FYCOMPA perampanel (as hemisesquihydrate) 12 mg film coated tablet blister
Main information
- Trade name:
- FYCOMPA perampanel (as hemisesquihydrate) 12 mg film coated tablet blister
- Active ingredient:
- perampanel
- Available from:
- Eisai Australia Pty Ltd
- INN (International Name):
- perampanel
- Medicine domain:
- Humans
- Medicine type:
- Allopathic drug
Documents
- for the general public:
- Patient Information leaflet
-
- for healthcare professionals:
- Summary of Product characteristics
-
- for the general public:
- Public Assessment Report
-
Localization
- Available in:
-
Australia
- Language:
- English
Status
- Source:
- Dept. of Health,Therapeutic Goods Administration - Australia
- Authorization status:
- Registered
- Authorization number:
- 207691
- Last update:
- 20-05-2019
Public Assessment Report
Public Summary
Summary for ARTG Entry:
207691
FYCOMPA perampanel (as hemisesquihydrate) 12 mg film coated tablet blister
ARTG entry for
Medicine Registered
Sponsor
Eisai Australia Pty Ltd
Postal Address
Level 2 / 437 St Kilda Road,MELBOURNE, VIC, 3004
Australia
ARTG Start Date
23/05/2014
Product category
Medicine
Status
Active
Approval area
Drug Safety Evaluation Branch
Conditions
Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods
Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered
or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Products
1. FYCOMPA perampanel (as hemisesquihydrate) 12 mg film coated tablet blister
Product Type
Single Medicine Product
Effective date
13/05/2016
Warnings
See Product Information and Consumer Medicine Information for this product
Standard Indications
Specific Indications
·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.
Additional Product information
Container information
Type
Material
Life Time
Temperature
Closure
Conditions
Blister Pack
PVC/Al
5 Years
Store below 30
degrees Celsius
Neither child resistant
closure nor restricted
flow insert
Store in Original
Container
Pack Size/Poison information
Pack Size
Poison Schedule
28 tablets per pack
(S4) Prescription Only Medicine
Components
1. FYCOMPA perampanel (as hemisesquihydrate) 12 mg film coated tablet blister
Dosage Form
Tablet, film coated
Route of Administration
Oral
Visual Identification
blue, round, biconvex film coated tablets, debossed with 'E297' on one side
and '12' on other side
Active Ingredients
perampanel
12 mg
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Public Summary
Page 1 of
Produced at 28.11.2017 at 12:10:44 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information
Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation
Fycompa
Perampanel (as hemisesquihydrate) film-coated tablet
(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
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
this medicine against the
benefits they expect it will have
for you.
If you have any concerns
about taking this medicine,
ask your 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 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
generalisation”).
It is also used to treat certain
fits that affect all of your
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 have.
Ask your doctor if you have
any questions about why this
medicine has been prescribed
for you.
Your doctor may have
prescribed it for another reason.
This medicine is available only
with a doctor’s prescription.
Fycompa has some potential for
abuse and misuse and should be
used with caution in patients
with a history of drug abuse.
There is not enough information
to know whether Fycompa
would be addictive if abused.
Fycompa should be used with
caution in patients aged 65 years
or older due to the high rates of
dizziness and falls in those
patients.
Fycompa should be used with
caution in patients with a history
of severe mental conditions or
aggression.
There is not enough information
to recommend the use of this
medicine for children under the
age of 12 years.
BEFORE YOU TAKE
FYCOMPA
When you must not take it
Do not take this medicine if
you have an allergy to:
Perampanel, the active
ingredient, or to any of the
other ingredients listed at the
end of this leaflet under
Product Description
Fycompa contains lactose.
you have been told by your
doctor that you have intolerance
to some sugars, tell your doctor
before taking it.
Some of the symptoms of an
allergic reaction may include:
shortness of breath
wheezing or difficulty
breathing
swelling of the face, lips,
tongue or other parts of the
body
rash, itching or hives on the
skin
Do not give this medicine to a
child under the age of 12
years.
Safety and effectiveness in
children younger than 12 years
have not been established.
Do not take this medicine after
the expiry date printed on the
Eisai Australia Pty Ltd
Version 3.1
pack or if the packaging is
torn or shows signs of
tampering.
If it has expired or is damaged,
return it to your pharmacist for
disposal.
If you are not sure whether
you should start taking this
medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have
allergies to any other
medicines, foods, preservatives
or dyes.
Tell your doctor if you have or
have had any of the following
medical conditions:
liver problems
moderate or severe kidney
problems
history of alcoholism, drug
dependence or other
psychiatric illness
Tell your doctor if you are
pregnant or plan to become
pregnant or are breastfeeding.
Fycompa is not recommended in
pregnancy.
You must use a reliable
method of contraception to
avoid becoming pregnant
while you are being treated
with Fycompa.
You should continue doing this
for one month after stopping
treatment.
Tell your doctor if you are
taking hormonal
contraceptives.
Fycompa may
make certain hormonal
contraceptives such as
levonorgestrel less effective.
You should use other forms of
safe and effective
contraception (such as a
condom or coil) when taking
Fycompa. You should also do
this for one month after
stopping treatment.
Discuss
with your doctor what may be
appropriate contraception for
you.
It is not known whether the
ingredients of Fycompa can pass
into breast milk.
The doctor will weigh up the
benefit and risks to your baby of
taking Fycompa while you are
breastfeeding.
If you have not told your
doctor about any of the above,
tell him/her before you start
taking Fycompa.
Taking other medicines
Tell your doctor or pharmacist
if you are taking any other
medicines, including any that
you get without a prescription
from your pharmacy,
supermarket or health food
shop.
Some medicines and Fycompa
may interfere with each other.
These include:
Carbamazepine, phenytoin,
oxcarbazepine
Rifampicin,
Hypericum (St. John’s wort),
Felbamate
Ketoconazole
Oral contraceptives
These medicines may be
affected by Fycompa or may
affect how well it works. You
may need different amounts of
your medicines, or you may
need to take different medicines.
Your doctor and pharmacist
have more information on
medicines to be careful with or
avoid while taking this
medicine.
HOW TO TAKE
FYCOMPA
Follow all directions given to
you by your doctor or
pharmacist carefully.
They may differ from the
information contained in this
leaflet.
If you do not understand the
instructions, ask your doctor
or pharmacist for help.
How much to take
The usual starting dose for this
medicine is 2 mg once a day
before you go to bed.
Your doctor may increase the
dose in 2 mg steps to a
maintenance dose between 4 and
12 mg depending on your
response.
If you have mild or moderate
liver problems, your dose should
not be more than 8 mg each day
and your dose increases should
be at least 2 weeks apart.
Your doctor may have
prescribed a different dose.
Ask your doctor or pharmacist
if you are unsure of the correct
dose for you.
They will tell you exactly how
much to take.
Follow the instructions they
give you.
If you take the wrong dose,
Fycompa may not work as well
and your problem may not
improve.
Eisai Australia Pty Ltd
Version 3.1
How to take it
Swallow the tablets whole with
a full glass of water.
You can take Fycompa with or
without food.
Do not chew, crush or split the
tablet. The tablets cannot be split
accurately as there is no break
line. To ensure you get the entire
dose, the tablets should be
swallowed whole without
chewing or crushing.
When to take Fycompa
Take your medicine at about
the same time each day before
going to bed.
Taking it at the same time each
day will have the best effect. It
will also help you remember
when to take it.
How long to take Fycompa
Continue taking your
medicine for as long as your
doctor tells you.
Do not stop unless your doctor
advises you to.
Your doctor may reduce your
dose slowly to avoid your fits
(seizures) coming back or
getting worse.
If you have any further
questions on the use of this
medicine, ask your doctor or
pharmacist.
If you forget to take it
Wait until your next dose, and
then continue to take it as you
would normally.
Do not take a double dose to
make up for the dose that you
missed.
This may increase the chance of
you getting an unwanted side
effect.
If you have missed less than 7
days of treatment with
Fycompa, continue taking
your daily tablet as originally
instructed by your doctor.
If you have missed more than
7 days of treatment with
Fycompa, talk to your doctor
immediately.
If you are not sure what to do,
ask your doctor or
pharmacist.
If you have trouble
remembering to take your
medicine, ask your pharmacist
for some hints.
If you take too much
(overdose)
Immediately telephone your
doctor or the Poisons
Information Centre (telephone
Australia 13 11 26 for advice,
or go to Accident and
Emergency at the nearest
hospital, if you think that you
or anyone else may have taken
too much Fycompa. Do this
even if there are no signs of
discomfort or poisoning.
You may need urgent medical
attention.
WHILE YOU ARE
TAKING FYCOMPA
Things you must do
If you are about to be started
on any new medicine, remind
your doctor and pharmacist
that you are taking Fycompa.
Tell any other doctors, dentists
and pharmacists who treat you
that you are taking Fycompa.
If you are going to have
surgery, tell the surgeon or
anaesthetist that you are
taking Fycompa.
It may affect other medicines
used during surgery.
If you become pregnant while
taking Fycompa, tell your
doctor immediately.
Do not
stop treatment without first
discussing it with your doctor.
If you are about to have any
blood tests, tell your doctor
that you are taking Fycompa.
It may interfere with the results
of some tests.
Keep all of your doctor’s
appointments so that your
progress can be checked.
Things you must not do
Do not take Fycompa to treat
any other complaints unless
your doctor tells you to.
Do not give your medicine to
anyone else, even if they have
the same condition as you.
Do not stop taking your
medicine or lower the dosage
without checking with your
doctor.
Things to be careful of
Serious or life-threatening
psychiatric and behavioural
adverse reactions including
aggression, hostility, irritability,
anger, suicidal ideation and
homicidal ideation and threats
have been reported in patients
taking Fycompa.
Patients and caregivers should
contact a healthcare provider
immediately if any of these
reactions or changes in mood,
behaviour, or personality that
are not typical for the patient
Eisai Australia Pty Ltd
Version 3.1
are seen while they are taking
Fycompa or after stopping
Fycompa.
If changes in behaviour or
personality are seen notify
your doctor immediately. They
may reduce your dose of
Fycompa or stop treatment
with Fycompa.
Patients starting Fycompa
should be carefully observed
especially when starting
treatment and if the dose is
increased.
Do not drive or operating
machinery until you know how
Fycompa affects you.
You must talk to your doctor
about the effect of your epilepsy
on driving and using machines.
Fycompa may make you feel
dizzy or sleepy, particularly at
the beginning of treatment. If
this happens to you, do not drive
or use any tools or machines.
Fycompa may make you more
likely to fall over, particularly if
you are an older person; this
might be due to your illness.
Avoid alcohol while taking
Fycompa as it may make these
effects worse.
SIDE EFFECTS
Tell your doctor or pharmacist
as soon as possible if you do
not feel well while you are
taking Fycompa
All medicines can have side
effects. Sometimes they are
serious, most of the time they
are not. You may need medical
attention if you get some of the
side effects.
Do not be alarmed by the
following lists of side effects.
You may not experience any of
them.
A small number of people
being treated with anti-
epileptics have had thoughts of
harming or killing themselves.
If at any time you have these
thoughts, contact your doctor
or go to accident & emergency
straight away.
If you get a skin rash, or fever,
and/or enlarged lymph nodes,
these could be signs of an
allergic reaction. See your
doctor immediately as very
occasionally this may become
serious.
Very common
(may affect more
than 1 user in 10) side effects
are:
feeling dizzy
feeling sleepy (drowsiness or
somnolence).
Common
(may affect more than
1 user in 100) side effects are:
increased or decreased
appetite, weight gain
feeling aggressive, angry,
irritable, anxious or confused
difficulty with walking or
other balance problems
(ataxia, gait disturbance,
balance disorder)
slow speech (dysarthria)
blurred vision or double
vision (diplopia)
spinning sensation (vertigo)
feeling sick (nausea)
back pain
feeling very tired (fatigue)
falling down.
Not known
(the frequency of
this side effect cannot be
estimated from the available
data) are:
thoughts about harming
yourself or ending your own
life (suicidal thoughts), tried
to end your own life
(attempted suicide)
skin rash
fever
enlarged lymph nodes
If you get any side effects, talk
to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet.
Ask your doctor or pharmacist
to answer any questions you
may have.
Tell your doctor or pharmacist
if you notice anything else that
is making you feel unwell.
Other side effects not listed
above may also occur in some
people.
AFTER TAKING
FYCOMPA
Storage
Keep your medicine in the
original container.
If you take it out of its original
container it may not keep well.
Keep your medicine in a cool
dry place where the temperature
stays below 30°C.
Do not store Fycompa or any
other medicine in the bathroom
or near a sink. Do not leave it on
a window sill or in the car.
Heat and dampness can destroy
some medicines.
Keep it where children cannot
reach it.
A locked cupboard at least one-
and-a-half metres above the
ground is a good place to store
medicines.
Eisai Australia Pty Ltd
Version 3.1
Disposal
If your doctor tells you to stop
taking this medicine or the
expiry date has passed, ask your
pharmacist what to do with any
medicine that is left over.
PRODUCT
DESCRIPTION
What it looks like
Fycompa 2 mg film coated
tablet is an orange, round,
biconvex film-coated tablet,
engraved with E275 on one side
and 2 on other side. Available in
packs of 7.
Fycompa 4 mg film coated
tablet is a red, round, biconvex
film-coated tablet, engraved
with E277 on one side and 4 on
other side. Available in packs of
Fycompa 6 mg film coated
tablet is a pink, round, biconvex
film-coated tablet, engraved
with E294 on one side and 6 on
other side. Available in packs of
Fycompa 8 mg film coated
tablet is a purple, round,
biconvex film-coated tablet,
engraved with E295 on one side
and 8 on other side. Available in
packs of 28.
Fycompa 10 mg film coated
tablet is a green, round,
biconvex film-coated tablet,
engraved with E296 on one side
and 10 on other side. Available
in packs of 28.
Fycompa 12 mg film coated
tablet is a blue, round, biconvex
film-coated tablet, engraved
with E297 on one side and 12 on
other side. Available in packs of
Ingredients
Active ingredient:
Perampanel (as
hemisesquihydrate)
Excipient Ingredients:
lactose,
hypromellose,
povidone,
purified talc,
magnesium stearate,
microcrystalline cellulose (6
mg, 8 mg, 10 mg and 12 mg
only)
macrogol 8000,
titanium dioxide,
iron oxide yellow (2 mg, 10
mg),
iron oxide red (2mg, 4 mg, 6
mg, and 8 mg only),
iron oxide black (8 mg only)
Indigo carmine aluminium
lake (10 mg & 12 mg only).
This medicine does not contain
gluten, tartrazine or any other
azo dyes.
SPONSOR
Eisai Australia Pty. Ltd.
Level 2
437 St Kilda Road
Melbourne
Victoria 3004
This leaflet was prepared 06
December 2017.
Australian Register Number(s)
Fycompa 2 mg film coated
tablet:
AUST R 207690
Fycompa 4 mg film coated
tablet:
AUST R 207689
Fycompa 6 mg film coated
tablet:
AUST R 207688
Fycompa 8 mg film coated
tablet:
AUST R 207687
Fycompa 10 mg film coated
tablet:
AUST R 207692
Fycompa 12 mg film coated
tablet:
AUST R 207691
Eisai Australia Pty Ltd
Version 3.1
- Access to this document is only available to registered users.
Register now for full access