くすりのしおり

Internal
Revised: 4/2017

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 :
GABAPEN Tablets 300mg
 Active ingredient:
Gabapentin
 Dosage form:
white tablet, diameter: 9.4 mm, thickness: 4.8 mm
 Print on wrapping:
ガバペン300mg, GABAPEN300mg, GPN300

Effects of this medicine

This medicine exerts anticonvulsant effect by two types of actions: decreasing calcium inflow and free neurotransmitter in the excitatory presynaptic terminal and increasing GABA in the brain to maintain/strengthen the GABA in nerve function.
It is usually used to treat partial seizures of epilepsy with concomitant therapy.

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 dysfunction.
  • 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 and children over 13 years old: In general, take 200 mg of the active ingredient 3 times on the first day. On the second day, take 400 mg 3 times. From the third day on, take 400 to 600 mg 3 times a day as maintenance doses. For adults with renal disorder, the dosage and dose frequency may be adjusted. The dosage may be adjusted according to the symptoms. The maximum daily dose is 8 tablets (2,400 mg).
    For children 3 to 12 years old: In general, take 10 mg/kg (10 mg per 1 kilogram of the body weight) as the active ingredient in 3 divided doses on the first day. On the second day, take 20 mg/kg in 3 divided doses. From the third day on, take 40 mg/kg in 3 divided doses for children 3 to 4 years old and 25 to 35 mg/kg in 3 divided doses for children 5 to 12 years old as maintenance doses. The dosage may be adjusted according to the symptoms. The maximum daily dose is 50 mg/kg. The dose in children 3 to 12 years old should not exceed the dose in adults and children over 13 years old.
    This preparation contains 300 mg of the active ingredient in a tablet. It may be combined with other antiseizure drugs. In any case, strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as possible. The maximum time interval between doses should not exceed 12 hours. 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, or decrease of attention, concentration or reflex action. Avoid driving a car or operating dangerous machinery.
  • This medicine may cause an increase of body weight. If you have signs of overweight, consult with your doctor or pharmacist.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include sleepiness, dizziness, headache, diplopia, malaise, convulsion, excessive appetite, excessive salivation, rash, unstable emotion, constipation, vomiting and urinary incontinence. 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.
  • decreased urine output, edema of limbs and face, malaise [acute renal failure]
  • high fever, reddened skin, stomatitis [Stevens-Johnson syndrome]
  • general malaise, loss of appetite, yellowing of the skin and the white of eyes [hepatitis, liver dysfunction, jaundice]
  • muscle pain, lassitude, reddish brown urine  [rhabdomyolysis]
  • swelling of the face/tongue/lips/throat (angioedema), respiratory distress, hives [anaphylaxis]
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.
  • Since this medicine may be affected by heat, do not keep at high temperature and keep in a cool place.
  • Discard the remainder. Do not store them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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