くすりのしおり

Internal
Published: 8/2015

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 :
SODIUM VALPROATE TABLETS 200mg "FUJINAGA" [antiepileptic drug, medication for mania and manic state]
 Active ingredient:
Sodium valproate
 Dosage form:
white tablet, diameter: 9.1 mm, thickness: 4.8 mm
 Print on wrapping:
バルプロ酸Na200mg「フジナガ」, SodiumValproate200mg“FUJINAGA”, EP200

Effects of this medicine

This medicine is considered to suppress development of migraine viaγ-aminobutyric acid (GABA, an inhibitory neurotransmitter) and dopamine concentration in the brain, and promotes metabolism of serotonin. It consequently activates inhibitory systems in the brain and shows antiepileptic action. It is also considered that promoting effect of GABA neurotransmission contributes to antimanic effect.
It is usually used to treat various types of epilepsy, personality and behavior disorders resulting from epilepsy (moroseness, irascibility, etc.), mania and manic phase of manic-depressive psychosis.

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 disorder, encephalopathy or coma of unknown cause, or urea cycle disorder.
    If you have a family history of infant death of unknown cause.
  • If you are pregnant, possibly 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))
  • In general, take 2 to 6 tablets (400 mg to 1,200 mg of the active ingredient) a day, in 2 to 3 divided doses. The dosage may be adjusted according to your age and symptoms. Strictly follow the instructions.
  • If you missed a dose, take a dose as soon as possible or it may result in developing an epileptic seizure (symptom). However, wait approximately 4 hours before the next dose. 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

  • The medicine may cause drowsiness, decreased attention/concentration/reflex motor activities. Avoid driving a car or operating dangerous machinery.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include somnolence, ataxia, nausea/vomiting, loss of appetite and malaise. 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.
  • general malaise and loss of appetite, nausea, yellowing of the skin and the white of eyes [liver disorder including fulminant hepatitis]
  • general malaise and loss of appetite, somnolence, light headedness [conscious disorder accompanied with hyperammonemia]
  • general malaise and loss of appetite, bruise [hemolytic anemia, pure red cell aplasia, pancytopenia, decreased platelets, granulocytopenia]
  • severe abdominal pain, fever, nausea [acute pancreatitis]
  • fever, general malaise and loss of appetite, rash [mucocutaneous ocular syndrome, toxic epidermal necrosis]
  • dry cough, shortness of breath, fever [interstitial pneumonia, eosinophilic pneumonia]
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 healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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