Medication info
Donepezil 10 mg (Donepezil Hydrochloride)

Donepezil 10 mg (Donepezil Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride›10.43mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200708819 · Notified 2007.07.30 · Insurance code 657804470

Summary

Main use
Improvement of symptoms of Alzheimer’s type dementia
Who takes it
Adults · Children
Adult dose
Adults: Administer 5 mg of Donepezil Hydrochloride once daily at bedtime. If sleep disturbances such as strange dreams, nightmares, or insomnia occur, morning administration of this medication can be considered. Donepezil concentration reaches a steady state 15 days after administration, and the frequency of adverse reactions can be affected by the rate of dosage increase, so administer 5 mg for 4 to 6 weeks. After evaluating the clinical response during this period, dosage may be increased up to 10 mg. When increasing to 10 mg daily, be cautious of gastrointestinal adverse reactions while administering. When discontinuing this medication, its effects gradually decrease, and rebound effects due to sudden discontinuation do not occur. For underweight elderly female patients over 85 years old: Careful monitoring is necessary due to the increased occurrence of adverse reactions. Underweight elderly females should not exceed 5 mg daily.
Child dose
Children: There is no experience in using this medication in children.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Improvement of symptoms of Alzheimer’s type dementia

  • Symptoms of Alzheimer’s type dementia
View approved original text

This medication is used in the treatment of symptoms of Alzheimer's type dementia. Dementia is a disease characterized by a decline in memory and cognitive function, and this medication helps to improve these symptoms so patients can live their daily lives more smoothly. It contributes to enhancing the quality of life by helping to slow the progression of symptoms and improve cognitive function.

How to take

Adult dose

Adults: Administer 5 mg of Donepezil Hydrochloride once daily at bedtime. If sleep disturbances such as strange dreams, nightmares, or insomnia occur, morning administration of this medication can be considered. Donepezil concentration reaches a steady state 15 days after administration, and the frequency of adverse reactions can be affected by the rate of dosage increase, so administer 5 mg for 4 to 6 weeks. After evaluating the clinical response during this period, dosage may be increased up to 10 mg. When increasing to 10 mg daily, be cautious of gastrointestinal adverse reactions while administering. When discontinuing this medication, its effects gradually decrease, and rebound effects due to sudden discontinuation do not occur. For underweight elderly female patients over 85 years old: Careful monitoring is necessary due to the increased occurrence of adverse reactions. Underweight elderly females should not exceed 5 mg daily.

Child dose

Children: There is no experience in using this medication in children.

Precautions

This medication contains Donepezil Hydrochloride and is used for the treatment of Alzheimer’s type dementia. First, this medication should not be used in certain patients. Those with allergic reactions to this medication, piperidine derivatives, or any of its components should not take it. Women who are pregnant, may become pregnant, or are breastfeeding should also avoid this medication. Additionally, because this product contains lactose, individuals with Galactose intolerance, Lapp lactase deficiency syndrome, or glucose-galactose malabsorption should not use it. Patients with heart disease, especially those with bradycardia or heart conduction disorders, should use this medication with caution, as it may slow heart rate or cause arrhythmias. Those taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should also be cautious, as increased gastric acid secretion may worsen symptoms. Patients with asthma or obstructive pulmonary disease history may experience worsening symptoms while taking this medication and should take care. Individuals with extrapyramidal disorders such as Parkinson’s disease should use this drug cautiously as it may exacerbate symptoms. Various side effects may occur during the use of this medication. Examples include dizziness, nausea, vomiting, diarrhea, loss of appetite, insomnia, hallucinations, and changes in heart rhythms. In severe cases, serious symptoms such as heart block, liver dysfunction, cerebrovascular disorders, muscle symptoms, respiratory distress, acute pancreatitis, and acute renal failure can occur, so should any unusual symptoms arise, immediate consultation with medical personnel is advised. This medication is not approved for use in other forms of dementia or memory disorders apart from Alzheimer’s type dementia and must be used under the diagnosis and supervision of an experienced physician. Treatment effects should be regularly evaluated, and if no effect is observed, discontinuation of medication might be considered. Moreover, this medication may slow the heart rate and affect cardiac conduction, so patients with cardiovascular disease should be particularly cautious. It may affect the gastrointestinal system by increasing gastric acid secretion or promoting gastrointestinal motility, thus those with a history of peptic ulcers should observe for any worsening symptoms. Driving or operating machinery may be affected, so caution is advised at the beginning of treatment or when dosage changes occur, especially as fatigue or dizziness may arise. This medication may interact with various drugs. Particularly, when used in combination with medications metabolized in the liver, the effectiveness may be altered, so it is crucial to inform your doctor or pharmacist if you're taking other drugs. Women who are pregnant or breastfeeding should refrain from using this medication as a principle and should make careful considerations even when necessary. Safety in children has not been established; therefore, this medication should not be used in pediatric patients. In case of overdose, severe symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur and immediate emergency treatment is needed. Finally, this medication should be stored out of reach of children and should not be transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory issues accompanied by cough and fever, jaundice, extreme fatigue, sudden and severe headaches, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, significantly reduced urine output

Mild side effects

  • Loss of appetite
  • hallucinations
  • agitation
  • aggressive behavior
  • anxiety
  • insomnia
  • drowsiness
  • increased libido
  • talkativeness
  • mania
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  • nightmares
  • irritability
  • incoherence
  • delusions
  • depression
  • confusion
  • indifference
  • hyperactivity
  • increased sexual desire
  • dizziness
  • insomnia
  • tremors
  • delirium
  • palpitations
  • hypertension
  • hypotension
  • atrial fibrillation
  • diarrhea
  • nausea
  • vomiting
  • abdominal disorders
  • constipation
  • salivation
  • dysphagia
  • fecal incontinence
  • rash
  • itching
  • muscle cramps
  • myalgia
  • urinary incontinence

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a closed container that prevents air from entering, and it is best to keep it at room temperature between 1°C and 30°C. Storing it this way can help maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.