くすりのしおり

Internal
Revised: 1/2018

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 :
ABILIFY Tablets 6mg
 Active ingredient:
Aripiprazole
 Dosage form:
white tablet, diameter: 7 mm, thickness: 2.7 mm
 Print on wrapping:
(Front)OG71, エビリファイ錠, Otsuka, 6mg, (Back)エビリファイ錠6mg

Effects of this medicine

This medicine acts on receptors for dopamine, a neurotransmitter in the brain, to suppress symptoms such as hallucination and delusion and to stabilize unstable mental status. It also improves moods of lack of motivation and apathy, and symptoms such as unrestrained emotions and behaviors.
It is usually used in the treatment of schizophrenia, for improvement of manic episodes associated with bipolar disorder, for depression/depressive state and for irritability associated with autism spectrum disorder in pediatric patients (as a rule, 6 years or older and younger than 18 years of age).

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 diabetes or if you or your family has a history of diabetes.
    If you have hepatic disorder, cardiovascular disease or hypotension.
    If you have a convulsive disease such as epilepsy, or a history thereof.
    If you have suicidal attempt or suicidal ideation.
    If you have a predisposition to organic brain disorder.
    If you have a highly impulsive comorbid disorder.
  • 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 schizophrenia: In general, for adults, start with taking 1 to 2 tablets (6 to 12 mg of the active ingredient) daily at one time or in two divided doses, then take 1 to 4 tablets (6 to 24 mg of the active ingredient) daily at one time or in two divided doses as a maintenance dose. The dosage may be adjusted according to age and symptoms. However, the daily dose should not exceed 5 tablets (30 mg of the active ingredient).
    For improvement of manic episodes associated with bipolar disorder: In general, for adults, take 2 to 4 tablets (12 to 24 mg of the active ingredient) at one time, once daily. The starting dose is determined as 4 tablets (24 mg of the active ingredient), and the dosage may be adjusted according to age and symptoms. However, the daily dose should not exceed 5 tablets (30 mg of the active ingredient).
    For depression/depressive state (administration should be limited to patients who showed an inadequate response to existing antidepressant therapy.): In general, for adults, take 3 mg of the active ingredient at one time, once daily. The dosage may be adjusted according to age and symptoms. The dose increase per day should be 3 mg. However, the daily dose should not exceed 15 mg of the active ingredient.
    For irritability associated with autism spectrum disorder in pediatric patients: In general, take 1 to 15 mg of the active ingredient at one time, once daily. The starting dose is determined as 1 mg, and the dosage may be adjusted according to symptoms. The maximum dose increase per day should be 3 mg. However, the daily dose should not exceed 15 mg of the active ingredient.
    This preparation contains 6 mg of the active ingredient in a tablet. In any case, strictly follow the instructions.
  • If you miss a dose, take a dose as soon as you remember. 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; decreased attentiveness, concentration and reflex movements. Avoid operating dangerous machinery such as driving a car.
  • Alcohol may intensify the therapeutic effects of the medicine. Be careful when drinking alcohol.
  • Uncontrollable behavioral symptoms (impulse control disorders) may appear, including repetitive gambling despite adverse social consequences such as a ruined personal life, a pathological increase in sexual desire, repeated excessive unplanned shopping, and binge eating. If any of these symptoms appear, consult with your doctor.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include insomnia, nervousness, akathisia (restlessness), tremor (trembling of limbs), anxiety, weight loss, muscle rigidity, loss of appetite, increased appetite, malaise, somnolence, hypokinesia (expressionless face), salivation (drooling), weight gain, nausea, vomiting, dystonia (muscle tone abnormalities) and constipation. 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.
  • dry mouth, excessive intake of water, increased urine output  [diabetic ketoacidosis, diabetic coma]
  • being silent without moving, muscle stiffness, sudden fever  [neuroleptic malignant syndrome]
  • moving the tongue, putting the tongue out and pulling it back in, continual movement of the mouth appearing to chew something  [tardive dyskinesia]
  • nausea, vomiting, constipation, intense abdominal pain  [paralytic ileus]
  • weakness, muscle pain, 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 out of the reach of children. Store away from direct sunlight, heat and humidity.
  • If there is a remainder, this is to be discarded. Do not store it. Ask the pharmacy or medical institution about how to discard the remainder.
  • [To family members] The patient may experience impulse control disorders such as pathological gambling, a pathological increase in sexual desire, repeated excessive unplanned shopping, and binge eating. Please pay attention to the patient's language and behavior, and if any of these symptoms appear, consult with the patient's doctor.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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