くすりのしおり

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Revised: 10/2008

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 :
PREDONEMA Enema 20mg
 Active ingredient:
Prednisolone sodium phosphate
 Dosage form:
colorless limpid enema solution
 Print on wrapping:
プレドネマ注腸20mg, PREDONEMA Enema20mg, 1本 (60mL)入, KP-009

Effects of this medicine

This medicine is a adrenal corticosteroid, and suppresses inflammation to reduce ulcerative lesion attributed to colitis.
It is usually used in the treatment of ulcerative colitis and localized colitis.

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 infections, systemic mycosis, peptic ulcer, psychiatric disease, tuberculous disease, herpes simplex keratitis, posterior subcapsular cataract, glaucoma, hypertension, electrolyte abnormality, thrombosis, acute myocardial infarction, varicella or measles (have a history of measles or measles vaccination).
    If you have got a surgical wound in an organ recently.
  • 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))
  • General dosage regimen: For adults, instill a pack of enema (20 mg of prednisolone phosphate) into the rectum at a time. The dosage may be adjusted according to the diseases, age or symptoms. Strictly follow the instructions of your doctor/pharmacist.
  • Insert the enema nozzle into the rectum carefully not to damage the rectal mucosa.
  • Use a dose as soon as possible when you remember that you missed a rectal instillation. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. DO NOT use double doses to make up for the missed dose.
  • If you used too much of the medicine (more than ordered), check with your doctor/pharmacist.
  • Do not stop using the medicine without the instructions of your doctor.

Precautions while taking this medicine

Possible adverse reactions to this medicine

Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: menstrual disorder, diarrhea, insomnia, muscular pain, moon face, edema, retinal disorder, acne, fever, 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.
  • abdominal pain, tenderness, melena, hematemesis, black stool, fever  [gastrointestinal ulcer, gastrointestinal perforation, gastrointestinal bleeding]
  • schizophrenia, depression, convulsively muscular contraction (convulsion)  [mental disorder, depressed state, convulsion]
  • eye pain, headache, acute deterioration of vision  [glaucoma, posterior subcapsular cataract, central serous chorioretinopathy, multifocal posterior pigment epitheliopathy]
  • acute precordial pressure, anginal pain, cold sweat, numbness, headache, impaired consciousness  [myocardial infarction, cerebral infarction, aneurysm]
  • breathing difficulty, systemic flush, angioedema (swelling in the eyelids and lips) [shock, anaphylactoid symptoms]
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 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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