くすりのしおり

Internal
Revised: 1/2019

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 Syrup 5% "Nichiiko" [medication for migraine]
 Active ingredient:
Sodium valproate
 Dosage form:
colorless to slightly yellow clear syrup
 Print on wrapping:
禁注射,バルプロ酸ナトリウムシロップ5%「日医工」,内服用,200mg,4mL

Effects of this medicine

This medicine is considered to suppress the migraine attack via an inhibitory neurotransmitter, γ-aminobutyric acid (GABA), in the brain.
It is usually used to suppress migraine attack. It is not aimed to improve migraine attack 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 and urea cycle disorder.
  • 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, for adults, take 2 to 4 packets (8 to 16 mL, 400 to 800 mg of the active ingredient) a day, in 2 or 3 divided doses. The dosage may be adjusted according to age and symptoms of the patient. DO NOT exceed the daily maximum number of dosage, 5 packets (20mL, 1,000mg). This preparation contains 200 mg of the active ingredient in a packet (4 ml). Strictly follow the instructions.
  • DO NOT use this medicine besides oral administration. Take this medicine immediately after opening the packet and discard the liquid left in the packet.
  • Read the instruction, <患者さんへ (For the patients) >, about the way to open the packet (This instruction is written only in Japanese) .
  • If you miss a dose, take a dose as soon as you remember. However, the next dose should be approximately 4 hours apart. 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 and lack of attention, concentration and reflex movement. Avoid operating in potentially hazardous activities such as driving a car.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include somnolence, ataxia (limb movement incoordination), nausea/vomiting, anorexia 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, yellowing of the skin and the whites of the eyes [serious liver disorder such as fulminant hepatitis]
  • faint consciousness, flapping tremor (shivering), impaired mind [consciousness disorder with hyperammonemia]
  • general malaise, nasal bleeding, high fever [hemolytic anemia, pure red-cell aplasia, pancytopenia, serious thrombocytopenia, granulocytopenia]
  • severe abdominal pain, fever, nausea/vomiting [acute pancreatitis]
  • fever, rash, hand tremor [interstitial nephritis, fanconi 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 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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