くすりのしおり

Internal
Revised: 3/2019

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 OD Tab. 0.25mg "TEVA"
 Active ingredient:
Brotizolam
 Dosage form:
white tablet with 1/2 split line on one side, diameter: 8.0 mm, thickness: 2.9 mm
 Print on wrapping:
(face) ブロチゾラムOD 0.25mg「テバ」, ブロチゾラムOD「テバ」, t 071, 0.25mg, (back) Brotizolam OD 0.25mg“TEVA”, ブロチゾラムOD「テバ」, 0.25mg

Effects of this medicine

This medicine acts on benzodiazepine receptors and inhibits cerebral limbic system or hypothalamic area. It consequently relieves psychic tension and anxiety, and helps you fall asleep easier.
It is usually used to treat insomnia and for preanesthetic medication.

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 narrow-angle glaucoma, myasthenia gravis or decreased respiratory functions.
  • 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))
  • Insomnia: In general, for adults, take 1 tablet (0.25 mg of the active ingredient) at a time, once a day 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 evening before surgery, and take 2 tablets (0.5 mg) at a time, before anesthesia.
    In any cases, the dosage may be adjusted according to your age, symptoms or disease. Strictly follow the instructions.
  • For insomnia, take this medicine right before bedtime. In case you need to wake up temporarily for work, etc., do not take this medicine.
  • This medicine is orally disintegrating tablet. You can moisten the tablet with saliva on your tongue, then crush it lightly with your tongue, and swallow the tablet with saliva. You can also take this medicine with water or lukewarm water as you do an ordinary tablet. Avoid taking the medicine without water when you are lying down.
  • If you miss a dose, you can take the missed dose only when you have enough time until you wake up. 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. Especially, if you suddenly reduce the dose or stop the medication, adverse reactions such as insomnia and anxiety may occur.

Precautions while taking this medicine

  • The effects of this medicine may carry over to the next morning and afterwards and may cause drowsiness or decreased attention/concentration/reflex movement. Do not operate dangerous machinery such as driving a car.
  • Avoid drinking alcohol with this medicine, since alcohol (drinking) may intensify the sedative effects of this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include residual sleepiness/drowsiness, lightheadedness, dull headache, dizziness, headache, restlessness, excitation, dullness, malaise, 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, yellowing of the skin and the whites of eyes [hepatic dysfunction, jaundice]
  • inability to recall events that occurred, decreased consciousness [transient anterograde amnesia, twilight state]
  • inability to stop taking the medicine, insomnia and anxiety (when reducing the dose or discontinuing the medicine) [dependency]
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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