Effects of this medicine

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 6 to 12 mg of the active ingredient daily at one time or in two divided doses, then take 6 to 24 mg 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 30 mg of the active ingredient.
  For improvement of manic episodes associated with bipolar disorder: In general, for adults, take 1 to 2 tablets (12 to 24 mg of the active ingredient) at one time, once daily. The starting dose is determined as 2 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 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 12 mg of the active ingredient in a tablet. In any case, strictly follow the instructions.
• You may swallow this medicine with saliva after soaking the tablet with saliva on the tongue and crushing it gently with the tongue. You may also take this medicine with a cup of cold or lukewarm water.
• You should not take this medicine without water while in a lying-down position.
• Sometimes you may find the tablet is cracked or split when you take it out from the package, however, this will not affect its therapeutic effects. Take a whole tablet including the fragments.
• Peel off the sheet and take out the tablet from the package with dry hands immediately before taking it.

• 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 or impairment of attention, concentration, reflex movements, etc. 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

• thirst, excessive intake of water, excessive urination [diabetic ketoacidosis, diabetic coma]
• sudden fever, trembling limbs, muscle stiffness [neuroleptic malignant syndrome]
• moving/in-and-out of the tongue, continual chewing motions [tardive dyskinesia]
• nausea/vomiting, constipation, abdominal bloating [paralytic ileus]
• weakness, muscle pain, reddish brown urine  [rhabdomyolysis]

Storage conditions and other information

• This medicine should be stored in the package sheet without peeling off since it has hygroscopic property.
• Keep out of the reach of children. Store away from direct sunlight, heat and humidity.
• Discard the remainder. Do not store them. 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