Ampenaia

Patient Information Leaflet: Information for the Patient

Ampenaia 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

perampanel
Generic medicine
Please read this leaflet carefully before taking this medicine because 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 you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Ampenaia is and what it is used for
2. What you need to know before taking Ampenaia
3. How to take Ampenaia
4. Possible side effects
5. How to store Ampenaia
6. Package contents and other information

1. What Ampenaia is and what it is used for

Ampenaia contains an active substance called perampanel. It belongs to a group of medicines
called antiepileptics. These medicines are used for the treatment of epilepsy, a condition in
which a person has repeated seizures (epileptic seizures). Your doctor has prescribed it for you to reduce the
number of epileptic seizures.
Ampenaia is used in combination with other antiepileptic medicines for the treatment of certain forms 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 seizures”).
• These partial 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 should know before taking Ampenaia

DO NOT TAKE Ampenaia:

• 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 Ampenaia if you have liver problems or moderate to severe kidney problems.
You must not take Ampenaia 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 Ampenaia in combination with other antiepileptic drugs.

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

A small number of people treated with antiepileptic medicines have had thoughts about harming themselves or taking their own life. If you have these 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 rash accompanied by high body temperature, elevated liver enzyme levels 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, usually located on the trunk. In addition, ulcers may develop in the mouth, throat, nose, genitals and eyes (red, swollen eyes). These serious skin rashes are often preceded by fever and/or flu-like symptoms. Skin rashes may progress to widespread peeling and potentially life-threatening complications, or may be fatal.

If any of the above occur after taking Ampenaia (or if you are unsure), consult your doctor or pharmacist.
Children
Ampenaia is not recommended for 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 Ampenaia
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 Ampenaia with certain other medicines may cause unwanted 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 epileptic seizures, may affect Ampenaia. 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 Ampenaia. 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 (sudden) seizures, for sedation and for sleep problems) may be affected by Ampenaia. 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 (used for mild anxiety) and ketoconazole (used to treat fungal infections), may affect Ampenaia. 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 using hormonal contraceptives. Ampenaia may reduce the effectiveness of certain hormonal contraceptives, such as levonorgestrel. During treatment with Ampenaia, you should 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 which contraceptive method is suitable for you.

Ampenaia and alcohol
Consult your doctor before drinking alcohol. Be cautious about alcohol consumption when taking antiepileptic medicines, including Ampenaia.

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

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor for advice before taking this medicine. Do not stop treatment without first discussing it with your doctor.

• Ampenaia is not recommended during pregnancy.
• To avoid becoming pregnant during treatment with Ampenaia, 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. Ampenaia may reduce the effectiveness of certain hormonal contraceptives, such as levonorgestrel. During treatment with Ampenaia, you should 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 which contraceptive method is suitable for you. It is not known whether the components of Ampenaia pass into breast milk. Your doctor will assess the benefits and risks to the baby if treatment with Ampenaia is needed during breastfeeding.

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

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

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

3. How to take Ampenaia

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 seizures and generalized seizures:
The usual starting dose is 2 mg once daily before bedtime.

• Your doctor may increase this dose by increments of 2 mg, 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 should 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 Ampenaia higher than that recommended by your doctor. It may take several weeks to find the right dose of Ampenaia for you. The table below 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. 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 seizures:
The usual initial dose is 2 mg once daily before bedtime.

• The doctor may increase this dose in increments of 2 mg, up to a maintenance dose between 4 mg and 8 mg, depending on the 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 higher dose of Ampenaia than that recommended by the doctor. It may take several weeks to find the correct dose of Ampenaia for the child.

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

• The doctor may increase this dose in increments of 1 mg, up to a maintenance dose between 4 mg and 6 mg, depending on the 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 higher dose of Ampenaia than that recommended by the doctor. It may take several weeks to find the correct dose of Ampenaia for the child.

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

• The doctor may increase this dose in increments of 1 mg, up to a maintenance dose between 2 mg and 4 mg, depending on the 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 higher dose of Ampenaia than that recommended by the doctor. It may take several weeks to find the correct dose of Ampenaia for the child.

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

• The doctor may increase this dose in increments of 2 mg, up to a maintenance dose between 4 mg and 8 mg, depending on the 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 higher dose of Ampenaia than that recommended by the doctor. It may take several weeks to find the correct dose of Ampenaia for the child.

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

• The doctor may increase this dose in increments of 1 mg, up to a maintenance dose between 4 mg and 6 mg, depending on the 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 higher dose of Ampenaia than that recommended by the doctor. It may take several weeks to find the correct dose of Ampenaia for the child.

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

• The doctor may increase this dose in increments of 1 mg, up to a maintenance dose between 2 mg and 4 mg, depending on the 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 higher dose of Ampenaia than that recommended by the doctor. It may take several weeks to find the correct dose of Ampenaia for the child.

How to take Ampenaia
The tablet should be swallowed whole with a glass of water. You may take Ampenaia with or without food.
Do not chew, crush, or divide the tablet. The tablets cannot be accurately divided because they do not have a score line.

If you take more Ampenaia than you should
If you have taken more Ampenaia than you should, contact your doctor immediately. Symptoms such as confusion, agitation, aggressive behavior, and reduced level of consciousness may occur.

If you forget to take Ampenaia

• 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 missed dose.
• If you have missed less than 7 days of Ampenaia treatment, continue taking the daily tablet according to the doctor's initial instructions.
• If you have missed more than 7 days of Ampenaia treatment, inform your doctor immediately.

If you stop taking Ampenaia
Take Ampenaia for the entire duration recommended by your doctor. Do not stop treatment unless instructed by your doctor. The doctor may gradually reduce the dose to prevent seizures (epileptic seizures) from recurring or worsening. If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
A small number of people treated with antiepileptic medicines have had thoughts about harming themselves or ending their life. If at any time you have such thoughts, contact your doctor immediately.

Very common: may affect more than 1 in 10 people

• dizziness
• feeling sleepy (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 abnormality, disturbance of equilibrium]
• slowness of speech (dysarthria)
• blurred vision or double vision (diplopia)
• feeling of vertigo
• nausea
• back pain
• feeling very tired (fatigue)
• fall

Uncommon: may affect up to 1 in 100 people

• thoughts of self-harm or of ending your life (suicidal thoughts), attempt to end your life (suicide attempt)
• hallucinations (seeing, hearing or sensing things that do not exist)
• abnormal thinking and/or loss of contact with reality (psychotic disorder)

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 rash may appear as red spots “target-like” or circular spots often with central blisters on the trunk, skin peeling, mouth ulcers, sores in throat, nose, genitals and eyes and may be preceded by fever and flu-like symptoms. Stop taking perampanel if you develop these symptoms and contact your doctor or seek immediate medical help. See also section 2.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to 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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Ampenaia

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 any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Ampenaia contains
The active substance is perampanel.
Ampenaia 2 mg film-coated tablets
Each film-coated tablet contains 2.08 mg of perampanel sesquihydrate, equivalent to 2 mg of
perampanel.
Ampenaia 4 mg film-coated tablets
Each film-coated tablet contains 4.15 mg of perampanel sesquihydrate, equivalent to 4 mg of
perampanel.
Ampenaia 6 mg film-coated tablets
Each film-coated tablet contains 6.23 mg of perampanel sesquihydrate, equivalent to 6 mg of
perampanel.
Ampenaia 8 mg film-coated tablets
Each film-coated tablet contains 8.31 mg of perampanel sesquihydrate, equivalent to 8 mg of
perampanel.
Ampenaia 10 mg film-coated tablets
Each film-coated tablet contains 10.39 mg of perampanel sesquihydrate, equivalent to 10 mg of
perampanel.
Ampenaia 12 mg film-coated tablets
Each film-coated tablet contains 12.46 mg of perampanel sesquihydrate, equivalent to 12 mg of
perampanel.

The other components are:
Tablet core:
Monohydrate lactose, low-substituted hydroxypropylcellulose, povidone, microcrystalline cellulose,
magnesium stearate
Tablet coating:
Hypromellose, talc, macrogol 8000, titanium dioxide, colourants*
*The colourants are:
2 mg tablet: Iron oxide yellow (E172), Iron oxide red (E172)
4 mg tablet: Iron oxide red (E172)
6 mg tablet: Iron oxide red (E172)
8 mg tablet: Iron oxide red (E172), Iron Oxide, Black (E172)
10 mg tablet: Iron oxide yellow (E172), Indigo carmine aluminium lake (E132)
12 mg tablet: Indigo carmine aluminium lake (E132)

Description of the appearance of Ampenaia and pack contents
All Ampenaia tablets are biconvex, round, film-coated tablets.
2 mg: orange, marked with L1 on one side and smooth on the other
4 mg: red, marked with L2 on one side and smooth on the other
6 mg: pink, marked with L3 on one side and smooth on the other
8 mg: purple, marked with L4 on one side and smooth on the other
10 mg: green, marked with L5 on one side and smooth on the other
12 mg: blue, marked with L6 on one side and smooth on the other

Ampenaia is available in the following pack sizes:
2 mg tablet – pack of 7 and 28
4 mg, 6 mg, 8 mg, 10 mg, 12 mg tablets – pack of 7, 28 and 98
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Desitin Arzneimittel GmbH
Weg beim Jäger 214
22335 Hamburg
Germany

This medicinal product is authorised in the European Economic Area countries under the
following names:
Germany Ampenaia 2 mg Filmtabletten
Ampenaia 4 mg Filmtabletten
Ampenaia 6 mg Filmtabletten
Ampenaia 8 mg Filmtabletten
Ampenaia 10 mg Filmtabletten
Ampenaia 12 mg Filmtabletten
Czech Republic Ampenaia
Spain Ampenaia 2 mg comprimido recubierto con película
Ampenaia 4 mg comprimido recubierto con película
Ampenaia 6 mg comprimido recubierto con película
Ampenaia 8 mg comprimido recubierto con película
Ampenaia 10 mg comprimido recubierto con película
Ampenaia 12 mg comprimido recubierto con película
Italy Ampenaia
Slovakia Ampenaia 2 mg filmom obalená tablety
Ampenaia 4 mg filmom obalená tablety
Ampenaia 6 mg filmom obalená tablety
Ampenaia 8 mg filmom obalená tablety
Ampenaia 10 mg filmom obalená tablety
Ampenaia 12 mg filmom obalená tablety