くすりのしおり

Internal
Published: 12/2018

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 :
Atomoxetine Capsules 10mg "Nichiiko"
 Active ingredient:
Atomoxetine hydrochloride
 Dosage form:
white opaque capsule, major axis: approx. 15.8 mm, minor axis: approx. 5.7 mm
 Print on wrapping:
アトモキセチンカプセル10mg「日医工」,アトモキセチン,10mg,n138,Atomoxetine Cap. 10mg

Effects of this medicine

This medicine inhibits noradrenaline reuptake in the brain to improve symptoms such as inattention, hyperactivity and impulsive behavior.
It is usually used to treat attention deficit/hyperactivity disorder (AD/HD).

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 cardiovascular disease or angle-closure glaucoma.
    If you have pheochromocytoma or a history of it.
  • 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 patients under 18 years : In general, start with 0.5 mg of atomoxetine per kg of body weight (mg/kg) a day, then increase up to 0.8 mg/kg a day. After that, increase up to 1.2 mg/kg a day. The maintenance dose is 1.2 to 1.8 mg/kg a day. The dosage may be increased at intervals of 1 week or longer. In any case, take it in 2 divided doses. The dosage may be adjusted according to your symptoms. DO NOT exceed the daily maximum dosage, 1.8 mg/kg or 12 capsules (120 mg), whichever is less.
    For patients 18 years or over : In general, start with 4 capsules (40 mg of atomoxetine) a day, then increase up to 8 capsules (80 mg) a day. The maintenance dose is 8 to 12 capsules (80 to 120 mg) a day. The dosase may be increased up to 8 capsules (80 mg) at intervals of 1 week or longer. After the dosage reaches 8 capsules (80 mg), it may be increased at 2 weeks or longer. In any case, take it once or in 2 divided doses a day.The dosage may be adjusted according to your symptoms. DO NOT exceed the daily maximum dosage, 12 capsules (120 mg).
    This preparation contains 10 mg of atomoxetine in a capsule. Strictly follow the instructions in any case.
  • The content of the capsule is irritative to the eye. Do not open the capsule, swallow as whole. If the content gets in your eyes, wash with water immediately and consult with your doctor.Immediately wash off anything that may be attached to your hands or to other places.
  • 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 and dizziness. Avoid operating in potentially hazardous activities such as driving a car.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include headache, decreased appetite, somnolence, abdominal pain and nausea. 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.
  • general malaise, loss of appetite, yellowing of the skin and the white of eyes [liver dysfunction, jaundice, liver failure]
  • angioneurotic edema, hives, respiratory distress [anaphylaxis]
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 moisture.
  • Discard the remainder. Do not store them. Ask the pharmacist or medical facility how to discard unneeded medicines.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.