2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg film-coated tablets
perampanel

1. What Fycompa is and what it is used for

Fycompa contains the medicine perampanel. It belongs to a group of medicines called antiepileptics . These drugs are used to treat epilepsy , ie conditions when someone has repeated seizures (seizures). It has been prescribed for you by your doctor to reduce the number of seizures.

Fycompa is used together with other medicines to treat epilepsy to treat some forms of epilepsy:

In adults, adolescents (aged 12 years and older) and children (from 4 to 11 years)

  • It is used to treat seizures that affect a part of the brain (a “partial seizure”).
  • These partial seizures can, but do not have to, be followed by seizures that affect the whole brain (a “secondary generalization”).

In adults, adolescents (aged 12 years and older) and children (from 7 to 11 years)

  • It is also used to treat certain seizures that affect the whole brain from the beginning (called “generalized seizures”) and cause seizures or absenteeism attacks.

2. What you need to know before taking Fycompa

DO NOT Fycompa:

  • if you have ever had a severe rash or flaky skin, blisters and / or cold sores after taking the perampanel.
  • if you are allergic to perampanel or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

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 alcohol or drug addiction.

Cases of elevated liver enzyme levels have been reported in some patients taking Fycompa in combination with other antiepileptic drugs.

  • Fycompa may make you feel dizzy or drowsy, especially at the beginning of treatment.
  • Fycompa may make you more likely to fall, especially if you are older, which may also be due to your illness.
  • Fycompa can make you aggressive, angry or violent. It can also cause you to experience unusual or extreme changes in your behavior or mood.

Talk to a doctor or pharmacist if any of these happen.

Suicidal ideation and self-harm have been reported in a small number of patients treated with antiepileptic drugs . Contact your doctor immediately if you ever have such thoughts.

Serious skin reactions including drug- side effects with eosinophilia and systemic symptoms (DRESS) and Stevens-Johnson syndrome (SJS) have been reported with the use of perampanel.

  • DRESS most often, but not only, occurs as flu-like symptoms and rashes with body temperature above normal, elevated liver enzyme levels in blood tests and increased number of a type of white blood cell ( eosinophilia ) and enlarged lymph nodes .
  • Stevens-Johnson syndrome (SJS) can initially appear as reddish spots with a “target-like appearance” or circular rash on the torso, often with blisters in the middle. In addition, sores can occur on the mouth, throat, nose, genitals and eyes (red and swollen eyes). These severe skin rashes are often preceded by fever and / or flu-like symptoms . The rash can develop into extensive skin loss and life-threatening complications or be fatal.

If you experience any of the above after taking Fycompa (or if you are not sure) talk to your doctor or pharmacist.

Children

Fycompa is not recommended for children under 4 years. Safety and efficacy are not yet known 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. This also includes over-the-counter and herbal remedies. Fycompa in combination with other medicines can cause side effects or affect how the medicines work. Do not start or stop other drug treatments without first talking to a doctor or pharmacist.

  • Other medicines for epilepsy , e.g. 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 your dose may need to be adjusted.
  • Felbamate (a medicine used to treat epilepsy ) can also affect Fycompa. Tell your doctor if you are taking or have recently taken this medicine as your dose may need to be adjusted.
  • Midazolam (a medicine used to stop prolonged, acute (sudden) seizures, as a sedative and for insomnia) may be affected by Fycompa. Tell your doctor if you are taking midazolam as your dose may need to be adjusted.
  • Some other medicines like rifampicin (a medicine for bacterial infections ), hypericum ( St. John’s wort ) (a medicine for mild anxiety) and ketoconazole (a medicine for fungal infections) may affect Fycompa. Tell your doctor if you are taking or have recently taken these medicines as your dose may need to be adjusted.
  • Hormonal contraceptives (including oral contraceptives, implants , injections and patches )

Tell your doctor if you are taking hormonal contraceptives. Fycompa may make certain hormonal contraceptives, such as levonorgestrel, less effective. You should use other types of safe and effective contraceptives (such as condoms or IUDs ) when taking Fycompa. You should continue to do this for one month after stopping treatment. Discuss with your doctor which contraceptives are best for you.

Fycompa with alcohol

Talk to your doctor before drinking alcohol. Be careful with alcohol consumption when taking antiepileptic medicines such as Fycompa.

  • Drinking alcohol while taking Fycompa may make you less alert and affect your ability to drive or use tools or machines.
  • Alcohol with Fycompa can also aggravate feelings of anger, confusion and sadness.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Do not stop treatment without first talking to your doctor.

  • Fycompa is not recommended during pregnancy.
  • You must use reliable contraception to avoid getting pregnant while you are being treated with Fycompa. You should continue to do this for one month after stopping treatment. Tell your doctor if you are taking hormonal contraceptives. Fycompa can make certain hormonal contraceptives, e.g. levonorgestrel, less effective. You should use other types of safe and effective contraceptives (such as condoms or IUDs ) when taking Fycompa. You should continue to do this for one month after stopping treatment. Discuss with your doctor which contraceptives are best for you

There is no information on whether Fycompa’s ingredients can be transferred to breast milk.

Your doctor will assess the benefits and risks of treatment with Fycompa in combination with breast-feeding for your baby.

Driving and using machines

Do not drive or use machines until you know how Fycompa affects you.

You must talk to your doctor about the effect of your epilepsy on driving and using machines.

  • Fycompa may make you feel dizzy or drowsy, especially at the beginning of treatment. If this happens to you, do not drive or use any tools or machines.
  • If you drink alcohol while taking Fycompa, these effects may be exacerbated.

Fycompa contains lactose

Fycompa contains lactose (a 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

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

How much medicine to take

Adults and adolescents (aged 12 years and older) in the treatment of partial onset seizures and generalized seizures:

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

  • Your doctor may increase the dose one by 2 mg at a time up to a maintenance dose of between 4 mg and 12 mg depending on how you respond to the increase.
  • If you have mild or moderate liver problems, do not take a dose higher than 8 mg per day and your dose increases should be made at least two weeks apart.
  • Do not take a higher dose of Fycompa than your doctor has prescribed. It may take a few weeks to find the right dose of Fycompa for you.

The table below summarizes the recommended doses for the treatment of partial seizures in children between 4 and 11 years of age and generalized seizures in children between 7 and 11 years of age. More information can be found under the table.



Children weighing:
More than 30 kg 20 kg to less than 30 kg Less than 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 (from 4 to 11 years) weighing 30 kg or more in the treatment of partial seizures:

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

  • Your doctor may increase the dose one by 2 mg at a time up to a maintenance dose of between 4 mg and 8 mg depending on how you respond to the treatment. Depending on the individual treatment response and how well you tolerate the medicine, the dose can be increased to a maximum dose of 12 mg / day.
  • If you have mild or moderate liver problems, do not take a dose higher than 4 mg per day and your dose increases should be made at least two weeks apart.
  • Do not take a higher dose of Fycompa than your doctor has prescribed. It may take a few weeks to find the right dose of Fycompa for you.

Children (from 4 to 11 years) weighing 20 kg to less than 30 kg in the treatment of partial seizures:

The starting dose is usually 1 mg once a day before bedtime.

  • Your doctor may increase the dose one by 1 mg at a time up to a maintenance dose of between 4 mg and 6 mg depending on how you respond to the treatment. Depending on the individual treatment response and how well you tolerate the medicine, the dose can be increased to a maximum dose of 8 mg / day.
  • If you have mild or moderate liver problems, do not take a dose higher than 4 mg per day and your dose increases should be made at least two weeks apart.
  • Do not take a higher dose of Fycompa than your doctor has prescribed. It may take a few weeks to find the right dose of Fycompa for you.

Children (from 4 to 11 years) weighing less than 20 kg in the treatment of partial seizures:

The starting dose is usually 1 mg once a day before bedtime.

  • Your doctor may increase the dose one by 1 mg at a time up to a maintenance dose of between 2 mg and 4 mg depending on how you respond to the treatment. Depending on the individual treatment response and how well you tolerate the medicine, the dose can be increased to a maximum dose of 6 mg / day.
  • If you have mild or moderate liver problems, do not take a dose higher than 4 mg per day and your dose increases should be made at least two weeks apart.
  • Do not take a higher dose of Fycompa than your doctor has prescribed. It may take a few weeks to find the right dose of Fycompa for you.

Children (from 7 to 11 years of age) weighing 30 kg or more in the treatment of generalized seizures:

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

  • Your doctor may increase the dose one by 2 mg at a time up to a maintenance dose of between 4 mg and 8 mg depending on how you respond to the treatment. Depending on the individual treatment response and how well you tolerate the medicine, the dose can be increased to a maximum dose of 12 mg / day.
  • If you have mild or moderate liver problems, do not take a dose higher than 4 mg per day and your dose increases should be made at least two weeks apart.
  • Do not take a higher dose of Fycompa than your doctor has prescribed. It may take a few weeks to find the right dose of Fycompa for you.

Children (from 7 to 11 years) weighing 20 kg to less than 30 kg in the treatment of generalized seizures:

The starting dose is usually 1 mg once a day before bedtime.

  • Your doctor may increase the dose one by 1 mg at a time up to a maintenance dose of between 4 mg and 6 mg depending on how you respond to the treatment. Depending on the individual treatment response and how well you tolerate the medicine, the dose can be increased to a maximum dose of 8 mg / day.
  • If you have mild or moderate liver problems, do not take a dose higher than 4 mg per day and your dose increases should be made at least two weeks apart.
  • Do not take a higher dose of Fycompa than your doctor has prescribed. It may take a few weeks to find the right dose of Fycompa for you.

Children (from 7 to 11 years of age) weighing less than 20 kg in the treatment of generalized seizures:

The starting dose is usually 1 mg once a day before bedtime.

  • Your doctor may increase the dose one by 1 mg at a time up to a maintenance dose of between 2 mg and 4 mg depending on how you respond to the treatment. Depending on the individual treatment response and how well you tolerate the medicine, the dose can be increased to a maximum dose of 6 mg / day.
  • If you have mild or moderate liver problems, do not take a dose higher than 4 mg per day and your dose increases should be made at least two weeks apart.
  • Do not take a higher dose of Fycompa than your doctor has prescribed. It may take a few weeks to find the right dose of Fycompa for you.

How to take Fycompa

Swallow the tablet whole with a glass of water. You can take Fycompa with or without food. The tablet should not be chewed, crushed or divided. The tablets cannot be divided exactly because they do not have a breaking score.

If you take more Fycompa than you should

If you take more Fycompa than you should, contact your doctor immediately. You may become confused, anxious or aggressive.

If you forget to take Fycompa

  • If you forget to take a dose , wait until it is time for the next dose and then continue as usual.
  • Do not take a double dose to make up for a forgotten dose .
  • If you have missed less than seven days of treatment with Fycompa, continue to take your daily dose as prescribed by your doctor.
  • If you have missed more than seven days of treatment with Fycompa, talk to your doctor immediately.

If you stop taking Fycompa

Take Fycompa for as long as your doctor prescribes it. Do not stop taking this medicine unless your doctor tells you to. Your doctor may reduce your dose slowly to prevent your seizures (relapses) from coming back or getting worse.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them.

Suicidal ideation and self-harm have been reported in a small number of patients treated with antiepileptic drugs . Contact your doctor immediately if you ever have such thoughts.

Very common side effect is (occurring in more than 1 in 10):

  • dizziness
  • drowsiness (drowsiness or very great need for sleep)

Common adverse s (occurring in more than 1 in 100):

  • increased or decreased appetite, weight gain
  • aggression, anger, irritability, anxiety or confusion
  • difficulty walking or other balance problems ( ataxia , gait disturbance, balance disorder)
  • slow speech ( dysarthria )
  • blurred vision or double vision ( diplopia )
  • a tingling sensation ( vertigo )
  • nausea
  • back pain
  • feeling very tired
  • case

Less common side effects are (may affect more than 1 in 1000 patients):

  • thoughts of harming oneself or ending one’s life (suicidal thoughts), attempting to end one’s life (suicide attempt)

No known frequency (cannot be calculated from the available data):

  • Drug side effect with eosinophilia and systemic symptoms, also called DRESS or hypersensitivity reaction during drug treatment: widespread rash, body temperature above normal, elevated level of liver enzymes, blood abnormalities ( eosinophilia ), enlarged lymph nodes and other organ involvement.
  • Stevens-Johnson syndrome (SJS). These severe skin rashes can appear reddish, “target-like” spots or circular rashes on the torso, often with blisters in the middle, missing skin and sores on the mouth, throat, nose, genitals and eyes and preceded by fever and flu-like symptoms .

Stop using perampanel if you get these symptoms and contact your doctor or seek medical attention immediately. See also section 2.

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 carton and blister. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is perampanel. Each film-coated tablet contains 2 mg, 4 mg, 6 mg, 8 mg, 10 mg or 12 mg perampanel.

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).

Film coating (2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg tablets):

Hypromellose 2910, talc, Macrogol 8000, titanium dioxide (E171), dyes *.

* The dyes 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), FD&C blue no. 2 indigo carmine aluminum lacquer (E132)

12 mg tablet: FD&C blue no. 2 indigo carmine aluminum lacquer (E132)

What the medicine looks like and contents of the pack

All strengths of Fycompa are round, biconvex, film-coated tablets,

2 mg: orange, marked with E275 on one side and “2” on the other.

4 mg: red, marked with E277 on one side and “4” on the other.

6 mg: pink, marked with E294 on one side and “6” on the other.

8 mg: purple, marked with E295 on one side and “8” on the other.

10 mg: green, marked with E296 on one side and “10” on the other.

12 mg: blue, marked with E297 on one side and “12” on the other.

Fycompa is supplied in packs of:

2 mg tablet – pack of 7, 28 and 98 tablets

4 mg, 6 mg, 8 mg, 10 mg, 12 mg tablets – packs of 7, 28, 84 and 98 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am Main

Germany

email: medinfo_de@eisai.net

Manufacturer

Eisai GmbH

Edmund-Rumpler-Straße 3

60549 Frankfurt am Main

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Eisai AB

Tel: + 46 (0) 8 501 01 600

Muhammad Nadeem

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