Drug Information Sheet("Kusuri-no-Shiori")
Internal
Revised: 11/2013
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:TAMIFLU Dry Syrup 3%[for treatment]
Active ingredient:Oseltamivir phosphate
Dosage form:white to faintly yellow dry-syrup (mixture of coarse and fine granule)
Print on wrapping:
Effects of this medicine
This medicine blocks influenza virus from leaving the cell infected with it in order to suppress viral reproduction.
It is usually used to treat influenza type A and type B infection.
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 renal function disorder.
If 48 or more hours have been passed since you had influenza symptoms.
・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, for adults, take 2.5g (75mg of oseltamivir) at a time, twice a day, for 5 consecutive days. Mix this
medicine with water when you take it.
In general, for children, take 66.7mg/kg (2mg/kg of oseltamivir) at a time, twice a day, for 5 consecutive days. Mix
this medicine with water when you take it. However, a dose should not exceed 75mg of oseltamivir at a time.
Strictly follow the instructions.
・As for mixing this medicine with water, only prepare it when you need it and drink it right after mixing. If there is any
leftover in the glass/cup, add more water and drink it.
In addition, if you take this medicine as a form of granule, take a dose of this medicine with water or lukewarm water.
・Patients aged 10 or over but under 20 cannot take this medicine unless they are high risk patients. Whether they
are high risk patients will be judged from their complicating disease or health history.
・If you miss a dose, take the missed dose as soon as possible. However, 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. Even influenza infection will cause
symptoms such as fever, runny nose, sore throat, muscle pain, headache, cough, loss of appetite, lassitude, chills
and diarrhea. So, in some cases, it is difficult to tell the difference between influenza symptoms and side effects of
this medicine.
Precautions while taking this medicine
・In patients aged 10 or over but under 20 who were receiving this medicine, there have been reports of abnormal
behavior in rare cases resulting in fall accidents. The contribution of medicine to those events is unknown. If a
patient is a child aged under 20, pay attention to these precautions as follows;
-After starting this medication, a patient may behave abnormally.
-In the case that your child aged under 20 is treated at home, please be careful not to leave him/her alone for at
least 2 days.
-Please note that influenza-associated encephalopathy is reported to have the same kinds of symptoms as
mentioned above.
Possible adverse effects of this medicine
The most commonly reported adverse reaction include abdominal pain, diarrhea, nausea, vomiting, hypothermia,
rash, shock, anaphylaxis, fulminant hepatitis, hepatic function disorder, jaundice, mucocutaneous ocular syndrome,
toxic epidermal necrolysis, acute renal failure, psycho-neurologic symptoms (consciousness disorder, abnormal
behavior, delirium, hallucination, delusion, convulsion, etc.), hemorrhagic colitis, etc. If any of these symptoms
1/4
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.
・cold sweat, dizziness, hoarseness, swelling around the eye and lips, urticaria, impaired judgment/mind, pale face,
palpitation, shortness of breath, breathlessness, lassitude, glow, faint consciousness, lightheadedness [shock,
anaphylaxis]
・fever, chills, cough/phlegm, shortness of breath [pneumonia]
・fever, loss of consciousness, decreased consciousness, impaired judgment/mind, headache, flapping tremor in
hands, yellowness in the skin and/or the white of the eye, yellow urine, lassitude, itch, loss of appetite, nausea,
vomiting [fulminant hepatitis, hepatic function disorder, jaundice]
・lassitude, fever, inflamed eyelid and eye, conjunctival sore, lip/intraoral sore, loss of appetite, red rash, red rash
with dropsical swelling in the center, red spots and breakable blisters (bullas) all over the body, pain in the
genitalia, joint pain [mucocutaneous ocular syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis
(TEN)]
・decreased urinary volume, urinary retention, decreased consciousness, easy fatigability, headache, lassitude,
breathlessness, swollen body/eyes [acute renal failure]
・fever, sore throat [leukopenia]
・nose/gum bleeding, continuous bleeding, blue spot, subcutaneous bleeding [thrombocytopenia]
・decreased consciousness, impaired mind/judgment, unusual bizarre behavior, abnormal behavior, seeing or hearing
something that is not really there, groundless belief, strong belief in something untrue, convulsion
[psycho-neurologic symptoms (consciousness disorder, abnormal behavior, delirium, hallucination, delusion,
convulsion, etc.)]
・diarrhea, severe abdominal pain, bloody stool [hemorrhagic colitis]
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
・This medicine is sensitive to heat and moisture. 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 or healthcare facility how to discard them.
For healthcare professional use only
/
/
For further information, talk to your doctor or pharmacist.
2/4
Drug Information Sheet("Kusuri-no-Shiori")
Internal
Revised: 11/2013
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:TAMIFLU Dry Syrup 3%[for prevention]
Active ingredient:Oseltamivir phosphate
Dosage form:white to faintly yellow dry-syrup (mixture of coarse and fine granule)
Print on wrapping:
Effects of this medicine
This medicine blocks influenza virus from leaving the cell infected with it in order to suppress viral reproduction.
It is usually used to prevent influenza type A and type B infection. However, the basic protection against influenza
infection is vaccination. This medicine is not the alternative for vaccination.
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 renal function disorder.
・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, for adults, take 2.5g (75mg of oseltamivir) at a time, once a day, for 7 to 10 consecutive days. Mix this
medicine with water when you take it.
In general, for children, take 66.7mg/kg (2mg/kg of oseltamivir) at a time, once a day, for 10 consecutive days. Mix
this medicine with water when you take it. However, a dose should not exceed 75mg of oseltamivir at a time.
Strictly follow the instructions.
・As for mixing this medicine with water, only prepare it when you need it and drink it right after mixing. If there is any
leftover in the glass/cup, add more water and drink it.
In addition, if you take this medicine as a form of granule, take a dose of this medicine with water or lukewarm water.
・Patients aged 10 or over but under 20 cannot take this medicine unless they are high risk patients. Whether they
are high risk patients will be judged from their complicating disease or health history.
・If you miss a dose, take the missed dose as soon as possible. However, 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. The protection against influenza lasts
only as long as this medicine is administered. Even influenza infection will cause symptoms such as fever, runny
nose, sore throat, muscle pain, headache, cough, loss of appetite, lassitude, chills and diarrhea. So, in some cases,
it is difficult to tell the difference between influenza symptoms and side effects of this medicine.
Precautions while taking this medicine
・Even if you take this medicine, you may have influenza virus infection. Take preventative measures such as wearing
a mask, gargling and washing your hands after getting home, and keeping an appropriate level of moisture at home
by using a humidifier.
・In patients aged 10 or over but under 20 who were receiving this medicine, there have been reports of abnormal
behavior in rare cases resulting in fall accidents. The contribution of medicine to those events is unknown. If a
patient is a child aged under 20, pay attention to these precautions as follows;
-After starting this medication, a patient may behave abnormally.
-In the case that your child aged under 20 is treated at home, please be careful not to leave him/her alone for at
least 2 days.
-Please note that influenza-associated encephalopathy is reported to have the same kinds of symptoms as
mentioned above.
Possible adverse effects of this medicine
The most commonly reported adverse reaction include abdominal pain, diarrhea, nausea, vomiting, hypothermia,
3/4
rash, shock, anaphylaxis, fulminant hepatitis, hepatic function disorder, jaundice, mucocutaneous ocular syndrome,
toxic epidermal necrolysis, acute renal failure, psycho-neurologic symptoms (consciousness disorder, abnormal
behavior, delirium, hallucination, delusion, convulsion, etc.), hemorrhagic colitis, 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 effects indicated in
brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
・cold sweat, dizziness, hoarseness, swelling around the eye and lips, urticaria, impaired judgment/mind, pale face,
palpitation, shortness of breath, breathlessness, lassitude, glow, faint consciousness, lightheadedness [shock,
anaphylaxis]
・fever, chills, cough/phlegm, shortness of breath [pneumonia]
・fever, loss of consciousness, decreased consciousness, impaired judgment/mind, headache, flapping tremor in
hands, yellowness in the skin and/or the white of the eye, yellow urine, lassitude, itch, loss of appetite, nausea,
vomiting [fulminant hepatitis, hepatic function disorder, jaundice]
・lassitude, fever, inflamed eyelid and eye, conjunctival sore, lip/intraoral sore, loss of appetite, red rash, red rash
with dropsical swelling in the center, red spots and breakable blisters (bullas) all over the body, pain in the
genitalia, joint pain [mucocutaneous ocular syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis
(TEN)]
・decreased urinary volume, urinary retention, decreased consciousness, easy fatigability, headache, lassitude,
breathlessness, swollen body/eyes [acute renal failure]
・fever, sore throat [leukopenia]
・nose/gum bleeding, continuous bleeding, blue spot, subcutaneous bleeding [thrombocytopenia]
・decreased consciousness, impaired mind/judgment, unusual bizarre behavior, abnormal behavior, seeing or hearing
something that is not really there, groundless belief, strong belief in something untrue, convulsion
[psycho-neurologic symptoms (consciousness disorder, abnormal behavior, delirium, hallucination, delusion,
convulsion, etc.)]
・diarrhea, severe abdominal pain, bloody stool [hemorrhagic colitis]
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
・This medicine is sensitive to heat and moisture. 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 or healthcare facility how to discard them.
For healthcare professional use only
/
/
For further information, talk to your doctor or pharmacist.
4/4