Patient leaflet - Perampanel Eisai 12 mg film coated tablets
1. What Perampanel Eisai is and what it is used for
Perampanel Eisai 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. Perampanel Eisai 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 Perampanel Eisai
DO NOT TAKE Perampanel Eisai:
If you have ever developed a severe skin rash or skin peeling, blistering
and/or mouth sores after taking perampanel.
If you are allergic to perampanel or any of the other ingredients of this
medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Perampanel Eisai if you have liver problems or moderate or severe kidney problems. You should not take Perampanel Eisai if you have serious liver problems or moderate or serious kidney problems. Before taking this medicine you should tell your doctor if you have a history of alcoholism or drug dependence. Cases of increased liver enzymes have been reported in some patients taking Perampanel Eisai in combination with other antiepileptic drugs.
Perampanel Eisai may make you feel dizzy or sleepy, particularly at the
beginning of treatment.
Perampanel Eisai may make you more likely to fall over, particularly if
you are an older person; this might be due to your illness.
Perampanel Eisai may make you aggressive, angry or violent. It may also
cause you to have unusual or extreme changes in behaviour or mood, abnormal thinking and/or loss of touch with reality.
If you or your family and/or friends notice any of these reactions, talk to your doctor or pharmacist.
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 straight away.
Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) and Stevens - Johnson Syndrome (SJS) have been reported with the use of perampanel.
DRESS typically, although not exclusively, appears as flu-like symptoms
and a rash with a high body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
Stevens - Johnson Syndrome (SJS) can appear initially as reddish target-
like spots or circular patches often with central blisters on the trunk. Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin and life-threatening complications or be fatal. If you experience any of the above after taking Perampanel Eisai (or you are not sure) talk to your doctor or pharmacist.
Children
Perampanel Eisai is not recommended for children aged under 4. The safety and effectiveness are not yet known in children under 4 years of age for partial seizures and under 7 years of age in generalised seizures. Other medicines and Perampanel Eisai
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. Taking Perampanel Eisai with certain other medicines may cause side effects or affect how they work. Do not start or stop other medicines without talking to your doctor or pharmacist.
Other anti-epileptic medicines, such as carbamazepine, oxcarbazepine,
and phenytoin that are used to treat fits may affect Perampanel Eisai. Tell your doctor if you are taking or have recently taken these medicines as your dose may need to be adjusted.
Felbamate (a medicine used to treat epilepsy) may also affect
Perampanel Eisai. Tell your doctor if you are taking or have recently taken this medicine as your dose may need to be adjusted.
Midazolam (a medicine used to stop prolonged, acute (sudden)
convulsive seizures, for sedation and sleep problem) may be affected by Perampanel Eisai. Tell your doctor if you are taking midazolam as your
dose may need to be adjusted.
Some other medicines such as rifampicin (a medicine used
to treat bacterial infections), hypericum (St. John’s Wort) (a medicine used to treat mild anxiety) and ketoconazole (a medicine used to treat fungal infections) may affect Perampanel Eisai. Tell your doctor if you are taking or have recently taken these medicines as your dose may need to be adjusted.
Hormonal contraceptives (including oral contraceptives, implants,
injections, and patches)
Tell your doctor if you are taking hormonal contraceptives. Perampanel Eisai 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 Perampanel Eisai. You should continue doing this for one month after stopping treatment. Discuss with your doctor what may be appropriate contraception for you. Perampanel Eisai with alcohol
Speak to your doctor before drinking alcohol. Be careful about consuming alcohol with epilepsy medicines including Perampanel Eisai.
Drinking alcohol while taking Perampanel Eisai can make you less alert
and affect your ability to drive or use tools or machines.
Drinking alcohol while taking Perampanel Eisai can also make any
feelings of anger, confusion or sadness worse.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not stop treatment without first discussing it with your doctor.
- Perampanel Eisai is not recommended in pregnancy.
You must use a reliable method of contraception to avoid becoming
pregnant while you are being treated with Perampanel Eisai. You should continue doing this for one month after stopping treatment. Tell your doctor if you are taking hormonal contraceptives. Perampanel Eisai 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 Perampanel Eisai. 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 Perampanel Eisai can pass into breast milk.
The doctor will weigh up the benefit and risks to your baby of taking Perampanel Eisai while you are breast-feeding.
Driving and using machines
Do not drive or use machines until you know how Perampanel Eisai affects you.
You must talk to your doctor about the effect of your epilepsy on driving and using machines.
- Perampanel Eisai 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.
- Drinking alcohol while taking Perampanel Eisai may make these effects worse.
Perampanel Eisai contains lactose
Perampanel Eisai contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Perampanel Eisai
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. How much to take
Adults, adolescents (aged 12 years and older) in treating partial seizures and generalised seizures:
The usual starting dose is 2 mg once a day before you go to bed.
- Your doctor may increase this in 2 mg steps to a maintenance dose between 4 mg 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.
Don’t take more Perampanel Eisai than your doctor has recommended. It may take a few weeks to find the right dose of Perampanel Eisai for you.
The following table summarises the recommended doses in treating partial seizures in children 4 to 11 years of age and generalised seizures in children 7 to 11 years of age. More details are provided below the table.
Children weighing:
More than 30 kg 20 kg to less than 30 kg Less than 20 kg
Recommended starting dose 2 mg/day 1 mg/day 1 mg/day
Recommended maintenance dose 4 – 8 mg/day 4 – 6 mg/day 2 – 4 mg/day
Recommended maximum dose 12 mg/day 8 mg/day 6 mg/day
Children (from 4 to 11 years of age) weighing 30 kg or more in treating partial seizures:
The usual starting dose is 2 mg once a day before you go to bed.
- Your doctor may increase this in 2 mg steps to a maintenance dose between 4 mg and 8 mg - depending on your response. Depending upon individual clinical response and tolerability, the dose may be increased to a maximum dose of 12 mg/day.
- If you have mild or moderate liver problems, your dose should not be more than 4 mg each day and your dose increases should be at least 2 weeks apart.
Don’t take more Perampanel Eisai than your doctor has recommended.
It may take a few weeks to find the right dose of Perampanel Eisai for you.
ENGLISH
MYRIAD PRO (9pt)
LEAF003 v06 630 x 135 mm
FOR PLACEMENT ONLY TEXT FREE AREA
PAGE
200XXXX Children (from 4 to 11 years of age) weighing 20 kg and less than 30 kg in treating partial seizures:
The usual starting dose is 1 mg once a day before you go to bed.
Your doctor may increase this in 1 mg steps to a maintenance dose
between 4 mg and 6 mg - depending on your response. Depending upon individual clinical response and tolerability, the dose may be increased to a maximum dose of 8 mg/day.
If you have mild or moderate liver problems, your dose should not be
more than 4 mg each day and your dose increases should be at least 2 weeks apart.
Don’t take more Perampanel Eisai than your doctor has recommended.
It may take a few weeks to find the right dose of Perampanel Eisai for you.
Children (from 4 to 11 years of age) weighing less than 20 kg in treating partial seizures:
The usual starting dose is 1 mg once a day before you go to bed.
Your doctor may increase this in 1 mg steps to a maintenance dose
between 2 mg and 4 mg - depending on your response. Depending upon individual clinical response and tolerability, the dose may be increased to a maximum dose of 6 mg/day.
If you have mild or moderate liver problems, your dose should not be
more than 4 mg each day and your dose increases should be at least 2 weeks apart.
Don’t take more Perampanel Eisai than your doctor has recommended.
It may take a few weeks to find the right dose of Perampanel Eisai for you.
Children (from 7 to 11 years of age) weighing 30 kg or more in treating generalised seizures:
The usual starting dose is 2 mg once a day before you go to bed.
Your doctor may increase this in 2 mg steps to a maintenance dose
between 4 mg and 8 mg - depending on your response. Depending upon individual clinical response and tolerability, the dose may be increased to a maximum dose of
12 mg/day.
If you have mild or moderate liver problems, your dose should not be
more than 4 mg each day and your dose increases should be at least 2 weeks apart.
Don’t take more Perampanel Eisai than your doctor has recommended.
It may take a few weeks to find the right dose of Perampanel Eisai for you.
Children (from 7 to 11 years of age) weighing 20 kg and less than 30 kg in treating generalised seizures:
The usual starting dose is 1 mg once a day before you go to bed.
Your doctor may increase this in 1 mg steps to a maintenance dose
between 4 mg and 6 mg - depending on your response. Depending upon individual clinical response and tolerability, the dose may be increased to a maximum dose of 8 mg/day.
If you have mild or moderate liver problems, your dose should not be
more than 4 mg each day and your dose increases should be at least 2 weeks apart.
Don’t take more Perampanel Eisai than your doctor has recommended.
It may take a few weeks to find the right dose of Perampanel Eisai for you.
Children (from 7 to 11 years of age) weighing less than 20 kg in treating generalised seizures:
The usual starting dose is 1 mg once a day before you go to bed.
Your doctor may increase this in 1 mg steps to a maintenance dose
between 2 mg and 4 mg - depending on your response. Depending upon individual clinical response and tolerability, the dose may be increased to a maximum dose of 6 mg/day.
If you have mild or moderate liver problems, your dose should not be
more than 4 mg each day and your dose increases should be at least 2 weeks apart.
Don’t take more Perampanel Eisai than your doctor has recommended. It may take a few weeks to find the right dose of Perampanel Eisai for you. How to take
Swallow the tablet whole with a glass of water. You can take Perampanel Eisai with or without food. Do not chew, crush or split the tablet. The tablets cannot be split accurately as there is no break line.
If you take more Perampanel Eisai than you should
If you have taken more Perampanel Eisai than you should, contact your doctor straight away. You may experience confusion, agitation, aggressive behaviour, vomiting, and reduced level of consciousness. If you forget to take Perampanel Eisai
If you forget to take a tablet, wait until your next dose and then carry on
as usual.
- Do not take a double dose to make up for a forgotten dose.
If you have missed less than 7 days of treatment with Perampanel Eisai,
continue taking your daily tablet as originally instructed by your doctor.
If you have missed more than 7 days of treatment with Perampanel
Eisai, talk to your doctor immediately.
If you stop taking Perampanel Eisai
Take Perampanel Eisai for as long as your doctor recommends. 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets 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 straight away. Very common (may affect more than 1 user in 10) are:
- feeling dizzy
- feeling sleepy (drowsiness or somnolence)
Common (may affect more than 1 user in 100) 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.
Uncommon (may affect more than 1 user in 1000) are:
thoughts about harming yourself or ending your own life (suicidal
thoughts), tried to end your own life (attempted suicide)
- hallucinations (seeing, hearing or feeling things that are not there)
- Abnormal thinking and/or loss of touch with reality (psychotic disorder) Not known (the frequency of this side effect cannot be estimated from the available data) are:
Drug Reaction with Eosinophilia and Systemic Symptoms which is also
known as DRESS or drug hypersensitivity syndrome:widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement.
Stevens - Johnson syndrome, SJS. This serious skin rash can appear
as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. Stop using perampanel if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2. Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play and Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Perampanel Eisai
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of the month. This medicinal product does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Perampanel Eisai contains
The active substance is perampanel. Each film-coated tablet contains 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg perampanel.
The other ingredients are:
Tablet core (2 mg and 4 mg tablets):
Lactose monohydrate, low-substituted hydroxypropyl cellulose, povidone, magnesium stearate (E470b)
Tablet core (6 mg, 8 mg, 10 mg and 12 mg tablets)
Lactose monohydrate, low-substituted hydroxypropyl cellulose, povidone, microcrystalline cellulose, magnesium stearate (E470b)
Film coating (2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg tablets) Hypromellose 2910, talc, Macrogol 8000, titanium dioxide (E171), colourants*
*The colourants are:
2 mg tablet: Ferric Oxide, Yellow (E172), Ferric Oxide, Red (E172) 4 mg tablet: Ferric Oxide, Red (E172)
6 mg tablet: Ferric Oxide, Red (E172)
8 mg tablet: Ferric Oxide, Red (E172), Ferric Oxide, Black (E172) 10 mg tablet: Ferric Oxide, Yellow (E172), FD&C Blue #2 Indigo carmine aluminium lake (E132)
12 mg tablet: FD&C Blue #2 Indigo carmine aluminium lake (E132) What Perampanel Eisai looks like and contents of the pack
All strengths of Perampanel Eisai are round, biconvex film-coated tablets 2 mg: orange, marked with E275 on one side and 2 on other side 4 mg: red, marked with E277 on one side and 4 on other side
6 mg: pink, marked with E294 on one side and 6 on other side 8 mg: purple, marked with E295 on one side and 8 on other side 10 mg: green, marked with E296 on one side and 10 on other side 12 mg: blue, marked with E297 on one side and 12 on other side Perampanel Eisai is available in packs of:
2 mg tablet – pack of 7, 28 and 98
4 mg, 6 mg, 8 mg, 10 mg, 12 mg tablets – packs of 7, 28, 84 and 98 Not all pack sizes may be marketed
Marketing Authorisation Holder
Eisai Europe Limited
European Knowledge Centre
Mosquito Way
Hatfield
AL10 9SN
United Kingdom
Manufacturer
Eisai Manufacturing Limited,
European Knowledge Centre
Mosquito Way
Hatfield
AL10 9SN
United Kingdom
Company Contact Address: For further information on your medicine contact Medical Information at Eisai Europe Limited in Hatfield. Tel: + 44 (0) 208 600 1400
This leaflet was last revised in 06/2026
Detailed information on this medicine is available on the Medicines and Healthcare products Regulatory Agency web site: https://products.mhra.gov.uk/
ENGLISH
MYRIAD PRO (9pt)
LEAF003 v06 630 x 135 mm
FOR PLACEMENT ONLY TEXT FREE AREA
PAGE