くすりのしおり

Internal
Revised: 1/2016

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 :
Silece Tablets 2mg
 Active ingredient:
Flunitrazepam
 Dosage form:
little blue tablet (diameter: 9.1 mm, thickness: 3.4 mm)
 Print on wrapping:
(Face) サイレース2mg, E202,2mg,サイレース
(Back) サイレース2mg,2, Silece,サイレース

Effects of this medicine

This medicine binds to benzodiazepine receptors in the brain to enhance action of neurological system GABA. It consequently improves sleep-onset insomnia, nocturnal awakening, and early-morning awakening.
It is usually used in the treatment of insomnia, and as an anesthetic premedication.

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

  • If you have previously experienced any allergic reactions (itch, rach, etc.) to any medicines.
    If you are a patient with glaucoma, myasthenia gravis, cor pulmonale, emphysema, or bronchial asthma.
  • 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 0.5 to 2 mg of the active ingredient at a time, before going to bed or a surgery. The dosage may be adjusted according to the disease, age or symptoms, however, the dose for elderly patients is limited to 1 mg at a time. This tablet contains 2 mg of the active ingredient. Strictly follow the instructions.
  • For insomnia, take the medicine immediately before going to bed. Do not take the medicine if you need to get up and work after sleeping for a few hours.
  • If you miss a dose, for insomnia, take a dose as soon as possible if you remember that you missed a dose before falling asleep. However, if you remember it in the next morning, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time. For anesthetic premedication, take a dose as soon as possible if you remember that you missed a dose before falling asleep on the night before the surgery. However, if you remember it in the morning of the day of surgery, skip the missed dose and tell your doctor/nurse that you did not take the medicine.
  • 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 medicine may cause drowsiness; or decline of ability to pay attention, to concentrate or reflex movement even in the next morning. Avoid driving a car or operating dangerous machinery after taking the medicine.
  • Drinking alcohol may enhance the effect of the medicine. Avoid drinking alcohol while you are receiving the medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include rash, lightheadedness, drowsiness and malaise. 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.
  • being unable to stop taking the medicine, symptoms develop when you stop taking the medicine (convulsion, impaired consciousness, shaking limbs, insomnia, anxiety, or hallucination, delusion, etc.) [dependency]
  • excitation, consciousness disturbance  [irritable excitation, confusion]
  • breathing difficulty, twilight state  [respiratory depression, carbon dioxide narcosis]
  • nausea, vomiting, loss of appetite, yellowing in the skin or conjunctiva  [hepatic dysfunction, jaundice]
  • muscular pain, malaise, reddish brown urine  [rhabdomyolysis]
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 the medicine out of the reach of children. Store it 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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