くすりのしおり

Internal
Revised: 4/2019

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 :
AMOBANTES Tablets 7.5
 Active ingredient:
Zopiclone
 Dosage form:
white tablet, major axis: approx. 9.5 mm, minor axis: approx. 5.0 mm, thickness: approx. 3.4 mm
 Print on wrapping:
(face)アモバンテス7.5, 7.5mg, KN114
(reverse side)AMOBANTES 7.5, アモバンテス7.5, 7.5mg

Effects of this medicine

This medicine acts on benzodiazepine receptors in the brain to induce sleep.
It is usually used to treat insomnia and for preanesthesic medication to induce sleep on the evening before surgery (anesthesia) or in the preoperative period.

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 myasthenia gravis, acute narrow-angle glaucoma, decreased respiratory function caused by cor pulmonale, pulmonary emphysema, bronchial asthma, acute phase of cerebrovascular disorder, etc.
  • 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 7.5 to 10 mg of the
    active ingredient at a time, before bedtime. The dosage may be adjusted according to age and symptoms of the patient. DO NOT exceed the maximum dosage, 10 mg.
    Preanesthesic medication: In general, for adults, take 7.5 to 10 mg of the active ingredient at a time, before bedtime or before surgery. The dosage may be adjusted according to age and
    symptoms of the patient. DO NOT exceed the maximum dosage,10 mg.
    This preparation contains 7.5 mg of the active ingredient in a tablet. Strictly follow the instructions in any case.
  • If you have insomnia, take this medicine just before bedtime. In case you need to wake up in a short period of
    time for work reasons, do not take this medicine
  • If you miss a dose and have enough time before getting up next morning, take a 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

  • This medicine may show its effects even on the next day and may cause sleepiness and lack of concentration. Avoid operating in potentially hazardous activities such as driving a car.
  • Intake of alcohol may enhance the effect of this medicine and cause adverse reactions. Refrain from drinking alcohol.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include bitter taste, lightheadedness, sleepiness, dry mouth, malaise, dull headache, headache, nausea, feeling unwell, dizziness, itch and rash. 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.
  • unable to stop taking this medicine, symptoms develop when you stop taking the medicine; shaking limbs, insomnia, anxiety, convulsion and hallucination [dependence]
  • breathing difficulty, shortness of breath [respiratory depression]
  • yellowing of the skin and the whites of the eyes, malaise, loss of appetite [liver dysfunction]
  • abnormal behavior during sleep, uncoordinated movement or conversation, lowering of concentration, judgement and consciousness [mental disorder, consciousness disorder]
  • transient memory loss, no memory until sleep stage or during awakening at nighttime, semi-consciousness [transient anterograde amnesia, semi-consciousness]
  • hoarseness, hives, lowering of judgement and consciousness, palpitation [anaphylaxis]
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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