FYCOMPA 2 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Fycompa 2mg, 4mg, 6mg, 8mg, 10mg and 12mg film-coated tablets

perampanel

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Fycompa and what is it used for
2. What you need to know before you take Fycompa
3. How to take Fycompa
4. Possible side effects
5. Storing Fycompa
6. Contents of the pack and other information

1. What is Fycompa and what is it used for

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 epileptic seizures (fits). Your doctor has prescribed it to reduce the number of epileptic seizures you have.

Fycompa is used together with other antiepileptics to treat certain 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 epileptic seizures that affect only a part of the brain ("partial seizures").
• These partial seizures may or may not be followed by a seizure that affects the whole brain ("secondary generalisation").

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

• It is also used to treat epileptic seizures that affect the whole brain from the start ("generalised seizures") and cause convulsions.

2. What you need to know before you take Fycompa

DO NOT TAKE FYCOMPA:

• if you have ever had a severe skin rash or peeling of the skin, blisters and/or sores in the mouth 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

Tell your doctor or pharmacist before you start taking Fycompa if you have liver or moderate to severe kidney problems.

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

Before you start taking this medicine, tell your doctor if you have a history of alcohol or drug abuse.

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

• Fycompa may make you feel dizzy or drowsy, especially at the start of treatment.
• Fycompa may make you more prone to falls, especially if you are elderly; this may be due to your illness.
• Fycompa may make you aggressive, angry or violent. It may also cause changes in your behaviour or mood that are unusual or extreme, abnormal thoughts or loss of contact with reality.

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

A small number of people taking antiepileptics have had thoughts of harming themselves or suicide. If at any time you have these thoughts, contact your doctor immediately.

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

• DRESS typically presents with flu-like symptoms and a rash with a high body temperature, elevated liver enzymes and eosinophilia, as well as lymph node swelling.
• Stevens-Johnson syndrome (SJS) may start with a red target-like rash or circular patches, often with blisters in the centre, located on the trunk. Ulcers in the mouth, throat, nose, genitals and eyes (eye swelling and redness) can also occur. These severe skin rashes may be preceded by fever or flu-like symptoms. The rashes may lead to widespread skin peeling, life-threatening complications, or be fatal.

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

Children

Fycompa should not be used in children under 4 years of age. The safety and efficacy in children under 4 years of age for partial seizures and in children under 7 years of age for generalised seizures have not yet been established.

Other medicines and Fycompa

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. Taking Fycompa with some other medicines may cause side effects or affect how they work. Do not start or stop taking other medicines without talking to your doctor or pharmacist.

• Other antiepileptics, such as carbamazepine, oxcarbazepine and phenytoin used to treat seizures, may affect Fycompa. 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 Fycompa. 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 acute (sudden) and prolonged seizures, for sedation and sleep problems) may be affected by Fycompa. Tell your doctor if you are taking midazolam as your dose may need to be adjusted.

• Other medicines, such as rifampicin (a medicine used to treat bacterial infections), St John's Wort (a herbal medicine used to treat mild anxiety) and ketoconazole (a medicine used to treat fungal infections) may affect Fycompa. 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. Fycompa may make certain hormonal contraceptives, such as levonorgestrel, less effective. You should use other reliable and effective methods of contraception (such as condoms or an intrauterine device) when taking Fycompa. You should continue to do this for one month after stopping treatment. Ask your doctor which contraceptive method is suitable for you.

Taking Fycompa with alcohol

Talk to your doctor before drinking alcohol. Be careful with drinking alcohol and taking medicines for epilepsy, including Fycompa.

• Drinking alcohol while taking Fycompa may make your alertness decrease and affect your ability to drive or use tools and machines.
• Drinking alcohol while taking Fycompa may 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 discussing it with your doctor.

• Fycompa should not be used during pregnancy.
• You should use a reliable method of contraception to prevent pregnancy while being treated with Fycompa. You should continue to do 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 reliable and effective methods of contraception (such as condoms or an intrauterine device) when taking Fycompa. You should also do this for one month after stopping treatment. Ask your doctor which contraceptive method is suitable for you.

It is not known if the components of Fycompa can pass into breast milk.

Your doctor will weigh the benefits of treatment with Fycompa for the mother against the risks for the baby while breast-feeding.

Driving and using machines

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

Talk to your doctor about the effects of epilepsy on driving and using machines.

• Fycompa may make you feel dizzy or drowsy, especially at the start of treatment. If this happens, do not drive or use tools or machines.
• Drinking alcohol while taking Fycompa may make these effects worse.

Fycompa contains lactose

Fycompa contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Fycompa

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take

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

The recommended starting dose is 2 mg once a day before going to bed.

• 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 be more than 8 mg a day and dose increases should be made at intervals of at least 2 weeks.
• Do not take more Fycompa than your doctor has recommended. It may take a few weeks to find the right dose of Fycompa for you.

The following table shows a summary of the recommended doses for the treatment of partial seizures in children from 4 to 11 years of age and generalised seizures in children from 7 to 11 years of age. For more information, see below the table.

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

The recommended starting dose is 2 mg once a day before going to bed.

• 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 the individual clinical response and 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 be more than 4 mg a day and dose increases should be made at intervals of at least 2 weeks.
• Do not take more Fycompa than your doctor has recommended. It may take a few weeks to find the right dose of Fycompa for you.

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

The recommended starting dose is 1 mg once a day before going to bed.

• 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 the individual clinical response and 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 be more than 4 mg a day and dose increases should be made at intervals of at least 2 weeks.
• Do not take more Fycompa than your doctor has recommended. It may take a few weeks to find the right dose of Fycompa for you.

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

The recommended starting dose is 1 mg once a day before going to bed.

• 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 the individual clinical response and 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 be more than 4 mg a day and dose increases should be made at intervals of at least 2 weeks.
• Do not take more Fycompa than your doctor has recommended. It may take a few weeks to find the right dose of Fycompa for you.

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

The recommended starting dose is 2 mg once a day before going to bed.

• 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 the individual clinical response and 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 be more than 4 mg a day and dose increases should be made at intervals of at least 2 weeks.
• Do not take more Fycompa than your doctor has recommended. It may take a few weeks to find the right dose of Fycompa for you.

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

The recommended starting dose is 1 mg once a day before going to bed.

• 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 the individual clinical response and 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 be more than 4 mg a day and dose increases should be made at intervals of at least 2 weeks.
• Do not take more Fycompa than your doctor has recommended. It may take a few weeks to find the right dose of Fycompa for you.

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

The recommended starting dose is 1 mg once a day before going to bed.

• 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 the individual clinical response and 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 be more than 4 mg a day and dose increases should be made at intervals of at least 2 weeks.
• Do not take more Fycompa than your doctor has recommended. It may take a few 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 divided exactly as they are not scored.

If you take more Fycompa than you should

If you have taken more Fycompa than you should, tell your doctor immediately. You may experience dizziness, agitation, aggressive behaviour and decreased level of consciousness.

If you forget to take Fycompa

• If you forget to take a tablet, wait until it is time for your next dose and then continue as normal.
• Do not take a double dose to make up for a forgotten dose.
• 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, contact your doctor immediately.

If you stop taking Fycompa

Take Fycompa for as long as your doctor has told you. Do not stop treatment unless your doctor tells you to. Your doctor may gradually reduce your dose to prevent your seizures (fits) from coming back or getting worse.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

A small number of people being treated with antiepileptics 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 sensation
• 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)
• feeling that everything is spinning (vertigo)
• nausea
• back pain
• feeling of great fatigue (fatigue)
• falls

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

• thoughts of self-harm 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)

Frequency Not Known(the frequency of this adverse effect cannot be estimated from the available data):

• Drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome: widespread rash, elevated body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swelling of the lymph nodes, and involvement of other organs of the body.
• Stevens-Johnson syndrome, SSJ. This severe skin rash may appear as reddish spots with a target 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Fycompa

Keep this medicine out of sight and reach of children.

Do not use this medicine 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 thrown away through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Fycompa

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

The other components are:

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

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

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

Lactose monohydrate, low-substituted hydroxypropylcellulose, 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), colorants*

• The colorants are:

2 mg tablet: Iron oxide, Yellow (E172), Iron oxide, Red (E172)

4 mg tablet: Iron oxide, Red (E172)

6 mg tablet: Iron oxide, Red (E172)

8 mg tablet: Iron oxide, Red (E172), Iron oxide, Black (E172)

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

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

Appearance of the Product and Package Contents

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

2 mg: orange, with the mark E275 on one side and 2 on the other side

4 mg: red, with the mark E277 on one side and 4 on the other side

6 mg: pink, with the mark E294 on one side and 6 on the other side

8 mg: purple, with the mark E295 on one side and 8 on the other side

10 mg: green, with the mark E296 on one side and 10 on the other side

12 mg: blue, with the mark E297 on one side and 12 on the other side

Fycompa is available in packages of:

2 mg tablet - package of 7, 28, and 98

4 mg, 6 mg, 8 mg, 10 mg, and 12 mg tablets - packages of 7, 28, 84, and 98

Only some package sizes may be marketed.

Marketing Authorization Holder

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am Main

Germany

e-mail: medinfo_de@eisai.net

Manufacturer

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am Main

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Prospectus:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.