Patient Information Leaflet

Fycompa 2mg, 4mg, 6mg, 8mg, 10mg and 12mg Film-Coated Tablets

perampanel

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

1.What Fycompa is and what it is used for

2.What you need to know before you start taking Fycompa

3.How to take Fycompa

4.Possible side effects

5. Storage of Fycompa

6.Contents of the pack and additional information

Fycompa contains a medicine called perampanel. It belongs to a group of medicines called antiepileptics. These medicines are used to treat epilepsy, when a person has repeated seizure attacks (convulsive crises). Your doctor has prescribed it for you to reduce the number of seizure attacks you have.

Fycompa is used in combination with other antiepileptics to treat specific forms of epilepsy:

In adults, adolescents (12 years of age and older) and children (4 to 11 years of age)

• It is used to treat seizure attacks that affect a part of the brain (“partial seizures”).
• These partial seizures may or may not be followed by a seizure that affects the entire brain (“secondary generalization”).

In adults, adolescents (12 years of age and older) and children (7 to 11 years of age)

• It is also used to treat seizure attacks that affect the entire brain from the start (“generalized seizures”) and cause convulsions.

DO NOT TAKE Fycompa:

-if you have ever had a severe skin rash or skin peeling, blisters, and/or mouth sores after taking perampanel.

-if you are allergic to perampanel or any of the other ingredients in this medication (listed in section6).

Warnings and Precautions

Consult your doctor or pharmacist before starting Fycompa if you have liver problems or moderate to severe kidney problems.

You should not take Fycompa if you have severe liver problems or moderate to severe kidney problems.

Before starting this medication, you must inform your doctor if you have a history of alcoholism or drug dependence.

There have been reports of increased liver enzymes in some patients taking Fycompa with other antiepileptic medications.

-Fycompa may make you feel dizzy or drowsy, especially at the beginning of treatment.

-Fycompa may make you more prone to falls, especially if you are an older person; this could be due to your underlying condition.

-Fycompa may make you become aggressive, furious, or violent. It may also cause unusual or extreme changes in your behavior or mood, abnormal thoughts, or loss of contact with reality.

If you, a family member, or a friend notice any of these reactions, consult your doctor or pharmacist.

A reduced number of people taking antiepileptic medications have had thoughts of self-harm or suicide. If, at any time, you have these thoughts, consult your doctor immediately.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), and Stevens-Johnson syndrome (SSJ), have been reported associated with perampanel treatment.

• DRESS typically manifests, although not exclusively, with flu-like symptoms and a rash with elevated body temperature, increased liver enzymes, and eosinophilia in blood tests, as well as lymph node swelling.
• Stevens-Johnson syndrome (SSJ) may initially appear as red spots with a bull's-eye shape or circular patches, often with blisters in the center, located on the trunk. It may also cause ulcers in the mouth, throat, nose, genitals, and eyes (conjunctivitis and eye redness). These severe skin reactions often come with fever or flu-like symptoms. The rash may progress to extensive skin peeling and life-threatening complications, or be fatal.

If you experience any of the above problems after taking Fycompa (or are unsure), consult your doctor or pharmacist.

Children

Fycompa is not recommended for children under 4years of age. The safety and efficacy in children under 4years of age for partial seizures, or under 7years of age for generalized seizures, have not been established.

Other Medications and Fycompa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes over-the-counter medications and herbal medications. Taking Fycompa with some other medications may cause adverse effects or affect how they work. Do not start or stop taking other medications without consulting your doctor or pharmacist.

-Other antiepileptic medications, such as carbamazepine, oxcarbazepine, and phenytoin, used to treat seizures, may affect Fycompa.Inform your doctorif you are takingorhave takenrecentlythese medications as your dose may need to be adjusted.

-Felbamate (a medication used to treat epilepsy) may also affect Fycompa.Inform your doctorif you are takingorhave takenrecentlythis medication as your dose may need to be adjusted.

• Midazolam (a medication used to stop acute and prolonged seizures, for sedation, and sleep problems) may be affected by Fycompa. Inform your doctor if you are taking midazolam as your dose may need to be adjusted.

-Other medications, such as rifampicin (a medication used to treat bacterial infections),St. John's Wort(a medication used to treat mild anxiety), and ketoconazole (a medication used to treat fungal infections) may affect Fycompa.Inform your doctorif you are takingorhave takenrecentlythese medications as your dose may need to be adjusted.

-Birth control pills (including oral contraceptives, implants, injections, and patches).

Inform your doctor if you are taking birth control pills. Fycompa may make certain birth control pills, such as levonorgestrel, less effective. You should use other safe and effective birth control methods (such as condoms or an intrauterine device) when taking Fycompa. You should continue to do so for a month after stopping treatment. Consult your doctor about which birth control method is suitable for you.

Fycompa and Alcohol

Talk to your doctor before taking alcohol. Be careful with alcohol consumption and epilepsy medications, including Fycompa.

-Drinking alcohol while taking Fycompa may reduce your alertness and affect your ability to drive or use tools and machines.

-Drinking alcohol while taking Fycompa may also worsen any feelings of anger, confusion, or sadness.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.Do not stop treatment without consulting your doctor first.

-Fycompa is not recommended during pregnancy.

-You should use a reliable birth control method to prevent pregnancy while receiving Fycompa treatment. You should continue to do so for a month after stopping treatment. Inform your doctor if you are taking birth control pills. Fycompa may make certain birth control pills, such as levonorgestrel, less effective. You should use other safe and effective birth control methods (such as condoms or an intrauterine device) when taking Fycompa. Also, you should do so for a month after stopping treatment. Consult your doctor about which birth control method is suitable for you.

The safety of Fycompa components in breast milk is unknown.

Your doctor will weigh the benefits of Fycompa treatment for the mother against the risks for the baby while breastfeeding.

Driving and Using Machines

Do not drive or use machines until you know how Fycompa affects you.

You should talk to your doctor about the effect of epilepsy on driving and using machines.

-Fycompa may make you feel dizzy or drowsy, especially at the beginning of treatment. If this happens, do not drive or use tools or machines.

-Drinking alcoholwhile taking Fycompamay make these effects worse.

Fycompa contains lactose

Fycompa contains lactose (a type of sugar). If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How much to take

Adults, adolescents (12 years of age and older) in the treatment of partial seizures and generalized seizures:

The initial recommended dose is 2 mg once a day before bedtime.

-Your doctor may increase this dose in increments of 2 mg up 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 exceed 8 mg per day, and dose increases should be made with an interval of at least 2 weeks.

-Do not take more Fycompa than recommended by your doctor. It may take several weeks to find the right dose of Fycompa for you.

In the following table, the recommended doses for the treatment of partial seizures in children between 4 and 11 years of age and generalized seizures in children between 7 and 11 years of age are shown. For more information, see below the table.

Children (4 to 11 years of age) who weigh 30 kg or more in the treatment of partial seizures:

The initial recommended dose is 2 mg once a day before bedtime.

• Your doctor may increase this dose in increments of 2 mg up to a maintenance dose between 4 mg and 8 mg, depending on your response. Depending on clinical response and patient tolerability, the dose may be increased to a maximum of 12 mg/day.
• If you have mild or moderate liver problems, your dose should not exceed 4 mg per day, and dose increases should be made with an interval of at least 2 weeks.
• Do not take more Fycompa than recommended by your doctor. It may take several weeks to find the right dose of Fycompa for you.

Children (4 to 11 years of age) who weigh 20 kg and less than 30 kg in the treatment of partial seizures:

The initial recommended dose is 1 mg once a day before bedtime.

• Your doctor may increase this dose in increments of 1 mg up to a maintenance dose between 4 mg and 6 mg, depending on your response. Depending on clinical response and patient tolerability, the dose may be increased to a maximum of 8 mg/day.
• If you have mild or moderate liver problems, your dose should not exceed 4 mg per day, and dose increases should be made with an interval of at least 2 weeks.
• Do not take more Fycompa than recommended by your doctor. It may take several weeks to find the right dose of Fycompa for you.

Children (4 to 11 years of age) who weigh less than 20 kg in the treatment of partial seizures:

The initial recommended dose is 1 mg once a day before bedtime.

• Your doctor may increase this dose in increments of 1 mg up to a maintenance dose between 2 mg and 4 mg, depending on your response. Depending on clinical response and patient tolerability, the dose may be increased to a maximum of 6 mg/day.
• If you have mild or moderate liver problems, your dose should not exceed 4 mg per day, and dose increases should be made with an interval of at least 2 weeks.
• Do not take more Fycompa than recommended by your doctor. It may take several weeks to find the right dose of Fycompa for you.

Children (7 to 11 years of age) who weigh 30 kg or more in the treatment of generalized seizures:

The initial recommended dose is 2 mg once a day before bedtime.

• Your doctor may increase this dose in increments of 2 mg up to a maintenance dose between 4 mg and 8 mg, depending on your response. Depending on clinical response and patient tolerability, the dose may be increased to a maximum of 12 mg/day.
• If you have mild or moderate liver problems, your dose should not exceed 4 mg per day, and dose increases should be made with an interval of at least 2 weeks.
• Do not take more Fycompa than recommended by your doctor. It may take several weeks to find the right dose of Fycompa for you.

Children (7 to 11 years of age) who weigh 20 kg and less than 30 kg in the treatment of generalized seizures:

The initial recommended dose is 1 mg once a day before bedtime.

• Your doctor may increase this dose in increments of 1 mg up to a maintenance dose between 4 mg and 6 mg, depending on your response. Depending on clinical response and patient tolerability, the dose may be increased to a maximum of 8 mg/day.
• If you have mild or moderate liver problems, your dose should not exceed 4 mg per day, and dose increases should be made with an interval of at least 2 weeks.
• Do not take more Fycompa than recommended by your doctor. It may take several weeks to find the right dose of Fycompa for you.

Children (7 to 11 years of age) who weigh less than 20 kg in the treatment of generalized seizures:

The initial recommended dose is 1 mg once a day before bedtime.

• Your doctor may increase this dose in increments of 1 mg up to a maintenance dose between 2 mg and 4 mg, depending on your response. Depending on clinical response and patient tolerability, the dose may be increased to a maximum of 6 mg/day.
• If you have mild or moderate liver problems, your dose should not exceed 4 mg per day, and dose increases should be made with an interval of at least 2 weeks.
• Do not take more Fycompa than recommended by your doctor. It may take several weeks to find the right dose of Fycompa for you.

How to take

Swallow the tablet whole with a glass of water. Fycompa can be taken with or without food. Do not chew, crush, or break the tablet. The tablets cannot be split exactly since they do not have a score.

If you take more Fycompa than you should

If you have taken more Fycompa than you should, consult your doctor immediately. You may experience drowsiness, agitation, aggressive behavior, and decreased level of consciousness.

If you forget to take Fycompa

-If you forget to take a tablet, wait until it is time to take the next dose and continue as usual.

-Do not take a double dose to compensate for the missed doses.

-If you have missed less than 7 days of treatment with Fycompa, continue taking the tablet daily as originally indicated by your doctor.

-If you have missed more than 7 days of treatment with Fycompa, consult your doctor immediately.

If you interrupt treatment with Fycompa

Take Fycompa for the recommended time by your doctor. Do not interrupt treatment unless your doctor advises you to. Your doctor may gradually reduce your dose to avoid seizures (convulsions) returning or worsening.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

A reduced number of people taking antiepileptic medications have had thoughts of self-harm or suicide. If, at any time, you have these thoughts, consult your doctor immediately.

Very common(may affect more than 1 in 10 users):

-Dizziness

-Drowsiness (drowsiness or somnolence)

Common(may affect up to 1 in 10 users):

-Increased or decreased appetite, weight gain

-Feeling of aggression, anger, irritability, anxiety, or confusion

-Difficulty walking or other balance problems (ataxia, gait disorder, balance disorder)

-Slow speech (dysarthria)

-Blurred vision or double vision (diplopia)

-Sensation of spinning (vertigo)

-Nausea (gagging)

-Back pain

-Sensation of extreme fatigue (fatigue)

-Falls

Rare(may affect up to 1 in 100 users):

-Thoughts of self-aggression or ending one's life (suicidal thoughts), attempt to end one's life (suicide attempt)

-Hallucinations (seeing, hearing, or feeling things that do not exist)

-Abnormal thoughts or loss of contact with reality (psychotic disorder)

Unknown frequency(the frequency of this side effect cannot be estimated from the available data):

• Drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug hypersensitivity syndrome: generalized rash, elevated body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), lymph node swelling, and involvement of other body organs.
• Stevens-Johnson syndrome, SSJ. This severe skin eruption may appear as red macules with a target-like shape or as circular patches, often with blisters in the center, located on the trunk; skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms.

Stop using perampanel if any of these symptoms appear and consult your doctor or seek immediate medical attention. See also section 2.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medication that you no longer need. This will help protect the environment.

Composition of Fycompa

The active ingredient is perampanel. Each film-coated tablet contains 2mg, 4mg, 6mg, 8mg, 10mg, or 12mg of perampanel.

The other components are:

Core of the tablet (tablets of 2mg and 4mg):

Lactose monohydrate, low-substituted hydroxypropylcellulose, povidone, magnesium stearate (E470b)

Core of the tablet (tablets of 6mg, 8mg, 10mg, and 12mg)

Lactose monohydrate, low-substituted hydroxypropylcellulose, povidone, microcrystalline cellulose, magnesium stearate (E470b)

Film coating (tablets of 2mg, 4mg, 6mg, 8mg, 10mg, and 12mg)

Hydroxypropyl methylcellulose 2910, talc, Macrogol 8000, titanium dioxide (E171), colorants*

* The colorants are:

Tablet of 2mg: Iron oxide, Yellow (E172), Iron oxide, Red (E172)

Tablet of 4mg:Iron oxide, Red (E172)

Tablet of 6mg:Iron oxide, Red (E172)

Tablet of 8mg:Iron oxide, Red (E172), Iron oxide, Black (E172)

Tablet of 10mg: Iron oxide, Yellow (E172), FD&C Blue No. 2 Aluminum Lake Indigo Carmine (E132)

Tablet of 12mg:FD&C Blue No. 2 Aluminum Lake Indigo Carmine (E132)

Appearance of the product and contents of the package

All concentrations of Fycompa are film-coated, round, and biconvex tablets.

2mg: Orange in color, with the mark E275 on one face and 2 on the other face

4mg: Red in color, with the mark E277 on one face and 4 on the other face

6mg: Pink in color, with the mark E294 on one face and 6 on the other face

8mg: Purple in color, with the mark E295 on one face and 8 on the other face

10mg: Green in color, with the mark E296 on one face and 10 on the other face

12mg: Blue in color, with the mark E297 on one face and 12 on the other face

Fycompa is available in packages of:

Tablet of 2mg – package of 7, 28, and 98

Tablets of 4mg, 6mg, 8mg, 10mg, and 12mg – packages of 7, 28, 84, and 98

Only some package sizes may be commercially available.

Marketing Authorization Holder

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am Main

Germany

e-mail: [email protected]

Responsible for Manufacturing

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am Main

Germany

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last revision date of this leaflet:

The detailed information about this medication is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.