くすりのしおり

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Published: 1/2016

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 :
Calonal Suppositories 200
 Active ingredient:
Acetaminophen
 Dosage form:
white to pale yellow spindle-shaped suppository, maximum diameter: 9 mm, length: 26 mm
 Print on wrapping:
SD CAL・SUP 200, カロナール坐剤200

Effects of this medicine

This medicine lowers fever by directly acting to the temperature-regulating center and increasing heat dissipation.
It is usually used for relief of fever and pain associated with pediatric diseases.

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: blood disease, liver disorder, kidney disorder, heart dysfunction, aspirin-induced asthma or its history.
  • 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))
  • In general, for babies, infants and children, insert 10 to 15 mg of the active ingredient per kilogram of the body weight into rectum at a time. The dosage interval should be longer than 4 to 6 hours. The maximum daily dose is up to 60 mg per kilogram of the body weight. The dosage may be adjusted according to the disease, age or symptoms. However, the dosage should not exceed the adult dosage (the maximum single dose is up to 500 mg and the maximum daily dose is up to 1,500 mg). This preparation contains 200 mg of the active ingredient in a suppository. Strictly follow the instructions.
  • Never take orally. Use the suppository after defecation preferably. Take a suppository out of the package and insert it into the rectum deeply from the thick side of the suppository.
  • If you miss a dose, use the missed dose as soon as possible. You should never use two doses at one time. Take an interval of 4 to 6 hours to use the next dose.
  • If you accidentally use more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop using this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • Do not take other medicines containing acetaminophen (OTC cold remedy, etc.) while using this medicine. Liver dysfunction may occur because of acetaminophen overdose.
  • If long-term administration is performed, liver function test may be regularly conducted. Conduct liver function test at the designated time and date.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include diarrhea, loose stool, hypersensitivity (eruption), cyanosis, vomiting and loss of appetite. 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.
  • breathing difficulty, generalized flushing, hives [shock, anaphylaxis]
  • high fever, eruptions or blisters on skin or mucosa, bloodshot eyes [toxic epidermal necrolysis, Stevens-Johnson syndrome, and acute generalized exanthematous pustulosis]
  • breathing difficulty, wheezing (whistling sound) [induction of asthma attacks]
  • malaise, loss of appetite, yellowing in skin and white of eyes [fulminant hepatitis, liver dysfunction, jaundice]
  • sore throat, fever [granulocytopenia]
  • breathing difficulty, cough, fever [interstitial pneumonia]
  • fever, rash, joint pain [interstitial nephritis, acute renal failure]
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 heat and moisture. Store in a cold place such as a refrigerator.
  • 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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