Download Drug Information Sheet("Kusuri-no-Shiori") Internal Published: 12

Drug Information Sheet("Kusuri-no-Shiori")
Internal
Published: 12/2015
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:PENTASA Granules 94%
Active ingredient:Mesalazine
Dosage form:grayish-white to pale-grayish-yellow cylindrical granules
Print on wrapping:［yellow,250mg］ペンタサ顆粒 94%,メサラジン 250mg 含有,KP-012
［green,500mg］ペンタサ顆粒 94%,メサラジン 500mg 含有,KP-012
［blue,1,000mg］ペンタサ顆粒 94%,メサラジン 1,000mg 含有,KP-012
［orange,2,000mg］ペンタサ顆粒 94%,メサラジン 2,000mg 含
有,KP-012
Effects of this medicine
This medicine eliminates activated oxygen released from inflammatory cells and inhibits the synthesis of leukotriene.
It suppresses development of inflammation and tissue damage, and consequently improves abdominal pain and
hematochezia.
It is usually used in the treatment of ulcerative colitis and Crohn's disease.
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 are a patient with renal or hepatic disorder.
・If you are 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>>
・For ulcerative colitis: In general, for adults, take 1,500 mg of the active ingredient daily in 3 divided doses, after
meals. In the remission stage, however, you may be instructed to take the medicine once daily, as necessary. The
dosage may be adjusted according to the age or symptoms, and the daily dose is limited to 2,250 mg. In the active
stage, however, you may be instructed to take 4,000 mg daily in 2 divided doses, as necessary. For children, take
30 to 60 mg of the active ingredient per kilogram of body weight daily in 3 divided doses, after meals. The dosage
may be adjusted according to the age or symptoms, and the daily dose is limited to 2,250 mg.
For Crohn's disease: In general, for adults, take 1,500 to 3,000 mg of the active ingredient daily in 3 divided doses,
after meals. The dosage may be reduced according to the age or symptoms. For children, take 40 to 60 mg of the
active ingredient per kilogram of body weight daily in 3 divided doses, after meals. The dosage may be adjusted
according to the age or symptoms.
There are four kinds of preparations containing 250 mg, 500mg, 1,000mg,and 2,000mg of the active ingredient in a
sachet. Strictly follow the instructions of your doctor/pharmacist.
・This medicine is a controlled-active ingredient release preparation and so swallow it without chewing.
・If you miss a dose, take a dose as soon as possible when you remember that you missed a dose. However, if it is
almost time for the next dose, skip the missed dose and continue your regular dosing schedule. You should not
take two doses at one time.
・If you took too much of the medicine (more than prescribed), check with your doctor/pharmacist.
・Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
・Sometimes you will find white object in your stool. It is ethylcellulose, the coating agent.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include diarrhea, melena, bloody stool, abdominal pain, rash, fever
and colored urine. 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.
・fever, respiratory distress, dry cough [interstitial lung disease]
・chest pain, fever, respiratory distress [myocarditis, pericarditis, pleuritis]
・fever, decreased urine output, respiratory distress [interstitial nephritis, nephrotic syndrome, deteriorated renal
function, acute renal failure]
・anemic tendency, bleeding tendency, fever [aplastic anemia, pancytopenia, agranulocytosis, thrombocytopenia]
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・general malaise, loss of appetite, yellowing of the skin/eyes [hepatitis, liver dysfunction, jaundice]
・severe pain in the upper abdomen or lower back, fever, nausea, vomiting [pancreatitis]
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 the medicine out of the reach of children. Store it away from light, heat and moisture. The medicine may be
colored during storage, however, it does not affect its efficacy.
・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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