くすりのしおり

Internal
Revised: 7/2018

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 :
Neoral 50mg capsules [for transplantation]
 Active ingredient:
Ciclosporin
 Dosage form:
yellowish white capsule, major axis: 21.9 mm, minor axis: 8.5 mm
 Print on wrapping:
Neoral 50mg, ネオーラル50mgカプセル

Effects of this medicine

This medicine shows specific and reversible immunosuppressive effect on lymphocytes, and mainly suppresses activation of T-helper cells. It consequently suppresses abnormal immune reactions.
It is usually used for inhibition of the rejection of organ transplantation (kidney, liver, heart, lung, pancreas, small bowel), or inhibition of the rejection and graft-versus-host disease following bone-marrow transplantation.

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 neural Behcet's disease, renal dysfunction, hepatic dysfunction, infection, malignant tumor or its history.
  • 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))
  • For kidney transplantation, In general, take 4.5-6 mg/kg of body weight (225-300 mg for 50 kg of body weight) of the active ingredient at a time, twice a day, started on the day before transplantation. After transplantation, reduce gradually and as maintenance dosage take 2-3 mg/kg (100-150 mg for 50 kg of body weight) of the active ingredient at a time, twice a day.
    For liver transplantation, In general, take 7-8 mg/kg of body weight (350-400 mg for 50 kg of body weight) of the active ingredient at a time, twice a day, started on the day before transplantation. After transplantation, reduce gradually and as maintenance dosage take 2.5-5 mg/kg (125-250 mg for 50 kg of body weight) of the active ingredient at a time, twice a day.
    For heart/lung/pancreas transplantation, In general, take 5-7.5 mg/kg of body weight (250-375 mg for 50 kg of body weight) of the active ingredient at a time, twice a day, started on the day before transplantation. After transplantation, reduce gradually and as maintenance dosage take 1-3 mg/kg (50-150 mg for 50 kg of body weight) of the active ingredient at a time, twice a day.
    For small bowel transplantation, In general, take 7-8 mg/kg of body weight (350-400 mg for 50kg of body weight) of the active ingredient at a time, twice a day. After transplantation, reduce gradually and as maintenance dosage take 2.5-5 mg/kg (125-250 mg for 50 kg of body weight) of the active ingredient at a time, twice a day.However, in general, take the injection medicine of ciclosporin started on the day before transplantation. After becoming the oral administration possible, start to take the capsules.
    For bone-marrow transplantation, In general, take 3-6 mg/kg of body weight (150-300 mg for 50 kg of body weight) of the active ingredient at a time, twice a day, started on the day before transplantation. After transplantation, maintain the dosage for 3-6 months and then gradually reduce until discontinuation.
    This preparation contains 50 mg of the active ingredient in a capsule, and may be used with capsules of different content amount. The dosage should be adjusted according to the symptoms after tansplantation.Strictly follow the instructions.
  • If you miss a dose, take a dose as soon as possible. However, take the next dose at least 5 hours apart. You should never 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. Do not take Sandimmun instead of the medicine.

Precautions while taking this medicine

  • While taking this medicine, your natural immunity will be reduced. To prevent infections, often wash your hands, gargle, and brush your teeth.
  • Consult with your doctor when you receive a vaccination.
  • Grapefruit juice may intensify the effect of the medicine by increasing its blood level. Health foods containing St. Jone's wart may reduce the effect of the medicine by decreasing its blood level. Avoid taking these foods and drinks.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include renal dysfunction (decrease of urine output, edema), hepatic dysfunction (malaise, yellowness of hand or in conjunctiva), nausea, excessive hair growth, tremor (trembling of limbs), headache, dizziness, gum hyperplasia, hypertension, hot feeling, rash and fever, etc. 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.
  • convulsion, disturbed consciousness, visual disorder [central nervous system disorder such as reversible posterior leukoencephalopathy syndrome or hypertensive encephalopathy]
  • severe pain in upper abdomen, fever, nausea [acute pancreatitis]
  • bleeding tendency, malaise, edema [hemolytic uremic syndromes, thrombotic thrombocytopenic purpura, hemolytic anemia, thrombocytopenia]
  • pain/stiffness of muscle, muscle weakness [rhabdomyolysis]
  • enlargement of lymph nodes, fever, loss of appetite [malignant lymphoma, lymphoproliferative disease, malignant tumor (especially of the skin)]
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. Keep in press-through package (PTP) sheet just before taking.
  • Discard the remainder.Do not store them. Ask the pharmacy how to discard.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.