くすりのしおり

Internal
Published: 1/2020

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
Fycompa Fine Granules 1%
 Active ingredient:
Perampanel hydrate
 Dosage form:
yellow fine granule
 Print on wrapping:

Effects of this medicine

This medicine suppresses epileptic attacks by calming excessively excited nerves in the brain.
It is usually used to treat partial-onset seizures in epilepsy patients (including secondary generalized seizures) and concomitantly with antiepileptic agents to treat tonic-clonic attacks in epileptic patients with inadequate response to other antiepileptic agents.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you have liver dysfunction.
  • If you are pregnant, possible pregnant, or breastfeeding.
  • If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

  • Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
  • Partial-onset seizures (including secondarily generalized seizures):
    [Monotherapy] In general, for adults and children 4 years old or over, start with 2 mg as perampanel at a time, once a day, before bedtime. The dosage will then be gradually increased by 2 mg at an interval of 2 week or longer. The maintenance dose is 4 to 8 mg once daily. The dosage may be adjusted by 2 mg or less at an interval of 2 week or longer according to your symptoms. However, the maximum daily dose is up to 8 mg.
    [Combination therapy] In general, for adults and children 12 years old or over, start with 2 mg as perampanel at a time, once a day, before bedtime. The dosage will then be gradually increased by 2 mg at an interval of 1 week or longer. If you do not take this medicine concomitantly with other antiepileptic agents that promote the metabolism of this medicine, the maintenance dose is 4 to 8 mg once a day. If you do, the maintenance dose is 8 to 12 mg once a day. The dosage may be adjusted by 2 mg or less at an interval of 1 week or longer according to your symptoms. However, the maximum daily dose is up to 12 mg.
    In general, for children aged 4 to 12 years, start with 2 mg as perampanel at a time, once a day, before bedtime. The dosage will then be gradually increased by 2 mg at an interval of 2 week or longer. if you do not take this medicine concomitantly with other antiepileptic agents that promote the metabolism of this medicine, the maintenance dose is 4 to 8 mg once a day. If you do, the maintenance dose is 8 to 12 mg once a day. The dosage may be adjusted by 2 mg or less at an interval of 2 week or longer according to your symptoms. However, the maximum daily dose is up to 12 mg.
    Tonic-clonic seizures:
    [Combination therapy] In general, for adults and children 12 years old or over, start with 2 mg as perampanel at a time, once a day, before bedtime. The dosage will then be gradually increased by 2 mg at an interval of 1 week or longer. If you do not take this medicine concomitantly with other antiepileptic agents that promote the metabolism of this medicine, the maintenance dose is 8 mg once a day. If you do, the maintenance dose is 8 to 12 mg once a day. The dosage may be adjusted by 2 mg or less at an interval of 1 week or longer according to your symptoms. However, the maximum daily dose is up to 12 mg.
    This medicine contains 10 mg as perampanel in 1 g of fine granules. Strictly follow the instructions.
  • If you miss a dose, take the missed before bedtime on the next day. Follow your regular dosing schedule from the next day. You should never take two doses at one time.
  • If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop taking this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • Immediately consult a doctor if symptoms such as slight stimulus cause feelings or physical changes, harassment or violence in the surroundings, destruction of property, hostility, anxiety, or feeling desirous to die, may appear.
  • This medicine may cause dizziness, drowsiness or decreased attention/concentration/refrex movement. Avoid operating dangerous machinery, such as driving a car.
  • Avoid taking any food containing St. John's wort, since it may decrease the blood level of the medicine.
  • Alcohol (drinking) may intensify decreased psychomotor fuctions.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include dizziness, somnolence, rash, itch and irritability. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
  • Slight stimulus cause feelings or physical changes [irritability]
  • Harassment or violence in the surroundings, destruction of property, hostility [aggression]
  • Feel like something that doesn't really exist [hallucination]
  • Thinking of impossible things even if there is no basis [delusion]
  • Mild consciouness clouding [delirium]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

  • Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them.
  • 【For families】
    With the use of this medicine, a slight stimulus may cause feelings and physical changes, harassment and violence in the surroundings, destruction of property, hostility, anxiety, feel like something that doesn't really exist, thinking of impossible things even if there is no basis, mild consciousness clouding, and feeling desirous to die may appear.
    Ask your doctor about these possibilities until you fully understand them. Call your doctor if you notice any changes in patient. If you feel that you have changed, please tell your family and others.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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