 
 
 
2. What you need to know before you take Fycompa 
 
DO NOT TAKE Fycompa: 
- If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores 

after taking perampanel. 
- If you are allergic to perampanel or any of the other ingredients of this medicine (listed in 

section 6). 
 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Fycompa if you have liver problems or moderate or 
severe kidney problems. 
You should not take Fycompa if you have serious liver problems or moderate or serious kidney 
problems. 
Before taking this medicine you should tell your doctor if you have a history of alcoholism or drug 
dependence. 



 71 

Cases of increased liver enzymes have been reported in some patients taking Fycompa in combination 
with other antiepileptic drugs. 
 
- Fycompa may make you feel dizzy or sleepy, particularly at the beginning of treatment. 
- Fycompa may make you more likely to fall over, particularly if you are an older person; this 

might be due to your illness. 
- Fycompa may make you aggressive, angry or violent. It may also cause you to have unusual or 

extreme changes in behaviour or mood. 
If any of these happens, talk to your doctor or pharmacist. 
 
A small number of people being treated with anti-epileptics have had thoughts of harming or killing 
themselves. If at any time you have these thoughts, contact your doctor straight away. 
 
Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) and 
Stevens - Johnson Syndrome (SJS) have been reported with the use of perampanel. 
- DRESS typically, although not exclusively, appears as flu-like symptoms and a rash with a high 

body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type 
of white blood cell (eosinophilia) and enlarged lymph nodes. 

- Stevens - Johnson Syndrome (SJS) can appear initially as reddish target- like spots or circular 
patches often with central blisters on the trunk. Also, ulcers of mouth, throat, nose, genitals and 
eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever 
and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin and life-
threatening complications or be fatal. 

 
If you experience any of the above after taking Fycompa (or you are not sure) talk to your doctor or 
pharmacist. 
 
Children 
Fycompa is not recommended for children aged under 4. The safety and effectiveness are not yet 
known in children under 4 years of age for partial seizures and under 7 years of age in generalised 
seizures. 
 
Other medicines and Fycompa 
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other 
medicines. This includes medicines obtained without a prescription and herbal medicines. Taking 
Fycompa with certain other medicines may cause side effects or affect how they work. Do not start or 
stop other medicines without talking to your doctor or pharmacist. 
- Other anti-epileptic medicines, such as carbamazepine, oxcarbazepine, and phenytoin that are 

used to treat fits may affect Fycompa. Tell your doctor if you are taking or have recently taken 
these medicines as your dose may need to be adjusted. 

- Felbamate (a medicine used to treat epilepsy) may also affect Fycompa. Tell your doctor if you 
are taking or have recently taken this medicine as your dose may need to be adjusted. 

- Midazolam (a medicine used to stop prolonged, acute (sudden) convulsive seizures, for sedation 
and sleep problem) may be affected by Fycompa. Tell your doctor if you are taking midazolam 
as your dose may need to be adjusted. 

- Some other medicines such as rifampicin (a medicine used to treat bacterial infections), 
hypericum (St. John’s Wort) (a medicine used to treat mild anxiety) and ketoconazole (a 
medicine used to treat fungal infections) may affect Fycompa. Tell your doctor if you are taking 
or have recently taken these medicines as your dose may need to be adjusted. 

- Hormonal contraceptives (including oral contraceptives, implants, injections, and patches) 
Tell your doctor if you are taking hormonal contraceptives. Fycompa may make certain hormonal 
contraceptives such as levonorgestrel less effective. You should use other forms of safe and effective 
contraception (such as a condom or coil) when taking Fycompa. You should continue doing this for 
one month after stopping treatment. Discuss with your doctor what may be appropriate contraception 
for you. 
 



 72 

Fycompa with alcohol 
Speak to your doctor before drinking alcohol. Be careful about consuming alcohol with epilepsy 
medicines including Fycompa. 
- Drinking alcohol while taking Fycompa can make you less alert and affect your ability to drive 

or use tools or machines. 
- Drinking alcohol while taking Fycompa can also make any feelings of anger, confusion or 

sadness worse. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask 
your doctor for advice before taking this medicine. Do not stop treatment without first discussing it 
with your doctor. 
- Fycompa is not recommended in pregnancy. 
- You must use a reliable method of contraception to avoid becoming pregnant while you are 

being treated with Fycompa. You should continue doing this for one month after stopping 
treatment. Tell your doctor if you are taking hormonal contraceptives. Fycompa may make 
certain hormonal contraceptives such as levonorgestrel less effective. You should use other 
forms of safe and effective contraception (such as a condom or coil) when taking Fycompa. You 
should also do this for one month after stopping treatment. Discuss with your doctor what may 
be appropriate contraception for you. 

It is not known whether the ingredients of Fycompa can pass into breast milk. 
The doctor will weigh up the benefit and risks to your baby of taking Fycompa while you are 
breast-feeding. 
 
Driving and using machines 
Do not drive or use machines until you know how Fycompa affects you. 
You must talk to your doctor about the effect of your epilepsy on driving and using machines. 
- Fycompa may make you feel dizzy or sleepy, particularly at the beginning of treatment. If this 

happens to you, do not drive or use any tools or machines. 
- Drinking alcohol while taking Fycompa may make these effects worse. 
 
Fycompa contains lactose 
Fycompa contains lactose (a type of sugar). If you have been told by your doctor that you have an 
intolerance to some sugars, contact your doctor before taking this medicine. 
 
 
3. How to take Fycompa 
 
Always take this medicine exactly as your doctor has told you. You should check with your doctor or 
pharmacist if you are not sure. 
 
How much to take 
 
Adults, adolescents (aged 12 years and older) in treating partial seizures and generalised seizures: 
 
The usual starting dose is 2 mg once a day before you go to bed. 
- Your doctor may increase this in 2 mg steps to a maintenance dose between 4 mg and 12 mg - 

depending on your response. 
- If you have mild or moderate liver problems, your dose should not be more than 8 mg each day 

and your dose increases should be at least 2 weeks apart. 
- Don’t take more Fycompa than your doctor has recommended. It may take a few weeks to find 

the right dose of Fycompa for you. 
 



 73 

The following table summarises the recommended doses in treating partial seizures in children 4 to 
11 years of age and generalised seizures in children 7 to 11 years of age. More details are provided 
below the table. 
 

 Children weighing: 
More than 30 kg 20 kg to less than 30 kg Less than 20 kg 

Recommended 
starting dose 2 mg/day 1 mg/day 1 mg/day 

Recommended 
maintenance dose 4 – 8 mg/day 4 – 6 mg/day 2 – 4 mg/day 

Recommended 
maximum dose 12 mg/day 8 mg/day 6 mg/day 

 
Children (from 4 to 11 years of age) weighing 30 kg or more in treating partial seizures: 
 
The usual starting dose is 2 mg once a day before you go to bed. 
- Your doctor may increase this in 2 mg steps to a maintenance dose between 4 mg and 8 mg - 

depending on your response. Depending upon individual clinical response and tolerability, the 
dose may be increased to a maximum dose of 12 mg/day. 

- If you have mild or moderate liver problems, your dose should not be more than 4 mg each day 
and your dose increases should be at least 2 weeks apart. 

- Don’t take more Fycompa than your doctor has recommended. It may take a few weeks to find 
the right dose of Fycompa for you. 

 
Children (from 4 to 11 years of age) weighing 20 kg and less than 30 kg in treating partial seizures: 
 
The usual starting dose is 1 mg once a day before you go to bed. 
- Your doctor may increase this in 1 mg steps to a maintenance dose between 4 mg and 6 mg - 
 depending on your response. Depending upon individual clinical response and tolerability, the 
 dose may be increased to a maximum dose of 8 mg/day. 
- If you have mild or moderate liver problems, your dose should not be more than 4 mg each day 

and your dose increases should be at least 2 weeks apart. 
- Don’t take more Fycompa than your doctor has recommended. It may take a few weeks to find 

the right dose of Fycompa for you. 
 
Children (from 4 to 11 years of age) weighing less than 20 kg in treating partial seizures: 
 
The usual starting dose is 1 mg once a day before you go to bed. 
- Your doctor may increase this in 1 mg steps to a maintenance dose between 2 mg and 4 mg - 

depending on your response. Depending upon individual clinical response and tolerability, the 
dose may be increased to a maximum dose of 6 mg/day. 

- If you have mild or moderate liver problems, your dose should not be more than 4 mg each day 
and your dose increases should be at least 2 weeks apart. 

- Don’t take more Fycompa than your doctor has recommended. It may take a few weeks to find 
the right dose of Fycompa for you. 
 

Children (from 7 to 11 years of age) weighing 30 kg or more in treating generalised seizures: 
 
The usual starting dose is 2 mg once a day before you go to bed. 
- Your doctor may increase this in 2 mg steps to a maintenance dose between 4 mg and 8 mg - 
 depending on your response. Depending upon individual clinical response and tolerability, the 
 dose may be increased to a maximum dose of 12 mg/day. 
- If you have mild or moderate liver problems, your dose should not be more than 4 mg each day 

and your dose increases should be at least 2 weeks apart. 
- Don’t take more Fycompa than your doctor has recommended. It may take a few weeks to find 

the right dose of Fycompa for you. 



 74 

 
Children (from 7 to 11 years of age) weighing 20 kg and less than 30 kg in treating generalised 
seizures: 
 
The usual starting dose is 1 mg once a day before you go to bed. 
- Your doctor may increase this in 1 mg steps to a maintenance dose between 4 mg and 6 mg - 
 depending on your response. Depending upon individual clinical response and tolerability, the 
 dose may be increased to a maximum dose of 8 mg/day. 
- If you have mild or moderate liver problems, your dose should not be more than 4 mg each day 

and your dose increases should be at least 2 weeks apart. 
- Don’t take more Fycompa than your doctor has recommended. It may take a few weeks to find 

the right dose of Fycompa for you. 
 
Children (from 7 to 11 years of age) weighing less than 20 kg in treating generalised seizures: 
 
The usual starting dose is 1 mg once a day before you go to bed. 
- Your doctor may increase this in 1 mg steps to a maintenance dose between 2 mg and 4 mg - 

depending on your response. Depending upon individual clinical response and tolerability, the 
dose may be increased to a maximum dose of 6 mg/day. 

- If you have mild or moderate liver problems, your dose should not be more than 4 mg each day 
and your dose increases should be at least 2 weeks apart. 

- Don’t take more Fycompa than your doctor has recommended. It may take a few weeks to find 
the right dose of Fycompa for you. 

 
How to take 
Swallow the tablet whole with a glass of water. You can take Fycompa with or without food. Do not 
chew, crush or split the tablet. The tablets cannot be split accurately as there is no break line. 
 
If you take more Fycompa than you should 
If you have taken more Fycompa than you should contact your doctor straight away. You may 
experience confusion, agitation and aggressive behaviour. 
 
If you forget to take Fycompa 
- If you forget to take a tablet, wait until your next dose and then carry on as usual. 
- Do not take a double dose to make up for a forgotten dose. 
- If you have missed less than 7 days of treatment with Fycompa, continue taking your daily 

tablet as originally instructed by your doctor. 
- If you have missed more than 7 days of treatment with Fycompa, talk to your doctor 

immediately. 
 
If you stop taking Fycompa 
Take Fycompa for as long as your doctor recommends. Do not stop unless your doctor advises you to. 
Your doctor may reduce your dose slowly to avoid your fits (seizures) coming back or getting worse. 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
A small number of people being treated with anti-epileptics have had thoughts of harming or killing 
themselves. If at any time you have these thoughts, contact your doctor straight away. 
 
Very common (may affect more than 1 user in 10) are: 
- feeling dizzy 
- feeling sleepy (drowsiness or somnolence) 



 75 

 
Common (may affect more than 1 user in 100) are: 
- increased or decreased appetite, weight gain 
- feeling aggressive, angry, irritable, anxious or confused 
- difficulty with walking or other balance problems (ataxia, gait disturbance, balance disorder) 
- slow speech (dysarthria) 
- blurred vision or double vision (diplopia) 
- spinning sensation (vertigo) 
- feeling sick (nausea) 
- back pain 
- feeling very tired (fatigue) 
- falling down 
 
Uncommon (may affect more than 1 user in 1000) are: 
- thoughts about harming yourself or ending your own life (suicidal thoughts), tried to end your 

own life (attempted suicide) 
 
Not known (the frequency of this side effect cannot be estimated from the available data) are: 
- Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or 

drug hypersensitivity syndrome: widespread rash, high body temperature, liver enzyme 
elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs 
involvement. 

- Stevens - Johnson syndrome, SJS. This serious skin rash can appear as reddish target-like 
macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of 
mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. 
 

Stop using perampanel if you develop these symptoms and contact your doctor or seek medical 
attention immediately. See also section 2. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Fycompa 
 
Keep out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date 
refers to the last day of the month. 
 
This medicinal product does not require any special storage conditions. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Fycompa contains 
The active substance is perampanel. Each film-coated tablet contains 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, 
or 12 mg perampanel. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 76 

The other ingredients are: 
Tablet core (2 mg and 4 mg tablets): 
Lactose monohydrate, low-substituted hydroxypropyl cellulose, povidone, magnesium stearate 
(E470b) 
 
Tablet core (6 mg, 8 mg, 10 mg and 12 mg tablets) 
Lactose monohydrate, low-substituted hydroxypropyl cellulose, povidone, microcrystalline cellulose, 
magnesium stearate (E470b) 
 
Film coating (2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg tablets) 
Hypromellose 2910, talc, Macrogol 8000, titanium dioxide (E171), colourants* 
 
*The colourants are: 
2 mg tablet: Ferric Oxide, Yellow (E172), Ferric Oxide, Red (E172) 
4 mg tablet: Ferric Oxide, Red (E172) 
6 mg tablet: Ferric Oxide, Red (E172) 
8 mg tablet: Ferric Oxide, Red (E172), Ferric Oxide, Black (E172) 
10 mg tablet: Ferric Oxide, Yellow (E172), FD&C Blue #2 Indigo carmine aluminium lake (E132) 
12 mg tablet: FD&C Blue #2 Indigo carmine aluminium lake (E132) 
 
What Fycompa looks like and contents of the pack 
All strengths of Fycompa are round, biconvex film-coated tablets 
2 mg: orange, marked with E275 on one side and 2 on other side 
4 mg: red, marked with E277 on one side and 4 on other side 
6 mg: pink, marked with E294 on one side and 6 on other side 
8 mg: purple, marked with E295 on one side and 8 on other side 
10 mg: green, marked with E296 on one side and 10 on other side 
12 mg: blue, marked with E297 on one side and 12 on other side 
 
Fycompa is available in packs of: 
2 mg tablet – pack of 7, 28 and 98 
4 mg, 6 mg, 8 mg, 10 mg, 12 mg tablets – packs of 7, 28, 84 and 98 
 
Not all pack sizes may be marketed 
 
Marketing Authorisation Holder 
 
Eisai GmbH 
Edmund-Rumpler-Straße 3 
60549 Frankfurt am Main 
Germany 
e-mail: medinfo_de@eisai.net 
 
Manufacturer 
Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, 
AL10 9SN, United Kingdom 
 
Or 
 
Eisai GmbH 
Edmund-Rumpler-Straße 3 
60549 Frankfurt am Main 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 



 77 

 
België/Belgique/Belgien 
Eisai SA/NV 
Tél/Tel: +32 (0)800 158 58 
 

Lietuva 
Eisai GmbH 
Tel: + 49 (0) 69 66 58 50 
(Vokietija) 
 

България 
Eisai GmbH 
Teл.: + 49 (0) 69 66 58 50 
(Германия) 
 

Luxembourg/Luxemburg 
Eisai SA/NV 
Tél/Tel: +32 (0)800 158 58 
(Belgique/Belgien) 
 

Česká republika 
Eisai GesmbH organizačni složka 
Tel: + 420 242 485 839 
 

Magyarország 
Eisai GmbH 
Tel.: + 49 (0) 69 66 58 50 
(Németország) 
 

Danmark 
Eisai AB 
Tlf: + 46 (0) 8 501 01 600 
(Sverige) 
 

Malta 
Associated Drug Co. Ltd 
Tel: + 356 2277 8000 
 

Deutschland 
Eisai GmbH 
Tel: + 49 (0) 69 66 58 50 
 

Nederland 
Eisai B.V. 
Tel: + 31 (0) 900 575 3340 
 

Eesti 
Eisai GmbH 
Tel: + 49 (0) 69 66 58 50 
(Saksamaa) 
 

Norge 
Eisai AB 
Tlf: + 46 (0) 8 501 01 600 
(Sverige) 
 

Ελλάδα 
Arriani Pharmaceutical S.A. 
Τηλ: + 30 210 668 3000 
 

Österreich 
Eisai GesmbH 
Tel: + 43 (0) 1 535 1980-0 
 

España 
Eisai Farmacéutica, S.A. 
Tel: + (34) 91 455 94 55 
 

Polska 
Eisai GmbH 
Tel: + 49 (0) 69 66 58 50 
(Niemcy) 
 

France 
Eisai SAS 
Tél: + (33) 1 47 67 00 05 
 

Portugal 
Eisai Farmacêtica, Unipessoal Lda 
Tel: + 351 214 875 540 
 

Hrvatska 
Eisai GmbH 
Tel: + 49 (0) 69 66 58 50 
(Njemačka) 

România 
Eisai GmbH 
Tel: + 49 (0) 69 66 58 50 
(Germania) 
 

Ireland 
Eisai GmbH 
Tel: + 49 (0) 69 66 58 50 
(Germany) 

Slovenija 
Eisai GmbH 
Tel: + 49 (0) 69 66 58 50 
(Nemčija) 
 



 78 

Ísland 
Eisai AB 
Sími: + 46 (0)8 501 01 600 
(Svíþjóð) 
 

Slovenská republika 
Eisai GesmbH organizačni složka 
Tel.: + 420 242 485 839 
(Česká republika) 
 

Italia 
Eisai S.r.l. 
Tel: + 39 02 5181401 
 

Suomi/Finland 
Eisai AB 
Puh/Tel: + 46 (0) 8 501 01 600 
(Ruotsi) 
 

Κύπρος 
Arriani Pharmaceuticals S.A. 
Τηλ: + 30 210 668 3000 
(Ελλάδα) 
 

Sverige 
Eisai AB 
Tel: + 46 (0) 8 501 01 600 

Latvija 
Eisai GmbH 
Tel: + 49 (0) 69 66 58 50 
(Vācija) 
 

United Kingdom 
Eisai Europe Ltd. 
Tel: +44 (0)208 600 1400 
 

 
This leaflet was last revised in {MM/YYYY} 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu 
 



 79 

Package leaflet: Information for the user 
 

Fycompa 0.5 mg/ml oral suspension 
Perampanel 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet: 
 
1. What Fycompa is and what it is used for 
2. What you need to know before you take Fycompa 
3. How to take Fycompa 
4. Possible side effects 
5. How to store Fycompa 
6. Contents of the pack and other information 
 
 
1. What Fycompa is and what it is used for 
 
Fycompa contains a medicine called perampanel. It belongs to a group of medicines called 
anti-epileptics. These medicines are used to treat epilepsy - where someone has repeated fits 
(seizures). It has been given to you by your doctor to reduce the number of fits that you have. 
 
Fycompa is used in association with other antiepileptic drugs to treat certain forms of epilepsy:  
In adults, adolescents (aged 12 years and older), and children (from 4 to 11 years) 
- It is used to treat fits that affect one part of your brain (called a “partial seizure”). 
- These partial seizures may or may not then be followed by a fit affecting all of your brain 

(called a “secondary generalisation”). 
In adults and adolescents (aged 12 years and older), and children (from 7 to 11 years) 
- It is also used to treat certain fits that affect all of your brain from the start (called “generalised 

seizures”) and cause convulsions or staring spells. 
 
 
2. What you need to know before you take Fycompa 
 
 DO NOT TAKE Fycompa: 
- If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores 

after taking perampanel. 
- If you are allergic to perampanel or any of the other ingredients of this medicine (listed in 

section 6). 
 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Fycompa if you have liver problems or moderate or 
severe kidney problems. 
You should not take Fycompa if you have serious liver problems or moderate or serious kidney 
problems. 
Before taking this medicine you should tell your doctor if you have a history of alcoholism or drug 
dependence. 



 80 

Cases of increased liver enzymes have been reported in some patients taking Fycompa in combination 
with other antiepileptic drugs. 
 
- Fycompa may make you feel dizzy or sleepy, particularly at the beginning of treatment. 
- Fycompa may make you more likely to fall over, particularly if you are an older person; this 

might be due to your illness. 
- Fycompa may make you aggressive, angry or violent. It may also cause you to have unusual or 

extreme changes in behaviour or mood. 
If any of these happens, talk to your doctor or pharmacist. 
 
A small number of people being treated with anti-epileptics have had thoughts of harming or killing 
themselves. If at any time you have these thoughts, contact your doctor straight away. 
 
Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) and 
Stevens - Johnson Syndrome (SJS) have been reported with the use of perampanel. 
- DRESS typically, although not exclusively, appears as flu-like symptoms and a rash with a high 

body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type 
of white blood cell (eosinophilia) and enlarged lymph nodes. 

- Stevens - Johnson Syndrome (SJS) can appear initially as reddish target- like spots or circular 
patches often with central blisters on the trunk. Also, ulcers of mouth, throat, nose, genitals and 
eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever 
and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin and life- 
threatening complications or be fatal. 

 
If you experience any of the above after taking Fycompa (or you are not sure) talk to your doctor or 
pharmacist. 
 
Children 
Fycompa is not recommended for children aged under 4. The safety and effectiveness are not yet 
known in children under 4 years of age for partial seizures and under 7 years of age in generalised 
seizures.  
 
Other medicines and Fycompa 
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other 
medicines. This includes medicines obtained without a prescription and herbal medicines. Taking 
Fycompa with certain other medicines may cause side effects or affect how they work. Do not start or 
stop other medicines without talking to your doctor or pharmacist. 
- Other anti-epileptic medicines, such as carbamazepine, oxcarbazepine, and phenytoin that are 

used to treat fits may affect Fycompa. Tell your doctor if you are taking or have recently taken 
these medicines as your dose may need to be adjusted. 

- Felbamate (a medicine used to treat epilepsy) may also affect Fycompa. Tell your doctor if you 
are taking or have recently taken this medicine as your dose may need to be adjusted. 

- Midazolam (a medicine used to stop prolonged, acute (sudden) convulsive seizures, for sedation 
and sleep problem) may be affected by Fycompa. Tell your doctor if you are taking midazolam 
as your dose may need to be adjusted. 

- Some other medicines such as rifampicin (a medicine used to treat bacterial infections), 
hypericum (St. John’s Wort) (a medicine used to treat mild anxiety) and ketoconazole (a 
medicine used to treat fungal infections) may affect Fycompa. Tell your doctor if you are taking 
or have recently taken these medicines as your dose may need to be adjusted. 

- Hormonal contraceptives (including oral contraceptives, implants, injections, and patches) 
- Tell your doctor if you are taking hormonal contraceptives. Fycompa may make certain 

hormonal contraceptives such as levonorgestrel less effective. You should use other forms of 
safe and effective contraception (such as a condom or coil) when taking Fycompa. You should 
continue doing this for one month after stopping treatment. Discuss with your doctor what may 
be appropriate contraception for you. 

 



 81 

Fycompa with alcohol 
Speak to your doctor before drinking alcohol. Be careful about consuming alcohol with epilepsy 
medicines including Fycompa. 
- Drinking alcohol while taking Fycompa can make you less alert and affect your ability to drive 

or use tools or machines. 
- Drinking alcohol while taking Fycompa can also make any feelings of anger, confusion or 

sadness worse. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask 
your doctor for advice before taking this medicine. Do not stop treatment without first discussing it 
with your doctor. 
- Fycompa is not recommended in pregnancy. 
- You must use a reliable method of contraception to avoid becoming pregnant while you are 

being treated with Fycompa. You should continue doing this for one month after stopping 
treatment. Tell your doctor if you are taking hormonal contraceptives. Fycompa may make 
certain hormonal contraceptives such as levonorgestrel less effective. You should use other 
forms of safe and effective contraception (such as a condom or coil) when taking Fycompa. You 
should also do this for one month after stopping treatment. Discuss with your doctor what may 
be appropriate contraception for you. 

It is not known whether the ingredients of Fycompa can pass into breast milk. 
The doctor will weigh up the benefit and risks to your baby of taking Fycompa while you are 
breast-feeding. 
 
Driving and using machines 
Do not drive or use machines until you know how Fycompa affects you. 
You must talk to your doctor about the effect of your epilepsy on driving and using machines. 
- Fycompa may make you feel dizzy or sleepy, particularly at the beginning of treatment. If this 

happens to you, do not drive or use any tools or machines. 
- Drinking alcohol while taking Fycompa may make these effects worse. 
 
Fycompa contains sorbitol 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking Fycompa. 
 
Taking Fycompa with other anti-epileptic medicine, which contains sorbitol, may affect how much 
they work. Tell your doctor or pharmacist if you are taking any other anti-epileptic medicine(s) with 
sorbitol. 
 
 
3. How to use Fycompa 
 
Always take this medicine exactly as your doctor has told you. You should check with your doctor or 
pharmacist if you are not sure. 
 
How much to take 
 
Adults, adolescents (aged 12 years and older) in treating partial seizures and generalised seizures: 
 
The usual starting dose is 2 mg (4 ml) once a day before you go to bed. 
- Your doctor may increase this in 2 mg (4 ml) steps to a maintenance dose between 4 mg (8 ml) 

and 12 mg (24 ml) depending on your response. 
- If you have mild or moderate liver problems, your dose should not be more than 8 mg each day 

and your dose increases should be at least 2 weeks apart. 
- Don’t take more Fycompa than your doctor has recommended. It may take a few weeks to find 

the right dose of Fycompa for you. 



 82 

 
The following table summarises the recommended doses in treating partial seizures in children 4 to 
11 years of age and generalised seizures in children 7 to 11 years of age. More details are provided 
below the table. 
 

 Children weighing: 
More than 30 kg 20 kg to less than 30 kg Less than 20 kg 

Recommended 
starting dose 

2 mg/day 
(4 ml/day) 

1 mg/day 
(2 ml/day) 

1 mg/day 
(2 ml/day) 

Recommended 
maintenance dose 

4 – 8 mg/day 
(8 – 16 ml/day) 

4 – 6 mg/day 
(8 – 12 ml/day) 

2 – 4 mg/day 
(4 – 8 ml/day) 

Recommended 
maximum dose 

12 mg/day 
(24 ml/day) 

8 mg/day 
(16 ml/day) 

6 mg/day 
(12 ml/day) 

 
Children (from 4 to 11 years of age) weighing 30 kg or more in treating partial seizures: 
 
The usual starting dose is 2 mg (4 ml) once a day before you go to bed. 
- Your doctor may increase this in 2 mg (4 ml) steps to a maintenance dose between 4 mg (8 ml) 

and 8 mg (16 ml) - depending on your response. Depending upon individual clinical response 
and tolerability, the dose may be increased to a maximum dose of 12 mg/day (24 ml/day). 

- If you have mild or moderate liver problems, your dose should not be more than 4 mg (8 ml) 
each day and your dose increases should be at least 2 weeks apart. 

- Don’t take more Fycompa than your doctor has recommended. It may take a few weeks to find 
the right dose of Fycompa for you. 

 
Children (from 4 to 11 years of age) weighing 20 kg and less than 30 kg in treating partial seizures: 
 
The usual starting dose is 1 mg (2 ml) once a day before you go to bed. 
- Your doctor may increase this in 1 mg (2 ml) steps to a maintenance dose between 4 mg (8 ml) 

and 6 mg (12 ml) - depending on your response. Depending upon individual clinical response 
and tolerability, the dose may be increased to a maximum dose of 8 mg/day (16 ml/day). 

- If you have mild or moderate liver problems, your dose should not be more than 4 mg (8 ml) 
each day and your dose increases should be at least 2 weeks apart. 

- Don’t take more Fycompa than your doctor has recommended. It may take a few weeks to find 
the right dose of Fycompa for you. 

 
Children (from 4 to 11 years of age) weighing less than 20 kg in treating partial seizures: 
 
The usual starting dose is 1 mg (2 ml) once a day before you go to bed. 
- Your doctor may increase this in 1 mg (2 ml) steps to a maintenance dose between 2 mg (4 ml) 

and 4 mg (8 ml) - depending on your response. Depending upon individual clinical response and 
tolerability, the dose may be increased to a maximum dose of 6 mg/day (12 ml/day). 

- If you have mild or moderate liver problems, your dose should not be more than 4 mg (8 ml) 
each day and your dose increases should be at least 2 weeks apart. 

- Don’t take more Fycompa than your doctor has recommended. It may take a few weeks to find 
the right dose of Fycompa for you. 
 

Children (from 7 to 11 years of age) weighing 30 kg or more in treating generalised seizures: 
 
The usual starting dose is 2 mg (4 ml) once a day before you go to bed. 
- Your doctor may increase this in 2 mg (4 ml) steps to a maintenance dose between 4 mg (8 ml) 

and 8 mg (16 ml) - depending on your response. Depending upon individual clinical response 
and tolerability, the dose may be increased to a maximum dose of 12 mg/day (24 ml/day). 

- If you have mild or moderate liver problems, your dose should not be more than 4 mg (8 ml) 
each day and your dose increases should be at least 2 weeks apart. 



 83 

- Don’t take more Fycompa than your doctor has recommended. It may take a few weeks to find 
the right dose of Fycompa for you. 

 
Children (from 7 to 11 years of age) weighing 20 kg and less than 30 kg in treating generalised 
seizures: 
 
The usual starting dose is 1 mg (2 ml) once a day before you go to bed. 
- Your doctor may increase this in 1 mg (2 ml) steps to a maintenance dose between 4 mg (8 ml) 

and 6 mg (12 ml) - depending on your response. Depending upon individual clinical response 
and tolerability, the dose may be increased to a maximum dose of 8 mg/day (16 ml/day). 

- If you have mild or moderate liver problems, your dose should not be more than 4 mg (8 ml) 
each day and your dose increases should be at least 2 weeks apart. 

- Don’t take more Fycompa than your doctor has recommended. It may take a few weeks to find 
the right dose of Fycompa for you. 

 
Children (from 7 to 11 years of age) weighing less than 20 kg in treating generalised seizures: 
 
The usual starting dose is 1 mg (2 ml) once a day before you go to bed. 
- Your doctor may increase this in 1 mg steps to a maintenance dose between 2 mg (4 ml) and 

4 mg (8 ml) - depending on your response. Depending upon individual clinical response and 
tolerability, the dose may be increased to a maximum dose of 6 mg/day (12 ml/day). 

- If you have mild or moderate liver problems, your dose should not be more than 4 mg (8 ml) 
each day and your dose increases should be at least 2 weeks apart. 

- Don’t take more Fycompa than your doctor has recommended. It may take a few weeks to find 
the right dose of Fycompa for you. 

 
How to take 
Fycompa is for oral use. You can take Fycompa with or without food and should always take it the 
same way. For example, if you decide to take Fycompa with food, always take it that way. 
 
For dosing please use the oral syringe and adaptor provided. 
 
Instructions on how to use the oral syringe and adaptor are provided below: 
 
 
 
 
 
 
 
 
 
 



 84 

1. Shake for at least 5 seconds before use. 
2. Push down (1) and turn cap (2) to open bottle. 
3. Insert adaptor into the neck of the bottle until a tight seal is made. 
4. Push plunger of oral syringe completely down. 
5. Insert the oral syringe into the opening of the adaptor as far as possible. 
6. Turn upside down and withdraw the prescribed amount of Fycompa from the bottle. 
7. Turn upright and remove the oral syringe. 
8. Leave the adaptor in place and replace cap on bottle. 
9. After dose administration, separate barrel and plunger, and fully immerse both components in 

HOT soapy water. 
10. Immerse the barrel and plunger in water to remove any residual detergent, shake off excess 

water and leave components to air dry. Do not wipe dry the dispensers. 
11. Do not clean and reuse the syringe after 40 uses, or if the markings on the syringe wash off. 
 
 
If you take more Fycompa than you should 
If you have taken more Fycompa than you should contact your doctor straight away. You may 
experience confusion, agitation and aggressive behaviour. 
 
If you forget to take Fycompa 
- If you forget to take Fycompa, wait until your next dose and then carry on as usual. 
- Do not take a double dose to make up for a forgotten dose. 
- If you have missed less than 7 days of treatment with Fycompa, continue taking your daily dose 

as originally instructed by your doctor. 
- If you have missed more than 7 days of treatment with Fycompa, talk to your doctor 

immediately. 
 
If you stop taking Fycompa 
Take Fycompa for as long as your doctor recommends. Do not stop unless your doctor advises you to. 
Your doctor may reduce your dose slowly to avoid your fits (seizures) coming back or getting worse. 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
A small number of people being treated with anti-epileptics have had thoughts of harming or killing 
themselves. If at any time you have these thoughts, contact your doctor straight away. 
 
Very common (may affect more than 1 user in 10) are: 
- feeling dizzy 
- feeling sleepy (drowsiness or somnolence) 
 
Common (may affect more than 1 user in 100) are: 
- increased or decreased appetite, weight gain 
- feeling aggressive, angry, irritable, anxious or confused 
- difficulty with walking or other balance problems (ataxia, gait disturbance, balance disorder) 
- slow speech (dysarthria) 
- blurred vision or double vision (diplopia) 
- spinning sensation (vertigo) 
- feeling sick (nausea) 
- back pain 
- feeling very tired (fatigue) 
- falling down. 
 



 85 

Uncommon (may affect more than 1 user in 1000) are: 
- thoughts about harming yourself or ending your own life (suicidal thoughts), tried to end your 

own life (attempted suicide) 
 
Not known (the frequency of this side effect cannot be estimated from the available data) are: 
- Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or 

drug hypersensitivity syndrome: widespread rash, high body temperature, liver enzyme 
elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs 
involvement. 

- Stevens - Johnson syndrome, SJS. This serious skin rash can appear as reddish target-like 
macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of 
mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. 

Stop using perampanel if you develop these symptoms and contact your doctor or seek medical 
attention immediately. See also section 2. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Fycompa 
 
Keep out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the bottle label and carton. The expiry 
date refers to the last day of the month. 
 
This medicinal product does not require any special storage conditions. 
 
If you have any suspension left in the bottle more than 90 days after it was first opened, you should 
not use it. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Fycompa contains 
- The active substance is perampanel. Each millilitre contains 0.5 mg of perampanel. 
- The other ingredients are sorbitol (E420) liquid (crystallising), microcrystalline 

cellulose (E460), carmellose sodium (E466), poloxamer 188, simethicone emulsion 30% 
(containing purified water, silicone oil, polysorbate 65, methylcellulose, silica gel, macrogol 
stearate, sorbic acid, benzoic acid and sulfuric acid), citric acid, anhydrous (E330), sodium 
benzoate (E211) and purified water. 

 
What Fycompa looks like and contents of the pack 
Fycompa 0.5 mg/ml oral suspension is a white to off-white suspension. It comes in a bottle of 340 ml 
with 2 graduated oral syringes and an LDPE press-in bottle adapter (PIBA). 
 
Marketing Authorisation Holder 
 
Eisai GmbH 
Edmund-Rumpler-Straße 3 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 86 

60549 Frankfurt am Main 
Germany 
e-mail: medinfo_de@eisai.net 
 
Manufacturer 
Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, 
AL10 9SN, United Kingdom 
 
Or 
 
Eisai GmbH 
Edmund-Rumpler-Straße 3 
60549 Frankfurt am Main 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Eisai SA/NV 
Tél/Tel: +32 (0)800 158 58 
 

Lietuva 
Eisai GmbH 
Tel: + 49 (0) 69 66 58 50 
(Vokietija) 
 

България 
Eisai GmbH 
Teл.: + 49 (0) 69 66 58 50 
(Германия) 
 

Luxembourg/Luxemburg 
Eisai SA/NV 
Tél/Tel: +32 (0)800 158 58 
(Belgique/Belgien) 
 

Česká republika 
Eisai GesmbH organizačni složka 
Tel: + 420 242 485 839 
 

Magyarország 
Eisai GmbH 
Tel.: + 49 (0) 69 66 58 50 
(Németország) 
 

Danmark 
Eisai AB 
Tlf: + 46 (0) 8 501 01 600 
(Sverige) 
 

Malta 
Associated Drug Co. Ltd 
Tel: + 356 2277 8000 
 

Deutschland 
Eisai GmbH 
Tel: + 49 (0) 69 66 58 50 
 

Nederland 
Eisai B.V. 
Tel: + 31 (0) 900 575 3340 
 

Eesti 
Eisai GmbH 
Tel: + 49 (0) 69 66 58 50 
(Saksamaa) 
 

Norge 
Eisai AB 
Tlf: + 46 (0) 8 501 01 600 
(Sverige) 
 

Ελλάδα 
Arriani Pharmaceutical S.A. 
Τηλ: + 30 210 668 3000 
 

Österreich 
Eisai GesmbH 
Tel: + 43 (0) 1 535 1980-0 
 



 87 

España 
Eisai Farmacéutica, S.A. 
Tel: + (34) 91 455 94 55 
 

Polska 
Eisai GmbH 
Tel: + 49 (0) 69 66 58 50 
(Niemcy) 
 

France 
Eisai SAS 
Tél: + (33) 1 47 67 00 05 
 

Portugal 
Eisai Farmacêtica, Unipessoal Lda 
Tel: + 351 214 875 540 
 

Hrvatska 
Eisai GmbH 
Tel: + 49 (0) 69 66 58 50 
(Njemačka) 

România 
Eisai GmbH 
Tel: + 49 (0) 69 66 58 50 
(Germania) 
 

Ireland 
Eisai GmbH 
Tel: + 49 (0) 69 66 58 50 
(Germany) 

Slovenija 
Eisai GmbH 
Tel: + 49 (0) 69 66 58 50 
(Nemčija) 
 

Ísland 
Eisai AB 
Sími: + 46 (0)8 501 01 600 
(Svíþjóð) 
 

Slovenská republika 
Eisai GesmbH organizačni složka 
Tel.: + 420 242 485 839 
(Česká republika) 
 

Italia 
Eisai S.r.l. 
Tel: + 39 02 5181401 
 

Suomi/Finland 
Eisai AB 
Puh/Tel: + 46 (0) 8 501 01 600 
(Ruotsi) 
 

Κύπρος 
Arriani Pharmaceuticals S.A. 
Τηλ: + 30 210 668 3000 
(Ελλάδα) 
 

Sverige 
Eisai AB 
Tel: + 46 (0) 8 501 01 600 

Latvija 
Eisai GmbH 
Tel: + 49 (0) 69 66 58 50 
(Vācija) 
 

United Kingdom 
Eisai Europe Ltd. 
Tel: +44 (0)208 600 1400 
 

 
This leaflet was last revised in {MM/YYYY} 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET