FYCOMPA perampanel (as hemisesquihydrate) 6 mg film coated tablet blister
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
22-02-2021
Summary of Product characteristics
(SPC)
14-06-2022
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
perampanel hemisesquihydrate, Quantity: 6.2 mg (Equivalent: perampanel, Qty 6 mg)
Available from:
Eisai Australia Pty Ltd
INN (International Name):
perampanel
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: titanium dioxide; macrogol 8000; hypromellose; purified talc; lactose monohydrate; microcrystalline cellulose; iron oxide red; magnesium stearate; povidone
Administration route:
Oral
Units in package:
28 tablets per pack
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
FYCOMPA is indicated for the adjunctive treatment of:,1) Partial-onset seizures (POS) with or without secondarily generalised seizures in patients from 4 years of age with epilepsy.,2) Primary generalised tonic-clonic seizures (PGTCS) in patients from 7 years of age with idiopathic generalised epilepsy.
Product summary:
Visual Identification: pink, round, biconvex film coated tablets, debossed with 'E294' on one side and '6' on other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2014-05-23
Patient Information leaflet
Eisai Australia Pty Ltd
Version 4
1
This medicine is subject to additional monitoring due to approval of
an extension of indications. This
will allow quick identification of new safety information. You can
help by reporting any side effects you
may get. You can report side effects to your doctor, or directly at
www.tga.gov.au/reporting-problems.
FYCOMPA
_ _
PERAMPANEL (AS HEMISESQUIHYDRATE) FILM-COATED TABLET AND ORAL
SUSPENSION_ _
_(per-amp-an-el) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Fycompa.
It does not contain all the
available information. It does
not take the place of talking to
the doctor or pharmacist.
All medicines have risks and
benefits. The doctor has
weighed the risks of you or your
child taking this medicine
against the benefits they expect
it will have for you or your
child.
IF YOU OR YOUR CHILD HAVE ANY
CONCERNS ABOUT TAKING THIS
MEDICINE, ASK THE DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT FYCOMPA IS
USED FOR
Fycompa is used to treat
certain
forms of epilepsy. In
adults,
adolescents and children aged
4 years and older
.
•
It is used to treat fits that
affect one part of the brain
(called a “partial seizure”).
These partial seizures may or
may not then be followed by
a fit affecting all of the brain
(called a “secondary
generalisation”).
In adults, adolescents and
children aged 7 years and older:
•
It is also used to treat certain
fits that affect all of the brain
from the start and cause
convulsions (called “primary
generalised tonic-clonc
seizures).
_ _
It contains the active ingredient
perampanel. Perampanel
belongs to a group of medicines
called anti epileptics.
It works by reducing the number
of fits that you or your children
have.
ASK THE DOCTOR IF YOU OR YOUR
CHILD HAVE ANY QUESTIONS ABOUT
WHY THIS MEDICINE HAS BEEN
PRESCRIBED FOR YOU OR YOUR
CHILD.
The doctor may have prescribed
it for another reason.
This medicine is available only
with a doctor’s presc
Read the complete document
Summary of Product characteristics
Fycompa PI Version 4.1
Page 1
This medicinal product is subject to additional monitoring in
Australia due to approval of
an extension of indications. This will allow quick identification of
new safety information.
Healthcare professionals are asked to report any suspected adverse
events at
www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – FYCOMPA
®
(PERAMPANEL)
FILM-COATED TABLETS AND ORAL SUSPENSION
1
NAME OF THE MEDICINE
Perampanel (as hemisesquihydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
F
ILM
-C
OATED
T
ABLETS
FYCOMPA 2 MG FILM-COATED TABLETS
Each 2 mg FYCOMPA film-coated tablet contains 2 mg of perampanel (as
hemisesquihydrate).
Excipient with known effect:
Each 2 mg tablet contains 78.5 mg of lactose (as monohydrate).
FYCOMPA 4 MG FILM-COATED TABLETS
Each 4 mg FYCOMPA film-coated tablet contains 4 mg of perampanel (as
hemisesquihydrate).
Excipient with known effect:
Each 4 mg tablet contains 157 mg of lactose (as monohydrate).
FYCOMPA 6 MG FILM-COATED TABLETS
Each 6 mg FYCOMPA film-coated tablet contains 6 mg of perampanel (as
hemisesquihydrate).
Excipient with known effect:
Each 6 mg tablet contains 151 mg of lactose (as monohydrate).
Fycompa PI Version 4.1
Page 2
FYCOMPA 8 MG FILM-COATED TABLETS
Each 8 mg FYCOMPA film-coated tablet contains 8 mg of perampanel (as
hemisesquihydrate).
Excipient with known effect:
Each 8 mg tablet contains 149 mg of lactose (as monohydrate).
FYCOMPA 10 MG FILM-COATED TABLETS
Each 10 mg FYCOMPA film-coated tablet contains 10 mg of perampanel (as
hemisesquihydrate).
Excipient with known effect:
Each 10 mg tablet contains 147 mg of lactose (as monohydrate).
FYCOMPA 12 MG FILM-COATED TABLETS
Each 12 mg FYCOMPA film-coated tablet contains 12 mg of perampanel (as
hemisesquihydrate).
Excipient with known effect:
Each 12 mg tablet contains 145 mg of lactose (as monohydrate).
ALL FILM-COATED TABLETS
Excipients with known effect: Sugars (as lactose)
For the full list of excipients, see Section 6.1 List of excipients.
2.2
O
RAL SUSPENSION
Each bottle of
Read the complete document
