くすりのしおり

Internal
Revised: 10/2017

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 :
E Keppra Tablets 500mg
 Active ingredient:
Levetiracetam
 Dosage form:
yellow tablets, long axis: approx. 16.4 mm, short axis: approx. 7.7 mm, thickness: approx. 5.8 mm
 Print on wrapping:
Front; Otsuka, ucb500, 500mg Back; イーケプラ錠, 500mg

Effects of this medicine

This medicine controls epileptic seizures by suppressing excess excitation of brain nerves.
It is usually used to treat partial epileptic seizures or used with other antiepileptic drugs to treat generalized tonic-clonic seizures.

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 renal disorder or liver disorder.
  • If you are 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))
  • For adults: In general, for adults, take 2 tablets (1,000 mg of the active ingredient) a day in 2 divided doses. The dosage may be adjusted according to symptoms, but should not exceed 6 tablets (3,000 mg) a day. The dose may be increased by an increment not greater than 2 tablets (1,000 mg) daily with an interval of at least two weeks.
    For children: In general, for children from 4 years of age, take 20 mg of the active ingredient/kg/day in 2 divided doses. The dosage may be adjusted according to symptoms, but should not exceed 60 mg/kg/day. The dose may be increased by an increment not greater than 20 mg/kg/day with an interval of at least two weeks. The dosage in children 50 kg or greater is the same as in adults.
    This preparation contains 500 mg of the active ingredient in a tablet. Strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and follow your regular dosing schedule. 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

  • This medicine may cause sleepiness, memory loss (forgetfulness), loss of concentration, diminished responsiveness, etc. Avoid performing dangerous operations such as driving a car.
  • Psychiatric symptom, such as change in mental or physical condition due to slight irritation, confusion, feeling irritated, easily excited and aggressive tendency, may occur and may lead to suicide attempt. If any of mental changes occur, check with your doctor or pharmacist.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nasopharyngitis, somnolence, headache, dizziness, diarrhea, constipation, upper respiratory infection and rash. 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.
  • fever, erythema, general malaise [toxic epidermal necrolysis: TEN, Stevens-Johnson syndrome]
  • bleeding tendency, fever, sore throat [severe blood disorder (pancytopenia, agranulocytosis, leukocytopenia, neutropenia, thrombocytopenia)]
  • general malaise, loss of appetite, yellowness in skin or conjunctiva [hepatic failure, hepatitis]
  • severe upper abdominal pain, fever, nausea [pancreatitis]
  • change in mental or physical condition due to slight irritation, aggressive tendency, attempt suicide [aggression, suicide attempt]
  • muscle pain, lassitude, reddish brown urine [rhabdomyolysis]
  • decreased urine output, swelling, generalized fatigability [acute kidney injury]
  • sudden fever, muscle stiffness, rapid pulse [neuroleptic malignant syndrome]
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 reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them.
  • [To family members] The patient and his/her families need to receive information about the possibility of developing symptoms, such as aggressive behaviors and suicidal thoughts, until you fully understand it. Keep close contact with your doctor. If you notice unusual behavior and symptoms, consult your doctor or pharmacist immediately.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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