くすりのしおり

Internal
Revised: 5/2019

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 fine granules 20% "EMEC" [antiepileptic drug, medication for mania and manic state]
 Active ingredient:
Sodium valproate
 Dosage form:
white fine granule
 Print on wrapping:
(front) バルプロ酸ナトリウム細粒20%「EMEC」, 1包(1g)中200mg
(back) Sodium Valproate fine granules 20%「EMEC」, 1包(1g)中200mg

Effects of this medicine

This medicine increases gamma-aminobutyric acid (GABA, an inhibitory neurotransmitter) or dopamine consistency in the brain, and promotes metabolism of serotonin to activate inhibitory systems in the brain and to show antiepileptic action. It is also considered that promoting effect of GABA neurotransmission contributes to antimanic effect.
It is usually used in the treatment of 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: hepatic disorder, encephalopathy or coma of unknown cause, urea cycle disorder, or 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 g (400 to 1,200 mg of the active ingredient) daily, in two or three divided doses. The dosage may be adjusted according to the disease, age or symptoms. Strictly follow the instructions.
  • If you miss a dose, take a dose as soon as possible or it may result in developing an epileptic seizure (symptom). After taking the medicine, wait about 4 hours to take 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, lowering of attentiveness, concentration and 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 (limb movement incoordination), 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, loss of appetite, nausea, yellowing in skin and white of eyes [hepatic disorder such as fulminant hepatitis]
  • general malaise, loss of appetite, somnolence, light-headed feeling [consciousness disturbance associated with hyperammonemia]
  • general malaise, dizziness, bruise [hemolytic anemia, pure red-cell aplasia, pancytopenia, thrombocytopenia, granulocytopenia]
  • intense abdominal pain, fever, nausea [acute pancreatitis]
  • fever, general malaise, loss of appetite, rash [oculomucocutaneous syndrome, toxic epidermal necrolysis]
  • 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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