Fycompa 0,5 mg/ml suspension oral

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 is Fycompa and what it is used for

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

3.How to take Fycompa

4.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 people:

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 section 6).

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 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.

There have been reports of severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), and Stevens-Johnson syndrome (SSJ), 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 bullseye pattern 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 4 years old. The safety and efficacy in children under 4 years old for partial seizures, and under 7 years old 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 doctor if you are taking or have taken these medications recently, as your dose may need to be adjusted.

-Felbamate (a medication used to treat epilepsy) may also affect Fycompa. Inform your doctor if you are taking or have taken this medication recently, 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 doctor if you are taking or have taken these medications recently, as your dose may need to be adjusted.

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

Inform your doctor if you are taking birth control medications. Fycompa may make certain birth control medications, such as levonorgestrel, less effective. You should use other safe and effective birth control methods (such as condoms or an intrauterine device) while 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

Discuss with 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, 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 medications. Fycompa may make certain birth control medications, such as levonorgestrel, less effective. You should use other safe and effective birth control methods (such as condoms or an intrauterine device) while taking Fycompa. You should also 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 discuss with 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 alcohol while taking Fycompa may worsen these effects.

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 and adolescents (12 years of age and older) in 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, 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 aged 4 to 11 years and generalized seizures in children aged 7 to 11 years 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 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. Depending on clinical response and tolerability, the dose may be increased to a maximum of 12 mg/day (24 ml/day).
• If you have mild or moderate liver problems, your dose should not exceed 4 mg (8 ml) 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 to less than 30 kg in 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. Depending on clinical response and tolerability, the dose may be increased to a maximum of 8 mg/day (16 ml/day).
• If you have mild or moderate liver problems, your dose should not exceed 4 mg (8 ml) 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 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. Depending on clinical response and tolerability, the dose may be increased to a maximum of 6 mg/day (12 ml/day).
• If you have mild or moderate liver problems, your dose should not exceed 4 mg (8 ml) 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 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. Depending on clinical response and tolerability, the dose may be increased to a maximum of 12 mg/day (24 ml/day).
• If you have mild or moderate liver problems, your dose should not exceed 4 mg (8 ml) 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 to less than 30 kg in 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. Depending on clinical response and tolerability, the dose may be increased to a maximum of 8 mg/day (16 ml/day).
• If you have mild or moderate liver problems, your dose should not exceed 4 mg (8 ml) 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 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. Depending on clinical response and tolerability, the dose may be increased to a maximum of 6 mg/day (12 ml/day).
• If you have mild or moderate liver problems, your dose should not exceed 4 mg (8 ml) 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

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

Use the oral syringe and adapter provided for administration.

Below are the instructions for use of 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 securely closed.

4.Insert the plunger of the syringe completely.

5.Insert the syringe into the opening of the adapter as far as possible.

6.Place the bottle upside down and extract the prescribed amount of Fycompa.

7.Place 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 detergent residue, shake off excess water, and let air dry. Do not manually dry the dispensers.

11.Do not clean or reuse the syringe after 40 uses or if the syringe marks are erased when washing.

.

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 Fycompa, wait until it is time to take the next dose and continue as usual.

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

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

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

If you interrupt Fycompa treatment

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 prevent seizures from returning or worsening.

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

Like all medications, this medication 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 1in 10users):

-dizziness

-drowsiness (drowsiness or somnolence)

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

-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 (gag reflex)

-back pain

-feeling extremely tired (fatigue)

-falls

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

-thoughts of self-harm or suicide, attempt to end 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 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 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, mouth, throat, nose, genital, and eye ulcers, 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 section2.

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 Humanowww.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

No special storage conditions are required.

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

Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Fycompa

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

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

Appearance of the product and contents of the package

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

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

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

Last review date of this leaflet:

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