Download Drug Information Sheet("Kusuri-no-Shiori") Internal Revised: 04

Drug Information Sheet("Kusuri-no-Shiori")
Internal
Revised: 03/2017
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:TAMIFLU Capsule 75[for prevention]
Active ingredient:Oseltamivir phosphate
Dosage form:pale yellow/light gray capsule (major axis: approx. 17.8mm)
Print on wrapping:タミフル 75mg
Effects of this medicine
This medicine blocks influenza virus from leaving the infected cell 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 prophylactic vaccination. This medicine is not an alternative to prophylactic 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 1 capsule (75mg of oseltamivir) at a time, once a day, for 7-10 consecutive days.
In general, for children weighing 37.5kg or more, take 1 capsule (75mg of oseltamivir) at a time, once a day, for 10
consecutive days.
Strictly follow the instructions.
・Patients aged 10 or over but under 20 cannot take this medicine in principle unless they are a high risk patient. The
decision of "a high risk patient" will be made from their complications 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, general malaise, 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 humidity at home
by using a humidifier.
・There have been reports of abnormal behavior in patients aged 10 or over but under 20, of cases resulting in fall
accidents. The relation between this medicine and those events are unknown. Parents or guardians with
children/minor patients should pay attention to these precautions as follows;
-After starting this medication, a patient may behave abnormally.
-If the patient is treated at home, please be sure not to leave your child/minors 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 reactions to this medicine
The most commonly reported adverse reactions 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, ischemic colitis. 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.
・cold sweat, dizziness, hoarseness, swelling around the eye and lips, hives, impaired judgment/mind, pale face,
palpitation, shortness of breath, breathing difficulty, general malaise, glow, faint consciousness, lightheadedness
[shock, anaphylaxis]
・fever, chills, cough/phlegm, shortness of breath [pneumonia]
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・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, general malaise, itch, loss of appetite,
nausea, vomiting [fulminant hepatitis, hepatic function disorder, jaundice]
・general malaise, 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, general malaise,
breathing difficulty, 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.)]
・fever, nausea, vomiting, feeling sick at the stomach, sudden abdominal pain, severe abdominal pain, diarrhea, bloody
stool [hemorrhagic colitis, ischemic 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
・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
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For further information, talk to your doctor or pharmacist.
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