Download Drug Information Sheet("Kusuri-no-Shiori") Internal Published: 06

Drug Information Sheet("Kusuri-no-Shiori")
Internal
Published: 06/2014
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:TAKELDA Combination Tablets
Active ingredient:Aspirin
Lansoprazole
Dosage form:white to yellowish white tablet with redbrown to dark-brown flecks,
diameter 10.0 mm, thickness 5.4 mm
Print on wrapping:(face) タケルダ, 水でお飲みください (back) タケルダ, アスピリン・
ランソプラゾール配合
Effects of this medicine
Aspirin inhibits activities of platelet cyclooxygenase-1 to suppress platelet aggregation and eventually delay or
prevent blood coagulation while lansoprazole inhibits the enzymatic activity of proton pump in the gastric mucosa to
suppress gastric acid secretion.
Aspirin prevents obstruction of a blood vessel by a blood clot that has formed but may cause gastric or duodenal
ulcers; therefore, lansoprazole prevents such untoward events.
It is usually used to suppress thrombus/embolus formation due to angina pectoris, myocardial infarction, or ischemic
cerebrovascular disorder or to suppress thrombus/embolus formation after coronary artery bypass grafting (CABG)
or percutaneous transluminal coronary angioplasty (PTCA) in patients with a history of gastric or duodenal ulcers.
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, hematological disorder or a history of hematological disorder, bleeding tendency or
predisposition to bleeding tendency, bronchial asthma or a history of bronchial asthma, liver disorder or a history of
liver disorder, renal disorder or a history of renal disorder.
If you drink alcohol on a regular basis.
If you are scheduled for surgery, cardiac catheter test 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 adults: In general, take 1 tablet at a time, once a day. Strictly follow the instructions.
・This medicine cannot be dissolved in the mouth. Take the medicine with water without chewing or breaking it into
pieces.
・If you miss a dose, take the missed dose as soon as possible. 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
・This medicine may induce or enhance gastrointestinal bleeding; therefore, avoid taking this medicine with any
alcoholic beverage.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include constipation, diarrhea, rash, itching, polymorphic erythema,
swelling, anemia, platelet hypofunction (prolonged bleeding time), enlarged feeling of abdomen, stomatitis, colitis,
headache, dizziness, excitement, conjunctivitis, gynecomastia, malaise, over breathing, and hypoglycemia. 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.
・generalized rash, facial swelling, breathlessness [anaphylaxis, shock]
・dullness, fever, shortness of breath, nasal bleeding/subcutaneous hemorrhage, red-brown urine [pancytopenia,
1/2
agarnulocytosis, aplastic anemia, granulocytopenia, hemolytic anemia, decreased platelet count, anemia]
・yellowing of the skin or whites of the eyes, dullness, loss of appetite [serous liver dysfunction]
・fever, general malaise, eruptions on/reddening of the skin and eyes and eruptions/reddening in the mouth,
exfoliation of skin [toxic epidermal necrolysis, mucocutaneous-ocular syndrome, exfoliative dermatitis]
・fever, dry cough, breathlessness [interstitial pneumonia]
・fever, skin eruption, joint pain [interstitial nephritis]
・headache, nausea/vomiting, disturbance of consciousness, motor paralysis, bloody phlegm, bloody stool, nose
bleeding, vision disorder [intracranial bleeding, pulmonary hemorrhage, gastrointestinal hemorrhage, epistaxis,
ocular fundus bleeding]
・breathlessness, whistling sound [asthmatic attack]
・heartburn, heavy feeling of stomach, back pain, abdominal pain, diarrhea, bloody stool [peptic ulcer, small/large
intestine ulcer]
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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