Download Drug Information Sheet("Kusuri-no-Shiori") Internal Published: 09

Drug Information Sheet("Kusuri-no-Shiori")
Internal
Published: 09/2016
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:Aspirin Bayer
Active ingredient:Aspirin
Dosage form:white powder
Print on wrapping:
Effects of this medicine
This medicine acts on hypothalamic thermoregulatory center to bring down fever. It also inhibits synthesis of
prostaglandines to show analgesic/anti-inflammatory action.
It inhibits synthesis of thromboxane A2 by inhibiting cyclooxygenase (COX)-1 to suppress platelet aggregation. It
consequently prevents blood clotting and vessel constriction.
It is usually used to treat painful diseases such as chronic rheumatoid arthritis and osteoarthritis and to bring down
fever and relieve pains in acute upper respiratory tract inflammation. It is also used to treat Kawasaki disease and its
cardiovascular aftereffect.
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, liver disorder, renal disorder, cardiac function failure, bleeding tendency, blood
abnormality, chickenpox or influenza.
If you have aspirin-induced asthma or have a history of it.
If you are scheduled for surgery or tooth extraction.
・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 rheumatoid arthritis, osteoarthritis, etc.: In general, for adults, take 0.5 to 1.5 g of active ingredient at a time,
1.0 to 4.5 g a day. The dosage may be adjusted according to your disease, age and symptoms. The maximum single
dose is 1.5 g and the maximum daily dose is 4.5 g.
For antipyresis/analgesia in acute upper respiratory tract inflammation: In general, for adults, take 0.5 to 1.5 g of
active ingredient at a time as needed. The dosage may be adjusted according to your age and symptoms. The
maximum frequency of medication is twice a day and the maximum daily dose is 4.5 g. Avoid taking this medicine on
an empty stomach.
For Kawasaki disease: For duration of fever in acute phase, in general, take 30 to 50 mg of active ingredient per kg
of body weight a day, in 3 divided doses. For recovery phase after fever has subsided and chronic phase, take 3 to
5 mg per kg of body weight at a time, once a day. The dosage may be adjusted according to your symptoms.
In any case, strictly follow the instructions.
・If you miss a dose, take the missed dose as soon as possible. However, 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
・Avoid taking this medicine with alcohol since it may induce/enhance gastrointestinal bleeding
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include loss of appetite, heart burn, hives, rash, edema, rhinitis-like
symptoms, conjunctivitis, dizziness, headache, excitement, hyperventilation, dull, anemia and decrease in platelet
function (prolongation of bleeding time). 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.
・facial pallor/cold sweat, dizziness, respiratory distress [shock, anaphylaxis]
・vomiting of coffee-colored substance, black stools, headache [bleeding from the gastrointestinal tract etc.]
・skin/mucosal erosion, blister, fever [muco-cutaneo-ocular syndrome, toxic epidermal necrosis, exfoliative
dermatitis]
・decrease in platelet function, prolongation of bleeding time [aplastic anemia, decreased platelets, leukopenia]
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・breathing difficulty, wheezing or short gasp [induction of asthma attack]
・general malaise, loss of appetite, yellowing of the skin and the white of eyes [hepatic dysfunction, jaundice]
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.
・Discard the remainder. Do not store them.
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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