くすりのしおり

Internal
Revised: 1/2008

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 :
Lendormin D Tablets 0.25mg
 Active ingredient:
Brotizolam
 Dosage form:
white tablet (taken without water) (diameter: 8.0mm, thickness: 2.7mm)
 Print on wrapping:
(Face) Lendormin D 0.25mg, 13C
(Back) レンドルミンD 0.25mg, company logo, Boehringer Ingelheim, recycle mark

Effects of this medicine

This medicine inhibits the hypothalamus and cerebral limbic system controlling emotion through GABA, a typical inhibitory transmitter of central nervous system. As a result, unnecessary stimulation from the autonomic nervous system and other sites is blocked, demonstrating central nervous action including hypnosis, sedation and anti-anxiety.
Usually, this medicine is used to treat insomnia and for anesthetic premedication.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have ever had any unusual or allergic reaction (itch, rash etc.) to any medicines.
    If you have glaucoma, myasthenia (muscle weakness), diminished respiratory function due to cor pulmonale, pulmonary emphysema, bronchial asthma, cerebrovascular disorder.
    If you are in a debilitated state.
    If you have heart/liver/kidney disorder or organic brain disorder.
  • If you are already pregnant or are 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))
  • General dosage regimen:Insomnia, Usually for adults, one tablet (0.25mg of brotizolam) is orally administered once daily at bedtime.
    Preanesthetic
    , Usually for adults, one tablet (0.25mg of brotizolam) is orally administered once daily at bedtime on the day before surgery, and two tablets (0.5mg) for anesthetic premedication.
    The dosage may be adjusted according to the desease to be treated, patient's age and severity of symptoms. Follow your doctor's instructions.
    If you temporarily wake up during sleeping after taking this medicine for insomnia, you may have no recollection of what happened during that time. Do not take this medicine if you are going to wake up and work.
  • If you missed a dose and still have a long time before getting up in the next morning, take as soon as possible. DO NOT take a double dose to make up for the missed dose.
  • If you took too much of this medicine, check with your doctor or pharmacist.
  • Do not stop your medication without the instructions of your doctor. Especially if you suddenly decrease the dosage or stop your medication, side effects such as insomnia and anxiety may occur.

Precautions while taking this medicine

  • Avoid drinking alcohol since it may increase the sedative effect of this medicine.
  • Do not engage in driving a car, operating machinery, or other hazardous activities. The effects of this medicine may carry over to the next morning and afterwards causing drowsiness, diminishied attention or concentration and decreased reflex movements.

Possible adverse reactions to this medicine

Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: residual sleepiness, drowsiness, lightheadedness, heaviness of the head, fatigue, dizziness, headache, restlessness, excitation, rash.
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.
  • fatigue, loss of appetite, yellowness of the skin and the whites of the eyes [hepatic dysfunction and jaundice]
  • temporary loss of memory after taking this medicine, hazy feeling in the head  [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 heat, moisture and light.
  • Discard unused medicine.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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