くすりのしおり

Internal
Revised: 8/2012

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 Tablets 250mg
 Active ingredient:
Mesalazine
 Dosage form:
white to pale yellow tablet with mottled grayish white to pale grayish yellow (φ: 9.5 mm, thickness: 4.6 mm)
 Print on wrapping:
(face) ペンタサ錠 250mg, 250mg, KP-007, (back) PENTASA Tab.250mg, ペンタサ錠250mg, 250mg

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.
    This preparation contains 250 mg of the active ingredient in a tablet. Strictly follow the instructions of your doctor and pharmacist.
  • You may split the tablet in half to take, however, the medicine is a controlled-release preparation. 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 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

  • 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, hematochezia, 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, breathing difficulty, dry cough  [interstitial lung disease]
  • chest pain, fever, breathing difficulty  [myocarditis, pericarditis, pleuritis]
  • fever, decreased urine output, breathing difficulty  [interstitial nephritis, nephrotic syndrome, deteriorated renal function, acute renal failure]
  • anemic tendency, bleeding tendency, fever  [aplastic anemia, pancytopenia, agranulocytosis, thrombocytopenia]
  • general fatigue, 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 : Day Month Year

For further information, talk to your doctor or pharmacist.

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