くすりのしおり

Internal
Revised: 8/2019

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 :
BROTIZOLAM TABLETS 0.25mg "NISSIN"
 Active ingredient:
Brotizolam
 Dosage form:
white tablet, major axis 10.0 mm, minor axis 6.5 mm, thick 2.8 mm
 Print on wrapping:
(front) ブロチゾラム錠0.25mg「日新」, ブロチゾラム, 0.25mg, NS116, (back) Brotizolam Tab.0.25mg “NISSIN”, ブロチゾラム「日新」, 0.25mg

Effects of this medicine

This medicine inhibits the hypothalamus and cerebral limbic system controlling emotion through GABA that is a typical inhibitory transmitter of central nervous system. It follows that unnecessary stimulation from the autonomic nervous system and other sites is blocked, and decrease psychic tension and anxiety caused by insomnia or pre-operation to get to sleep easily.
It is usually used to treat insomnia and for anesthetic premedication.

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 acute angle closure glaucoma, myasthenia gravis, respiratory disability (cor pulmonale, pulmonary emphysema, bronchial asthma, acute phase of cerebrovascular disorder, etc. ).
    If you are debilitated.
    If you have heart, liver or kidney disorder or organic brain disorder.
  • 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 the treatment of insomnia: In general, for adults, take 1 tablet (0.25 mg of the active ingredient) at a time, once daily before bedtime.
    Preanesthetic medication: In general, for adults, take 1 tablet (0.25 mg of the active ingredient) at a time before bedtime on the day before surgery and 2 tablets (0.5 mg) at a time for anesthetic premedication.
    The dosage may be adjusted according to disease, age and symptoms of the patient in any case. Strictly follow the instructions in any case.
  • If you are going to wake up and briefly work between sleep, do not take this medicine.
  • If you miss a dose and have a long hour until waking up next morning, take one 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

  • The effects of this medicine may continue after the next morning and may cause drowsiness, diminished attentiveness, impairment of concentration or decrease of reflex movements. Avoid operating dangerous machinery such as driving a car.
  • Alcohol may intensify the sedative effect of this medicine. Avoid drinking alcohol while taking this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include residual sleepiness, drowsiness, light headedness, heaviness of the head, dizziness, headache, malaise, restlessness, excitation, rash and erythema. 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.
  • general malaise, loss of appetite, yellowness of the skin and the whites of the eyes [hepatic dysfunction, jaundice]
  • no memory at arousal during sleep, semi-consciousness [temporary anterograde amnesia, twilight state]
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 light, heat and moisture.
  • Discard the remainder. Do not store them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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