Fycompa 2 mg film-coated tablets

Negara: Uni Eropa

Bahasa: Inggris

Sumber: myHealthbox

Bahan aktif:

Perampanel

Tersedia dari:

Eisai Europe Limited

Kode ATC:

N03AX22

INN (Nama Internasional):

Perampanel

Dosis:

2 mg

Bentuk farmasi:

Film-coated tablet

Rute administrasi :

Oral use

Unit dalam paket:

7, 28, 98

Jenis Resep:

Subject to medical prescription

Diproduksi oleh:

Eisai Manufacturing Limited

Kelompok Terapi:

Antiepileptics, other antiepileptics

Area terapi:

Epilepsies, Partial

Indikasi Terapi:

Indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older

Status otorisasi:

Authorized

Tanggal Otorisasi:

2012-07-23

Selebaran informasi

105

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT  
_ _
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 
Perampanel 

This medicine is subject to additional monitoring. This will allow
quick identification of new 
safety information. You can help by reporting any side effects you
may get. See the end of section 4 
for how to report side effects. 

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 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 ge

Karakteristik produk

2
This medicinal product is subject to additional monitoring. This will
allow quick identification of 
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 

_ _
1. 
NAME OF THE MEDICINAL PRODUCT 

Fycompa 2 mg film-coated tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each film-coated tablet contains 2 mg perampanel.  

Excipient with known effect: Each 2 mg tablet contains 78.5 mg of
lactose monohydrate.  
For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Film-coated tablet (tablet) 
Orange, round, biconvex tablet, engraved with E275 on one side and
‘2’ on 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. 

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. 
Perampanel should be taken orally once daily before bedtime. 
Perampanel 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/day 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