Fycompa
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
10-05-2023
Charakterystyka produktu
(SPC)
10-05-2023
Sprawozdanie z oceny publicznego
(PAR)
13-01-2021
Składnik aktywny:
perampanel
Dostępny od:
Eisai GmbH
Kod ATC:
N03AX22
INN (International Nazwa):
perampanel
Grupa terapeutyczna:
Antiepileptics, , Other antiepileptics
Dziedzina terapeutyczna:
Epilepsies, Partial
Wskazania:
Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy.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.
Podsumowanie produktu:
Revision: 32
Status autoryzacji:
Authorised
Data autoryzacji:
2012-07-23
Ulotka dla pacjenta
69
B. PACKAGE LEAFLET
70
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FYCOMPA 2 MG, 4 MG, 6 MG, 8 MG, 10 MG, AND 12 MG FILM-COATED TABLETS
Perampanel
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 in association with other antiepileptic drugs to treat
certain forms of epilepsy:
In adults, adolescents (aged 12 years and older), and children (from 4
to 11 years)
-
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”).
In adults and adolescents (aged 12 years and older), and children
(from 7 to 11 years)
-
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FYCOMPA
DO NOT TAKE FYCOMPA:
-
If you have ever developed a severe skin rash or skin peeling
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
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 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).
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
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Fycompa 2 mg film-coated tablets
Orange, round, biconvex tablet, engraved with E275 on one side and
‘2’ on other side
Fycompa 4 mg film-coated tablets
Red, round, biconvex tablet, engraved with E277 on one side and
‘4’ on other side
Fycompa 6 mg film-coated tablets
Pink, round, biconvex tablet, engrav
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