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Drug Information Sheet("Kusuri-no-Shiori")

Internal

Revised: 07/2021

|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:CELLCEPT Capsules 250 |[pic] |

|Active ingredient:Mycophenolate mofetil | |

|Dosage form:pale blue/pale red-brown capsule (major axis: approx. 19.6mm) | |

|Print on wrapping:セルセプト250mg | |

|Effects of this medicine |

|This medicine controls immune function by suppressing lymphocyte growth. |

|It is usually used to treat refractory rejection after renal transplant (when you do not respond to the existing medicines, or can not be treated |

|due to adverse reactions, and when the rejections are diagnosed as refractory), to suppress rejection in renal/heart/liver/lung/pancreas transplant,|

|lupus nephritis and for suppression of graft-versus-host disease after hematopoietic stem cell 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 have digestive disease or chronic renal failure. |

|If your renal function is showing slow recovery after renal transplant. |

|If you are a hepatitis virus carrier. |

|・If you are pregnant, possibly 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)) |

|・To treat refractory rejection after renal transplant: In general, for adults, take 6 capsules (1,500 mg of the active ingredient) at a time, twice|

|a day, every 12 hours after meals. It should be adjusted according to the age and symptoms. |

|To suppress rejection after renal transplant: In general, for adults, take 4 capsules (1,000 mg of the active ingredient) at a time, twice a day, |

|every 12 hours after meals. It should be adjusted according to the age and symptoms. The maximum dosage is 12 capsules (3,000 mg of the active |

|ingredient) a day. In general, for children, take 300 to 600 mg/m2 of the active ingredient at a time, twice a day, every 12 hours after meals. It |

|should be adjusted according to the age and symptoms. The maximum dosage is 8 capsules (2,000 mg of the active ingredient) a day. |

|To suppress rejection after heart/liver/lung/pancreas transplant: In general, for adults, take 2 to 6 capsules (500 to 1,500 mg of the active |

|ingredient) at a time, twice a day, every 12 hours after meals. The tolerance dose and the effective dose vary according to each patient. The dosage|

|should be carefully adjusted to obtain the optimum curative effect. |

|Lupus nephritis: In general, for adults, take 1 to 4 capsules (250 to 1,000 mg of the active ingredient) at a time, twice a day, every 12 hours |

|after meals. It should be adjusted according to the age and symptoms. The maximum dosage is 12 capsules (3,000 mg of the active ingredient) a day. |

|In general, for children, take 150 to 600 mg/m2 of the active ingredient at a time, twice a day, every 12 hours after meals. It should be adjusted |

|according to the age and symptoms. The maximum dosage is 8 capsules (2,000 mg of the active ingredient) a day. |

|Suppression of graft-versus-host disease after hematopoietic stem cell transplantation: In general, for adults, take 1 to 6 capsules (250 to 1,500 |

|mg of the active ingredient) at a time, twice a day, every 12 hours after meals. It should be adjusted according to the age and symptoms. It can |

|also be taken 3 times a day after meals within the maximum dosage of 12 capsules (3,000 mg of the active ingredient) a day. In general, for |

|children, take 300 to 600 mg/m2 of the active ingredient at a time, twice a day, every 12 hours after meals. It should be adjusted according to the |

|age and symptoms. The maximum dosage is 8 capsules (2,000 mg of the active ingredient) a day. |

|1 capsule contains 250 mg of the active ingredient. |

|Strictly follow the instructions in any case. |

|・The maximum dosage for severe chronic renal failure is 4 capsules (1,000 mg of the active ingredient) at a time, twice a day. |

|・If you miss a dose, take the missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your |

|regular dosing schedule. You should never take two doses at one time. |

|・If you accidentally take more than your prescribed dose, see your doctor immediately. |

|・Do not stop taking this medicine unless your doctor instructs you to do so. (Your life can be endangered by discontinuing the medicine, or |

|adjusting the dose on your own just because you feel better.) |

|Precautions while taking this medicine |

|・In using the medicine, you and your family need to be informed of these precautions as follows until everyone fully understands them. |

|-Teratogenic action (possibility to cause fetal malformation) has been reported in humans. If you have a possibility to become pregnant, pregnancy |

|test will be performed before use of the medicine in order to confirm that you are not already pregnant. You must avoid pregnancy and confirm that |

|you do not become pregnant before/during use of the medicine and for 6 weeks after discontinuing it. If you think you may be pregnant, tell your |

|doctor immediately. |

|-Contact your doctor immediately when you notice that you are having infectious symptoms, oblivious bruise, internal bleeding, bleeding, anemia, and|

|diarrhea. |

|-In order to avoid the risk of skin cancer caused by sunlight/ultraviolet rays, put on clothes such as a hat and effective sunscreen. |

|・While taking the medicine, you may have to take a blood test frequently. |

|・Avoid breastfeeding. |

|Possible adverse reactions to this medicine |

|The most commonly reported adverse reactions include diarrhea. 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. |

|・fever, chills, general dullness [infection] |

|・convulsion, decreased consciousness, loss of consciousness, speaking difficulty, loss of memory, paralysis of limbs [progressive multifocal |

|leukoencephalopathy (PML)] |

|・general dullness, headache, fever, swelling, lower abdominal pain, frequent urination, feeling of residual urine, bloody urine, decreased urinary |

|volume [BK virus associated nephropathy] |

|・dizziness, headache, nose bleeding, ear ringing, gum bleeding, shortness of breath, palpitation, blue spot, bleeding tendency, continuous |

|bleeding, fever, sudden high fever, chills, general dullness, sore throat [blood disorder] |

|・swollen lymph node (neck, armpit, inguinal region, etc.), night sweat, weight loss, fever, loss of appetite, bleeding tendency, anemia, tumors, |

|bruises, or moles that are asymmetrical and suddenly grow, easy to bleed from tumor, rise suddenly or become an ulcer [malignant lymphoma, |

|lymphoproliferative disease, malignancy (especially on the skin)] |

|・nausea, vomiting, lead to blood in the vomiting (red to dark brown or black), abdominal pain, severe abdominal pain, abdominal bloating, feeling |

|sick at the stomach, bloody/black stool, failure of passing stool/gas, chills, fever, lightheadedness, shortness of breath, decreased consciousness |

|[gastrointestinal disorder] |

|・frequent watery stool, lower abdominal pain, general dullness, fever [severe diarrhea] |

|・nausea, vomiting, hyperventilation, decreased consciousness, loss of consciousness, shaky hands and legs, breathing difficulty, bluish purple |

|lips/ fingertips of limbs, palpitation, general dullness, weight loss, thirst, excess intake of water, increased urinary volume, dizziness on |

|standing up, dizziness, easy fatigability, general weakness, cramp [acidosis, hypoxia, diabetes, dehydration] |

|・sudden decreased consciousness, sudden loss of consciousness, sudden paralysis in one side of the body, sudden headache, sudden vomiting, sudden |

|dizziness, sudden difficulty speaking, sudden difficulty to utter a word, sudden reduced visual acuity, sudden visual field disorder, distorted |

|vision, chest constrictive pain, shortness of breath, low back pain, severe peripheral limbs pain, paralysis, numbness [thrombosis] |

|・decreased urinary volume, red urine, edema, general dullness, low back pain, back pain, abdominal pain [serious renal disorder] |

|・breathing difficulty, shortness of breath, easy fatigability, edema, weight gain, chest constrictive pain, chest oppressive feeling, chest |

|disorder feeling, chest uncomfortable feeling, cold sweat, jaw and left arm pain, faint, dizziness, palpitation, slow pulse, fast pulse, irregular |

|pulse, disturbed pulse, general dullness, decreased blood pressure [cardiac disorder] |

|・easy fatigability, general dullness, loss of strength, nausea, loss of appetite, yellowness in the white of the eye, yellowness in the skin, dark |

|urine, itching of the body [hepatic function disorder, jaundice] |

|・breathing difficulty, breathing wheezingly, cough, phlegm, fast breathing, fast pulse, easy breathing in upright position, cessation of breathing |

|for long time, chest pain, shortness of breath [pulmonary edema, apnea, pneumothorax] |

|・twitching face or limbs, temporal absent-mindedness, decreased consciousness, stiff muscles/tremor in the limbs, distraction, wrong answer, |

|inconsistent behavior, feeling something that is not really there, hallucination, delusion, excitement, depression [convulsion, confusion, |

|hallucination, psychosis] |

|・generalized itching, hives, itchy throat, lightheadedness, palpitation, breathing difficulty, inability to hear voices/sounds, difficulty hearing,|

|ear ringing [allergic reaction, hearing loss] |

|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 at room temperature (1 to 30℃), away from direct sunlight and moisture. |

|・Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility how to discard them. |

|For healthcare professional use only / / |

| |

For further information, talk to your doctor or pharmacist.

Drug Information Sheet("Kusuri-no-Shiori")

Internal

Revised: 07/2021

|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:CELLCEPT Powder for Oral Suspension 31.8% |[pic] |

|Active ingredient:Mycophenolate mofetil | |

|Dosage form:white powder | |

|Print on wrapping: | |

|Effects of this medicine |

|This medicine controls immune function by suppressing lymphocyte growth. |

|It is usually used to treat refractory rejection after renal transplant (when you do not respond to the existing medicines, or can not be treated |

|due to adverse reactions, and when the rejections are diagnosed as refractory), to suppress rejection in renal/heart/liver/lung/pancreas transplant,|

|lupus nephritis and for suppression of graft-versus-host disease after hematopoietic stem cell 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 have digestive disease, chronic renal failure, phenylketonuria or hereditary fructose intolerance. |

|If your renal function is showing slow recovery after renal transplant. |

|If you are a hepatitis virus carrier. |

|・If you are pregnant, possibly 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)) |

|・To treat refractory rejection after renal transplant: In general, for adults, take 1,500 mg of the active ingredient at a time, twice a day, every|

|12 hours after meals. It should be adjusted according to the age and symptoms. |

|To suppress rejection after renal transplant: In general, for adults, take 1,000 mg of the active ingredient at a time, twice a day, every 12 hours |

|after meals. It should be adjusted according to the age and symptoms. The maximum dosage is 3,000 mg of the active ingredient a day. In general, for|

|children, take 300 to 600 mg/m2 of the active ingredient at a time, twice a day, every 12 hours after meals. It should be adjusted according to the |

|age and symptoms. The maximum dosage is 2,000 mg of the active ingredient a day. |

|To suppress rejection after heart/liver/lung/pancreas transplant: In general, for adults, take 500 to 1,500 mg of the active ingredient at a time, |

|twice a day, every 12 hours after meals. The tolerance dose and the effective dose vary according to each patient. The dosage should be carefully |

|adjusted to obtain the optimum curative effect. |

|Lupus nephritis: In general, for adults, take 250 to 1,000 mg of the active ingredient at a time, twice a day, every 12 hours after meals. It should|

|be adjusted according to the age and symptoms. The maximum dosage is 3,000 mg of the active ingredient a day. In general, for children, take 150 to |

|600 mg/m2 of the active ingredient at a time, twice a day, every 12 hours after meals. It should be adjusted according to the age and symptoms. The |

|maximum dosage is 2,000 mg of the active ingredient a day. |

|Suppression of graft-versus-host disease after hematopoietic stem cell transplantation: In general, for adults, take 250 to 1,500 mg of the active |

|ingredient at a time, twice a day, every 12 hours after meals. It should be adjusted according to the age and symptoms. It can also be taken 3 times|

|a day after meals within the maximum dosase of 3,000 mg of the active ingredient a day. In general, for children, take 300 to 600 mg/m2 of the |

|active ingredient at a time, twice a day, every 12 hours after meals. It should be adjusted according to the age and symptoms. The maximum dosage is|

|2,000 mg of the active ingredient a day. |

|This medicine is a made-up suspension by adding purified water to the powder at the pharmacy/healthcare facility. 1 mL of made-up suspension contain|

|200 mg of the active ingredient. |

|Strictly follow the instructions in any case. |

|・The maximum dosage for severe chronic renal failure is 1,000 mg of the active ingredient at a time, twice a day. |

|・If you miss a dose, take the missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your |

|regular dosing schedule. You should never take two doses at one time. |

|・If you accidentally take more than your prescribed dose, see your doctor immediately. |

|・Do not stop taking this medicine unless your doctor instructs you to do so. (Your life can be endangered by discontinuing the medicine, or |

|adjusting the dose on your own just because you feel better.) |

|Precautions while taking this medicine |

|・In using the medicine, you and your family need to be informed of these precautions as follows until everyone fully understands them. |

|-Teratogenic action (possibility to cause fetal malformation) has been reported in humans. If you have a possibility to become pregnant, pregnancy |

|test will be performed before use of the medicine in order to confirm that you are not already pregnant. You must avoid pregnancy and confirm that |

|you do not become pregnant before/during use of the medicine and for 6 weeks after discontinuing it. If you think you may be pregnant, tell your |

|doctor immediately. |

|-Contact your doctor immediately when you notice that you are having infectious symptoms, oblivious bruise, internal bleeding, bleeding, anemia, and|

|diarrhea. |

|-In order to avoid the risk of skin cancer caused by sunlight/ultraviolet rays, put on clothes such as a hat and effective sunscreen. |

|・While taking the medicine, you may have to take a blood test frequently. |

|・Avoid breastfeeding. |

|Possible adverse reactions to this medicine |

|The most commonly reported adverse reactions include diarrhea. 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. |

|・fever, chills, general dullness [infection] |

|・convulsion, decreased consciousness, loss of consciousness, speaking difficulty, loss of memory, paralysis of limbs [progressive multifocal |

|leukoencephalopathy (PML)] |

|・general dullness, headache, fever, swelling, lower abdominal pain, frequent urination, feeling of residual urine, bloody urine, decreased urinary |

|volume [BK virus associated nephropathy] |

|・dizziness, headache, nose bleeding, ear ringing, gum bleeding, shortness of breath, palpitation, blue spot, bleeding tendency, continuous |

|bleeding, fever, sudden high fever, chills, general dullness, sore throat [blood disorder] |

|・swollen lymph node (neck, armpit, inguinal region, etc.), night sweat, weight loss, fever, loss of appetite, bleeding tendency, anemia, tumors, |

|bruises, or moles that are asymmetrical and suddenly grow, easy to bleed from tumor, rise suddenly or become an ulcer [malignant lymphoma, |

|lymphoproliferative disease, malignancy (especially on the skin)] |

|・nausea, vomiting, lead to blood in the vomiting (red to dark brown or black), abdominal pain, severe abdominal pain, abdominal bloating, feeling |

|sick at the stomach, bloody/black stool, failure of passing stool/gas, chills, fever, lightheadedness, shortness of breath, decreased consciousness |

|[gastrointestinal disorder] |

|・frequent watery stool, lower abdominal pain, general dullness, fever [severe diarrhea] |

|・nausea, vomiting, hyperventilation, decreased consciousness, loss of consciousness, shaky hands and legs, breathing difficulty, bluish purple |

|lips/ fingertips of limbs, palpitation, general dullness, weight loss, thirst, excess intake of water, increased urinary volume, dizziness on |

|standing up, dizziness, easy fatigability, general weakness, cramp [acidosis, hypoxia, diabetes, dehydration] |

|・sudden decreased consciousness, sudden loss of consciousness, sudden paralysis in one side of the body, sudden headache, sudden vomiting, sudden |

|dizziness, sudden difficulty speaking, sudden difficulty to utter a word, sudden reduced visual acuity, sudden visual field disorder, distorted |

|vision, chest constrictive pain, shortness of breath, low back pain, severe peripheral limbs pain, paralysis, numbness [thrombosis] |

|・decreased urinary volume, red urine, edema, general dullness, low back pain, back pain, abdominal pain [serious renal disorder] |

|・breathing difficulty, shortness of breath, easy fatigability, edema, weight gain, chest constrictive pain, chest oppressive feeling, chest |

|disorder feeling, chest uncomfortable feeling, cold sweat, jaw and left arm pain, faint, dizziness, palpitation, slow pulse, fast pulse, irregular |

|pulse, disturbed pulse, general dullness, decreased blood pressure [cardiac disorder] |

|・easy fatigability, general dullness, loss of strength, nausea, loss of appetite, yellowness in the white of the eye, yellowness in the skin, dark |

|urine, itching of the body [hepatic function disorder, jaundice] |

|・breathing difficulty, breathing wheezingly, cough, phlegm, fast breathing, fast pulse, easy breathing in upright position, cessation of breathing |

|for long time, chest pain, shortness of breath [pulmonary edema, apnea, pneumothorax] |

|・twitching face or limbs, temporal absent-mindedness, decreased consciousness, stiff muscles/tremor in the limbs, distraction, wrong answer, |

|inconsistent behavior, feeling something that is not really there, hallucination, delusion, excitement, depression [convulsion, confusion, |

|hallucination, psychosis] |

|・generalized itching, hives, itchy throat, lightheadedness, palpitation, breathing difficulty, inability to hear voices/sounds, difficulty hearing,|

|ear ringing [allergic reaction, hearing loss] |

|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 at room temperature (1 to 30℃), away from direct sunlight. It can be stored in the refrigerator. Avoid |

|freezing. |

|・Use the made-up suspension within 60 days. The expiration date will be written on the bottle label. |

|・Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility how to discard them. |

|For healthcare professional use only / / |

| |

For further information, talk to your doctor or pharmacist.

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