Fycompa 0.5 mg/ml oral suspension

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

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

perampanel

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Fycompa is and what it is used for

Fycompa contains a medicine called perampanel. It belongs to a group of medicines called antiepileptics. These medicines are used to treat epilepsy, a condition in which a person has repeated epileptic seizures (convulsive fits). Your doctor has prescribed it to you to reduce the number of epileptic seizures you have.

Fycompa is used in combination with other antiepileptic medicines 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 epileptic seizures that affect one part of the brain (“partial seizures”).
• These partial seizures may or may not be followed by a seizure affecting 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 epileptic seizures that affect the entire brain from the onset (“generalized seizures”) and that cause convulsions.

2. What you need to know before taking Fycompa

DO NOT TAKE Fycompa:

• if you have ever had a severe skin rash, skin peeling, 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 taking Fycompa if you have liver problems or moderate to severe kidney problems.

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

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

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

• Fycompa may make you feel dizzy or drowsy, especially at the beginning of treatment.
• Fycompa may make you more likely to fall, especially if you are elderly; this could be due to your condition.
• Fycompa may cause you to become aggressive, angry, or violent. It may also cause unusual or extreme changes in your behaviour 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 small number of people taking antiepileptic medicines have had thoughts about harming themselves or suicide. If at any time you have such thoughts, contact your doctor immediately.

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

• DRESS typically, although not exclusively, presents with flu-like symptoms and a rash accompanied by fever. Blood tests may show increased liver enzyme levels and a type of white blood cell (eosinophilia), as well as swollen lymph nodes.
• Stevens-Johnson syndrome (SJS) may initially appear as red spots resembling targets or circular patches, often with blisters in the center, located on the trunk. Ulcerations may also occur in the mouth, throat, nose, genitals, and eyes (eye swelling and redness). These serious skin reactions are often preceded by fever or flu-like symptoms. The rashes may progress to extensive skin peeling and life-threatening complications, or may 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 use in children under 4 years of age. Safety and efficacy have not yet been established in children under 4 years of age for partial seizures, or in children under 7 years of age for generalized seizures.

Other medicines and Fycompa

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

• Other antiepileptic medicines, such as carbamazepine, oxcarbazepine, and phenytoin, used to treat seizures, may affect Fycompa. Inform 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. Inform 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. Inform 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. Inform 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).

Inform your doctor if you are taking hormonal contraceptives. Fycompa may reduce the effectiveness of certain hormonal contraceptives, such as levonorgestrel. You should use other safe and effective contraceptive methods (such as condoms or an intrauterine device) while taking Fycompa. You should continue using these methods 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 cautious about alcohol consumption and antiepileptic medicines, including Fycompa.

• Drinking alcohol while taking Fycompa may reduce your level of alertness and affect your ability to drive or operate tools and machinery.
• Drinking alcohol while taking Fycompa may also worsen feelings of anger, confusion, or sadness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Do not stop treatment without first talking to your doctor.

• Fycompa is not recommended during pregnancy.
• You should use a reliable method of contraception to prevent pregnancy while being treated with Fycompa. You should continue using contraception for one month after stopping treatment. Inform your doctor if you are taking hormonal contraceptives. Fycompa may reduce the effectiveness of certain hormonal contraceptives, such as levonorgestrel. You should use other safe and effective contraceptive methods (such as condoms or an intrauterine device) while taking Fycompa. You should also continue using them for one month after stopping treatment. Ask your doctor which contraceptive method is suitable for you.

It is unknown whether the components of Fycompa pass into breast milk.

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

Driving and using machines

Do not drive or operate machinery until you know how Fycompa affects you.

You should talk to your doctor about the effects of epilepsy on driving and using machinery.

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

Fycompa contains lactose

Fycompa contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to use Fycompa

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

How much to take

Adults and adolescents (aged 12 years and older) for the treatment of partial-onset seizures and generalized seizures

The recommended starting dose is 2 mg (4 ml) once daily before bedtime.

• Your doctor may increase this dose in 2 mg (4 ml) increments 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 (hepatic) problems, your dose should not exceed 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 several 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-onset seizures in children aged 4 to 11 years and generalized seizures in children aged 7 to 11 years. For further information, see below the table.

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

The recommended starting dose is 2 mg (4 ml) once daily 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 individual clinical response and tolerability, the dose may be increased up 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 at intervals of at least 2 weeks.
• Do not take more Fycompa than your doctor recommends. It may take several weeks to find the appropriate Fycompa dose for you.

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

The recommended starting dose is 1 mg (2 ml) once daily 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 individual clinical response and tolerability, the dose may be increased up 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 at intervals of at least 2 weeks.
• Do not take more Fycompa than your doctor recommends. It may take several weeks to find the appropriate Fycompa dose for you.

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

The recommended starting dose is 1 mg (2 ml) once daily 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 individual clinical response and tolerability, the dose may be increased up 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 at intervals of at least 2 weeks.
• Do not take more Fycompa than your doctor recommends. It may take several weeks to find the appropriate Fycompa dose for you.

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

The recommended starting dose is 2 mg (4 ml) once daily 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 individual clinical response and tolerability, the dose may be increased up 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 at intervals of at least 2 weeks.
• Do not take more Fycompa than your doctor recommends. It may take several weeks to find the appropriate Fycompa dose for you.

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

The recommended starting dose is 1 mg (2 ml) once daily 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 individual clinical response and tolerability, the dose may be increased up 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 at intervals of at least 2 weeks.
• Do not take more Fycompa than your doctor recommends. It may take several weeks to find the appropriate Fycompa dose for you.

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

The recommended starting dose is 1 mg (2 ml) once daily 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 individual clinical response and tolerability, the dose may be increased up 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 at intervals of at least 2 weeks.
• Do not take more Fycompa than your doctor recommends. It may take several weeks to find the appropriate Fycompa dose for you.

How to take

Fycompa is administered orally. Fycompa can be taken with or without food, but should always be taken 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.

Instructions for using the oral syringe and adapter are provided below:

1. Shake well before use.
2. Press and (1) twist the cap (2) to open the bottle.
3. Insert the adapter into the neck of the bottle until it is securely sealed.
4. Fully insert the plunger of the syringe.
5. Insert the syringe into the opening of the adapter as far as possible.
6. Turn the bottle upside down and withdraw the prescribed amount of Fycompa.
7. Turn the bottle upright and remove the syringe.
8. Leave the adapter in place and replace the cap on the bottle.
9. After administering the dose, separate the barrel and plunger and immerse them completely in HOT soapy water.
10. Rinse the barrel and plunger in water to remove any detergent residue, shake off excess water, and allow to air dry. Do not dry dispensers manually.
11. Do not clean or reuse the syringe after 40 uses or if the markings on the syringe become illegible when washed.

If you take more Fycompa than you should

If you have taken more Fycompa than you should, contact 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 missed doses.
• If you have missed less than 7 days of Fycompa treatment, continue taking your daily dose as originally directed by your doctor.
• If you have missed more than 7 days of Fycompa treatment, contact your doctor immediately.

If you stop taking Fycompa

Take Fycompa for the length of time recommended by your doctor. Do not stop treatment unless advised by your doctor. Your doctor may gradually reduce your dose to prevent seizures from returning or worsening.

If you have any further questions about 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 everyone experiences them.

A small number of people taking antiepileptic medicines have had thoughts about harming themselves 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
• feeling sleepy (drowsiness or somnolence)

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

• increased or decreased appetite, weight gain
• feelings of aggression, anger, irritability, anxiety, or confusion
• difficulty walking or other balance problems (ataxia, gait disturbance, balance disorder)
• slurred speech (dysarthria)
• blurred vision or double vision (diplopia)
• sensation of 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 (frequency of this adverse effect cannot be estimated from available data):

• Drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug hypersensitivity syndrome: widespread rash, elevated body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other body organs.
• Stevens-Johnson syndrome (SJS). This serious skin rash may appear as red, target-shaped spots or circular patches, often with blisters in the center, usually on the trunk; skin peeling, mouth, throat, nose, genital, or eye ulcers, and may be preceded by fever and flu-like symptoms.

Stop taking perampanel if any of these symptoms occur 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 not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 expiry date stated on the label of the bottle and on the carton. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

After 90 days have passed since first opening, the remaining suspension in the bottle must not be used.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fycompa

The active substance is perampanel. Each millilitre contains 0.5 mg of perampanel.

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

Nature and contents of the container

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

Marketing Authorisation 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

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

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