くすりのしおり

Internal
Revised: 1/2017

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 :
KOLBET Tablets 25mg
 Active ingredient:
Iguratimod
 Dosage form:
white tablet, diameter: approx. 7.6 mm, thickness: approx. 4.1 mm
 Print on wrapping:
コルベット25mg

Effects of this medicine

This medicine suppresses activities of cells involving in immune function and inflammation and improves symptoms such as swelling and pain in joints.
It is usually used in the treatment of rheumatoid arthritis.

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: hepatic disorder or its history, peptic ulcer or its history, anemia, leukopenia, thrombocytopenia, bone marrow disorder or renal disorder.
  • 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))
  • In general, for adults, take 1 tablet (25 mg of the active ingredient) at a time, once daily, after breakfast for longer than 4 weeks. If you are instructed by your doctor to increase the dosage, you will take 1 tablet at a time, twice daily (after breakfast and supper). The dosage is restricted to 2 tablets (50 mg) daily. Strictly follow the instructions.
  • If you miss a dose, skip the missed dose and take a dose (1 tablet) at the next scheduled time. You should never take two doses at one time.
  • If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
  • This medicine shows its effect within 16 weeks after starting administration. Do not stop taking this medicine or change the dosage unless your doctor instructs you to do so.

Precautions while taking this medicine

  • You should routinely undergo laboratory tests (blood test, urine test, etc.) according to the instruction by your doctor in order to find any adverse reaction earlier during the treatment with this medicine. Sometimes radiography or computed tomography of the chest may be performed.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include abdominal pain, rash, itch, stomatitis, nasopharyngitis, hives, erythema and photosensitivity. 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.
  • general malaise, loss of appetite, yellowing in skin and white of eyes  [hepatic dysfunction, jaundice]
  • throat pain, shortness of breath, nose bleeding, gum bleeding  [pancytopenia, agranulocytosis, leukopenia]
  • nausea, abdominal pain, melena  [peptic ulcer]
  • dry cough, fever, breathing difficulty  [interstitial pneumonia]
  • fever, chilliness, joint pain  [infection]
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 direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. Ask the pharmacist or medical facility how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.