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 0.625mg
Active ingredient:Bisoprolol fumarate
Dosage form:white scored tablet, major axis: 7.0mm, minor axis: 4.0mm, thickness:
2.35mm
Print on wrapping:メインテート 0.625mg, メインテート 0.625, Maintate 0.625, TA11
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 anti-heart failure effects.
It is usually used to treat 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.
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>>
・<Initiation and dose-adjustment period> In general, for adults, initially take 1 tablet (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 2 tablets (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 1 tablet (0.625 mg), 2 tablets (1.25
mg), 4 tablets (2.5 mg), 6 tablets (3.75 mg), or 8 tablets (5 mg). The dosage forms of this medicine include tablets
containing 2.5 and 5 mg of the active ingredient, as well as 0.625 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 2 to 8 tablets (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 8 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
・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 fatigue, dizziness, heart failure, bradycardia, dyspnea and
hypotension. 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
1/2
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.
2/2