Drug Information Sheet ("Kusuri-no-Shiori")
610432045
Revised: 09/2011
Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries
other than Japan.
In deciding to use a medicine, the risk (side effects) of taking the medicine must be weighed against the benefit
(effects) it will do. The patient's cooperation is indispensable here.
Brand name： CELLCEPT Capsule 250
Active ingredient： Mycophenolate mofetil
Dosage form： pale blue/pale red-brown capsule (major axis: approx. 19.6mm)
Printings on wrapping： セルセプト 250
Effects of this medicine
This medicine controls immune function by suppressing lymphocyte growth, and consequently prevents
rejection after organ transplant. 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 side effects, and when
the rejections are diagnosed as refractory). It is usually used to suppress rejection in
renal/heart/liver/lung/pancreas transplant, too.
Before using this medicine, tell your doctor/pharmacist
・ If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
If you are a patient with alimentary disease or chronic renal failure.
If it is taking time to improve your renal function after renal transplant.
・ If you are pregnant, possibly pregnant or breastfeeding.
・ If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce
the risk of drug interactions.)
Dosage regimen (proper use of this medicine)
・ Your dosage regimen is:≪
:order of your doctor≫
・ General dosage regimen:To treat refractory rejection after renal transplant: For adults, take 6
capsules (1,500 mg of the active ingredient) at a time, twice a day, every 12 hours after meal. It
should be adjusted according to your age and symptoms.
To suppress rejection after renal transplant: For adults, take 4 capsules (1,000mg of the active
ingredient) at a time, twice a day, every 12 hours after meal. It should be adjusted according to your
age and symptoms. The maximum dosage is 12 capsules (3,000mg of the active ingredient) a day.
For children, take 300 to 600mg/m2 of the active ingredient at a time, twice a day, every 12 hours
after meal. It should be adjusted according to your age and symptoms. The maximum dosage is 8
capsules (2,000mg of the active ingredient) a day. 1 capsule contains 250mg of the active ingredient.
To suppress rejection after heart/liver/lung/pancreas transplant: For adults, take 2-6 capsules
(500-1,500mg of the active ingredient) at a time, twice a day, every 12 hours after meal. The
tolerance dose and the effective dose vary according to each patient. The dosage should be carefully
adjusted to get the optimum curative effect.
Strictly follow the instructions of your doctor/pharmacist in any case.
・ The maximum dosage for severe chronic renal failure is 4 capsules (1,000mg of the active ingredient)
at a time, twice a day.
・ Missed 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. DO NOT take double doses to make up for
the missed dose.
・ Overdose: If you took too much of the medicine (more than ordered), check with your
doctor/pharmacist immediately.
・ Others: Do not stop taking the medicine without the instructions of your doctor. (Your life can be
endangered by discontinuing the medicine, or adjusting the dose on your own just because you feel
better.)
Continued on next page.
Precautions while using this medicine
・ In using the medicine, you and your family need to be informed of these precautions as follows until
everyone fully understands them.
-If you have a possibility to get pregnant, avoid pregnancy before/during use of the medicine and for
6 weeks after discontinuing it.
-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.
Side effects of this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist:
diarrhea, cytomegalus virus infection, etc.
Symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur,
stop taking your medicine and check with your doctor immediately.
・ cold-like symptoms, lassitude, fever, vomiting［infection］
・ absent-mindedness, impaired mind, memory loss, loss of consciousness, paralysis of the limbs,
difficulty speaking, convulsion［progressive multifocal leukoencephalopathy］
・ lassitude, headache, fever, swelling, lower abdominal pain, frequent urination, feeling of residual
urine, bloody urine, decreased urinary volume［BK virus associated nephropathy］
・ dizziness, palpitation, ear ringing, nose/gum bleeding, bleeding tendency, blue spot, shortness of
breath［pancytopenia］
・ fever, sore throat［neutropenia, agranulocytosis, leukopenia］
・ gum/nose bleeding, continuous bleeding, subcutaneous bleeding, blue spot［thrombocytopenia］
・ palpitation/shortness of breath when going upstairs or uphill, headache, shortness of breath, ear
ringing, dizziness, lassitude［anemia］
・ lassitude, dizziness, shortness of breath, palpitation［pure red cell aplasia］
・ swollen lymph node, night sweat, fever, weight loss, loss of appetite［malignant lymphoma］
・ fever, loss of appetite, swollen lymph node, bleeding tendency, anemia［lymphoproliferative disease］
・ itchy/painful/bleeding/growing mole, red-brown scab, mole turning into ulcer［malignancy (especially
on the skin)］
・ bloody/black stool, nausea, vomiting, stomachache［gastrointestinal ulcer］
・ bloody/black stool, nausea, vomiting of blood, abdominal pain, vomiting［gastrointestinal bleeding］
・ nausea, severe abdominal pain, vomiting［perforation of the digestive tract］
・ severe abdominal pain, feeling sick at the stomach, vomiting, failure of passing stool/gas［ileus］
・ sweat, muddy stool, watery stool, severe abdominal pain, nausea［severe diarrhea］
・ impaired mind/judgment, shaky hands and legs, hyperventilation, decreased consciousness
［acidosis］
・ top-heavy feeling, breathlessness, brief cessation of breathing, dizziness, feeling of weariness
［hypoxia］
・ excess intake of water, increased urinary volume, lassitude, weight loss, thirst［diabetes］
・ faint consciousness, hyperventilation, shaky hands and fingers, impaired mind/judgment, lassitude,
decreased urinary volume, thirst［dehydration］
・ nausea, vomiting of blood, enlarged feeling of abdomen, vomiting, chest pain, chest
constrictive/oppressive feeling, severe abdominal/leg pain, bleeding, sensory numbness［thrombosis］
・ fever, decreased urinary volume, headache, loss of appetite, dry mouth, swollen hands and legs/face
［serious renal disorder］
・ easy breathing in upright position, breathlessness, shortness of breath, swollen body, lassitude,
palpitation when moving［cardiac failure］
・ chest pressured/constrictive feeling, cold sweat, chest pain, strong chest oppressive feeling［angina］
・ loss of consciousness, cessation of breathing［cardiac arrest］
・ irregular heartbeat, disturbed pulse, chest disorder feeling, decreased consciousness, pounding
heart/chest, palpitation, palpitation when moving, dizziness, faint, chest uncomfortable feeling, fast
pulse, shortness of breath, chest pain［arrhythmia (extrasystole, atrial fibrillation, atrial flutter,
supraventricular/ventricular tachycardia, etc.)］
Continued on next page.
・ easy fatigability, shortness of breath when moving, faint, chest pain［pulmonary hypertension］
・ lassitude, loss of appetite, breathlessness, shortness of breath［pericardial effusion collection］
・ yellowness in the skin and/or the white of the eye, vomiting, dark urine, nausea, loss of appetite,
itch, lassitude［hepatic function disorder］
・ yellowness in the skin and/or the white of the eye, brown urine［jaundice］
・ shortness of breath, breathlessness, nausea, vomiting, easy breathing in upright position
［pulmonary edema］
・ cessation of breathing for more than 10 seconds［apnea］
・ chest pain, breathlessness［pneumothorax］
・ convulsion［convulsion］
・ confused/disturbed consciousness, impaired mind［confusion］
・ seeing or hearing something that is not really there［hallucination］
・ inability to get along with others, bad temper, good mood, inability to control emotion［psychosis］
・ asthma, urticaria, stuffy/runny nose, itchy eye, sneeze［allergic reaction］
・ inability to hear voices/sounds, difficulty hearing, ear ringing［hearing loss］
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any
worrisome symptom.
Storage and other information
・ Keep out of the reach of children. Store at room temperature (1-30℃), away from direct sunlight and
moisture.
・ Discard the remainder. Do not store them. Ask the pharmacist how to discard.
For doctor use only: Day
Month
Year
For further information, ask your doctor/pharmacist. "Kanjamuke Iyakuhin Guide" and Japanese package insert
information (for medical professionals) is available on the website of Pharmaceuticals and Medical Devices
Agency.