Perampanel EG

Package leaflet: Information for the patient

Perampanel EG 2 mg film-coated tablets, 4 mg film-coated tablets, 6 mg film-coated tablets, 8 mg film-coated tablets, 10 mg film-coated tablets, 12 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. 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 the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Perampanel EG contains the active substance 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 seizures (epileptic seizures). Your doctor has prescribed it to you to reduce the number of epileptic seizures you experience.

Perampanel EG is used in combination with other antiepileptic medicines for the treatment of certain types of epilepsy:

In adults, adolescents (aged 12 years and older), and children (aged between 4 and 11 years):

• It is used to treat epileptic seizures affecting one part of the brain (called "partial epileptic seizures").
• These partial epileptic seizures may or may not be followed by a seizure affecting the entire brain (called "secondary generalization").

In adults, adolescents (aged 12 years and older), and children (aged between 7 and 11 years):

• It is also used to treat certain epileptic seizures that affect the entire brain from the onset (called "generalized seizures") and that cause convulsions or absence seizures.

2. What you need to know before taking Perampanel EG

Do not take Perampanel EG

• if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth ulcers after taking perampanel;
• if you are allergic to perampanel or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Perampanel EG if you have liver problems or moderate to severe kidney problems.
You must not take Perampanel EG if you have severe liver problems or moderate to severe kidney problems.
Before taking this medicine, inform your doctor if you have previously had problems with alcoholism or drug dependence.
Increased liver enzymes have been reported in some patients taking perampanel in combination with other antiepileptic drugs.

• Perampanel EG may cause dizziness or drowsiness, especially at the beginning of treatment.
• Perampanel EG may increase the risk of falls, particularly in elderly people; this may be due to the underlying disease.
• Perampanel EG may cause aggression, anger or violence. It may also cause unusual or extreme changes in your behaviour or mood, abnormal thoughts and/or loss of contact with reality. If you, your family members and/or friends notice any of these reactions, consult your doctor or pharmacist.

A small number of patients treated with antiepileptic medicines have had thoughts about harming themselves or suicide. If you have such thoughts at any time, contact your doctor immediately.
Serious skin reactions have been reported with the use of perampanel, including drug reaction with eosinophilia and systemic symptoms (DRESS) and Stevens-Johnson syndrome (SJS).

• DRESS usually presents, although not exclusively, with flu-like symptoms and a skin rash accompanied by high body temperature, increased levels of liver enzymes found in blood tests, an increase in a type of white blood cells (eosinophilia), and swollen lymph nodes.
• Stevens-Johnson syndrome (SJS) may initially appear as red, target-like spots or circular patches, often with central blisters, located on the trunk. In addition, ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes) may occur. These serious skin reactions are often preceded by fever and/or flu-like symptoms. The skin rashes may progress to widespread skin exfoliation and life-threatening or fatal complications. If any of the above cases occur after taking Perampanel EG (or if you are unsure), consult your doctor or pharmacist.

Children
Perampanel EG is not recommended 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 and under 7 years of age for generalized seizures.

Other medicines and Perampanel EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription and herbal medicines. Taking Perampanel EG with certain other medicines may cause side effects or affect their action. Do not start or stop treatment with other medicines without consulting your doctor or pharmacist.

• Other antiepileptic medicines, such as carbamazepine, oxcarbazepine, and phenytoin, used to treat seizures, may affect Perampanel EG. 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 Perampanel EG. 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 prolonged acute convulsive seizures, for sedation, and for sleep problems) may be affected by Perampanel EG. Inform your doctor if you are taking midazolam, as your dose may need to be adjusted.
• Other medicines, such as rifampicin (used to treat bacterial infections), St. John’s wort (a herbal remedy used for mild anxiety), and ketoconazole (used to treat fungal infections), may affect Perampanel EG. 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. Perampanel EG may reduce the effectiveness of some hormonal contraceptives, such as levonorgestrel. During treatment with Perampanel EG, you must use other effective and reliable contraceptive methods (such as condoms or an intrauterine device) and continue using them for one month after stopping treatment. Discuss with your doctor the most suitable contraceptive method for you.

Perampanel EG and alcohol
Consult your doctor before drinking alcohol. Be cautious about alcohol consumption when taking medicines for epilepsy, including Perampanel EG.

• Drinking alcohol during treatment with Perampanel EG may reduce your level of alertness and affect your ability to drive or operate tools or machinery.
• Drinking alcohol during treatment with Perampanel EG may also worsen possible feelings of anger, confusion, or sadness.

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

• The use of Perampanel EG is not recommended during pregnancy.
• To avoid becoming pregnant during treatment with Perampanel EG, you must use a reliable method of contraception and continue using it for one month after stopping treatment. Inform your doctor if you are taking hormonal contraceptives. Perampanel EG may reduce the effectiveness of some hormonal contraceptives, such as levonorgestrel. During treatment with Perampanel EG, you must use other effective and safe contraceptive methods (such as condoms or an intrauterine device) and continue using them for one month after stopping treatment. Discuss with your doctor the most suitable contraceptive method for you. It is not known whether the components of Perampanel EG pass into breast milk. Your doctor will assess the benefits and risks to the baby if treatment with Perampanel EG is necessary during breastfeeding.

Driving and using machines
Do not drive or operate machinery until you are certain how Perampanel EG affects you. Talk to your doctor about the effects of epilepsy on driving and operating machinery.

• Perampanel EG may cause dizziness or drowsiness, especially at the beginning of treatment. If this occurs, do not drive or use tools or machinery.
• Drinking alcohol during treatment with Perampanel EG may worsen these effects.

Perampanel EG contains lactose
Perampanel EG contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Perampanel EG

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Dosage
Adults and adolescents (aged 12 years and older) for the treatment of partial-onset seizures and generalized tonic-clonic seizures:
The usual starting dose is 2 mg taken once daily before bedtime.

• Your doctor may increase this dose in 2 mg increments, up to a maintenance dose ranging from 4 mg to 12 mg, depending on your response to treatment.
• If you have mild or moderate liver problems, the dose must not exceed 8 mg per day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Perampanel EG higher than that recommended by your doctor. It may take several weeks to find the right dose of Perampanel EG for you.

The following table summarizes the recommended doses for the treatment of partial-onset seizures in children
aged 4 to 11 years and generalized tonic-clonic seizures in children aged 7 to 11
years. Further details are provided below the table.

Children (aged 4 to 11 years) weighing at least 30 kg or more in the treatment of partial epileptic seizures:
The usual starting dose is 2 mg once daily before bedtime.

• The doctor may increase this dose in 2 mg increments, up to a maintenance dose ranging from 4 mg to 8 mg, depending on response to treatment. Depending on individual clinical response and tolerability, the dose may be increased up to a maximum dose of 12 mg/day.
• If the child has mild or moderate liver problems, the dose must not exceed 4 mg per day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Perampanel EG higher than that recommended by the doctor. It may take several weeks to find the correct dose of Perampanel EG for the child.

Children (aged 4 to 11 years) weighing between 20 kg and less than 30 kg in the treatment of partial epileptic seizures:
The usual starting dose is 1 mg once daily before bedtime.

• The doctor may increase this dose in 1 mg increments, up to a maintenance dose ranging from 4 mg to 6 mg, depending on response to treatment. Depending on individual clinical response and tolerability, the dose may be increased up to a maximum dose of 8 mg/day.
• If the child has mild or moderate liver problems, the dose must not exceed 4 mg per day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Perampanel EG higher than that recommended by the doctor. It may take several weeks to find the correct dose of Perampanel EG for the child.

Children (aged 4 to 11 years) weighing less than 20 kg in the treatment of partial epileptic seizures:
The usual starting dose is 1 mg once daily before bedtime.

• The doctor may increase this dose in 1 mg increments, up to a maintenance dose ranging from 2 mg to 4 mg, depending on response to treatment. Depending on individual clinical response and tolerability, the dose may be increased up to a maximum dose of 6 mg/day.
• If the child has mild or moderate liver problems, the dose must not exceed 4 mg per day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Perampanel EG higher than that recommended by the doctor. It may take several weeks to find the correct dose of Perampanel EG for the child.

Children (aged 7 to 11 years) weighing at least 30 kg or more in the treatment of generalized epileptic seizures:
The usual starting dose is 2 mg once daily before bedtime.

• The doctor may increase this dose in 2 mg increments, up to a maintenance dose ranging from 4 mg to 8 mg, depending on response to treatment. Depending on individual clinical response and tolerability, the dose may be increased up to a maximum dose of 12 mg/day.
• If the child has mild or moderate liver problems, the dose must not exceed 4 mg per day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Perampanel EG higher than that recommended by the doctor. It may take several weeks to find the correct dose of Perampanel EG for the child.

Children (aged 7 to 11 years) weighing between 20 kg and less than 30 kg in the treatment of generalized epileptic seizures:
The usual starting dose is 1 mg once daily before bedtime.

• The doctor may increase this dose in 1 mg increments, up to a maintenance dose ranging from 4 mg to 6 mg, depending on response to treatment. Depending on individual clinical response and tolerability, the dose may be increased up to a maximum dose of 8 mg/day.
• If the child has mild or moderate liver problems, the dose must not exceed 4 mg per day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Perampanel EG higher than that recommended by the doctor. It may take several weeks to find the correct dose of Perampanel EG for the child.

Children (aged 7 to 11 years) weighing less than 20 kg in the treatment of generalized epileptic seizures:
The usual starting dose is 1 mg once daily before bedtime.

• The doctor may increase this dose in 1 mg increments, up to a maintenance dose ranging from 2 mg to 4 mg, depending on response to treatment. Depending on individual clinical response and tolerability, the dose may be increased up to a maximum dose of 6 mg/day.
• If the child has mild or moderate liver problems, the dose must not exceed 4 mg per day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Perampanel EG higher than that recommended by the doctor. It may take several weeks to find the correct dose of Perampanel EG for the child.

How to take Perampanel EG
Perampanel EG is for oral use. Swallow the tablet whole with a glass of water. You may take Perampanel EG with or without food. Do not chew, crush, or split the tablet. The tablets cannot be accurately divided into equal halves because they do not have a score line.

If you take more Perampanel EG than you should
If you take more Perampanel EG than you should, contact your doctor immediately. Symptoms such as confusion, agitation, aggressive behaviour, and reduced level of consciousness may occur.

If you forget to take Perampanel EG

• If you forget to take a tablet, wait until the next scheduled dose and then continue as usual.
• Do not take a double dose to make up for the forgotten dose.
• If you have missed less than 7 days of Perampanel EG treatment, continue taking the daily tablet according to your doctor's initial instructions.
• If you have missed more than 7 days of Perampanel EG treatment, inform your doctor immediately.

If you stop taking Perampanel EG
Take Perampanel EG for as long as recommended by your doctor. Do not stop treatment unless instructed by your doctor. Your doctor may gradually reduce the dose to avoid recurrence or worsening of seizures.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
A small number of patients treated with antiepileptic medicines have had thoughts of harming themselves or of suicide. If you experience such thoughts at any time, contact your doctor immediately.

Very common (may affect more than 1 in 10 people):

• dizziness
• drowsiness (lethargy or somnolence)

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

• reduced or increased appetite, weight gain
• aggression, anger, irritability, anxiety, or confusion
• difficulty walking or other balance problems [ataxia (loss of muscular coordination), gait disturbance, balance disorder]
• slurred speech (dysarthria)
• blurred or double vision (diplopia)
• dizziness (vertigo)
• feeling unwell (nausea)
• back pain
• feeling very tired (fatigue)
• falls

Uncommon (may affect up to 1 in 100 people):

• thoughts of self-harm or suicide (suicidal thoughts), suicide attempt
• hallucinations (seeing, hearing, or perceiving things that do not exist)
• abnormal thoughts and/or loss of contact with reality (psychotic disorder)

Frequency not known (frequency 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, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs.
• Stevens-Johnson syndrome (SJS). This serious skin reaction may appear as red, target-like spots or circular patches, often with central blisters, usually on the trunk, skin peeling, mouth, throat, nose, genital, and eye ulcers, and may be preceded by fever and flu-like symptoms.

Stop taking perampanel if you develop any of these symptoms and contact your doctor or seek immediate medical attention. See also section 2.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Perampanel EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the
last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Perampanel EG contains
The active substance is perampanel.
Perampanel EG 2 mg film-coated tablets
Each film-coated tablet contains 2 mg of perampanel.
Perampanel EG 4 mg film-coated tablets
Each film-coated tablet contains 4 mg of perampanel.
Perampanel EG 6 mg film-coated tablets
Each film-coated tablet contains 6 mg of perampanel.
Perampanel EG 8 mg film-coated tablets
Each film-coated tablet contains 8 mg of perampanel.
Perampanel EG 10 mg film-coated tablets
Each film-coated tablet contains 10 mg of perampanel.
Perampanel EG 12 mg film-coated tablets
Each film-coated tablet contains 12 mg of perampanel.

The other components are:
Tablet core
Monohydrate lactose, microcrystalline cellulose, low-substituted hydroxypropylcellulose, povidone K 29/32, microcrystalline cellulose, magnesium stearate.

Coating
Perampanel EG 2 mg film-coated tablets
Hypromellose 3cp
Titanium dioxide (E171)
Talc
Macrogol 3350
Red iron oxide (E172)
Yellow iron oxide (E172)

Perampanel EG 4 mg, 6 mg film-coated tablets
Hypromellose 3cp
Titanium dioxide (E171)
Talc
Macrogol 3350
Red iron oxide (E172)

Perampanel EG 8 mg film-coated tablets
Hypromellose 3cp
Titanium dioxide (E171)
Talc
Macrogol 3350
Red iron oxide (E172)
Yellow iron oxide (E172)
Indigo carmine (E132)

Perampanel EG 10 mg film-coated tablets
Hypromellose 3cp
Titanium dioxide (E171)
Talc
Macrogol 3350
Yellow iron oxide (E172)
Indigo carmine (E132)

Perampanel EG 12 mg film-coated tablets
Hypromellose 3cp
Titanium dioxide (E171)
Talc
Macrogol 3350
Indigo carmine (E132)

Description of the appearance of Perampanel EG and contents of the pack
Film-coated tablet
Perampanel EG 2 mg: orange, biconvex, round, film-coated tablets with "2" engraved on one side and smooth on the other side.
Perampanel EG 4 mg: red, biconvex, round, film-coated tablets with "4" engraved on one side and smooth on the other side.
Perampanel EG 6 mg: pink, biconvex, round, film-coated tablets with "6" engraved on one side and smooth on the other side.
Perampanel EG 8 mg: purple, biconvex, round, film-coated tablets with "8" engraved on one side and smooth on the other side.
Perampanel EG 10 mg: green, biconvex, round, film-coated tablets with "10" engraved on one side and smooth on the other side.
Perampanel EG 12 mg: blue, biconvex, oval, film-coated tablets with "12" engraved on one side and smooth on the other side.

Perampanel EG is available in packs containing 7, 28 and 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milano, Italy

Manufacturers
Elpen Pharmaceutical Co. Inc
95 Marathonos Ave., Pikermi, Attiki, 19009, Greece
STADA Arzneimittel AG
Stadastrasse 2-18, Bad Vilbel, 61118, Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
DE Perampanel AL 2 mg; 4 mg; 6 mg; 8 mg; 10 mg; 12 mg Filmtabletten
IT Perampanel EG 2 mg; 4 mg; 6 mg; 8 mg; 10 mg; 12 mg Compresse rivestite con film