FYCOMPA

Country: Indonesia

Language: Indonesian

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Active ingredient:

PERAMPANEL

Available from:

EISAI INDONESIA - Indonesia

INN (International Name):

PERAMPANEL

Dosage:

8 MG

Pharmaceutical form:

TABLET SALUT SELAPUT

Units in package:

DUS, 2 BLISTER @ 14 TABLET

Manufactured by:

EISAI INDONESIA - Indonesia

Authorization date:

2019-09-06

Summary of Product characteristics

PT Eisai Indonesia | Product Information FYCOMPA
1
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, or 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
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.
Treatment with Fycompa should be initiated with a dose of 2 mg/day.
The dose may
be increased based on individual clinical response and tolerability to
a maintenance
dose of 4 mg/day to 8 mg/day and if necessary up to 12 mg/day.
Adult / Adolescent (12 years of age and older) and
Children (4-11 years), weighing 30 kg or more
Recommended starting
2 mg/day
dose
Titration (incremental
2 mg/day
steps)
(no more frequently than weekly intervals)
Fycompa is indicated for the adjunctive treatment of partial-onset
seizures (POS) with
Fycompa is indicated for the adjunctive treatment of primary
generalised tonic-
clonic
seizures (PGTC) i
n patients from 7 years of age and older weighing 30 kg or more
with idiopathic generalised epilepsy (IGE).
_Partial-Onset Seizures: 4 years of age and older, weighing 30 kg or
more_
DISETUJUI OLEH BPOM: 22/12/2023
ID: EREG17180812200009
EREG17180812200010
EREG17180812200011
PT Eisai Indonesia | Product Information FYCOMPA
2
Recommended
4 – 8 mg/day
maintenance dose
Titration (incremental
2 mg/day
steps)
(no more frequently than weekly intervals)
Recommended maxi