FYCOMPA 4 MG FILM COATED TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PERAMPANEL AS ANHYDROUS

Available from:

EISAI ISRAEL LTD., ISRAEL

ATC code:

N03AX22

Pharmaceutical form:

FILM COATED TABLETS

Composition:

PERAMPANEL AS ANHYDROUS 4 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

EISAI MANUFACTURING LIMITED, UK

Therapeutic group:

PERAMPANEL

Therapeutic area:

PERAMPANEL

Therapeutic indications:

Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 4 years and older.Fycompa is indicated for the adjunctive treatment of primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older with idiopathic generalised epilepsy..

Authorization date:

2018-07-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS - 1986
This medicine is dispensed with a physician’s prescription only
FYCOMPA FILM-COATED TABLETS
2 MG, 4 MG, 6 MG,
8 MG, 10 MG, 12 MG
FILM-COATED TABLETS
COMPOSITION:
ACTIVE INGREDIENT:
Perampanel (as anhydrous)
2 mg, 4 mg, 6 mg, 8 mg, 10 mg, 12 mg
Each 2 mg tablet contains 78.5 mg lactose
Each 4 mg tablet contains 157.0 mg lactose
Each 6 mg tablet contains 151.0 mg lactose
Each 8 mg tablet contains 149.0 mg lactose
Each 10 mg tablet contains 147.0 mg lactose
Each 12 mg tablet contains 145.0 mg lactose
For the full
list of ingredients and a list of allergens, see: Section 6,
”Additional information“.
READ THIS LEAFLET
CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE.
This leaflet
contains concise information about
the
medicine.
If
you have further questions,
consult
your physician or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them even if it seems to you that their
illness is similar.
1. WHAT IS THIS MEDICINE INTENDED FOR?
FYCOMPA FILM-COATED TABLETS is used in association with other
antiepileptic drugs.
FYCOMPA FILM-COATED TABLETS is
indicated for
the adjunctive
treatment
of
partial-onset
seizures with or
without
secondarily
generalized seizures in patients with epilepsy aged 4 years and
older.
FYCOMPA FILM-COATED TABLETS is
indicated for
the adjunctive
treatment
of
primary generalized tonic-clonic seizures in patients
with epilepsy aged 12 years and older with idiopathic generalized
epilepsy.
THERAPEUTIC GROUP:
Selective non-competitive AMPA receptor
antagonist.
FYCOMPA FILM-COATED TABLETS belong to a group of
anti-epileptic
medicines.
These medicines are used to treat epilepsy - a disease characterized
by fits (seizures) that occur repeatedly.
FYCOMPA FILM-COATED TABLETS have been given to you as treatment
to reduce the frequency of your fits.
2. BEFORE USING THE MEDICINE:
DO NOT USE THIS MEDICINE IF:
•
You have ever had a severe skin rash or skin peeling, bli

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Fycompa Oral suspension
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 Oral suspension
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.
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).
2
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.
3.
PHARMACEUTICAL FORM
Oral suspension
White to off-white suspension
FILM-COATED