Medication info
Donepezil 10 mg (Donepezil Hydrochloride Monohydrate)

Donepezil 10 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTabletOral
Ingredient · strength
Donepezil Hydrochloride Monohydrate›10.43mg / 1 tablet
Manufacturer / importer
Wonkwang Pharmaceutical Co., Ltd.
Appearance
This medicine is a yellow, round film-coated tablet.
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201804656 · Approved 2018.11.26 · Insurance code 662600800

Summary

Main use
Treats symptoms of Alzheimer-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 unusual dreams, nightmares, or insomnia occur, taking this medicine in the morning may be considered. Because donepezil concentrations reach steady state 15 days after administration and the frequency of adverse reactions may be affected by the rate of dose increase, administer the 5 mg dose for 4~6 weeks. After assessing the clinical response during this period, the dose may be increased to 10 mg. When increasing the dose to 10 mg daily, administer with caution regarding gastrointestinal adverse reactions. If this medicine is discontinued, its effects gradually diminish, and no rebound effect occurs after abrupt discontinuation. ○ Female patients aged 85 years or older with low body weight: Careful monitoring is required because adverse reactions occur more frequently. Elderly women with low body weight should not exceed 5 mg daily.
Child dose
There is no experience of use in pediatric patients.

Ingredients

Manufacturer
Wonkwang Pharmaceutical Co., Ltd.

Efficacy & effects

Treats symptoms of Alzheimer-type dementia

  • Symptoms of Alzheimer's dementia
View approved original text

This medication is used to treat symptoms of Alzheimer's dementia. It helps improve memory decline and cognitive function deterioration caused by dementia, thereby enhancing the quality of daily life.

How to take

Adult dose

○ Adults: Administer 5 mg of donepezil hydrochloride once daily at bedtime. If sleep disturbances such as unusual dreams, nightmares, or insomnia occur, taking this medicine in the morning may be considered. Because donepezil concentrations reach steady state 15 days after administration and the frequency of adverse reactions may be affected by the rate of dose increase, administer the 5 mg dose for 4~6 weeks. After assessing the clinical response during this period, the dose may be increased to 10 mg. When increasing the dose to 10 mg daily, administer with caution regarding gastrointestinal adverse reactions. If this medicine is discontinued, its effects gradually diminish, and no rebound effect occurs after abrupt discontinuation. ○ Female patients aged 85 years or older with low body weight: Careful monitoring is required because adverse reactions occur more frequently. Elderly women with low body weight should not exceed 5 mg daily.

Child dose

There is no experience of use in pediatric patients.

Precautions

This medication contains donepezil hydrochloride and is primarily used to improve symptoms of Alzheimer's dementia. First, this medication should not be used in individuals allergic to donepezil hydrochloride or any other components of this medication, in pregnant or potentially pregnant women, and in nursing women. Patients with heart diseases, especially those with bradycardia syndrome or heart conduction disorders, should be cautious because this medication may slow down the heart rate or cause arrhythmias. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should use this medication cautiously, as it may increase gastric acid secretion and enhance gastrointestinal motility, worsening ulcer symptoms. Patients with asthma or chronic obstructive pulmonary disease may experience worsened symptoms due to bronchospasm or increased mucus secretion, so extra caution is advised. Patients with extrapyramidal disorders such as Parkinson's disease may be at risk as this medication may affect the nervous system and exacerbate symptoms. While taking this medication, serious side effects such as fainting, heart failure, gastrointestinal bleeding, liver dysfunction, seizures, movement disorders, severe muscle cramps, breathing difficulties, acute pancreatitis, renal failure, and sudden death may occur. If such symptoms arise, consult a doctor immediately. Moreover, side effects such as nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, aggressive behavior, muscle pain, urinary incontinence, frequent urination, swelling, fever, thrombocytopenia, drowsiness, anxiety, hallucinations, aggressive behavior, decreased concentration, mental lethargy, palpitations, increased blood pressure, blood pressure fluctuations, sweating, vascular dilation, malaise, dehydration, hypotension, hypertension, depression, chatter, mania, increased libido, muscle cramps, and blood system abnormalities have also been reported. Notify healthcare providers if any unusual symptoms occur. This medication may affect heart rate, thus patients with a history of heart disease or a prolonged QT interval should have their condition checked with an electrocardiogram while on therapy. Caution is advised when driving or operating machinery, as dizziness or fatigue may occur during the initial stages of treatment. It is safer for pregnant or nursing women not to use this medication, and decisions should be made after consulting a specialist if absolutely necessary. Safety in children has not been established, hence it should not be used in pediatric patients. This medication may interact with other drugs, so patients taking substances affecting CYP3A4 and CYP2D6 enzymes, neuromuscular blockers, cholinergic drugs, anticholinergic drugs, heart-related medications, NSAIDs, etc., should consult a physician or pharmacist. In cases of overdose, symptoms such as nausea, vomiting, sweating, bradycardia, hypotension, respiratory depression, and seizures may occur, requiring immediate emergency treatment, and atropine can be used as an antidote. Finally, this medication should be stored out of reach of children and should not be transferred to other containers. Take this medication exactly as directed by the physician.

Side effects

  • Syncope
  • bradycardia
  • heart block
  • prolongation of QT interval
  • myocardial infarction
  • heart failure
  • peptic ulcer
  • perforation of duodenum
  • gastrointestinal bleeding
  • hepatitis
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  • liver dysfunction
  • jaundice
  • cerebral seizure
  • cerebral hemorrhage
  • cerebrovascular disorder
  • motor function disorder
  • ataxia
  • movement disorder
  • dystonia
  • tremor
  • involuntary movement
  • gait disturbance
  • abnormal posture
  • speech disorder
  • akinetic mutism
  • severe muscle rigidity
  • dysphagia
  • tachycardia
  • blood pressure fluctuations
  • sweating
  • myalgia
  • weakness
  • dyspnea
  • acute pancreatitis
  • acute renal failure
  • sudden death
  • cold
  • loss of appetite
  • hallucination
  • agitation
  • aggressive behavior
  • anxiety disorder
  • insomnia
  • drowsiness
  • increased libido
  • talkativeness
  • mania
  • nightmares
  • neurosensitivity
  • gibberish
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased sexual desire
  • hypersexuality
  • dizziness
  • tremor
  • seizure
  • stupor
  • chest rigidity
  • bradycardia
  • palpitation
  • sinus node block
  • atrioventricular block
  • hypertension
  • hypotension
  • atrial fibrillation
  • torsades de pointes
  • ECG QT interval prolongation
  • diarrhea
  • nausea
  • vomiting
  • abdominal disorders
  • gastrointestinal bleeding
  • gastric and duodenal ulcer
  • constipation
  • saliva secretion
  • dysphagia
  • fecal incontinence
  • rash
  • pruritus
  • muscle cramps
  • myalgia
  • urinary incontinence
  • frequent urination
  • urinary stasis
  • headache
  • fatigue
  • pain
  • toothache
  • facial flushing
  • lethargy
  • asthenia
  • edema
  • fever
  • decreased body temperature
  • decreased hematocrit
  • leukopenia
  • anemia
  • thrombocytopenia
  • cardiac arrest
  • urinary tract infection
  • decreased appetite
  • vasodilation
  • dehydration
  • hyperlipidemia
  • eczema
  • hostility
  • irritability
  • bizarre dreams
  • depression
  • confusion
  • emotional instability
  • personality disorder
  • eczema
  • urinary incontinence
  • hypotension
  • heart failure
  • myocardial infarction
  • angina
  • atrial fibrillation
  • congestive heart failure
  • peripheral vascular disease
  • supraventricular ectopic contraction
  • ventricular ectopic contraction
  • cardiac hypertrophy
  • constipation
  • gastritis
  • fecal incontinence
  • dyspepsia
  • elevated γ-GT
  • gastric ulcer
  • periodontitis
  • gastric ulcer
  • periodontal abscess
  • abdominal distension
  • liver dysfunction
  • belching
  • esophagitis
  • anal bleeding
  • diabetes
  • anemia
  • leukocytosis
  • weight loss
  • peripheral edema
  • edema
  • increased LDH
  • increased alkaline phosphatase
  • hypercholesterolemia
  • hypokalemia
  • hypoglycemia
  • weight gain
  • hyperbilirubinemia
  • elevated BUN
  • B12 deficiency anemia
  • cachexia
  • increased creatinine
  • gout
  • hyponatremia
  • hypoproteinemia
  • iron deficiency anemia
  • elevated AST
  • elevated ALT
  • arthritis
  • arthrosis
  • bone fracture
  • arthralgia
  • leg cramps
  • osteoporosis
  • myalgia
  • anxiety
  • restlessness
  • seizures
  • transient mental disorders
  • gait abnormalities
  • apathy
  • delusions
  • cerebrovascular abnormalities
  • increased saliva secretion
  • ataxia
  • ecstatic state
  • cerebral hemorrhage
  • cerebral infarction
  • cerebral ischemia
  • dementia
  • grand mal seizures
  • hemiplegia
  • heightened tension
  • hypokinesis
  • pharyngitis
  • pneumonia
  • increased cough
  • bronchitis
  • rhinitis
  • asthma
  • skin ulcer
  • psoriasis
  • skin discoloration
  • herpes zoster
  • dry skin
  • urticaria
  • vesicular rash
  • conjunctivitis
  • glaucoma
  • visual disturbances
  • ear pain
  • tear disturbances
  • urinary tract infection
  • cystitis
  • hematuria
  • vaginitis
  • urination disorder
  • frequent urination
  • proteinuria
  • abdominal pain
  • anxiety
  • cholecystitis
  • seizures
  • heart block
  • hemolytic anemia
  • hyponatremia
  • pancreatitis

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

Storage

This medication should be kept in an airtight, sealed container and stored at room temperature between 1°C and 30°C. Proper storage helps maintain the medication's efficacy and safety.

Appearance and packaging

Appearance

This medicine is a 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.