FYCOMPA 0.5 mg/mL ORAL SUSPENSION

2. What you need to know before taking Fycompa

DO NOT TAKE Fycompa:

• if you have ever had a severe skin rash or peeling of the skin, blisters, 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 starting to take Fycompa if you have liver or kidney problems, moderate or severe.

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

Before starting to take this medicine, you must 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 being treated with antiepileptics have had thoughts of harming themselves or committing suicide. If at any time you have these thoughts, contact your doctor immediately.

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

• DRESS is usually, but not exclusively, characterized by flu-like symptoms and a rash with a high body temperature, elevated liver enzymes, and an increase in a type of white blood cell (eosinophilia), as well as swelling of the lymph nodes.
• Stevens-Johnson syndrome (SSJ) may initially appear as target-like spots or circular patches, often with blisters in the center, located on the trunk. Ulcerations of the mouth, throat, nose, genitals, and eyes (eye swelling and redness) may also occur. These serious 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 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 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 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, 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. Ask your doctor which contraceptive method 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 level of 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 plan to become pregnant, consult your doctor before using this medicine. Do not stop treatment without first talking to your doctor.

• 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. Ask your doctor which contraceptive method is suitable for you.

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

Your doctor will weigh the benefits of treatment with Fycompa for the mother and 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 start of treatment. If this happens, do not drive or use tools or machines.
• Drinking alcohol while taking Fycompa may make these effects worse.

Fycompacontainslactose

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 use Fycompa

Follow your doctor's administration instructions for this medication exactly. If in doubt, consult your doctor or pharmacist again.

How much to take

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

The recommended initial dose is 2 mg (4 ml) once a day before bedtime.

• Your doctor may increase this dose in increments of 2 mg (4 ml) up to a maintenance dose between 4 mg (8 ml) and 12 mg (24 ml), depending on your response.
• If you have mild or moderate liver problems (hepatic), 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 recommended by your doctor. It may take a few weeks to find the right dose of Fycompa for you.

In the following table, a summary of 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 is shown. For more information, see below the table.

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

The recommended initial dose is 2 mg (4 ml) once a day before bedtime.

• Your doctor may increase this dose in increments of 2 mg (4 ml) up to a maintenance dose between 4 mg (8 ml) and 8 mg (16 ml), depending on your response. Based on clinical response and tolerability of each patient, the dose may be increased to a maximum of 12 mg/day (24 ml/day).
• If you have mild or moderate liver problems (hepatic), your dose should not be more than 4 mg (8 ml) per day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take more Fycompa than recommended by your doctor. It may take a few weeks to find the right dose of Fycompa for you.

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

The recommended initial dose is 1 mg (2 ml) once a day before bedtime.

• Your doctor may increase this dose in increments of 1 mg (2 ml) up to a maintenance dose between 4 mg (8 ml) and 6 mg (12 ml), depending on your response. Based on clinical response and tolerability of each patient, the dose may be increased to a maximum of 8 mg/day (16 ml/day).
• If you have mild or moderate liver problems (hepatic), your dose should not be more than 4 mg (8 ml) per day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take more Fycompa than recommended by your doctor. It may take a few weeks to find the right dose of Fycompa for you.

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

The recommended initial dose is 1 mg (2 ml) once a day before bedtime.

• Your doctor may increase this dose in increments of 1 mg (2 ml) up to a maintenance dose between 2 mg (4 ml) and 4 mg (8 ml), depending on your response. Based on clinical response and tolerability of each patient, the dose may be increased to a maximum of 6 mg/day (12 ml/day).
• If you have mild or moderate liver problems (hepatic), your dose should not be more than 4 mg (8 ml) per day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take more Fycompa than recommended by your doctor. It may take a few weeks to find the right dose of Fycompa for you.

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

The recommended initial dose is 2 mg (4 ml) once a day before bedtime.

• Your doctor may increase this dose in increments of 2 mg (4 ml) up to a maintenance dose between 4 mg (8 ml) and 8 mg (16 ml), depending on your response. Based on clinical response and tolerability of each patient, the dose may be increased to a maximum of 12 mg/day (24 ml/day).
• If you have mild or moderate liver problems (hepatic), your dose should not be more than 4 mg (8 ml) per day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take more Fycompa than recommended by your doctor. It may take a few weeks to find the right dose of Fycompa for you.

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

The recommended initial dose is 1 mg (2 ml) once a day before bedtime.

• Your doctor may increase this dose in increments of 1 mg (2 ml) up to a maintenance dose between 4 mg (8 ml) and 6 mg (12 ml), depending on your response. Based on clinical response and tolerability of each patient, the dose may be increased to a maximum of 8 mg/day (16 ml/day).
• If you have mild or moderate liver problems (hepatic), your dose should not be more than 4 mg (8 ml) per day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take more Fycompa than recommended by your doctor. It may take a few weeks to find the right dose of Fycompa for you.

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

The recommended initial dose is 1 mg (2 ml) once a day before bedtime.

• Your doctor may increase this dose in increments of 1 mg up to a maintenance dose between 2 mg (4 ml) and 4 mg (8 ml), depending on your response. Based on clinical response and tolerability of each patient, the dose may be increased to a maximum of 6 mg/day (12 ml/day).
• If you have mild or moderate liver problems (hepatic), your dose should not be more than 4 mg (8 ml) per day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take more Fycompa than recommended by your doctor. It may take a few weeks to find the right dose of Fycompa for you.

How to take

Fycompa is administered orally. Fycompa can be taken with or without food and should always be taken in the same way. For example, if you decide to take Fycompa with food, always take it with food.

Use the oral syringe and adapter provided for administration.

The following are the instructions for using the oral syringe and adapter:

1. Shake well before use.
2. Press and (1) turn the cap (2) to open the bottle.
3. Insert the adapter into the neck of the bottle until it is tightly closed.
4. Insert the syringe plunger fully.
5. Insert the syringe into the adapter opening as far as possible.
6. Turn the bottle upside down and withdraw the prescribed amount of Fycompa.
7. Turn the bottle right side up and remove the syringe.
8. Leave the adapter in place and replace the cap on the bottle.
9. After administering the dose, separate the body and plunger and submerge them completely in warm soapy water.
10. Submerge the body and plunger in water to remove any remaining detergent, shake off excess water, and let them air dry. Do not manually dry the dispensers.
11. Do not clean or reuse the syringe after 40 uses or if the syringe markings are erased when washing.

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If you take more Fycompa than you should

If you have taken more Fycompa than you should, consult 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 Fycompa, wait until it is time for your next dose and then continue as usual.
• Do not take a double dose to make up for forgotten doses.
• If you have missed less than 7 days of treatment with Fycompa, continue taking the daily dose as originally instructed by your doctor.
• If you have missed more than 7 days of treatment with Fycompa, consult your doctor immediately.

If you stop treatment with Fycompa

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

If you have any other questions about the use of this medication, 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 taking antiepileptics have had thoughts of harming themselves or suicide. If you have these thoughts at any time, consult your doctor immediately.

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

• dizziness
• feeling of sleepiness (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 very tired (fatigue)
• falls

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

• thoughts of self-harm or ending your life (suicidal thoughts), attempt to end your 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 side 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. This severe skin rash can appear as red targets or 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fycompa

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

Do not use this medicine after the expiration date shown on the label of the bottle and on the carton. The expiration date is the last day of the month indicated.

No special storage conditions are required.

If more than 90 days have passed since the first opening, do not use the remaining suspension in the bottle.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Fycompa

The active ingredient is perampanel. Each milliliter contains 0.5 mg of perampanel.

The other ingredients are liquid sorbitol (E420) (crystallizing), microcrystalline cellulose (E460), sodium carmellose (E466), poloxamer 188, simethicone emulsion 30% (contains purified water, silicone oil, polysorbate 65, methylcellulose, silica gel, macrogol stearate, sorbic acid, benzoic acid (E210), and sulfuric acid), citric acid anhydrous (E330), sodium benzoate (E211), and purified water.

Appearance of the product and package contents

Fycompa 0.5 mg/ml oral suspension is a white to off-white suspension. It comes in a 340 ml bottle with 2 graduated oral syringes and a press-in bottle adapter (PIBA).

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 leaflet:

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