くすりのしおり

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Published: 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 :
DONEPEZIL HYDROCHLORIDE OD Tablets 3 mg "FFP"
 Active ingredient:
Donepezil hydrochloride
 Dosage form:
yellow tablet, diameter: approx. 8.0 mm, thickness: approx. 3.0 mm
 Print on wrapping:
(Face)ドネペジル塩酸塩 OD 3mg「FFP」, OD 3mg「FFP」, ドネペジル塩酸塩
(Back)Donepezil Hydrochloride OD 3mg「FFP」, ドネペジル塩酸塩 OD 3mg, 医師・薬剤師の指示どおり,お飲みください。

Effects of this medicine

This medicine inhibits an enzyme which hydrolyzes the neurotransmitter acetylcholine in brain, increase the amount of acetylcholine in brain and slows progression of the symptoms of dementia such as memory loss.
It is usually used to slow progression of the symptoms of dementia associated with Alzheimer's disease or Lewy body dementia.

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 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 slowing progression of symptoms of dementia associated with Alzheimer's disease: In general, for adults, start with giving 1 tablet (3 mg of the active ingredient) at a time once a day for the first one to two weeks. Subsequently, dosage should be increased to 5 mg of the active ingredient. Additionally, if the disease has progressed, after giving 5 mg for more than 4 weeks, the daily dose should be increased to 10 mg. The dosage should be decreased according to the symptoms.
    For slowing progression of symptoms of dementia associated with Lewy body dementia: In general, for adults, start with giving 1 tablet (3 mg) at a time once a day for the first one to two weeks. Subsequently, dosage should be increased to 5 mg at a time once a day. Additionally, after giving 5 mg at a time once a day for more than 4 weeks, the daily dose should be increased to 10 mg at a time once a day. The dosage may be decreased to 5 mg at a time once a day according to the symptoms.
    This preparation contains 3 mg of the active ingredient in a tablet. In any case, strictly follow the instructions.
  • This medicine can be given with saliva only. Crush the tablet lightly with your tongue and swallow it with saliva.
  • If you miss giving a dose, give the missed dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose. You should never give two doses at one time.
  • If you accidentally give more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop giving this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • In patients with Alzheimer's disease or Lewy body dementia, the ability to operate machinery such as driving a car may diminish. Since this medicine may cause disturbance of consciousness, dizziness or drowsiness may occur, do not let the patient engage in the operation of dangerous machinery such as driving a car.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include rash, itch, loss of appetite, nausea and diarrhea. 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.
  • chest pain, fainting, breathing difficulty [QT prolongation, ventricular tachycardia, ventricular fibrillation, sick sinus syndrome, sinus pause, severe bradycardia, heart block, syncope, myocardial infarction, heart failure]
  • pain in the pit of the stomach, nausea, vomiting of blood/melena [peptic ulcer, duodenal ulcer perforation, gastrointestinal bleeding]
  • general malaise, loss of appetite, yellowness in skin or in mucosa [hepatitis, liver dysfunction, jaundice]
  • headache, consciousness disorder, vomiting [cerebral seizure, cerebral bleeding, cerebrovascular disorder]
  • slow movement, muscle stiffness, shivering of limbs [extrapyramidal disorder]
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 light, heat and moisture.
  • Discard the remainder. Do not store them. Ask the pharmacy or medical institution on how to discard the remainder.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.