Drug Information Sheet("Kusuri-no-Shiori")
Injection
Published: 01/2014
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is
important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients
should understand their medication and cooperate with the treatment.
Brand name:PEGASYS S.C. Injection 45 mcg
Active ingredient:Peginterferon alfa-2a (genetical recombination)
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine inhibits growth of hepatitis B virus and hepatitis C virus, helps the body to eliminate virus and
improves liver dysfunction.
It is usually used to treat compensated cirrhosis related to hepatitis C and chronic active hepatitis B.
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 neurosychiatric disease such as depression, pneumonia, heart disease or diabetes.
If you ever had any of those diseases mentioned above.
If you are a patient with autoimmune disease (autoimmune hepatitis, psoriasis, systemic lupus erythematosus (SLE),
rheumatoid arthritis, etc.) or its predisposing condition.
If you are a patient with renal/hepatic disorder, hypertension, convulsive seizure, myelosuppresion (anemia,
leukopenia, thrombocytopenia), impaired glucose intolerance.
If any of your relatives ever had diabetes.
・If you are 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, inject subcutaneously once a week.
・Treatment period will be determined according to the symptoms.
・Before you use this medicine, you take blood sampling for blood examination.
Precautions while taking this medicine
・While you are taking this medicine, you need to take periodic blood examination. You also may need to take
periodic blood examination even after the use is completed. Following the instructions by the doctor, take the
examination.
・Since dizziness, confusion (confusion of consciousness), somnolence (hazy with drowsiness), and fatigue may occur,
avoid operating dangerous machinery such as driving a car.
・<For patients treated in combination with this medicine and COPEGUS Tablet.>
Teratogenic action (possibility to cause fetal malformation) has been reported in animal experiments for COPEGUS
Tablet. If you/your partner have/has a possibility of pregnancy, avoid pregnancy while you are taking COPEGUS
Tablet and for 6 months after you discontinue it. Also, you/your partner need to have a pregnancy test once a
month in order to confirm that you/your partner do/does not become pregnant.
Active ingredient of COPEGUS Tablet may be moved into sperm. If your partner is pregnant or she has a possibility
to have gotten pregnant, you need to be informed of it until you fully understand it. Use condom to prevent
COPEGUS Tablet from moving into the womb while you are taking it and for 6 months after you discontinue it.
Possible adverse effects of this medicine
The most commonly reported adverse reactions include headache, fever, lassitude, injection site reaction and
pruritus. 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 effects indicated in
brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
・shortness of breath, breathlessness, fever, cough, phlegm, weight loss, loss of appetite [interstitial pneumonia,
pulmonary infiltration, breathing difficulty]
1/9
・discouraged feeling, sleeplessness, depressed feeling, indisposition, anxiety, irritation, considering suicide on
impulse, suicide attempt [depression, suicidal thought, suicide attempt]
・coming up many ideas, difficulty in falling asleep, talkativeness, highly strung nerves, intense emotion, feeling
irritated, excitement, anxiety [manic high, aggressive behavior]
・palpitation, shortness of breath, headache, ear ringing, dizziness, lassitude, nose bleeding, blue spot, gum bleeding,
subcutaneous bleeding, continuous bleeding, bleeding tendency, fever, sore throat [anemia, aplastic anemia, pure
red-cell aplasia, pancytopenia, agranulocytosis, leukopenia, thrombocytopenia]
・gum/nose bleeding, fever, subcutaneous bleeding, purplish bruise, blue spot, anemia, shortness of breath,
breathlessness, yellowness in the skin and/or the white of the eye, yellow urine, decreased consciousness,
impaired mind/judgment, numbness, decreased urinary volume, convulsion, swelling [thrombotic
thrombocytopenic purpura (TTP), hemolytic uremic syndrome (HUS)]
・nausea, vomiting, loss of appetite, yellowness in the skin and/or the white of the eye, dark urine, itch, lassitude
[worsening of hepatitis, hepatic function disorder]
・nausea, vomiting, lassitude, loss of appetite, yellowness in the skin and/or the white of the eye, brown urine,
dizziness, lightheadedness, dizziness on standing up, easy fatigability, top-heavy feeling, palpitation/shortness of
breath when moving, gum bleeding, subcutaneous bleeding, nose bleeding, fever, abdominal pain, mucous/bloody
stool, diarrhea, joint pain, rigid hand in the morning, butterfly-shaped red punctum on the face, angialgia, purplish
bruise, swelling, bloodshot eye, seeing flash-like light, scotoma in the visual field, failing vision, ear ringing,
difficulty hearing, headache, loss of hair, gray hair, white spots on the skin [autoimmune phenomenon]
・breathlessness, shortness of breath, palpitation, palpitation when moving, pounding heart, fast pulse, easy breathing
in upright position, chest pain, anginal pain, chest oppressive/constrictive feeling, strongly pressured feeling in
the chest, swollen body, lassitude, cold sweat, dizziness, faint, fever [myocardiosis, cardiac failure, angina,
arrhymia (ventricular tachycardia), myocardial infarction, endocarditis, pericarditis]
・sudden fever with shiver, joint/muscle pain, chills [sepsis]
・nausea, vomiting, paralysis in one side of the body, paralysis/numbness of the limbs, partial paralysis, difficulty
speaking, headache, decreased consciousness, impaired mind/judgment, falling asleep in a faint [cerebral
hemorrhage, cerebral infarction]
・chest pain, sweat, decreased consciousness, cough, fever, breathlessness [pulmonary embolism]
・decreased/confused/disturbed consciousness, loss of consciousness, impaired mind/judgment, muscle
stiffness/tremor, retrograde amnesia, inability to recognize place, time, self and name, seeing or hearing something
that is not really there, bad memory loss, inability to memorize/calculate [consciousness disorder, convulsion,
epilepsy seizure, disorientation, coma, delirium, confusion, hallucination, dementia-like symptom]
・excess intake of water, increased urinary volume, lassitude, weight loss, thirst [diabetes]
・swollen thyroid, sleeplessness, weight loss, tendency to sweat, bulging eyes, pounding heart, shakey hands,
lassitude, slowness in conversation or in motion, swelling, intorelance to cold [thyroid dysfunction]
・high fever, fever, inflamed eyelid/eye, conjunctival sore, severe stomatitis, lip/intraoral sore, red rash with
dropsical swelling in the center, red rash, red spots and breakable blisters (bullas) all over the body, rash and
blister, joint pain, pain in the genitalia, lassitude, loss of appetite [mucocutaneous ocular syndrome
(Stevens-Johnson syndrome), toxic epidermal necrosis (TEN), erythema multiforme]
・itch, scab, dry skin [psoriasis]
・decreased consciousness, swollen eyes, easy fatigability, decreased urinary volume, headache, lassitude,
breathlessness, swollen body [acute renal failure, nephrotic syndrome]
・bloody stool, black stool, nausea, vomiting, vomiting of blood, abdominal pain, heavy stomach feeling, heartburn,
feeling sick at the stomach, back pain, fever, diarrhea [gastrointestinal bleeding (melena, bloody stool, etc.),
peptic ulcer, ischemic colitis]
・cold sweat, dizziness, faint consciousness, impaired judgment/mind, pale face, shortness of breath [shock]
・failing vision, scotoma in the visual field [retinopathy]
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
・To the family members:
This medicine may make patients feel depressed or feel like dying. It may also make patients feel high, be aggressive
or sometimes cause harm to others.
Patients and their families should be made fully aware of the possibility of developing such symptoms as those above
2/9
symptoms, manic state, sleeplessness, anxiety, frustrating, restlessness, excitement, aggression or irritability and
they should be instructed to immediately contact the doctor if such symptoms occur.
For healthcare professional use only
/
/
For further information, talk to your doctor or pharmacist.
3/9
Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 08/2012
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is
important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients
should understand their medication and cooperate with the treatment.
Brand name:PEGASYS S.C. Injection 90 mcg
Active ingredient:Peginterferon alfa-2a (genetical recombination)
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine inhibits growth of hepatitis B virus and hepatitis C virus, helps the body to eliminate virus and
improves liver dysfunction.
It is usually used to treat chronic hepatitis C, compensated cirrhosis related to hepatitis C and chronic active
hepatitis B.
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 neurosychiatric disease such as depression, pneumonia, heart disease or diabetes.
If you ever had any of those diseases mentioned above.
If you are a patient with autoimmune disease (autoimmune hepatitis, psoriasis, systemic lupus erythematosus (SLE),
rheumatoid arthritis, etc.) or its predisposing condition.
If you are a patient with renal/hepatic disorder, hypertension, convulsive seizure, myelosuppresion (anemia,
leukopenia, thrombocytopenia), impaired glucose intolerance.
If any of your relatives ever had diabetes.
・If you are 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, inject subcutaneously once a week.
・Treatment period will be determined according to the symptoms.
・Before you use this medicine, you take blood sampling for blood examination.
Precautions while taking this medicine
・While you are taking this medicine, you need to take periodic blood examination. You also may need to take
periodic blood examination even after the use is completed. Following the instructions by the doctor, take the
examination.
・Since dizziness, confusion (confusion of consciousness), somnolence (hazy with drowsiness), and fatigue may occur,
avoid operating dangerous machinery such as driving a car.
・<For patients treated in combination with this medicine and COPEGUS Tablet.>
Teratogenic action (possibility to cause fetal malformation) has been reported in animal experiments for COPEGUS
Tablet. If you/your partner have/has a possibility of pregnancy, avoid pregnancy while you are taking COPEGUS
Tablet and for 6 months after you discontinue it. Also, you/your partner need to have a pregnancy test once a
month in order to confirm that you/your partner do/does not become pregnant.
Active ingredient of COPEGUS Tablet may be moved into sperm. If your partner is pregnant or she has a possibility
to have gotten pregnant, you need to be informed of it until you fully understand it. Use condom to prevent
COPEGUS Tablet from moving into the womb while you are taking it and for 6 months after you discontinue it.
Possible adverse effects of this medicine
The most commonly reported adverse reactions include headache, fever, lassitude, injection site reaction and
pruritus. 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 effects indicated in
brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
・shortness of breath, breathlessness, fever, cough, phlegm, weight loss, loss of appetite [interstitial pneumonia,
pulmonary infiltration, breathing difficulty]
4/9
・discouraged feeling, sleeplessness, depressed feeling, indisposition, anxiety, irritation, considering suicide on
impulse, suicide attempt [depression, suicidal thought, suicide attempt]
・coming up many ideas, difficulty in falling asleep, talkativeness, highly strung nerves, intense emotion, feeling
irritated, excitement, anxiety [manic high, aggressive behavior]
・palpitation, shortness of breath, headache, ear ringing, dizziness, lassitude, nose bleeding, blue spot, gum bleeding,
subcutaneous bleeding, continuous bleeding, bleeding tendency, fever, sore throat [anemia, aplastic anemia, pure
red-cell aplasia, pancytopenia, agranulocytosis, leukopenia, thrombocytopenia]
・gum/nose bleeding, fever, subcutaneous bleeding, purplish bruise, blue spot, anemia, shortness of breath,
breathlessness, yellowness in the skin and/or the white of the eye, yellow urine, decreased consciousness,
impaired mind/judgment, numbness, decreased urinary volume, convulsion, swelling [thrombotic
thrombocytopenic purpura (TTP), hemolytic uremic syndrome (HUS)]
・nausea, vomiting, loss of appetite, yellowness in the skin and/or the white of the eye, dark urine, itch, lassitude
[worsening of hepatitis, hepatic function disorder]
・nausea, vomiting, lassitude, loss of appetite, yellowness in the skin and/or the white of the eye, brown urine,
dizziness, lightheadedness, dizziness on standing up, easy fatigability, top-heavy feeling, palpitation/shortness of
breath when moving, gum bleeding, subcutaneous bleeding, nose bleeding, fever, abdominal pain, mucous/bloody
stool, diarrhea, joint pain, rigid hand in the morning, butterfly-shaped red punctum on the face, angialgia, purplish
bruise, swelling, bloodshot eye, seeing flash-like light, scotoma in the visual field, failing vision, ear ringing,
difficulty hearing, headache, loss of hair, gray hair, white spots on the skin [autoimmune phenomenon]
・breathlessness, shortness of breath, palpitation, palpitation when moving, pounding heart, fast pulse, easy breathing
in upright position, chest pain, anginal pain, chest oppressive/constrictive feeling, strongly pressured feeling in
the chest, swollen body, lassitude, cold sweat, dizziness, faint, fever [myocardiosis, cardiac failure, angina,
arrhymia (ventricular tachycardia), myocardial infarction, endocarditis, pericarditis]
・sudden fever with shiver, joint/muscle pain, chills [sepsis]
・nausea, vomiting, paralysis in one side of the body, paralysis/numbness of the limbs, partial paralysis, difficulty
speaking, headache, decreased consciousness, impaired mind/judgment, falling asleep in a faint [cerebral
hemorrhage, cerebral infarction]
・chest pain, sweat, decreased consciousness, cough, fever, breathlessness [pulmonary embolism]
・decreased/confused/disturbed consciousness, loss of consciousness, impaired mind/judgment, muscle
stiffness/tremor, retrograde amnesia, inability to recognize place, time, self and name, seeing or hearing something
that is not really there, bad memory loss, inability to memorize/calculate [consciousness disorder, convulsion,
epilepsy seizure, disorientation, coma, delirium, confusion, hallucination, dementia-like symptom]
・excess intake of water, increased urinary volume, lassitude, weight loss, thirst [diabetes]
・swollen thyroid, sleeplessness, weight loss, tendency to sweat, bulging eyes, pounding heart, shakey hands,
lassitude, slowness in conversation or in motion, swelling, intorelance to cold [thyroid dysfunction]
・high fever, fever, inflamed eyelid/eye, conjunctival sore, severe stomatitis, lip/intraoral sore, red rash with
dropsical swelling in the center, red rash, red spots and breakable blisters (bullas) all over the body, rash and
blister, joint pain, pain in the genitalia, lassitude, loss of appetite [mucocutaneous ocular syndrome
(Stevens-Johnson syndrome), toxic epidermal necrosis (TEN), erythema multiforme]
・itch, scab, dry skin [psoriasis]
・decreased consciousness, swollen eyes, easy fatigability, decreased urinary volume, headache, lassitude,
breathlessness, swollen body [acute renal failure, nephrotic syndrome]
・bloody stool, black stool, nausea, vomiting, vomiting of blood, abdominal pain, heavy stomach feeling, heartburn,
feeling sick at the stomach, back pain, fever, diarrhea [gastrointestinal bleeding (melena, bloody stool, etc.),
peptic ulcer, ischemic colitis]
・cold sweat, dizziness, faint consciousness, impaired judgment/mind, pale face, shortness of breath [shock]
・failing vision, scotoma in the visual field [retinopathy]
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
・To the family members:
This medicine may make patients feel depressed or feel like dying. It may also make patients feel high, be aggressive
or sometimes cause harm to others.
Patients and their families should be made fully aware of the possibility of developing such symptoms as those above
5/9
symptoms, manic state, sleeplessness, anxiety, frustrating, restlessness, excitement, aggression or irritability and
they should be instructed to immediately contact the doctor if such symptoms occur.
For healthcare professional use only
/
/
For further information, talk to your doctor or pharmacist.
6/9
Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 08/2012
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is
important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients
should understand their medication and cooperate with the treatment.
Brand name:PEGASYS S.C. Injection 180 mcg
Active ingredient:Peginterferon alfa-2a (genetical recombination)
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine inhibits growth of hepatitis B virus and hepatitis C virus, helps the body to eliminate virus and
improves liver dysfunction.
It is usually used to treat chronic hepatitis C and chronic active hepatitis B.
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 neurosychiatric disease such as depression, pneumonia, heart disease or diabetes.
If you ever had any of those diseases mentioned above.
If you are a patient with autoimmune disease (autoimmune hepatitis, psoriasis, systemic lupus erythematosus (SLE),
rheumatoid arthritis, etc.) or its predisposing condition.
If you are a patient with renal/hepatic disorder, hypertension, convulsive seizure, myelosuppresion (anemia,
leukopenia, thrombocytopenia), impaired glucose intolerance.
If any of your relatives ever had diabetes.
・If you are 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, inject subcutaneously once a week.
・Treatment period will be determined according to the symptoms.
・Before you use this medicine, you take blood sampling for blood examination.
Precautions while taking this medicine
・While you are taking this medicine, you need to take periodic blood examination. You also may need to take
periodic blood examination even after the use is completed. Following the instructions by the doctor, take the
examination.
・Since dizziness, confusion (confusion of consciousness), somnolence (hazy with drowsiness), and fatigue may occur,
avoid operating dangerous machinery such as driving a car.
・<For patients treated in combination with this medicine and COPEGUS Tablet.>
Teratogenic action (possibility to cause fetal malformation) has been reported in animal experiments for COPEGUS
Tablet. If you/your partner have/has a possibility of pregnancy, avoid pregnancy while you are taking COPEGUS
Tablet and for 6 months after you discontinue it. Also, you/your partner need to have a pregnancy test once a
month in order to confirm that you/your partner do/does not become pregnant.
Active ingredient of COPEGUS Tablet may be moved into sperm. If your partner is pregnant or she has a possibility
to have gotten pregnant, you need to be informed of it until you fully understand it. Use condom to prevent
COPEGUS Tablet from moving into the womb while you are taking it and for 6 months after you discontinue it.
Possible adverse effects of this medicine
The most commonly reported adverse reactions include headache, fever, lassitude, injection site reaction and
pruritus. 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 effects indicated in
brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
・shortness of breath, breathlessness, fever, cough, phlegm, weight loss, loss of appetite [interstitial pneumonia,
pulmonary infiltration, breathing difficulty]
・discouraged feeling, sleeplessness, depressed feeling, indisposition, anxiety, irritation, considering suicide on
7/9
impulse, suicide attempt [depression, suicidal thought, suicide attempt]
・coming up many ideas, difficulty in falling asleep, talkativeness, highly strung nerves, intense emotion, feeling
irritated, excitement, anxiety [manic high, aggressive behavior]
・palpitation, shortness of breath, headache, ear ringing, dizziness, lassitude, nose bleeding, blue spot, gum bleeding,
subcutaneous bleeding, continuous bleeding, bleeding tendency, fever, sore throat [anemia, aplastic anemia, pure
red-cell aplasia, pancytopenia, agranulocytosis, leukopenia, thrombocytopenia]
・gum/nose bleeding, fever, subcutaneous bleeding, purplish bruise, blue spot, anemia, shortness of breath,
breathlessness, yellowness in the skin and/or the white of the eye, yellow urine, decreased consciousness,
impaired mind/judgment, numbness, decreased urinary volume, convulsion, swelling [thrombotic
thrombocytopenic purpura (TTP), hemolytic uremic syndrome (HUS)]
・nausea, vomiting, loss of appetite, yellowness in the skin and/or the white of the eye, dark urine, itch, lassitude
[worsening of hepatitis, hepatic function disorder]
・nausea, vomiting, lassitude, loss of appetite, yellowness in the skin and/or the white of the eye, brown urine,
dizziness, lightheadedness, dizziness on standing up, easy fatigability, top-heavy feeling, palpitation/shortness of
breath when moving, gum bleeding, subcutaneous bleeding, nose bleeding, fever, abdominal pain, mucous/bloody
stool, diarrhea, joint pain, rigid hand in the morning, butterfly-shaped red punctum on the face, angialgia, purplish
bruise, swelling, bloodshot eye, seeing flash-like light, scotoma in the visual field, failing vision, ear ringing,
difficulty hearing, headache, loss of hair, gray hair, white spots on the skin [autoimmune phenomenon]
・breathlessness, shortness of breath, palpitation, palpitation when moving, pounding heart, fast pulse, easy breathing
in upright position, chest pain, anginal pain, chest oppressive/constrictive feeling, strongly pressured feeling in
the chest, swollen body, lassitude, cold sweat, dizziness, faint, fever [myocardiosis, cardiac failure, angina,
arrhymia (ventricular tachycardia), myocardial infarction, endocarditis, pericarditis]
・sudden fever with shiver, joint/muscle pain, chills [sepsis]
・nausea, vomiting, paralysis in one side of the body, paralysis/numbness of the limbs, partial paralysis, difficulty
speaking, headache, decreased consciousness, impaired mind/judgment, falling asleep in a faint [cerebral
hemorrhage, cerebral infarction]
・chest pain, sweat, decreased consciousness, cough, fever, breathlessness [pulmonary embolism]
・decreased/confused/disturbed consciousness, loss of consciousness, impaired mind/judgment, muscle
stiffness/tremor, retrograde amnesia, inability to recognize place, time, self and name, seeing or hearing something
that is not really there, bad memory loss, inability to memorize/calculate [consciousness disorder, convulsion,
epilepsy seizure, disorientation, coma, delirium, confusion, hallucination, dementia-like symptom]
・excess intake of water, increased urinary volume, lassitude, weight loss, thirst [diabetes]
・swollen thyroid, sleeplessness, weight loss, tendency to sweat, bulging eyes, pounding heart, shakey hands,
lassitude, slowness in conversation or in motion, swelling, intorelance to cold [thyroid dysfunction]
・high fever, fever, inflamed eyelid/eye, conjunctival sore, severe stomatitis, lip/intraoral sore, red rash with
dropsical swelling in the center, red rash, red spots and breakable blisters (bullas) all over the body, rash and
blister, joint pain, pain in the genitalia, lassitude, loss of appetite [mucocutaneous ocular syndrome
(Stevens-Johnson syndrome), toxic epidermal necrosis (TEN), erythema multiforme]
・itch, scab, dry skin [psoriasis]
・decreased consciousness, swollen eyes, easy fatigability, decreased urinary volume, headache, lassitude,
breathlessness, swollen body [acute renal failure, nephrotic syndrome]
・bloody stool, black stool, nausea, vomiting, vomiting of blood, abdominal pain, heavy stomach feeling, heartburn,
feeling sick at the stomach, back pain, fever, diarrhea [gastrointestinal bleeding (melena, bloody stool, etc.),
peptic ulcer, ischemic colitis]
・cold sweat, dizziness, faint consciousness, impaired judgment/mind, pale face, shortness of breath [shock]
・failing vision, scotoma in the visual field [retinopathy]
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
・To the family members:
This medicine may make patients feel depressed or feel like dying. It may also make patients feel high, be aggressive
or sometimes cause harm to others.
Patients and their families should be made fully aware of the possibility of developing such symptoms as those above
symptoms, manic state, sleeplessness, anxiety, frustrating, restlessness, excitement, aggression or irritability and
8/9
they should be instructed to immediately contact the doctor if such symptoms occur.
For healthcare professional use only
/
/
For further information, talk to your doctor or pharmacist.
9/9