くすりのしおり

Internal
Revised: 7/2007

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
ROHYPNOL Tablet 1
 Active ingredient:
Flunitrazepam
 Dosage form:
white tablet (φ: approx. 7.0mm, thickness: approx. 2.1mm)
 Print on wrapping:
ロヒプノール1

Effects of this medicine

This medicine works on benzodiazepine receptor in the brain to make it easier for a patient to fall asleep. It is usually used to treat insomnia as well as used for preanesthetic medication before operation (getting anesthetized).

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

  • If you have previously experienced any allergic reaction (itch, rash etc.) to any medicine.
    If you are a patient with glaucoma, myasthenia gravis, decreased respiratory function, heart/hepatic/renal function disorder, or brain disorder.
    If you are debilitated.
  • 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 0.5-2 tablet(s) (0.5-2mg of the active ingredient) at a time, before bedtime or operation. It should be adjusted according to your disease, age and symptoms. However, elderly patients should not take more than 1 tablet (1mg of the active ingredient) at a time. Strictly follow the instructions.
  • For insomnia, take this medicine just before going to bed. If you need to get up and do something (work, etc.) after a short sleep, do not take it.
  • If you realize that you missed a dose and have considerable time before waking, you can take the missed dose. However, you should never take two doses at one time.
  • If you accidentally took 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

  • Alcohol causes this medicine to act excessively. Avoid drinking alcohol while taking it.
  • You may feel sleepy, defocus or destructed the following morning after taking this medicine. Do not drive a car, or operate dangerous machinery.

Possible adverse effects of this medicine

The most commonly reported adverse reactions include lightheadedness, sleepiness, lassitude 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 effects indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
  • compulsive medicine use, symptoms showing when suspending use of medicine (convulsion, consciousness disorder, shaky hands and legs, sleeplessness, anxiety, hallucination, delusion)[dependence]
  • abnormally excited and restless mind, impaired judgment, inability to have normal thoughts[irritable excitation, confusion]
  • shallow and fast breathing turning into breathlessness, increase in breathing, nausea, vomiting, abdominal pain, infrequent respiration, breathlessness, loss of strength, tremor, absent-mindedness, loss of consciousness[respiratory depression, carbon dioxide narcosis]
  • yellowness in the skin and/or the white of the eye, lassitude[hepatic function disorder, jaundice]
  • muscle pain, loss of strength, lassitude, dark brown urine[rhabdomyolysis]
  • breathlessness with fever, stiff muscles in the limbs, absent-mindedness, loss of consciousness[syndrome malin]
  • absent-mindedness, loss of consciousness[consciousness disorder]
  • temporary memory loss, stupor[transient anterogade amnesia, stupor]
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 at room temperature (1-30℃), away from light and moisture.
  • Discard the remainder. Do not store them. Ask the pharmacist how to discard.

For healthcare professional use only: Day Month Year

For further information, talk to your doctor or pharmacist.

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