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 :
Sandimmun Oral Solution 10% [for autoimmune disease]
 Active ingredient:
Ciclosporin
 Dosage form:
yellow solution
 Print on wrapping:

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 to treat Behcet's disease with symptoms in eye, psoriasis, aplastic anemia, pure red-cell aplasia, nephrotic syndrome.

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 treatment of Behcet's disease, In general, take 0.05 mL/kg of body weight (5 mg/kg of the active ingredient) [2.5 mL for 50 kg of body weight (250 mg)] a day in 1-2 divided doses. Reduce gradually and as maintenance dosage take 0.03-0.05 mL/kg (3-5 mg/kg) [1.5-2.5 mL for 50 kg of body weight (150-250 mg)] a day in 1-2 divided doses.
    For treatment of psoriasis
    , In general, take 0.025 mL/kg of body weight (2.5 mg/kg of the active ingredient) [1.25 mL for 50 kg of body weight (125 mg)] at a time, twice a day. Reduce gradually and as maintenance dosage take 0.015 mL/kg (1.5 mg/kg) [0.75 mL for 50 kg of body weight (75 mg)] at a time, twice a day.
    For aplastic anemia or pure red-cell aplasia
    , In general, take 0.03 mL/kg of body weight (3 mg/kg of the active ingredient) [1.5 mL for 50 kg of body weight (150 mg)] at a time, twice a day.
    For treatment of frequently-relapsing nephrotic syndrome
    , In general, for adults, take 0.075 mL/kg of body weight (0.75 mg/kg of the active ingredient) [0.375 mL for 50 kg of body weight (37.5 mg)] at a time, twice a day. For children, take 0.0125 mL/kg of body weight (1.25 mg/kg of the active ingredient) [0.25 mL for 20 kg of body weight (25 mg)] at a time, twice a day.
    For treatment of steroid-resistant nephrotic syndrome
    , In general, for adults, take 0.015 mL/kg of body weight (1.5 mg/kg of the active ingredient) [0.75 mL for 50 kg of body weight (75 mg)] at a time, twice a day. For children, take 0.025 mL/kg of body weight (2.5 mg/kg of the active ingredient) [0.5 mL for 20 kg of body weight (50 mg)] at a time, twice a day.
    The preparation contains 100 mg of the active ingredient in 1 mL. The dosage should be adjusted according to your disease or symptoms. Strictly follow the instructions.
  • If you miss a dose,take the missed 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 Neoral 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 or pharmacist 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. 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 in 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 the reach of children. Store away from direct sunlight, heat and moisture.
  • Storage at a low temperature (5℃ or lower) may produce precipitation. Dissolve it at room temperature before use.
  • 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.