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 EXTENDED RELEASE GRANULES 40% "FUJINAGA" [medication for migraine]
 Active ingredient:
Sodium valproate
 Dosage form:
white granules
 Print on wrapping:

Effects of this medicine

This medicine is considered to suppress development of migraine viaγ-aminobutyric acid (GABA, an inhibitory neurotransmitter) in the brain.
It is usually used to treat migraine to prevent or relieve development of migraine. It does not improve migraine which has already developed.

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 1 to 2 g (400 to 800 mg of the active ingredient) at a time, once a day. The dosage may be adjusted according to your age and symptoms. However, the maximum daily dose is 2.5 g (1,000 mg). Strictly follow the instructions.
  • Take the medicine without chewing as it is sustained-release preparation.
  • If you missed a dose, take a dose as soon as possible. However, if half a day has already passed from the scheduled time, skip the missed 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.
  • In case of prolonged diarrhea, consult with your doctor or pharmacist as it may affect the action of the medicine.
  • You may see white granules in your stools, however, it is the rest of absorbed medicine. It does not effect on the efficacy of the medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include somnolence, dizziness, nausea/vomiting, gastric discomfort, anemia, rash, enuresis and weight gain. 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.
  • rash, general malaise, yellowing of the skin and the white of eyes [liver disorder including fulminant hepatitis]
  • somnolence, loss of appetite, general malaise [conscious disorder accompanied with hyperammonemia]
  • severe abdominal pain, fever, nausea [acute pancreatitis]
  • fever, erythema/blister in wide area of skin, general malaise [mucocutaneous ocular syndrome, toxic epidermal necrosis]
  • muscle pain, lassitude, reddish-brown urine [rhabdomyolysis]
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.