くすりのしおり

Internal
Revised: 7/2019

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 :
Orap Fine Granules 1%
 Active ingredient:
Pimozide
 Dosage form:
white fine granules
 Print on wrapping:

Effects of this medicine

This medicine acts on a transmitter (dopamine) in the brain and improves such symptoms as severe anxiety or tension, and lowering of motivation.
It is usually used to treat abnormal behavior, pathological symptoms, psychological symptoms, etc. associated with children's autistic disorder or intellectual disability, and also for stabilization of the mental state.

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 congenital long QT syndrome or if your family has a history of congenital long QT syndrome.
    If you have or have a history of arrhythmia.
    If you have the predisposition to QT prolongation.
    If you are in a coma.
    If you have: depression or Parkinson's disease.
  • 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))
  • For children with symptoms associated with autistic disorder or intellectual disability: In general, for children, take 0.1 to 0.3 g (1 to 3 mg of the active ingredient) at a time, once a day. The dosage may be adjusted according to the age or symptoms, and the daily dosage may be increased up to 0.6 g (6 mg) that may be taken in two divided doses per day.
    For other conditions than the above: In general, for adults, take 0.1 to 0.3 g (1 to 3 mg of the active ingredient) at a time, once a day. The daily dosage may be taken in 2 to 3 divided doses when necessary. The daily dosage may be gradually increased to 0.4 to 0.6 g (4 to 6 mg) according to the symptoms. The maximum daily dose is 0.9 g (9 mg). In general, the maximum daily maintenance dose is 0.6 g (6 mg). The dosage may be adjusted according to the symptoms. Take this medicine in the morning as much as possible, if it is taken once a day.
    One gram of this preparation contains 10 mg of the active ingredient. In any case, strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and follow your regular dosing schedule. 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 cause sleepiness/dizziness/light headedness. Do not operate dangerous machinery, such as driving a car.
  • Alcohol drinking may intensify medicinal or medical effects. Refrain from drinking alcohol while taking this medicine.
  • Avoid taking grapefruit/grapefruit juice with this medicine, since it may intensify the therapeutic effects of this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include sleep disorder (insomnia, sleepiness), tremor (shivering of limbs), akathisia (hyperkinesia), salivation (drooling), rash and itching. 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.
  • palpitation, chest discomfort [ventricular tachycardia, sudden death]
  • acute fever, shivering of limbs, muscle stiffness [neuroleptic malignant syndrome]
  • convulsion [convulsive seizure]
  • loss of appetite, nausea/vomiting, convulsion [hyponatremia]
  • sore throat, headache, fever [agranulocytosis, decreased white blood cells]
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 reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. Consult with your dispensing pharmacy or medical institution when you discard the medicine.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.