FYCOMPA ORAL SUSPENSION

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

PERAMPANEL AS ANHYDROUS

Tilgjengelig fra:

EISAI ISRAEL LTD., ISRAEL

ATC-kode:

N03AX22

Legemiddelform:

SUSPENSION

Sammensetning:

PERAMPANEL AS ANHYDROUS 0.5 MG / 1 ML

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

EISAI MANUFACTURING LIMITED, UK

Terapeutisk område:

PERAMPANEL

Indikasjoner:

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.

Autorisasjon dato:

2023-05-16

Informasjon til brukeren

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS - 1986
This medicine is to be supplied upon
physician’s prescription only
FYCOMPA ORAL SUSPENSION, 0.5 MG/ML
COMPOSITION:
ACTIVE INGREDIENT: Perampanel (as anhydrous)
0.5 mg/ml
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 in combination with other antiepileptic drugs
is intended to treat the following:
-
Epilepsy characterized by partial-onset seizures with
or without secondarily generalized seizures in adults
and in children over 4 years old.
-
Generalized idiopathic epilepsy characterized
by seizures that affect the entire brain (primary
generalized tonic-clonic seizures) in adults and
children over 12 years old.
THERAPEUTIC GROUP: Selective non-competitive AMPA
receptor antagonist.
FYCOMPA belongs to a group of anti-epileptic
medicines.
These medicines are used to treat epilepsy - a disease
characterized by seizures that occur repeatedly.
FYCOMPA has been given to you as treatment to reduce
the frequency of the seizures that you suffer from.
2. BEFORE USING THE MEDICINE:
DO NOT USE THIS PREPARATION IF:
•
You have ever had a severe skin rash or skin
peeling, blistering and/or mouth sores after taking
Perampanel.
•
You are sensitive (allergic) to the active ingredient
Perampanel or to any of the additional ingredients
that the medicine contains (please see Section 6 -
"Additional information").
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE:
BEFORE TREATMENT WITH FYCOMPA, TELL YOUR PHYSICIAN IF:
•
You suffer from liver problems.
•
You suffer from moderate or severe kidney
p

Preparatomtale

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