FYCOMPA 2 mg Фильм-Coated Таблетки

Содержание инструкции

1. Fycompa 2 mg, 4 mg, 6 mg, 8 mg, 10 mg e 12 mg film-coated tablets
   1. What is Fycompa and what is it used for
   2. What you need to know before you take Fycompa
   3. How to take Fycompa
   4. Possible side effects
   5. How to store Fycompa
   6. Package contents and other information
2. Fycompa 0.5 mg/ml oral suspension
   1. What is Fycompa and what it is used for
   2. What you need to know before you take Fycompa
   3. How to use Fycompa
   4. Possible side effects
   5. How to store Fycompa
   6. Package contents and other information

Fycompa 2 mg, 4 mg, 6 mg, 8 mg, 10 mg e 12 mg film-coated tablets

Perampanel

Read this leaflet carefully before 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Fycompa and what is it used for

Fycompa contains a medicine 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). It has been prescribed by your doctor to reduce the
number of epileptic seizures.
Fycompa is used in association with other antiepileptic medicines for the treatment of certain forms of
epilepsy:
In adults, adolescents (age 12 years and older) and children (age between 4 and
11 years)

• It is used for the treatment of epileptic seizures that affect a part of the brain (called “partial seizures”).
• These partial seizures may or may not be followed by an epileptic seizure that affects the whole brain (called “secondary generalization”). In adults, adolescents (age 12 years and older) and children (age between 7 and 11 years)
• It is also used for the treatment of certain epileptic seizures that affect the whole brain from the beginning (called “generalized seizures”) and that cause convulsions or absence seizures.

2. What you need to know before you take Fycompa

DO NOT TAKE Fycompa:

• if you have ever developed a severe skin rash or skin exfoliation, blistering and/or ulcers 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 taking Fycompa if you have liver problems or moderate or
severe kidney problems.
Do not take Fycompa if you have severe liver problems or moderate or severe kidney problems.
Before taking this medicine, tell your doctor if you have a history of alcoholism or
drug addiction.
Cases of increased liver enzymes have been reported in some patients taking Fycompa in
combination with other antiepileptic drugs.

• Fycompa may cause dizziness or drowsiness, especially at the beginning of treatment.
• Fycompa may increase the likelihood of falls, particularly in the elderly; this may be due to the illness.
• Fycompa 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 notice any of these reactions, consult your doctor or pharmacist.

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

• DRESS usually manifests, although not exclusively, with flu-like symptoms and a rash with high body temperature, increased levels of liver enzymes found in blood tests and an increase in a type of white blood cells (eosinophilia) and enlargement of the lymph nodes.
• Initially, Stevens Johnson syndrome (SJS) may manifest as reddish “target” spots or circular patches often with central blisters located on the trunk. In addition, ulcers of the mouth, throat, nose, genitals and eyes (red and swollen eyes) may occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The skin rashes may progress to widespread peeling and potentially life-threatening or fatal complications.

If any of the above occur after taking Fycompa (or if you are unsure),
consult your doctor or pharmacist.

Children
Fycompa 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 Fycompa
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription and herbal medicines.
Taking Fycompa with certain other medicines may cause unwanted effects or affect their
action. Do not start or stop taking other medicines without consulting your doctor or
pharmacist.

• Other antiepileptic medicines, such as carbamazepine, oxcarbazepine and phenytoin, used to treat seizures, may affect Fycompa. Tell your doctor if you are taking or have recently taken these medicines, as the dose may need to be adjusted.
• Felbamate (a medicine used to treat epilepsy) may also affect Fycompa. Tell your doctor if you are taking or have recently taken this medicine, as the dose may need to be adjusted.
• Midazolam (a medicine used to stop prolonged (sudden) seizures, for sedation and for sleep problems) may be affected by Fycompa. Tell your doctor if you are taking midazolam, as the dose may need to be adjusted.
• Other medicines, such as rifampicin (a medicine used to treat bacterial infections), St John's wort (a medicine used to treat mild anxiety) and

ketoconazole (a medicine used to treat fungal infections), may affect Fycompa. Tell your doctor if you are taking or have recently taken these
medicines, as the dose may need to be adjusted.

• Hormonal contraceptives (including oral contraceptives, implants, injections and patches). Tell your doctor if you are taking hormonal contraceptives. Fycompa may make some hormonal contraceptives, such as levonorgestrel, less effective. During treatment with Fycompa you should use other effective and safe contraceptive measures (such as a condom or an intrauterine device) and continue to use them for one month after stopping treatment. Discuss with your doctor the contraceptive method that is right for you.

Fycompa with alcohol
Talk to your doctor before drinking alcohol. Be careful about consuming alcohol with medicines for
epilepsy, including Fycompa.

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

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

• Fycompa is not recommended during pregnancy.
• To avoid becoming pregnant during treatment with Fycompa, you should use a reliable method of contraception and continue to use it for one month after stopping treatment. Tell your doctor if you are taking hormonal contraceptives. Fycompa may make some hormonal contraceptives, such as levonorgestrel, less effective. During treatment with Fycompa you should use other effective and safe contraceptive measures (such as a condom or an intrauterine device) and continue to use them also for one month after stopping treatment. Discuss with your doctor the contraceptive method that is right for you. It is not known whether the components of Fycompa pass into breast milk. Your doctor will assess the benefits and risks for the baby if treatment with Fycompa is necessary during breastfeeding.

Driving and using machinery
Do not drive vehicles or use machinery until you are sure how Fycompa affects you.
Talk to your doctor about the effect of epilepsy on driving vehicles and using machinery.

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

Fycompa contains lactose
Fycompa contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicine.

3. How to take Fycompa

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.

Dosage to be taken
Adults and adolescents (age 12 years or older) in the treatment of partial seizures and generalized seizures:
The usual 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 the response to treatment.
• If you have mild or moderate liver problems, the dose should not exceed 8 mg per day and dose increments should be made at intervals of at least 2 weeks.
• Do not take a dose of Fycompa higher than that recommended by your doctor. It may take several weeks to find the right dose of Fycompa for you.

The following table summarizes the recommended doses in the treatment of partial seizures in children aged between 4 and 11 years and generalized seizures in children aged between 7 and 11 years.
More details are provided below the table.

Children (aged between 4 and 11 years) weighing at least 30 kg or more in the treatment of partial seizures:
The usual 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 the response to treatment. Depending on the individual clinical response and tolerability, the dose may be increased 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 increments should be made at intervals of at least 2 weeks.
• Do not take a dose of Fycompa higher than that recommended by your doctor. It may take several weeks to find the right dose of Fycompa for the child.

Children (aged between 4 and 11 years) weighing between 20 kg and less than 30 kg in the treatment of partial seizures:
The usual 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 the response to treatment. Depending on the individual clinical response and tolerability, the dose may be increased 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 increments should be made at intervals of at least 2 weeks.
• Do not take a dose of Fycompa higher than that recommended by your doctor. It may take several weeks to find the right dose of Fycompa for the child.

Children (aged between 4 and 11 years) weighing less than 20 kg in the treatment of partial seizures:
The usual 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 the response to treatment. Depending on the individual clinical response and tolerability, the dose may be increased 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 increments should be made at intervals of at least 2 weeks.
• Do not take a dose of Fycompa higher than that recommended by your doctor. It may take several weeks to find the right dose of Fycompa for the child.

Children (aged between 7 and 11 years) weighing at least 30 kg in the treatment of generalized seizures:
The usual 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 the response to treatment. Depending on the individual clinical response and tolerability, the dose may be increased 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 increments should be made at intervals of at least 2 weeks.
• Do not take a dose of Fycompa higher than that recommended by your doctor. It may take several weeks to find the right dose of Fycompa for the child.

Children (aged between 7 and 11 years) weighing between 20 kg and less than 30 kg in the treatment of generalized seizures:
The usual 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 the response to treatment. Depending on the individual clinical response and tolerability, the dose may be increased 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 increments should be made at intervals of at least 2 weeks.
• Do not take a dose of Fycompa higher than that recommended by your doctor. It may take several weeks to find the right dose of Fycompa for the child.

Children (aged between 7 and 11 years) weighing less than 20 kg in the treatment of generalized seizures:
The usual 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 the response to treatment. Depending on the individual clinical response and tolerability, the dose may be increased 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 increments should be made at intervals of at least 2 weeks.
• Do not take a dose of Fycompa higher than that recommended by your doctor. It may take several weeks to find the right dose of Fycompa for the child.

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

If you take more Fycompa than you should
If you have taken more Fycompa than you should, contact your doctor immediately. You may experience confusion, agitation, aggressive behavior and decreased level of consciousness.

If you forget to take Fycompa

• If you forget to take a tablet, wait until the next 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 Fycompa, continue to take the tablet daily as instructed by your doctor.
• If you have missed more than 7 days of treatment with Fycompa, inform your doctor immediately.

If you stop taking Fycompa
Take Fycompa for the entire period recommended by your doctor. Do not stop treatment unless instructed by your doctor. Your doctor may slowly reduce the dose to prevent seizures from recurring or worsening.
If you have any further questions on the use of this medicine, ask 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 antiepileptics have had thoughts of harming themselves or committing suicide. If you have these thoughts at any time, contact your doctor immediately.

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

• feeling dizzy
• feeling sleepy (drowsiness or lethargy)

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

• decreased 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]
• slowed speech (dysarthria)
• blurred vision or double vision (diplopia)
• feeling of spinning (vertigo)
• nausea
• back pain
• feeling very tired (fatigue)
• falls

Uncommon(may affect up to 1 in 1,000 people):

• thoughts of harming yourself or committing suicide (suicidal thoughts), attempt to take your own life (suicide attempt)
• hallucinations (seeing, hearing or feeling things that are not there)
• abnormal thinking and/or loss of contact with reality (psychotic disorder)

Not known(the frequency of this side effect cannot be estimated from available data):

• Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS or drug hypersensitivity syndrome: widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other body organs.
• Stevens Johnson Syndrome, SJS. This severe skin rash may appear as reddish “target” macules or circular spots often with central blisters located on the trunk, skin peeling, mouth, throat, nose, genital and eye ulcers and may be preceded by fever and flu-like symptoms.

Stop using perampanel if you develop these symptoms and see your doctor or seek
immediate medical attention. See also section 2.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Fycompa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and on the blister. The expiry
date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 Fycompa contains
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 ingredients are:
Tablet core (2 mg and 4 mg tablets):
lactose monohydrate, low-substituted hydroxypropylcellulose, povidone, magnesium stearate (E470b)
Tablet core (6 mg, 8 mg, 10 mg and 12 mg tablets)
lactose monohydrate, low-substituted hydroxypropylcellulose, povidone, microcrystalline cellulose,
magnesium stearate (E470b)
Tablet coating (2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg tablets)
Hypromellose 2910, talc, macrogol 8000, titanium dioxide (E171), colorants*
* The colorants are:
2 mg tablet: Yellow iron oxide (E172), red iron oxide (E172)
4 mg tablet: Red iron oxide (E172)
6 mg tablet: Red iron oxide (E172)
8 mg tablet: Red iron oxide (E172), black iron oxide (E172)
10 mg tablet: Yellow iron oxide (E172), indigo carmine aluminium lake FD&C Blue
#2 (E132)
12 mg tablet: Indigo carmine aluminium lake FD&C Blue #2 (E132)

Description of Fycompa’s appearance and package contents
All Fycompa tablets are biconvex, round film-coated tablets
2 mg: orange, with E275 imprinted on one side and ‘2’ on the other
4 mg: red, with E277 imprinted on one side and ‘4’ on the other
6 mg: pink, with E294 imprinted on one side and ‘6’ on the other
8 mg: purple, with E295 imprinted on one side and ‘8’ on the other
10 mg: green, with E296 imprinted on one side and ‘10’ on the other
12 mg: blue, with E297 imprinted on one side and ‘12’ on the other
Fycompa is available in packs of:
2 mg tablet – packs of 7, 28 and 98
4 mg, 6 mg, 8 mg, 10 mg, 12 mg tablets – packs of 7, 28, 84 and 98
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eisai GmbH
Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany
e-mail: [email protected]

Manufacturer
Eisai GmbH
Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany
For further information on this medicinal product, contact the local representative of the
Marketing Authorisation Holder:

België/Belgique/Belgien
Eisai SA/NV
Tél/Tel: +32 (0)800 158 58

Lietuva
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Germany)

България
Eisai GmbH
Тел.: + 49 (0) 69 66 58 50
(Germany)

Luxembourg/Luxemburg
Eisai SA/NV
Tél/Tel: +32 (0)800 158 58
(Belgique/Belgien)

Česká republika
Eisai GesmbH organizačni složka
Tel: + 420 242 485 839

Magyarország
Ewopharma Hungary Kft.
Tel.: + 36 1 200 46 50

Danmark
Eisai AB
Tlf: + 46 (0) 8 501 01 600
(Sweden)

Malta
Cherubino LTD
Tel: +356 21343270

Deutschland
Eisai GmbH
Tel: + 49 (0) 69 66 58 50

Nederland
Eisai B.V.
Tel: + 31 (0) 900 575 3340

Eesti
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Germany)

Norge
Eisai AB
Tlf: + 46 (0) 8 501 01 600
(Sweden)

Ελλάδα
Arriani Pharmaceutical S.A.
Τηλ: + 30 210 668 3000

Österreich
Eisai GesmbH
Tel: + 43 (0) 1 535 1980-0

España
Eisai Farmacéutica, S.A.
Tel: + (34) 91 455 94 55

Polska
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Germany)

France
Eisai SAS
Tél: + (33) 1 47 67 00 05

Portugal
Eisai Farmacêtica, Unipessoal Lda
Tel: + 351 214 875 540

Hrvatska
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Germany)

România
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Germany)

Ireland
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Germany)

Slovenija
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Germany)

Ísland
Eisai AB
Sími: + 46 (0)8 501 01 600
(Sweden)

Slovenská republika
Eisai GesmbH organizačni složka
Tel.: + 420 242 485 839
(Česká republika)

Italia
Eisai S.r.l.
Tel: + 39 02 5181401

Suomi/Finland
Eisai AB
Puh/Tel: + 46 (0) 8 501 01 600
(Sweden)

Κύπρος
Arriani Pharmaceuticals S.A.
Τηλ: + 30 210 668 3000
(Ελλάδα)

Sverige
Eisai AB
Tel: + 46 (0) 8 501 01 600

Latvija
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Germany)

United Kingdom (Northern Ireland)
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Germany)
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu.

Fycompa 0.5 mg/ml oral suspension

Perampanel

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Fycompa and what it is used for

Fycompa contains a medicine 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). It has been prescribed by your doctor to reduce the
number of epileptic seizures.
Fycompa is used in association with other antiepileptic medicines for the treatment of certain forms of
epilepsy:
In adults, adolescents (age 12 years and older) and children (age between 4 and
11 years)

• It is used for the treatment of epileptic seizures that affect a part of the brain (called “partial seizures”).
• These partial seizures may or may not be followed by an epileptic seizure that affects the whole brain (called “secondary generalization”). In adults and adolescents (age 12 years and older) and children (age between 7 and 11 years)
• It is also used for the treatment of certain epileptic seizures that affect the whole brain from the beginning (called “generalized seizures”) and that cause convulsions or absence seizures.

2. What you need to know before you take Fycompa

DO NOT TAKE Fycompa:

• if you have ever developed a severe skin rash or skin exfoliation, blistering and/or ulcers 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 taking Fycompa if you have liver problems or moderate or
severe kidney problems.
Do not take Fycompa if you have severe liver problems or moderate or severe kidney problems.
Before taking this medicine, tell your doctor if you have a history of alcoholism or
drug addiction.
Cases of increased liver enzymes have been reported in some patients taking Fycompa in
combination with other antiepileptic drugs.

• Fycompa may cause dizziness or drowsiness, especially at the beginning of treatment.
• Fycompa may increase the likelihood of falls, especially in elderly people; this may be due to the illness.
• Fycompa 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 notice any of these reactions, consult your doctor or pharmacist.

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

• DRESS usually manifests, although not exclusively, with flu-like symptoms and a rash with high body temperature, increased levels of liver enzymes found in blood tests and an increase in a type of white blood cells (eosinophilia) and enlargement of the lymph nodes.
• Initially, Stevens Johnson syndrome (SJS) may manifest as reddish “target” spots or circular patches often with central blisters located on the trunk. In addition, ulcers of the mouth, throat, nose, genitals and eyes (red and swollen eyes) may occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The skin rashes may evolve into widespread peeling and potentially life-threatening or fatal complications.

If any of the above occur after taking Fycompa (or if in doubt),
consult your doctor or pharmacist.

Children
Fycompa 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 Fycompa
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription and herbal medicines.
Taking Fycompa with certain other medicines may cause unwanted effects or affect their
action. Do not start or stop taking other medicines without consulting your doctor or
pharmacist.

• Other antiepileptic medicines, such as carbamazepine, oxcarbazepine and phenytoin, used to treat seizures, may affect Fycompa. Tell your doctor if you are taking or have recently taken these medicines, as the dose may need to be adjusted.
• Felbamate (a medicine used to treat epilepsy) may also affect Fycompa. Tell your doctor if you are taking or have recently taken this medicine, as the dose may need to be adjusted.
• Midazolam (a medicine used to stop prolonged (sudden) seizures, for sedation and for sleep problems) may be affected by Fycompa. Tell your doctor if you are taking midazolam, as the dose may need to be adjusted.
• Other medicines, such as rifampicin (a medicine used to treat bacterial infections), St John's wort (a medicine used to treat mild anxiety) and

ketoconazole (a medicine used to treat fungal infections), may affect Fycompa. Tell your doctor if you are taking or have recently taken these
medicines, as the dose may need to be adjusted.

• Hormonal contraceptives (including oral contraceptives, implants, injections and patches). Tell your doctor if you are taking hormonal contraceptives. Fycompa may make some hormonal contraceptives, such as levonorgestrel, less effective. During treatment with Fycompa you should use other effective and safe contraceptive measures (such as a condom or an intrauterine device) and continue to use them for one month after stopping treatment. Discuss with your doctor the contraceptive method that is right for you.

Fycompa with alcohol
Consult your doctor before drinking alcohol. Be careful about consuming alcohol with medicines for
epilepsy, including Fycompa.

• Drinking alcohol while taking Fycompa may reduce alertness and affect your ability to drive vehicles or operate tools or machinery.
• Drinking alcohol while taking Fycompa may also worsen possible feelings of anger, confusion or sadness.

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

• Fycompa is not recommended during pregnancy.
• To avoid becoming pregnant during treatment with Fycompa, you should use a reliable method of contraception and continue to use it for one month after stopping treatment. Tell your doctor if you are taking hormonal contraceptives. Fycompa may make some hormonal contraceptives, such as levonorgestrel, less effective. During treatment with Fycompa you should use other effective and safe contraceptive measures (such as a condom or an intrauterine device) and continue to use them even for one month after stopping treatment. Discuss with your doctor the contraceptive method that is right for you. It is not known whether the components of Fycompa pass into breast milk. Your doctor will assess the benefits and risks for the baby if treatment with Fycompa is given during breastfeeding.

Driving and using machines
Do not drive vehicles or use machines until you are sure how Fycompa affects you.
Talk to your doctor about the effect of epilepsy on driving vehicles and using machines.

• Fycompa may cause dizziness or drowsiness, especially at the beginning of treatment. If this happens, do not drive vehicles and do not use tools or machinery.
• Drinking alcohol while taking Fycompa may worsen these effects.

Fycompa contains 175 mg of sorbitol (E420) per mL.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) are intolerant to
some sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic illness
in which patients are unable to break down fructose, talk to your doctor before you (or your
child) take this medicine.
Taking Fycompa with other antiepileptic medicines containing sorbitol may affect their
effectiveness. Tell your doctor or pharmacist if you are taking other antiepileptic medicines containing
sorbitol.

Fycompa contains < 0.005 mg of benzoic acid (E210) and 1.1 mg of sodium benzoate (E211) per
mL.
Benzoic acid and sodium benzoate may increase jaundice (yellowing of the skin and eyes) in
newborns up to 4 weeks of age.

3. How to use Fycompa

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.

Dose to be taken
Adults and adolescents (age 12 years and over) in the treatment of partial seizures and generalized seizures:
The usual starting dose is 2 mg (4 ml) once a day before bedtime.

• Your doctor may increase this dose in increments of 2 mg (4 ml), up to a maintenance dose between 4 mg (8 ml) and 12 mg (24 ml), 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 Fycompa higher than that recommended by your doctor. It may take several weeks to find the right dose of Fycompa for you.

The following table summarizes the recommended doses in the treatment of partial seizures in children aged between 4 and 11 years and generalized seizures in children aged between 7 and 11 years.
More details are provided below the table.

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

• Your doctor may increase this dose in increments of 2 mg (4 ml), up to a maintenance dose between 4 mg (8 ml) and 8 mg (16 ml), depending on your response to treatment. Depending on the individual clinical response and tolerability, the dose may be increased up to a maximum dose of 12 mg/day (24 ml/day).
• If the child has mild or moderate liver problems, the dose should not exceed 4 mg (8 ml) per day and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Fycompa higher than that recommended by your doctor. It may take several weeks to find the right dose of Fycompa for the child.

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

• Your doctor may increase this dose in increments of 1 mg (2 ml), up to a maintenance dose between 4 mg (8 ml) and 6 mg (12 ml), depending on your response to treatment. Depending on the individual clinical response and tolerability, the dose may be increased up to a maximum dose of 8 mg/day (16 ml/day).
• If the child has mild or moderate liver problems, the dose should not exceed 4 mg (8 ml) per day and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Fycompa higher than that recommended by your doctor. It may take several weeks to find the right dose of Fycompa for the child.

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

• Your doctor may increase this dose in increments of 1 mg (2 ml), up to a maintenance dose between 2 mg (4 ml) and 4 mg (8 ml), depending on your response to treatment. Depending on the individual clinical response and tolerability, the dose may be increased up to a maximum dose of 6 mg/day (12 ml/day).
• If the child has mild or moderate liver problems, the dose should not exceed 4 mg (8 ml) per day and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Fycompa higher than that recommended by your doctor. It may take several weeks to find the right dose of Fycompa for the child.

Children (aged between 7 and 11 years) weighing at least 30 kg in the treatment of generalized seizures:
The usual starting dose is 2 mg (4 ml) once a day before bedtime.

• Your doctor may increase this dose in increments of 2 mg (4 ml), up to a maintenance dose between 4 mg (8 ml) and 8 mg (16 ml), depending on your response to treatment. Depending on the individual clinical response and tolerability, the dose may be increased up to a maximum dose of 12 mg/day (24 ml/day).
• If the child has mild or moderate liver problems, the dose should not exceed 4 mg (8 ml) per day and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Fycompa higher than that recommended by your doctor. It may take several weeks to find the right dose of Fycompa for the child.

Children (aged between 7 and 11 years) weighing between 20 kg and less than 30 kg in the treatment of generalized seizures:
The usual starting dose is 1 mg (2 ml) once a day before bedtime.

• Your doctor may increase this dose in increments of 1 mg (2 ml), up to a maintenance dose between 4 mg (8 ml) and 6 mg (12 ml), depending on your response to treatment. Depending on the individual clinical response and tolerability, the dose may be increased up to a maximum dose of 8 mg/day (16 ml/day).
• If the child has mild or moderate liver problems, the dose should not exceed 4 mg (8 ml) per day and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Fycompa higher than that recommended by your doctor. It may take several weeks to find the right dose of Fycompa for the child.

Children (aged between 7 and 11 years) weighing less than 20 kg in the treatment of generalized seizures:
The usual starting dose is 1 mg (2 ml) once a day before bedtime.

• Your doctor may increase this dose in increments of 1 mg (2 ml), up to a maintenance dose between 2 mg (4 ml) and 4 mg (8 ml), depending on your response to treatment. Depending on the individual clinical response and tolerability, the dose may be increased up to a maximum dose of 6 mg/day (12 ml/day).
• If the child has mild or moderate liver problems, the dose should not exceed 4 mg (8 ml) per day and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Fycompa higher than that recommended by your doctor. It may take several weeks to find the right dose of Fycompa for the child.

How to take Fycompa
Fycompa is for oral use. You can take Fycompa with or without food, but always in the same way. For example, if you decide to take Fycompa with food, always follow this method.
For administration, use the oral syringe and adapter provided.
Instructions for using the oral syringe and adapter are given below:

• 1. Shake for at least 5 seconds before use.
• 2. Press (1) and rotate (2) the cap to open the bottle.
• 3. Insert the adapter into the neck of the bottle until a perfect seal is achieved.
• 4. Press the syringe plunger all the way down.
• 5. Insert the syringe as far as possible into the opening of the adapter.
• 6. Turn upside down and draw the prescribed amount of Fycompa from the bottle.
• 7. Return to the vertical position and remove the syringe.
• 8. Leave the adapter in place and put the cap back on the bottle.
• 9. After administering the dose, separate the syringe body from the plunger and immerse both components completely in warm soapy water.
• 10. Immerse the syringe body and plunger in water to remove any residual detergent, remove excess water and allow the components to air dry. Do not dry the administration devices by rubbing them with a cloth.
• 11. Do not clean and reuse the syringe after 40 uses, or if the markings on the syringe are removed during washing.

If you take more Fycompa than you should
If you have taken more Fycompa than you should, contact your doctor immediately. You may experience confusion, agitation, aggression and decreased level of consciousness.

If you forget to take Fycompa

• If you forget to take Fycompa, wait until the next 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 Fycompa, continue to take the daily dose according to your doctor's initial instructions.
• If you have missed more than 7 days of treatment with Fycompa, tell your doctor immediately.

If you stop taking Fycompa
Take Fycompa for the entire period recommended by your doctor. Do not stop treatment unless instructed by your doctor. Your doctor may slowly reduce the dose to prevent seizures from recurring or worsening.
If you have any doubts about the use of this medicine, ask 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 antiepileptics have had thoughts about harming themselves or committing suicide. If at any time you have these thoughts, contact your doctor immediately.

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

• feeling dizzy
• feeling sleepy (drowsiness or lethargy)

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

• decreased 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]
• slowed speech (dysarthria)
• blurred vision or double vision (diplopia)
• feeling of spinning (vertigo)
• nausea
• back pain
• feeling very tired (fatigue)
• falls

Uncommon(may affect up to 1 in 1,000 people):

• thoughts about harming yourself or committing suicide (suicidal thoughts), attempt to end your life (suicide attempt)
• hallucinations (seeing, hearing or feeling things that are not there)
• abnormal thinking and/or loss of contact with reality (psychotic disorder)

Not known(the frequency of this side effect cannot be estimated from the available data):

• Drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome: widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other body organs.
• Stevens Johnson Syndrome, SJS. This severe skin rash can appear as red, “target-like” macules or circular spots often with central blisters localized on the trunk, skin peeling, mouth, throat, nose, genital and eye ulcers and may be preceded by fever and flu-like symptoms.

Stop using perampanel if you develop these symptoms and seek medical attention or
immediately request medical help. See also section 2.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system indicated in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Fycompa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the bottle and on the
pack. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
If any suspension remains in the bottle for more than 90 days after first opening, do not use it.
Do not dispose of any medicine in waste water 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 Fycompa contains

• The active substance is perampanel. Each millilitre contains 0.5 mg of perampanel.
• The other components are sorbitol (E420) liquid (crystallizing), microcrystalline cellulose (E460), sodium carboxymethyl cellulose (E466), poloxamer 188, simethicone emulsion 30% (containing purified water, silicone oil, polysorbate 65, methylcellulose, silica gel, macrogol stearate, sorbic acid, benzoic acid (E210) and sulfuric acid), anhydrous citric acid (E330), sodium benzoate (E211) and purified water.

Description of the appearance of Fycompa and package contents
Fycompa 0.5 mg/ml is an oral suspension of colour from white to whitish. It is supplied in a bottle
of 340 ml, with 2 graduated oral administration syringes and a pressure bottle adapter
(PIBA) in LDPE.

Marketing authorisation holder
Eisai GmbH
Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany
e-mail: [email protected]

Manufacturer
Eisai GmbH
Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Eisai SA/NV
Tél/Tel: +32 (0)800 158 58

Lietuva
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Germany)

България
Eisai GmbH
Teл.: + 49 (0) 69 66 58 50
(Germany)

Luxembourg/Luxemburg
Eisai SA/NV
Tél/Tel: +32 (0)800 158 58
(Belgique/Belgien)

Česká republika
Eisai GesmbH organizačni složka
Tel: + 420 242 485 839

Magyarország
Eisai GmbH
Tel.: + 49 (0) 69 66 58 50
(Germany)

Danmark
Eisai AB
Tlf: + 46 (0) 8 501 01 600
(Sweden)

Malta
Cherubino LTD
Tel: +356 21343270

Deutschland
Eisai GmbH
Tel: + 49 (0) 69 66 58 50

Nederland
Eisai B.V.
Tel: + 31 (0) 900 575 3340

Eesti
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Germany)

Norge
Eisai AB
Tlf: + 46 (0) 8 501 01 600
(Sweden)

Ελλάδα
Arriani Pharmaceutical S.A.
Τηλ: + 30 210 668 3000

Österreich
Eisai GesmbH
Tel: + 43 (0) 1 535 1980-0

España
Eisai Farmacéutica, S.A.
Tel: + (34) 91 455 94 55

Polska
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Germany)

France
Eisai SAS
Tél: + (33) 1 47 67 00 05

Portugal
Eisai Farmacêtica, Unipessoal Lda
Tel: + 351 214 875 540

Hrvatska
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Germany)

România
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Germany)

Ireland
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Germany)

Slovenija
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
( Germany )

Ísland
Eisai AB
Sími: + 46 (0)8 501 01 600
(Sweden)

Slovenská republika
Eisai GesmbH organizačni složka
Tel.: + 420 242 485 839
(Česká republika)

Italia
Eisai S.r.l.
Tel: + 39 02 5181401

Suomi/Finland
Eisai AB
Puh/Tel: + 46 (0) 8 501 01 600
(Sweden)

Κύπρος
Arriani Pharmaceuticals S.A.
Τηλ: + 30 210 668 3000
(Ελλάδα)

Sverige
Eisai AB
Tel: + 46 (0) 8 501 01 600

Latvija
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Germany)

United Kingdom (Northern Ireland)
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Germany)
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu.

ANNEX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR THE VARIATION OF THE
MARKETING AUTHORISATION
Scientific conclusions
Taking into account the assessment by the Pharmacovigilance and Risk Assessment Committee
(PRAC) of the Periodic Safety Update Report (PSUR) for perampanel, the scientific conclusions of the Committee for Human Medicinal Products (CHMP) are as follows:
In light of the 18 cases of psychotic disorders observed in clinical studies, including 10 cases with a positive response to treatment discontinuation (de-challenge), the literature (2 documented clinical cases), spontaneous reports, including 10 cases with a close temporal relationship, a positive response to treatment discontinuation (de-challenge) in 6 cases and to treatment re-challenge in 1 case, the PRAC considers that there is at least a reasonable possibility of a causal relationship between perampanel and psychotic disorder. The PRAC concluded that the product information for products containing perampanel should be amended accordingly.
The CHMP agrees with the scientific conclusions of the PRAC.

Justification for the variation of the marketing authorisation
Based on the scientific conclusions on perampanel, the CHMP considers that the benefit/risk ratio of the medicinal product containing perampanel remains unchanged, subject to the proposed amendments to the product information.
The CHMP recommends the variation of the marketing authorisation.