Patient leaflet - Perampanel Zydus 2 mg film-coated tablets
1. What Perampanel is and what it is used for
Perampanel 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 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 generalization”).
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
DO NOT TAKE Perampanel:
- 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 if you have liver problems or moderate or severe kidney problems. You should not take Perampanel 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 in combination with other antiepileptic drugs.
- Perampanel may make you feel dizzy or sleepy, particularly at the beginning of treatment.
- Perampanel may make you more likely to fall over, particularly if you are an older person; this might be due to your illness.
- Perampanel 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 (or you are not sure) talk to your doctor or pharmacist.
Children
Perampanel 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
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 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. 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. 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. 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. 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 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. You should continue doing this for one month after stopping treatment. Discuss with your doctor what may be appropriate contraception for you. Perampanel with alcohol
Speak to your doctor before drinking alcohol. Be careful about consuming alcohol with epilepsy medicines including Perampanel.
- Drinking alcohol while taking Perampanel can make you less alert and affect your ability to drive or use tools or machines.
- Drinking alcohol while taking Perampanel 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 is not recommended in pregnancy.
- You must use a reliable method of contraception to avoid becoming pregnant while you are being treated with Perampanel. You should continue doing this for one month after stopping treatment. Tell your doctor if you are taking hormonal contraceptives. Perampanel 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. 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 can pass into breast milk. The doctor will weigh up the benefit and risks to your baby of taking Perampanel while you are breast-feeding.
Driving and using machines
Do not drive or use machines until you know how Perampanel affects you. You must talk to your doctor about the effect of your epilepsy on driving and using machines.
- Perampanel 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 may make these effects worse. Perampanel contains lactose
Perampanel 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
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 than your doctor has recommended. It may take a few weeks to find the right dose of Perampanel 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 (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 than your doctor has recommended. It may take a few weeks to find the right dose of Perampanel for you.
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.
| 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 |
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- 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 than your doctor has recommended. It may take a few weeks to find the right dose of Perampanel 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 than your doctor has recommended. It may take a few weeks to find the right dose of Perampanel 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 than your doctor has recommended. It may take a few weeks to find the right dose of Perampanel 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 than your doctor has recommended. It may take a few weeks to find the right dose of Perampanel 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 than your doctor has recommended. It may take a few weeks to find the right dose of Perampanel for you.
How to take
Swallow the tablet whole with a glass of water. You can take Perampanel 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 than you should
If you have taken more Perampanel than you should contact your doctor straight away. You may experience confusion, agitation, aggressive behaviour and depressed level of consciousness.
If you forget to take Perampanel
- 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, continue taking your daily tablet as originally instructed by your doctor.
- If you have missed more than 7 days of treatment with Perampanel, talk to your doctor immediately.
If you stop taking Perampanel
Take Perampanel 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, pharmacist or nurse. 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 or Apple App store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Perampanel
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 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: Lactose Monohydrate, Hydroxypropyl Cellulose Low-Substituted, Povidone K-30, Microcrystalline cellulose, Magnesium Stearate
Film coating: Hypromellose (E464), Talc (E553b), Macrogol 8000 (E1521) or Macrogol 6000 (E1521) (for 8 mg), Titanium Dioxide (E171), colourants*
*The colourants are:
2 mg: Ferric Oxide Yellow (E172), Ferric Oxide Red (E172)
4 mg: Ferric Oxide Red (E172)
6 mg: Ferric Oxide Red (E172)
8 mg: Ferric Oxide Red (E172), Ferric Oxide Black (E172)
10 mg: Indigo Carmine (E132), Ferric Oxide Yellow (E172)
12 mg: Indigo Carmine (E132)
What Perampanel looks like and contents of the pack:
2 mg: Orange, round shaped, biconvex, film-coated tablets debossed with ‘L1’ on one side and plain on other side.
4 mg: Red, round shaped, biconvex, film-coated tablets debossed with ‘L2’ on one side and plain on other side.
6 mg: Pink, round shaped, biconvex, film-coated tablets debossed with ‘L3’ on one side and plain on other side.
8 mg: Purple, round shaped, biconvex, film-coated tablets debossed with ‘L4’ on one side and plain on other side.
10 mg: Green, round shaped, biconvex, film-coated tablets debossed with ‘L5’ on one side and plain on other side.
12 mg: Blue, round shaped, biconvex, film-coated tablets debossed with ‘L6’ on one side and plain on other side.
Perampanel film coated tablets are available in pack of 7, 28, 84 and 98 Film-Coated Tablets.
Not all the pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Zydus Pharmaceuticals UK Ltd
Sandretto Building
Cavalry Hill Industrial Park
Weedon
Northampton
England NN7 4PP
United Kingdom
This leaflet was last revised in Feb-2026.
To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the above address or telephone: 0800 9956034 / email: DrugSafety@ZydusUK.com