FYCOMPA 6 mg FILM-COATED TABLETS

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

Talk to 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 an elderly person; this may be due to your illness.
• Fycompa may make you aggressive, angry or violent. It may also cause changes in your behavior 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, talk to 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, talk to your doctor immediately.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), and Stevens-Johnson syndrome (SSJ), 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 are seen in blood tests, as well as swelling of the lymph nodes.
• Stevens-Johnson syndrome (SSJ) may initially appear as red target-like spots or circular patches, often with blisters in the center, located on the trunk. Ulcers in the mouth, throat, nose, genitals, and eyes (swelling and redness of the eyes) may also occur. These severe skin reactions often come with fever or flu-like symptoms. The rashes can lead to widespread skin peeling, life-threatening complications, or be fatal.

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

Children

Fycompa is not recommended for use 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 generalized 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 can 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 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 safe and effective contraceptive methods (such as condoms or an intrauterine device) when taking Fycompa. You should continue to do this for a month after stopping treatment. Talk to your doctor about the contraceptive method that is suitable for you.

Taking Fycompa with alcohol

Talk to your doctor before drinking alcohol. Be careful with alcohol consumption and epilepsy medicines, 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 breastfeeding

If you are pregnant or breastfeeding, 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 talking to your doctor first.

• Fycompa should not be used during pregnancy.
• You should use a reliable contraceptive method to prevent pregnancy while being treated with Fycompa. You should continue to do this for a 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 safe and effective contraceptive methods (such as condoms or an intrauterine device) when taking Fycompa. You should also do this for a month after stopping treatment. Talk to your doctor about the contraceptive method that 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 breastfeeding.

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, talk to them before taking this medicine.

3. How to take Fycompa

Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

How much to take

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

The recommended starting 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 be more than 8 mg per 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 generalized 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 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 the clinical response and tolerability in each patient, 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 per 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 and less than 30 kg for the treatment of partial seizures:

The recommended starting 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 the clinical response and tolerability in each patient, 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 per 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 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 the clinical response and tolerability in each patient, 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 per 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 generalized seizures:

The recommended starting 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 the clinical response and tolerability in each patient, 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 per 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 and less than 30 kg for the treatment of generalized seizures:

The recommended starting 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 the clinical response and tolerability in each patient, 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 per 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 generalized seizures:

The recommended starting 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 the clinical response and tolerability in each patient, 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 per 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 broken exactly as they do not have a score line.

If you take more Fycompa than you should

If you have taken more Fycompa than you should, talk to your doctor immediately. You may experience dizziness, 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 for your next dose and then continue 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 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 stop taking Fycompa

Take Fycompa for as long as your doctor has recommended. Do not stop treatment unless your doctor advises you to. Your doctor may gradually reduce your dose to prevent your seizures (convulsions) 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 red 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.

Adverse Effect Reporting

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed 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. Conservation 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 are no longer needed. This way, you will help protect the environment.

6. Package Contents and Additional Information

Fycompa Composition

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)

Product Appearance and Package Contents

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

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

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

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

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

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

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

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: [email protected]

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