Perampanel Doc Generici

Package leaflet: Information for the patient

PERAMPANEL DOC 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
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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What PERAMPANEL DOC is and what it is used for

PERAMPANEL DOC contains the active substance 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 to reduce the
number of epileptic seizures.
PERAMPANEL DOC 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 for the treatment of 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 for the treatment of 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 DOC

DO NOT TAKE PERAMPANEL DOC:

• 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 DOC if you have liver problems
or moderate to severe kidney problems.
You must not take PERAMPANEL DOC 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.
Cases of increased liver enzymes have been reported in some patients taking
PERAMPANEL DOC in combination with other antiepileptic drugs.

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

A small number of people treated with antiepileptic medicines have had thoughts of harming themselves or of suicide. If at any time you have these thoughts, 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 elevated body temperature, increased levels of liver enzymes found in blood tests, an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes.
• Stevens-Johnson syndrome (SJS) may initially appear as red spots “target-like” or circular patches, often with central blisters, located on the trunk. In addition, mouth, throat, nose, genital and eye ulcers (red and swollen eyes) may occur. 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 conditions occur after taking PERAMPANEL DOC (or if in doubt), consult your doctor or pharmacist.
Children
PERAMPANEL DOC 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 PERAMPANEL DOC
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 DOC 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 epileptic seizures, may affect PERAMPANEL DOC. 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 DOC. 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 PERAMPANEL DOC. Inform 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 DOC. 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 DOC may reduce the effectiveness of some hormonal contraceptives, such as levonorgestrel. During treatment with PERAMPANEL DOC, 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 contraceptive method suitable for you.

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

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

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

• PERAMPANEL DOC is not recommended during pregnancy.
• To avoid becoming pregnant during treatment with PERAMPANEL DOC, 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 DOC may reduce the effectiveness of some hormonal contraceptives, such as levonorgestrel. During treatment with PERAMPANEL DOC, 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 contraceptive method suitable for you. It is not known whether the components of PERAMPANEL DOC pass into breast milk. Your doctor will evaluate the benefits and risks for the infant if treatment with PERAMPANEL DOC is necessary during breastfeeding.

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

• PERAMPANEL DOC 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 PERAMPANEL DOC may worsen these effects.

PERAMPANEL DOC contains lactose
PERAMPANEL DOC contains lactose (a type of sugar). If your doctor has diagnosed you with an
intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take PERAMPANEL DOC

Take this medicine exactly as instructed 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, taken before bedtime.

• Your doctor may increase this dose by increments of 2 mg, up to a maintenance dose ranging between 4 mg and 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 two weeks.
• Do not take more PERAMPANEL DOC than your doctor has prescribed. It may take several weeks to find the correct dose of PERAMPANEL DOC for you.

The table below summarizes the recommended doses for 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.

| Child’s weight: | ≥ 30 kg | 20 to < 30 kg | < 20 kg | |-----------------|--------|-------------|--------| | Recommended starting dose | 2 mg/day | 1 mg/day | 1 mg/day | | Recommended maintenance dose | 4–8 mg/day | 4–6 mg/day | 2–4 mg/day | | Recommended maximum dose | 12 mg/day | 8 mg/day | 6 mg/day |

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

• Your doctor may increase this dose by increments of 2 mg, up to a maintenance dose ranging 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 should not exceed 4 mg per day, and dose increases should be made at intervals of at least two weeks.
• Do not take more PERAMPANEL DOC than prescribed by your doctor. It may take several weeks to find the correct dose of PERAMPANEL DOC for the child.

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

• Your doctor may increase this dose by increments of 1 mg, up to a maintenance dose ranging 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 should not exceed 4 mg per day, and dose increases should be made at intervals of at least two weeks.
• Do not take more PERAMPANEL DOC than prescribed by your doctor. It may take several weeks to find the correct dose of PERAMPANEL DOC for the child.

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

• Your doctor may increase this dose by increments of 1 mg, up to a maintenance dose ranging 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 should not exceed 4 mg per day, and dose increases should be made at intervals of at least two weeks.
• Do not take more PERAMPANEL DOC than prescribed by your doctor. It may take several weeks to find the correct dose of PERAMPANEL DOC for the child.

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

• Your doctor may increase this dose by increments of 2 mg, up to a maintenance dose ranging 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 should not exceed 4 mg per day, and dose increases should be made at intervals of at least two weeks.
• Do not take more PERAMPANEL DOC than prescribed by your doctor. It may take several weeks to find the correct dose of PERAMPANEL DOC for the child.

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

• Your doctor may increase this dose by increments of 1 mg, up to a maintenance dose ranging 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 should not exceed 4 mg per day, and dose increases should be made at intervals of at least two weeks.
• Do not take more PERAMPANEL DOC than prescribed by your doctor. It may take several weeks to find the correct dose of PERAMPANEL DOC for the child.

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

• Your doctor may increase this dose by increments of 1 mg, up to a maintenance dose ranging 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 should not exceed 4 mg per day, and dose increases should be made at intervals of at least two weeks.
• Do not take more PERAMPANEL DOC than prescribed by your doctor. It may take several weeks to find the correct dose of PERAMPANEL DOC for the child.

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

If you take more PERAMPANEL DOC than you should
If you have taken more PERAMPANEL DOC than prescribed, contact your doctor immediately. Symptoms may include confusion, agitation, aggressive behavior, and reduced level of consciousness.

If you forget to take PERAMPANEL DOC

• If you forget to take a dose, wait until your next scheduled dose and then continue as usual.
• Do not take a double dose to make up for a missed dose.
• If you have missed less than 7 days of treatment with PERAMPANEL DOC, continue taking your daily tablet as originally instructed by your doctor.
• If you have missed more than 7 days of treatment with PERAMPANEL DOC, contact your doctor immediately.

If you stop taking PERAMPANEL DOC
Take PERAMPANEL DOC for the entire duration 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 (epileptic attacks).

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
A small number of people treated with antiepileptic medicines have had thoughts of harming themselves or of suicide. If at any time you experience 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 muscle coordination), gait disturbance, balance disorder]
• 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 suicide (suicidal thoughts), attempt to take own 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 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 or eye ulcers, and may be preceded by fever and flu-like symptoms.

Stop using perampanel if you develop any of these symptoms and contact your doctor or seek immediate medical advice. See also section 2.
Reporting of side effects
If you experience any side effect, including those 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PERAMPANEL DOC

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 pack. 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. Package contents and other information

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

Film coating
PERAMPANEL DOC 2 mg film-coated tablets
Hypromellose 3cp
Titanium dioxide (E171)
Talc
Macrogol 3350
Iron oxide red (E172)
Iron oxide yellow (E172)

PERAMPANEL DOC 4 mg, 6 mg film-coated tablets
Hypromellose 3cp
Titanium dioxide (E171)
Talc
Macrogol 3350
Iron oxide red (E172)

PERAMPANEL DOC 8 mg film-coated tablets
Hypromellose 3cp
Titanium dioxide (E171)
Talc
Macrogol 3350
Iron oxide red (E172)
Iron oxide yellow (E172)
Indigo carmine (E132)

PERAMPANEL DOC 10 mg film-coated tablets
Hypromellose 3cp
Titanium dioxide (E171)
Talc
Macrogol 3350
Iron oxide yellow (E172)
Indigo carmine (E132)

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

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

PERAMPANEL DOC is available in packs of:
PERAMPANEL DOC 2 mg – packs of 7 and 28 film-coated tablets
PERAMPANEL DOC 4 mg – packs of 7, 28 and 98 film-coated tablets
PERAMPANEL DOC 6 mg, 8 mg, 10 mg, 12 mg – packs of 28 and 98 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan - Italy

Manufacturer
Elpen Pharmaceutical Co. Inc., Marathonos Avenue 95, Pikermi, 19009 Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Germany Perampanel DOC 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, 12 mg Filmtabletten
Italy PERAMPANEL DOC