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 :
ZOLPIDEM TARTRATE TABLETS 10mg "DSEP"
 Active ingredient:
Zolpidem tartrate
 Dosage form:
pale orange tablet with a split line, diameter : 8.6 mm, thickness : 3.3 mm
 Print on wrapping:
(front) ゾルピデム酒石酸塩10mg「DSEP」, 第一三共エスファ, ゾルピデム, 10mg, EP111, (back) ZOLPIDEM TARTRATE 10mg「DSEP」, ゾルピデム酒石酸塩10mg「DSEP」, 入眠剤, 10, 就寝直前服用

Effects of this medicine

This medicine enhances the suppressive mechanism of the GABA system by acting on the benzodiazepine receptors in the central nervous system, thus exerting hypnotic and sedative effects.
It is usually used for the treatment of insomnia (excluding insomnia resulting from schizophrenic disorder or manic-depressive psychosis).

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 hepatic disorders, myasthenia gravis, acute angle closure glaucoma, decreased respiratory function (cor pulmonale, pulmonary emphysema, bronchial asthma or acute phase cerebrovascular disorders).
  • 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))
  • In general, for adults, take 1/2 to 1 tablet (5 to 10 mg of the active ingredient) at a time just before bedtime. For patients who newly start the medicine, treatment should be started at a dose of 1/2 tablet (5 mg of the active ingredient) at a time. The dosage may be adjusted according to the patient's age, symptoms and disease; however, the dose at a time should not exceed 1 tablet (10 mg of the active ingredient). Strictly follow the instructions.
  • Since the medicine may cause amnesia; do not take it if you cannot take enough time to get started activities after getting up on the next morning or if you have to get up for temporarily work in the middle of the sleeping.
  • If you miss a dose and have a long hour until waking up next morning, you may 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.
  • If you are taking the medicine continuously, do not change the dose or stop taking the medicine on your own judgment unless your doctor instructs.

Precautions while taking this medicine

  • Alcohol intake just before or after taking this medicine may enhance a decrease in mental function, perception or motor function. Refrain from alcohol drinking as far as possible.
  • The effect of the medicine may persist after the next morning and induce sleepiness as well as a decrease in attention, concentration, and reflex movement, etc. Avoid performing dangerous operations such as driving a car, operating machinery or work at heights.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include rash, itch, lightheadedness, sleepiness, headache, malaise, residual sleepiness and nausea. 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.
  • inability to stop taking the medicine, anxious feeling and sleeplessness when reducing the dose or discontinuing the medicine [dependency, withdrawal symptoms]
  • hallucinations, decreased consciousness, impaired judgment [psychiatric symptoms, disturbance of consciousness]
  • inability to recall events that occurred before sleep or when the sleep was interrupted, semi-consciousness [transient anterograde amnesia, twilight state]
  • difficulty with breathing [respiratory depression]
  • general malaise, loss of appetite, yellowing of the skin and the whites of the eye [hepatic function disorder, jaundice]
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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