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

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Drug Information Sheet("Kusuri-no-Shiori")
Internal
Published: 09/2013
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:MAINTATE Tablets 2.5mg
Active ingredient:Bisoprolol fumarate
Dosage form:white scored tablet, diameter: 7.0mm, thickness: 2.7mm
Print on wrapping:メインテート 2.5mg, メインテート 2.5, Maintate 2.5, TA201
Effects of this medicine
This medicine blocks the β1-receptor, which transmits sympathetic nerve excitation to the heart, thus moderating
excessive cardiac activity, resulting in antihypertensive, antianginal, antiarrhythmic, and anti-heart failure effects.
It is usually used to treat mild to moderate essential hypertension, angina pectoris, ventricular extrasystole, chronic
heart failure (in patients receiving base treatment such as ACE inhibitors, angiotensin II receptor antagonist,
diuretic, digitalis preparation) due to ischemic heart disease or dilated cardiomyopathy and 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 bradycardia, atrioventricular block, sinoatrial block, sick sinus syndrome, diabetic ketoacidosis,
metabolic acidosis, cardiogenic shock, right-sided heart failure caused by pulmonary hypertension, uncompensated
heart failure, peripheral circulatory disorder, untreated pheochromocytoma.
・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 mild to moderate hypertension, angina pectoris, ventricular extrasystole: In general, for adults,
take 2 tablets (5 mg of the active ingredient) at a time, once a day. The dose may be adjusted according to your
disease, age and symptom. Strictly follow the instructions.
For treatment of chronic heart failure:
<Initiation and dose-adjustment period> In general, for adults, initially take 0.625 mg of the active ingredient at a
time, once a day. If you tolerate this medicine for 2 weeks or longer, this means you can continue to take the
medicine without any problems, the dose may be increased to 1.25 mg at a time, once a day. Then if you still
tolerate this medicine, the dose may be increased stepwise at intervals of at least 4 weeks. However if you no longer
tolerate this medicine, the dose may be decreased. Dose increase or decrease is always stepwise, and administration
is always once daily. Single dose is usually one of 0.625 mg, 1.25 mg, 2.5 mg, 3.75 mg, or 5 mg. The dosage forms of
this medicine include tablets containing 0.625 and 5 mg of the active ingredient, as well as 2.5 mg, and the regimen
sometimes involves use of these tablets. In addition, according to your age and symptom, the initial dose may be
lower than 0.625 mg/day, and the dose increment may be less than stated above.
<Maintenance period> In general, take 1.25 to 5 mg at a time, once a day. The dose may be adjusted according to
your response to this medicine, and maximum dose should not exceed 5 mg at a time, once a day. Strictly follow the
instructions.
For treatment of tachcardiac atrial fibrillation: In general, for adults, initially take 1 tablets (2.5 mg of the active
ingredient) at a time, once a day. If the effect is insufficient, the dose may be up to 2 tablets (5 mg) at a time, once
a day. The dose may be adjusted according to your age and symptom, and maximum dose should not exceed 2
tablets (5 mg) at a time, once a day. Strictly follow the instructions.
・If you miss a dose, take the 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
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・This medicine may cause dizziness or light headedness due to antihypertensive action. Be aware of driving a car or
operating dangerous machinery. Pay close attention to the beginning of the medication, since the medicine may
show the effect strongly.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include bradycardia, dizziness, light headedness, fatigue, heart
failure, dyspnea, hypotension, edema, headache, abdominal discomfort and pollakiuria. 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.
・dizziness, breathing difficulty, edema [heart failure, complete atrioventricular block, severe bradycardia, sick
sinus syndrome]
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 reach of children. Store away from direct sunlight, heat and moisture.
・Discard the remainder. Do not store them.
For healthcare professional use only
/
/
For further information, talk to your doctor or pharmacist.
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