Download Drug Information Sheet("Kusuri-no-Shiori") Internal Revised: 10

Drug Information Sheet("Kusuri-no-Shiori")
Internal
Revised: 10/2014
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse 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:COCARL Dry Syrup 40%
Active ingredient:Acetaminophen
Dosage form:orange dry syrup
Print on wrapping:(0.25g packet) コカールドライシロップ 40%, 100mg/0.25g, Sc114
(0.5g packet) コカールドライシロップ 40%, 200mg/0.5g, Sc115
Effects of this medicine
This medicine has central antipyretic analgesic action, and relieves fever accompanied by sweating by moving fluid in
the body and vasodilating peripheral vessels.
It is usually used to relieve various pains (headache, neuralgia, myalgia, etc.), osteoarthritis pain and for antipyresis
and pain relief of acute upper respiratory inflammation and pediatric diseases.
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: peptic ulcer, blood abnormality, liver disorder, renal disorder, cardiac function failure, aspirin-induced
asthma or a history of aspirin-induced asthma.
・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>>
・For pain relief of headache, earache, symptomatic neuralgia, low back pain, myalgia, pain of a bruise, pain of a
sprain, menstrual pain, pain after a delivery, cancer pain, tooth pain, pain after dental care, osteoarthritis: In
general, for adults, take 0.75 to 2.5 g (300 to 1,000 mg of the active ingredient) at a time, the dosage interval
should be longer than 4 to 6 hours. The dosage may be adjusted according to the diseases, age or symptoms,
however, the maximum daily dose is limited to 10 g (4,000 mg). Avoid taking the medicine on an empty stomach.
For antipyresis and pain relief of acute upper respiratory inflammation: In general, for adults, take 0.75 to 1.25 g
(300 to 500 mg of the active ingredient) at a time. The dosage may be adjusted according to the age or symptoms,
as a rule, up to twice a day and the maximum daily dose is limited to 3.75 g (1,500 mg). Avoid taking the medicine on
an empty stomach.
For antipyresis and pain relief of pediatric diseases: In general, for babies, infants and children, take 0.025 to
0.0375 g (10 to 15 mg of the active ingredient) per kilogram of the body weight at a time, the dosage interval should
be longer than 4 to 6 hours. The dosage may be adjusted according to the age or symptoms, however, the maximum
daily dose is limited to 0.15 g (60 mg) per kilogram of the body weight. However, it should not be exceeded the
dosage for adults [maximum 1.25 g (500 mg) at a time, maximum 3.75 g (1,500 mg) daily]. Avoid taking the medicine
on an empty stomach.
Strictly follow the instructions in any case.
・Take the medicine with dissolving in a cup of water, however, you can take the medicine as it is with water.
・If you miss a dose, take a 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, consult with your doctor or pharmacist.
・Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
・Drinking alcohol may cause liver disorder. Avoid drinking alcohol while taking this medicine.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include platelet hypofunction (prolonged bleeding) and
hypersensitivity. If any of these symptoms occurs, 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
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immediately.
・facial pallor/cold sweat, respiratory distress, hives [shock, anaphylaxis]
・fever, mucosal redness/erosion, erythema [toxic epidermal necrolysis, Stevens-Johnson syndrome, acute
generalized exanthematous pustulosis]
・breathing difficulty, wheezing, respiratory distress [inducing asthmatic attack]
・general malaise, nausea, yellowing of the skin and the conjunctiva [fulminant hepatitis, liver dysfunction, jaundice]
・sore throat, fever [granulocytopenia]
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 away from direct sunlight, heat and moisture.
・Do not store the remainder and consult your pharmacy or medical institution how to discard it.
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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