Fycompa 8mg Film-coated Tablets

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Perampanel

Boleh didapati daripada:

EISAI (MALAYSIA) SDN BHD (18039-D)

INN (Nama Antarabangsa):

Perampanel

Unit dalam pakej:

28 Tablets; 98 Tablets; 98 Tablets; 28 Tablets

Dikeluarkan oleh:

Eisai Manufacturing Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
FYCOMPA FILM-COATED TABLETS
®
Perampanel (2mg, 4mg, 6mg, 8mg, 10mg, 12mg)
1
WHAT IS IN THIS LEAFLET
1.
What
_Fycompa_
is used for
2.
How
_Fycompa_
works
3.
Before you use
_Fycompa_
4.
How to use
_Fycompa_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Fycompa_
8.
Product Description
9.
Manufacturer and
Product Registration
Holder
10.
Date of revision
WHAT _FYCOMPA_ 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 to treat a certain form
_ _
of epilepsy in people aged 12 years and
older.
-
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”).
-
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.
HOW _FYCOMPA_ WORKS
The
active
substance
in
_Fycompa_
,
perampanel,
is
an
anti-epileptic
medicine.
Epilepsy
is
caused
by
excessive electrical activity in the brain.
Although
the
precise
mechanism
by
which
_Fycompa_
works
is
not
fully
understood,
it is thought to block the
action of the neurotransmitter glutamate.
Neurotransmitters
are
naturally-
occurring
chemicals
in
the
nervous
system
that
allow
nerve
cells
to
communicate with each other. Glutamate
is the main stimulatory neurotransmitter
in nerve cells.
Therefore
by
blocking
glutamate’s
actions,
_Fycompa_
is
thought
to
stop
epileptic seizures from occurring.
BEFORE YOU USE _FYCOMPA _
-
_When you must not use it_
Do not take
_Fycompa_
if you are allergic
to
perampanel
or
any
of
the
other
ingredients of this medicine as listed in
Ingredients.
_Pregnancy

Ciri produk

FYCOMPA
Tablets 2mg, 4mg, 6mg, 8mg, 10mg,
12mg

1.
NAME OF THE MEDICINAL PRODUCT
Fycompa 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, 12 mg film-coated tablets
2.
QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2, 4, 6, 8, 10, or 12 mg perampanel.
The complete quantitative
composition can be found in Section 6.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet):
2mg tablet: Orange,round, biconvex tablet, debossed with €275 on one
side and ‘2’ on the other
side
4mg tablet: Red, round, biconvex tablet, debossed with €277 on one
side and ‘4’ on the other side
6mg tablet: Pink, round, biconvex tablet, debossed with €294 on one
side and ‘6’ on the other side
8mg tablet: Purple, round, biconvex tablet, debossed with €295 on
one side and ‘8’ on the other
side
10mg tablet: Green, round, biconvex tablet, debossed with €296 on
one side and ‘10’ on the other
side
12mg tablet: Blue, round, biconvex tablet, debossed with €297 on one
side and ‘12’ on the other side
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fycompa is indicated for the adjunctive treatment of partial-onset
seizures with or without secondarily
generalised seizures in patients with epilepsy aged 12 years and
older.
Fycompa is indicated for the adjunctive treatment of primary
generalised tonic-clonic seizures in adult
and adolescent patients from 12 years of age with idiopathic
generalised epilepsy (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents_
Fycompa must be titrated, according to individual patient response, in
order to optimise the balance
between efficacy and tolerability.
Fycompa should be taken orally once daily at bedtime.
_Partial-Onset Seizures _
Fycompa at doses of 4 mg/day to 12 mg/day has been shown to be
effective therapy in partial-
onset seizures.
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-