FYCOMPA

Main information

  • Trade name:
  • FYCOMPA perampanel (as hemisesquihydrate) 6 mg film coated tablet blister
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FYCOMPA perampanel (as hemisesquihydrate) 6 mg film coated tablet blister
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207688
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207688

FYCOMPA perampanel (as hemisesquihydrate) 6 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) 6 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 perampanel (as hemisesquihydrate) 6 mg film coated tablet blister

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

pink, round, biconvex film coated tablets, debossed with 'E294' on one side

and '6' on other side

Active Ingredients

perampanel

6 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 12:11:59 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

Eisai Australia Pty Ltd

Version 3

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. If

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

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

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 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

are seen while they are taking

Eisai Australia Pty Ltd

Version 3

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.

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.

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.

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.

Eisai Australia Pty Ltd

Version 3

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 10

May 2016.

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

25-9-2018

Fycompa (Eisai GmbH)

Fycompa (Eisai GmbH)

Fycompa (Active substance: Perampanel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6280 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002434/T/0040

Europe -DG Health and Food Safety