PERAMPANEL CINFA 2 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Perampanel Cinfa 2 mg Film-Coated Tablets EFG

Perampanel Cinfa 4 mg Film-Coated Tablets EFG

Perampanel Cinfa 6 mg Film-Coated Tablets EFG

Perampanel Cinfa 8 mg Film-Coated Tablets EFG

Perampanel Cinfa 10 mg Film-Coated Tablets EFG

Perampanel Cinfa 12 mg Film-Coated Tablets EFG

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

• Keep this package leaflet, 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Perampanel Cinfa and what is it used for
2. What you need to know before you take Perampanel Cinfa
3. How to take Perampanel Cinfa
4. Possible side effects
5. Storage of Perampanel Cinfa
6. Package Contents and Further Information

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

Perampanel Cinfa 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 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 only 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 you take Perampanel Cinfa

Do not take Perampanel Cinfa

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

Do not take perampanel 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 with other antiepileptic medicines.

• Perampanel may make you feel dizzy or drowsy, especially at the start of treatment.
• Perampanel may make you more prone to falls, especially if you are an elderly person; this could be due to your illness.
• Perampanel 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 you have these thoughts at any time, 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, although not exclusively, with flu-like symptoms and a rash with a high body temperature, elevated liver enzyme levels, 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 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 and life-threatening complications or be fatal.

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

Children

Perampanel 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 Perampanel Cinfa

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 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 perampanel. 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. 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. 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 perampanel. 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 may make certain hormonal contraceptives, such as levonorgestrel, less effective. You should use other reliable methods of contraception (such as condoms or an intrauterine device) when taking perampanel. You should continue to do this for a month after stopping treatment. Ask your doctor which contraceptive method is suitable for you.

Taking Perampanel Cinfa with Alcohol

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

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor for advice before taking this medicine. Do not stop treatment without consulting your doctor first.

• Perampanel should not be used during pregnancy.
• You should use a reliable method of contraception to prevent pregnancy while being treated with perampanel. You should continue to do this for a month after stopping treatment. Tell your doctor if you are taking hormonal contraceptives. Perampanel may make certain hormonal contraceptives, such as levonorgestrel, less effective. You should use other reliable methods of contraception (such as condoms or an intrauterine device) when taking perampanel. 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 if the components of perampanel can pass into breast milk.

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

Driving and Using Machines

Perampanel may cause symptoms such as drowsiness, dizziness, or changes in vision, and may decrease your reaction time. These effects, as well as your illness, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

Perampanel Cinfa Contains Lactose

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 Perampanel Cinfa

Always take this medicine exactly as your doctor has told you. If you are not sure, check with 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 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 than recommended by your doctor. It may take several weeks to find the right dose of perampanel for you.

The following table summarizes 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. 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. Based 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.
• Do not take more perampanel than recommended by your doctor. It may take several weeks to find the right dose of perampanel for you.

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. Based 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.
• Do not take more perampanel than recommended by your doctor. It may take several weeks to find the right dose of perampanel for you.

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. Based 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.
• Do not take more perampanel than recommended by your doctor. It may take several weeks to find the right dose of perampanel for you.

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. Based 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.
• Do not take more perampanel than recommended by your doctor. It may take several weeks to find the right dose of perampanel for you.

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. Based 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.
• Do not take more perampanel than recommended by your doctor. It may take several weeks to find the right dose of perampanel for you.

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. Based 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.
• Do not take more perampanel than recommended by your doctor. It may take several weeks to find the right dose of perampanel for you.

How to Take

Swallow the tablet whole with a glass of water. Perampanel can be taken with or without food. Do not chew, crush, or break the tablet. The tablets cannot be divided exactly as they do not have a score line.

If You Take More Perampanel Cinfa Than You Should

If you have taken more perampanel 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

If You Forget to Take Perampanel Cinfa

• If you forget to take a tablet, wait until it is time to take 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, continue taking the daily tablet as originally instructed by your doctor.
• If you have missed more than 7 days of treatment with perampanel, talk to your doctor immediately.

If You Stop Taking Perampanel Cinfa

Take perampanel 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 prevent your seizures (convulsions) from returning or worsening.

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):

• feeling of 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 of extreme tiredness (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(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, SJS. This severe skin rash may appear as red target-shaped patches 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 of Adverse Effects

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: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Perampanel cinfa

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

Do not use this medicine after the expiration date that appears on the box and 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 away through wastewater or household waste. 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 cinfa

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: lactose monohydrate, low-substituted hydroxypropylcellulose, povidone, microcrystalline cellulose, and magnesium stearate.

Coating (2 mg tablets): Opadry Y-1-7000 (hypromellose (E-464), titanium dioxide (E-171), macrogol (E-1521)), red iron oxide (E-172), and yellow iron oxide (E-172).

Coating (4 mg and 6 mg tablets): Opadry Y-1-7000 (hypromellose (E-464), titanium dioxide (E-171), macrogol (E-1521)), red iron oxide (E-172).

Coating (8 mg tablets): Opadry Y-1-7000 (hypromellose (E-464), titanium dioxide (E-171), macrogol (E-1521)), red iron oxide (E-172), black iron oxide (E-172), and yellow iron oxide (E-172).

Coating (10 mg tablets): Opadry Y-1-7000 (hypromellose (E-464), titanium dioxide (E-171), macrogol (E-1521)), indigo carmine (E-132), and yellow iron oxide (E-172).

Coating (12 mg tablets): Opadry Y-1-7000 (hypromellose (E-464), titanium dioxide (E-171), macrogol (E-1521)), indigo carmine (E-132).

Appearance of the Product and Package Contents

All concentrations of Perampanel cinfa are film-coated, cylindrical, biconvex tablets without a score.

2 mg: orange in color and with a "2" on one of the faces.

4 mg: red in color and with a "4" on one of the faces.

6 mg: pink in color and with a "6" on one of the faces.

8 mg: purple in color and with an "8" on one of the faces.

10 mg: green in color and with a "10" on one of the faces.

12 mg: blue in color and with a "12" on one of the faces.

Perampanel cinfa is presented in PVC-PVDC/aluminum blister packs of:

2 mg tablet - pack of 7 and 28 tablets.

4 mg, 6 mg, 8 mg, 10 mg, and 12 mg tablets - packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the Last Revision of this Prospectus: June 2025

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

Perampanel cinfa 2 mg film-coated tablets EFG

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/90387/P_90387.html

QR code to: https://cima.aemps.es/cima/dochtml/p/90387/P_90387.html

Perampanel cinfa 4 mg film-coated tablets EFG

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/90388/P_90388.html

QR code to: https://cima.aemps.es/cima/dochtml/p/90388/P_90388.html

Perampanel cinfa 6 mg film-coated tablets EFG

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/90389/P_90389.html

QR code to: https://cima.aemps.es/cima/dochtml/p/90389/P_90389.html

Perampanel cinfa 8 mg film-coated tablets EFG

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/90386/P_90386.html

QR code to: https://cima.aemps.es/cima/dochtml/p/90386/P_90386.html

Perampanel cinfa 10 mg film-coated tablets EFG

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/90394/P_90394.html

QR code to: https://cima.aemps.es/cima/dochtml/p/90394/P_90394.html

Perampanel cinfa 12 mg film-coated tablets EFG

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/90393/P_90393.html

QR code to: https://cima.aemps.es/cima/dochtml/p/90393/P_90393.html