Download Drug Information Sheet("Kusuri-no-Shiori") Internal Revised: 01

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Drug Information Sheet("Kusuri-no-Shiori")
Internal
Revised: 01/2014
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:DEPAKENE-R Tablets 200mg [medication for migraine]
Active ingredient:Sodium valproate
Dosage form:white tablet, φ: 10.6 mm, thickness: 6.6 mm
Print on wrapping:KH114 200mg デパケン R
Effects of this medicine
This medicine is considered to suppress development of migraine via gamma-aminobutyric acid (GABA, an inhibitory
neurotransmitter) in the brain.
It is usually used in the treatment of 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 ever experienced any allergic reaction (itch, rash etc.) to any medicine.
If you are a patient with hepatic 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, possible 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>>
・General dosage regimen: Take 2 to 4 tablets (400-800 mg of the active ingredient) daily, at one or two divided
doses. The dosage may be adjusted according to the age or symptoms. However, the dosage is restricted up to 5
tablets (1,000 mg) a day. Strictly follow the instructions of your doctor/pharmacist (never chew the tablet).
・If you missed a dose, take a dose as soon as possible. If you are instructed to take the medicine once daily, the next
dose should be taken at the scheduled time on the next day. If you are instructed to take the medicine twice daily,
wait about 6 hours to take the next dose. DO NOT take double doses to make up for the missed dose.
・If you accidently took too much of the medicine (more than instructed), check with your doctor/pharmacist.
・Do not stop taking the medicine without the instructions of your doctor.
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.
・The medicine may not be absorbed enough if you have prolonged diarrhea.
・You may find white dregs of the medicine in the stool, however, the medicine is already absorbed.
Possible adverse reactions to this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: somnolence,
sleepiness, nausea, vomiting, weight gain, obesity, ataxia, etc.
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
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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
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For further information, talk to your doctor or pharmacist.
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