FYCOMPA FILM-COATED TABLET 8MG

Country: Сингапур

Језик: Енглески

Извор: HSA (Health Sciences Authority)

Активни састојак:

Perampanel (Anhydrous basis)

Доступно од:

EISAI (SINGAPORE) PTE. LTD.

АТЦ код:

N03AX22

Дозирање:

8.0 mg

Фармацеутски облик:

TABLET, FILM COATED

Састав:

Perampanel (Anhydrous basis) 8.0 mg

Пут администрације:

ORAL

Тип рецептора:

Prescription Only

Произведен од:

Eisai Manufacturing Ltd.

Статус ауторизације:

ACTIVE

Датум одобрења:

2014-09-12

Информативни летак

An
ti-
epileptic drug
F
Y
COMPA®
Film-
coa
ted 
Tablets 
2mg
, 4mg
, 6mg
, 8mg
, 10mg
, 12mg
per
ampanel
1.
NAME OF 
THE MEDICINAL PR
ODUC
T
2 mg
, 4 mg
, 6 mg
, 8 mg
, 10 mg
, 12 mg film-
coa
ted tablets
2.
QU
ANTIT
A
TIVE C
OMPOSITION
E
ac
h
 fi
lm
-c
o
at
e
d
 t
ab
le
t 
co
n
ta
in
s 
2
, 4
, 6
, 8
, 1
0
, o
r 
1
2
 m
g
 p
e
ra
m
p
an
e
l.
T
h
e
 c
o
m
p
le
te
 q
u
a
n
ti
ta
ti
ve
 c
o
m
p
o
si
ti
o
n
 c
a
n
 b
e
 f
o
u
n
d
 in
 S
e
ct
io
n
 6
.
3.
PHARMA
CEUTIC
AL FORM
Film-
coa
ted tablet (tablet): 2 mg tablet: Or
ange
, r
ound
, bic
on
v
ex tablet, 
debossed with Є275 on one side and 
‘2’
 on the other side
4 mg tablet: R
ed
, r
ound
, bic
on
v
ex tablet, debossed with Є277 on one side 
and 
‘4’
 on the other side
6
 m
g
 t
a
b
le
t:
 P
in
k
, r
o
u
n
d
, b
ic
o
n
ve
x 
ta
b
le
t,
 d
e
b
o
ss
e
d
 w
it
h
 Є
2
9
4
 o
n
 one side 
and 
‘6’
 on the other side
8
 m
g
 t
ab
le
t:
 P
u
rp
le
, r
o
u
n
d
, b
ic
o
n
ve
x 
ta
b
le
t,
 d
e
b
o
ss
e
d
 w
it
h
 Є
2
9
5
 o
n
 one side 
and 
‘8’
 on the other side
1
0
 m
g
 t
ab
le
t:
 G
re
e
n
, r
o
u
n
d
, b
ic
o
n
ve
x 
ta
b
le
t,
 d
e
b
o
ss
e
d
 w
it
h
 Є
2
9
6
 o
n
 one side 
and 
‘10’
 on the other side
1
2
 m
g
 t
a
b
le
t:
 B
lu
e
, r
o
u
n
d
, b
ic
o
n
ve
x 
ta
b
le
t,
 d
e
b
o
ss
e
d
 w
it
h
 Є
2
9
7
 o
n
 one side 
and 
‘12’
 on the other side
4.
CLINIC
AL P
ARTICUL
ARS
4.1
T
HER
APEUTIC INDIC
A
TIONS
F
Y
C
O
M
PA
 is
 in
d
ic
at
e
d
 fo
r 
th
e
 a
d
ju
n
ct
iv
e
 t
re
at
m
e
n
t 
o
f 
p
ar
ti
al
-o
n
se
t 
se
iz
u
re
s 
w
it
h
 o
r 
w
it
h
o
u
t 
se
co
n
d
a
ri
ly
 g
e
n
e
ra
liz
e
d
 s
e
iz
u
re
s 
in
 p
a
ti
e
n
ts
 w
it
h
 e
p
ile
p
sy 
a
g
e
d
 1
2
 y
e
a
rs
 a
n
d
 o
ld
e
r.
4.2
P
OSOLOGY AND METHOD OF ADMINISTR
A
TION
D
osing C
onsider
ations
C
onc
omitant CY
P3A Enz
yme
-Inducing AED
s Signific
antly Reduc
e Both 
P
lasma L
ev
els and E
ffic
ac
y
C
ar
b
am
az
e
p
in
e
, o
xc
ar
b
az
e
p
in
e
 a
n
d
 p
h
e
n
y

Карактеристике производа

Anti-epileptic drug
Fycompa
®
Film-coated Tablets 2mg, 4mg, 8mg

1. NAME OF THE MEDICINAL PRODUCT
FYCOMPA 2 mg, 4 mg, 8 mg film-coated tablets
2. QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2, 4, 8 mg perampanel.
The complete quantitative composition can be found in Section 6.
3. PHARMACEUTICAL FORM
Film-coated tablet (tablet): 2 mg tablet: Orange, round, biconvex
tablet, debossed with Є275 on one side and
‘2’ on the other side
4 mg tablet: Red, round, biconvex tablet, debossed with Є277 on one
side and ‘4’ on the other side
8 mg tablet: Purple, round, biconvex tablet, debossed with Є295 on
one side and ‘8’ on the other side
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FYCOMPA is indicated for:
-
treatment of partial-onset seizures (POS) with or without secondarily
generalised seizures in patients
from 4 years of age and older.
-
adjunctive treatment of primary generalised tonic-clonic (PGTC)
seizures in patients from 7 years of
age and older with idiopathic generalized epilepsy (see section 5.1).
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 _
[Monotherapy]
The following table summarises the recommended posology for adults,
adolescents, and children from 4 years
of age. More details are provided below the table.
TABLE 1: RECOMMENDED POSOLOGY FOR ADULTS, ADOLESCENTS AND CHILDREN
FROM 4 YEARS OF AGE
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 intervals of
2 mg/day (no
more frequentl