PERAMPANEL ELPEN 4 mg FILM-COATED TABLETS

Introduction

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Perampanel Elpen 2 mg film-coated tablets EFG

Perampanel Elpen 4 mg film-coated tablets EFG

Perampanel Elpen 6 mg film-coated tablets EFG

Perampanel Elpen 8 mg film-coated tablets EFG

Perampanel Elpen 10 mg film-coated tablets EFG

Perampanel Elpen 12 mg film-coated tablets EFG

Read the entire 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 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

1. What is Perampanel Elpen and what is it used for

This medicine contains the active substance 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 (convulsions). Your doctor has prescribed it to reduce the number of epileptic seizures you have.

Perampanel is used together with other antiepileptics to treat specific 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 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 epileptic seizures that affect the entire brain from the start (“generalized seizures”) and cause convulsions.

2. What you need to know before taking Perampanel Elpen

DO NOT TAKE Perampanel Elpen:

• 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).

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Consult your doctor or pharmacist before starting to take perampanel if you have liver or kidney problems, moderate or severe.

You must not take Perampanel Elpen 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 Perampanel Elpen with other antiepileptic medicines.

• Perampanel Elpen may make you feel dizzy or drowsy, especially at the start of treatment.
• Perampanel Elpen may make you more prone to falls, especially if you are an elderly person; this may be due to your illness.
• Perampanel Elpen 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, consult 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, consult 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 is usually, but not exclusively, characterized by flu-like symptoms and a rash with elevated body temperature, elevated liver enzymes, and eosinophilia, as well as swelling of the lymph nodes.
• Stevens-Johnson syndrome (SSJ) may initially appear as target-like red spots or circular patches, often with blisters in the center, located on the trunk. Ulcers of the mouth, throat, nose, genitals, and eyes (swelling and redness of the eyes) may also occur. These severe skin reactions are often preceded by fever or flu-like symptoms. The rashes can lead to widespread skin peeling and life-threatening complications or be fatal.

If you experience any of the above problems after taking Perampanel Elpen (or are unsure), consult your doctor or pharmacist.

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Perampanel Elpen is not recommended for use in children under 4 years of age. The safety and efficacy in children under 4 years of age have not yet been established, in the case of partial seizures, or in children under 7 years of age, in the case of generalized seizures.

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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 Perampanel Elpen with some other medicines can cause side effects or affect how they work. Do not start or stop taking other medicines without consulting your doctor or pharmacist.

• Other antiepileptics, such as carbamazepine, oxcarbazepine, and phenytoin, used to treat seizures, may affect Perampanel Elpen. 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 Perampanel Elpen. 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 Perampanel Elpen. 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 medicine used to treat mild anxiety), and ketoconazole (a medicine used to treat fungal infections), may affect Perampanel Elpen. 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. Perampanel Elpen 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 Perampanel Elpen. You should continue to do so for a month after stopping treatment. Consult your doctor about the contraceptive method that is suitable for you.

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Talk to your doctor before taking alcohol. Be careful with alcohol consumption and epilepsy medicines, including Perampanel Elpen.

• Drinking alcohol while taking Perampanel Elpen may make your alertness decrease and affect your ability to drive or use tools and machines.
• Drinking alcohol while taking Perampanel Elpen may also make any feelings of anger, confusion, or sadness worse.

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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 consulting your doctor first.

• Perampanel Elpen is not recommended during pregnancy.
• You should use a reliable contraceptive method to prevent pregnancy while being treated with Perampanel Elpen. You should continue to do so for a month after stopping treatment. Tell your doctor if you are taking hormonal contraceptives. Perampanel Elpen 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 Perampanel Elpen. You should also do so for a month after stopping treatment. Consult your doctor about the contraceptive method that is suitable for you.

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

Your doctor will weigh the benefits of treatment with Perampanel Elpen for the mother and the risks for the baby while breastfeeding.

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

You should talk to your doctor about the effect of epilepsy on driving and using machines.

• Perampanel Elpen 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 Perampanel Elpen may make these effects worse.

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

3. How to take Perampanel Elpen

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

The recommended initial dose is 2 mg once a day before bedtime.

• Your doctor may increase this dose in increments of 2 mg 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 Perampanel Elpen than recommended by your doctor. It may take a few weeks to find the right dose of Perampanel Elpen for you.

In the following table, a summary of 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 is shown. 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 initial dose is 2 mg once a day before bedtime.

• Your doctor may increase this dose in increments of 2 mg to a maintenance dose between 4 mg and 8 mg, depending on your response. Depending on the clinical response and tolerability of 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.

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

The recommended initial dose is 1 mg once a day before bedtime.

• Your doctor may increase this dose in increments of 1 mg to a maintenance dose between 4 mg and 6 mg, depending on your response. Depending on the clinical response and tolerability of 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.

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

The recommended initial dose is 1 mg once a day before bedtime.

• Your doctor may increase this dose in increments of 1 mg to a maintenance dose between 2 mg and 4 mg, depending on your response. Depending on the clinical response and tolerability of 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.

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

The recommended initial dose is 2 mg once a day before bedtime.

• Your doctor may increase this dose in increments of 2 mg to a maintenance dose between 4 mg and 8 mg, depending on your response. Depending on the clinical response and tolerability of 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.

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

The recommended initial dose is 1 mg once a day before bedtime.

• Your doctor may increase this dose in increments of 1 mg to a maintenance dose between 4 mg and 6 mg, depending on your response. Depending on the clinical response and tolerability of 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.

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

The recommended initial dose is 1 mg once a day before bedtime.

• Your doctor may increase this dose in increments of 1 mg to a maintenance dose between 2 mg and 4 mg, depending on your response. Depending on the clinical response and tolerability of 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.

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Perampanel Elpen is for oral use. Swallow the tablet whole with a glass of water. Perampanel Elpen 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.

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If you have taken more Perampanel Elpen than you should, talk to your doctor immediately. You may experience dizziness, agitation, aggressive behavior, and decreased level of consciousness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

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• 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 forgotten doses.
• If you have missed less than 7 days of treatment with Perampanel Elpen, continue taking the daily tablet as originally instructed by your doctor.
• If you have missed more than 7 days of treatment with Perampanel Elpen, consult your doctor immediately.

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Take Perampanel Elpen 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 your seizures returning or getting worse.

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 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 people):

• dizziness sensation
• drowsiness (drowsiness or somnolence)

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

• 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 people):

• 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 in 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.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that is not listed in this prospectus. You can also report them directly through the national reporting system included in 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 Perampanel Elpen

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.

This medicine does not require special storage conditions.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that you no longer need in the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

6. Package Contents and Additional Information Composition of Perampanel Elpen

The active ingredient is perampanel.

Perampanel Elpen 2 mg film-coated tablets EFG

Each film-coated tablet contains 2 mg of perampanel.

Perampanel Elpen 4 mg film-coated tablets EFG

Each film-coated tablet contains 4 mg of perampanel.

Perampanel Elpen 6 mg film-coated tablets EFG

Each film-coated tablet contains 6 mg of perampanel.

Perampanel Elpen 8 mg film-coated tablets EFG

Each film-coated tablet contains 8 mg of perampanel.

Perampanel Elpen 10 mg film-coated tablets EFG

Each film-coated tablet contains 10 mg of perampanel.

Perampanel Elpen 12 mg film-coated tablets EFG

Each film-coated tablet contains 12 mg of perampanel.

The other components are:

Core of the tablet

Lactose monohydrate, microcrystalline cellulose, low-substitution hydroxypropylcellulose, povidone K-29/32, microcrystalline cellulose, magnesium stearate

Coating of the tablet

Perampanel Elpen 2 mg film-coated tablets EFG

Hypromellose 3cp

Titanium dioxide (E171)

Talc

Macrogol 3350

Red iron oxide (E172)

Yellow iron oxide (E172)

Perampanel Elpen 4 mg, 6 mg film-coated tablets EFG

Hypromellose 3cp

Titanium dioxide (E171)

Talc

Macrogol 3350

Red iron oxide (E172)

Perampanel Elpen 8 mg film-coated tablets EFG

Hypromellose 3cp

Titanium dioxide (E171)

Talc

Macrogol 3350

Red iron oxide (E172)

Yellow iron oxide (E172)

Carmine indigo (E132)

Perampanel Elpen 10 mg film-coated tablets EFG

Hypromellose 3cp

Titanium dioxide (E171)

Talc

Macrogol 3350

Yellow iron oxide (E172)

Carmine indigo (E132)

Perampanel Elpen 12 mg film-coated tablets EFG

Hypromellose 3cp

Titanium dioxide (E171)

Talc

Macrogol 3350

Carmine indigo (E132)

Appearance of the Product and Package Contents

Film-Coated Tablet

Perampanel Elpen 2 mg: orange, biconvex, film-coated, round tablets, marked with 2 on one side and smooth on the other side.

Perampanel Elpen 4 mg: red, biconvex, film-coated, round tablets, marked with 4 on one side and smooth on the other side.

Perampanel Elpen 6 mg: pink, biconvex, film-coated, round tablets, marked with 6 on one side and smooth on the other side.

Perampanel Elpen 8 mg: purple, biconvex, film-coated, round tablets, marked with 8 on one side and smooth on the other side.

Perampanel Elpen 10 mg: green, biconvex, film-coated, round tablets, marked with 10 on one side and smooth on the other side.

Perampanel Elpen 12 mg: blue, biconvex, oval, film-coated tablets, marked with 12 on one side and smooth on the other side.

Perampanel Elpen is available in packages of:

Perampanel Elpen 2 mg - packages of 7, 28, and 98 film-coated tablets.

Perampanel Elpen 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg - packages of 7, 28, 84, and 98 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

ELPEN Pharmaceutical Co. Inc.

95, Marathonos Ave., Pikermi, Attica

GR-19009, Greece

Perampanel Elpen is Authorized in the Member States of the European Economic Area with the Following Names:

Germany: Perampanel ELPEN 2 mg, 4mg, 6mg, 8mg, 10mg & 12 mg Filmtabletten

Date of the Last Revision of this Prospectus: July 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/