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

Drug Information Sheet("Kusuri-no-Shiori")
Internal
Revised: 10/2015
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:ARTIST TABLETS 2.5mg
Active ingredient:Carvedilol
Dosage form:tablet (white to faintly yellowish white) (with a split line), (major axis:
10.1mm, minor axis: 5.1mm, thickness: 3.1mm)
Print on wrapping:アーチスト 2.5mg, D317, Artist2.5mg
Effects of this medicine
This medicine exhibits vasodepressor effect by α1-blocking activity in addition to beta-blocking activity. It
maintains and decreases vascular resistance to improve heart pump function and consequently provides sufficient
blood flow to the body.
It is usually used to treat chronic heart failure due to ischemic heart disease or dilated cardiomyopathy, and
arrhythmia (tachycardiac atrial fibrillation).
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: bronchial asthma, bronchospasm, diabetic ketoacidosis, metabolic acidosis, arrhythmia, cardiogenic
shock, decompensated heart failure, right-sided heart failure secondary to pulmonary hypertension, untreated
pheochromocytoma, long fasting state, malnutrition, disorders in liver/kidney, peripheral circulatory disorder, or
hypotension.
・If you are pregnant, possibly 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 treatment of chronic heart failure due to ischemic heart disease or dilated cardiomyopathy: In general, for
adults, start with 1/2 tablet (1.25 mg of the active ingredient) at a time, twice a day after meals. If tolerated, this
dose will be increased step by step, each time after more than a week of assessment. The dose will be reduced if
intolerable. Dose adjustment is made in incremental steps without exception. Single dose is usually 1/2 tablet
(1.25 mg), 1 tablet (2.5 mg), 2 tablets (5 mg) or 4 tablets (10 mg). In any case, the medicine is taken twice a day
after meals. The standard maintenance dose is 1-4 tablets (2.5 to 10 mg) at a time, twice a day after meals.
According to your age and symptoms, you may be ordered to start with even smaller doses. Depending on how you
will respond to the medicine, maintenance dose will be suitably adjusted.
For treatment of tachycardiac atrial fibrillation: In general, for adults, start with 2 tablets (5 mg of the active
ingredient) at a time, once a day. If the effect is insufficient, this dose will be increased to 4 tablets (10 mg) or to 8
tablets (20 mg) step by step, at a time, once a day. The dose may be adjusted according to your age and symptom,
and maximum dose should not exceed 8 tablets (20 mg) at a time, once a day.
In any case, strictly follow the instructions.
・If you miss a dose, take the missed 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
・You may feel dizzy or light-headed, especially when starting/increasing dose.
Do not drive a car or operate dangerous machinery while you take the medicine.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include dizziness, chronic heart failure (short breath or lassitude,
etc.), deterioration of heart failure, palpitation, bradycardia, drop in blood pressure, deterioration of diabetes, and
general fatigue. 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.
・shortness of breath, dizziness, loss of consciousness [severe bradycardia, complete atrioventricular block, cardiac
failure and cardiac arrest]
・facial pallor, cold sweats, lightheadedness [shock]
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・general fatigue, loss of appetite, yellowing of the skin/white of eyes [liver dysfunction, jaundice]
・general fatigue, decreased urine output, swollen limbs/face [acute renal failure]
・fever, general malaise, rash on the skin/eyes and in mouth [toxic epidermal necrosis, oculomucocutaneous
syndrome]
・breathing difficulty, lightheadedness, swelling around eyes/lips [anaphylaxis]
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 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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