PERAMPANEL VIVANTA 12 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Perampanel Vivanta 2 mg film-coated tablets EFG

Perampanel Vivanta 4 mg film-coated tablets EFG

Perampanel Vivanta 6 mg film-coated tablets EFG

Perampanel Vivanta 8 mg film-coated tablets EFG

Perampanel Vivanta 10 mg film-coated tablets EFG

Perampanel Vivanta 12 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this 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 leaflet. See section 4.

Contents of the pack

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

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

Perampanel Vivanta 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 certain 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 whole 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 whole brain from the start (“generalized seizures”) and cause convulsions.

2. What you need to know before you take Perampanel Vivanta

DO NOT TAKE Perampanel Vivanta:

• if you have ever had a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth 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.

You should 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 together 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 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 at any time you have these thoughts, 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 is normally, although not exclusively, characterized by flu-like symptoms and a rash with high 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 spots or circular patches, often with blisters in the center, located on the trunk. Ulcerations 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 Vivanta

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 safe and effective contraceptive methods (such as condoms or an intrauterine device) when taking perampanel. You should continue to do this for a month after stopping treatment. Talk to your doctor about which contraceptive method is suitable for you.

Taking Perampanel Vivanta 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 make your alertness decrease and affect your ability to drive or use tools and machines.
• Drinking alcohol while taking perampanel 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 are planning to have a baby, 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 contraceptive method 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 safe and effective contraceptive methods (such as condoms or an intrauterine device) when taking perampanel. You should also do this for a month after stopping treatment. Talk to your doctor about which contraceptive method is suitable for you.

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

Your doctor will weigh the benefits of treatment with perampanel 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 perampanel affects you.

Talk to your doctor about the effects of epilepsy on driving and using machines.

• Perampanel 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 may make these effects worse.

Perampanel Vivanta contains lactose

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

3. How to take Perampanel Vivanta

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take

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

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

• Your doctor may increase this dose in increments of 2 mg up 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 a day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take more perampanel than your doctor recommends. It may take a few weeks to find the right dose of perampanel for you.

The following table shows a summary of the recommended doses for the treatment of partial seizures in children from 4 to 11 years of age and generalized seizures in children from 7 to 11 years of age. 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 starting dose is 2 mg once a day before bedtime.

• Your doctor may increase this dose in increments of 2 mg up 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 a day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take more perampanel than your doctor recommends. It may take a few 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 starting dose is 1 mg once a day before bedtime.

• Your doctor may increase this dose in increments of 1 mg up 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 a day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take more perampanel than your doctor recommends. It may take a few 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 starting dose is 1 mg once a day before bedtime.

• Your doctor may increase this dose in increments of 1 mg up 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 a day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take more perampanel than your doctor recommends. It may take a few 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 starting dose is 2 mg once a day before bedtime.

• Your doctor may increase this dose in increments of 2 mg up 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 a day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take more perampanel than your doctor recommends. It may take a few 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 starting dose is 1 mg once a day before bedtime.

• Your doctor may increase this dose in increments of 1 mg up 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 a day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take more perampanel than your doctor recommends. It may take a few 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 starting dose is 1 mg once a day before bedtime.

• Your doctor may increase this dose in increments of 1 mg up 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 a day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take more perampanel than your doctor recommends. It may take a few 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 broken exactly as they do not have a score line.

If you take more Perampanel Vivanta 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, talk to 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 Vivanta

• 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 your 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 Vivanta

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 coming back or getting worse.

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):

• dizziness sensation
• drowsiness (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 great fatigue (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 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 a possible adverse effect that does not appear in this prospectus. You can also report them directly through 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 Vivanta

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 on the blister, after CAD. 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 the sewers or in the trash. Deposit the packaging and any unused medicines in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging of medicines that are no longer needed. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Perampanel Vivanta

The active ingredient is perampanel.

Each film-coated tablet contains perampanel hydrate (4:3), equivalent to 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, microcrystalline cellulose (E460), low-substitution hydroxypropylcellulose, povidone (K-29/32), and magnesium stearate (E470b).

Film coating:

[2 mg]: hypromellose 2910 (E464), titanium dioxide (E171), macrogol 8000 (E1521), yellow iron oxide (E172), and red iron oxide (E172).

[4 mg]: hypromellose 2910 (E464), titanium dioxide (E171), macrogol 8000 (E1521), red iron oxide (E172), and talc (E553b).

[6 mg]: hypromellose 2910 (E464), titanium dioxide (E171), macrogol 8000 (E1521), and red iron oxide (E172).

[8 mg]: hypromellose 2910 (E464), titanium dioxide (E171), macrogol 8000 (E1521), talc (E553b), red iron oxide (E172), and black iron oxide (E172).

[10 mg and 12 mg]: hypromellose 2910 (E464), titanium dioxide (E171), macrogol 8000 (E1521), yellow iron oxide (E172), and indigo carmine, FD&C 2 (E 132).

Appearance of the Product and Package Contents

[2 mg]: orange, biconvex, round film-coated tablets, engraved with "P" on one side and "21" on the other.

[4 mg]: red brick-colored, biconvex, round film-coated tablets, engraved with "P" on one side and "22" on the other.

[6 mg]: pink, biconvex, round film-coated tablets, engraved with "P" on one side and "23" on the other.

[8 mg]: beige, biconvex, round film-coated tablets, engraved with "P" on one side and "24" on the other.

[10 mg]: green, biconvex, round film-coated tablets, engraved with "P" on one side and "25" on the other.

[12 mg]: blue, biconvex, round film-coated tablets, engraved with "P" on one side and "26" on the other.

Perampanel Vivanta is available in packages of:

2 mg:

Packages of 7 and 28 film-coated tablets.

Packages of 7 and 28 film-coated tablets in precut unit-dose blisters.

4 mg:

Packages of 7, 28, and 98 film-coated tablets.

Packages of 28 film-coated tablets in precut unit-dose blisters.

6 mg, 8 mg, 10 mg:

Packages of 28 and 98 film-coated tablets.

Packages of 28 film-coated tablets in precut unit-dose blisters.

12 mg:

Packages of 28 film-coated tablets.

Packages of 28 film-coated tablets in precut unit-dose blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder

Vivanta Generics s.r.o.

Trtinova 260/1, Cakovice,

19600, Prague 9

Czech Republic

Manufacturer

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park, Paola, PLA3000, Malta

or

MSN Labs Europe Limited

KW20A Corradino Park, Paola, PLA3000, Malta

This medicine is authorized in the Member States of the European Economic Areawith the following names:

Germany:Perampanel Vivanta 2 mg film-coated tablets

Perampanel Vivanta 4 mg film-coated tablets

Perampanel Vivanta 6 mg film-coated tablets

Perampanel Vivanta 8 mg film-coated tablets

Perampanel Vivanta 10 mg film-coated tablets

Perampanel Vivanta 12 mg film-coated tablets

Denmark:Perampanel Vivanta

Spain:Perampanel Vivanta 2 mg film-coated tablets EFG

Perampanel Vivanta 4 mg film-coated tablets EFG

Perampanel Vivanta 6 mg film-coated tablets EFG

Perampanel Vivanta 8 mg film-coated tablets EFG

Perampanel Vivanta 10 mg film-coated tablets EFG

Perampanel Vivanta 12 mg film-coated tablets EFG

Norway:Perampanel Vivanta

Sweden:Perampanel Vivanta 2 mg film-coated tablets

Perampanel Vivanta 4 mg film-coated tablets

Perampanel Vivanta 6 mg film-coated tablets

Perampanel Vivanta 8 mg film-coated tablets

Perampanel Vivanta 10 mg film-coated tablets

Perampanel Vivanta 12 mg film-coated tablets

Date of the Last Revision of this Prospectus 03/2025

Other Sources of Information

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/