Medication info
Donepezil 5 mg (Donepezil Hydrochloride Monohydrate)

Donepezil 5 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTabletOral
Ingredient · strength
Donepezil Hydrochloride Monohydrate›5.22mg / 1 tablet
Manufacturer / importer
Wonkwang Pharmaceutical Co., Ltd.
Appearance
This medication is a white, round film-coated tablet.
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201804657 · Approved 2018.11.26 · Insurance code 662600810

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
Children: There is no experience with use in children.

Ingredients

Manufacturer
Wonkwang Pharmaceutical Co., Ltd.

Efficacy & effects

Treats symptoms of Alzheimer-type dementia

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

This medicine is used to treat symptoms of Alzheimer's type dementia. It improves symptoms such as cognitive decline and memory impairment, assisting the patient's 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

Children: There is no experience with use in children.

Precautions

This medication should not be used in patients who are allergic to specific ingredients, or in women who are pregnant or nursing. Patients with heart disease or abnormalities in heart rhythm should use this medication cautiously, as it may cause a decrease in heart rate or arrhythmia. Patients with a history of gastric ulcers or those taking non-steroidal anti-inflammatory drugs should be cautious due to the risk of gastrointestinal bleeding or ulcer exacerbation. Patients with asthma or obstructive pulmonary disease may experience worsening symptoms due to bronchoconstriction and increased mucus secretion, so caution is advised. Patients with extrapyramidal disorders such as Parkinson's disease should be careful when using this medication as symptoms may worsen. Serious side effects such as fainting, heart issues, gastrointestinal bleeding, liver dysfunction, seizures, and movement disorders can occur, so if any abnormal symptoms occur, consult medical personnel immediately. During treatment, symptoms like nausea, vomiting, diarrhea, dizziness, and insomnia may occur, which are usually temporary; however, if they persist, consultation with a doctor is necessary. This medication is solely used for the treatment of Alzheimer's type dementia and is not approved for other forms of dementia or memory disorders, so it should be used after a proper diagnosis. Patients with heart diseases or electrolyte abnormalities may have a risk of cardiac arrhythmias, thus an electrocardiogram may be necessary. Drowsiness and dizziness may occur during driving or operating machinery, so caution is required. This medication may interact with other drugs, especially when taken with heart medications, antibiotics, antidepressants, antipsychotics, etc., so consultation with a doctor or pharmacist is advised. Pregnant or nursing women should avoid using this medication; if unavoidable, consultation with a specialist should be made to stop breastfeeding. Safety in pediatrics has not been established, hence it should not be used in children. In case of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, and respiratory depression may present, and immediate medical attention is necessary. Store this medication out of reach of children and do not transfer to other containers for safety.

Side effects

  • Syncope
  • bradycardia
  • heart block
  • QT interval prolongation
  • myocardial infarction
  • heart failure
  • peptic ulcer
  • perforated duodenal perforation
  • gastrointestinal bleeding
  • hepatitis
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  • liver dysfunction
  • jaundice
  • cerebral convulsions
  • cerebral hemorrhage
  • cerebrovascular disorders
  • motor dysfunction
  • ataxia
  • movement disorders
  • dystonia
  • tremor
  • involuntary movements
  • gait disorders
  • abnormal posture
  • speech disorders
  • akinetic mutism
  • extreme muscle rigidity
  • dysphagia
  • tachycardia
  • blood pressure fluctuations
  • sweating
  • myalgia
  • malaise
  • dyspnea
  • acute pancreatitis
  • acute renal failure
  • sudden death
  • cold
  • loss of appetite
  • hallucinations
  • agitation
  • aggressive behavior
  • anxiety disorder
  • insomnia
  • drowsiness
  • increased libido
  • talkativeness
  • mania
  • nightmare
  • nervous irritability
  • nonsensical talk
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • hypersexuality
  • dizziness
  • tremor
  • seizures
  • stupor
  • chest wall rigidity
  • palpitations
  • sinoatrial block
  • atrioventricular block
  • hypertension
  • hypotension
  • atrial fibrillation
  • torsades de pointes
  • QT prolongation on ECG
  • diarrhea
  • nausea
  • vomiting
  • abdominal disorders
  • gastric and duodenal ulcers
  • constipation
  • salivation
  • fecal incontinence
  • liver disorders
  • rash
  • pruritus
  • muscle cramps
  • myalgia
  • urinary incontinence
  • polyuria
  • urinary retention
  • headache
  • fatigue
  • pain
  • toothache
  • facial flushing
  • lethargy
  • asthenia
  • edema
  • fever
  • decreased temperature
  • decreased hematocrit
  • leukopenia
  • anemia
  • thrombocytopenia
  • petechiae
  • abnormal dreams
  • delusions
  • urinary tract infection
  • decreased appetite
  • dehydration
  • hyperlipidemia
  • eczema
  • constipation
  • gastroenteritis
  • fecal incontinence
  • indigestion
  • increased γ-GT
  • gastritis
  • dysphagia
  • periodontitis
  • gastric ulcer
  • periodontal abscess
  • abdominal distension
  • abnormal liver function
  • belching
  • esophagitis
  • anal bleeding
  • diabetes
  • anemia
  • leukocytosis
  • weight loss
  • peripheral edema
  • edema
  • increased LDH
  • elevated alkaline phosphatase
  • hypercholesterolemia
  • hypokalemia
  • hypoglycemia
  • weight gain
  • hyperbilirubinemia
  • increased BUN
  • vitamin B12 deficiency anemia
  • cachexia
  • increased creatinine
  • gout
  • hyponatremia
  • hypoproteinemia
  • iron deficiency anemia
  • increased AST
  • increased ALT
  • arthritis
  • arthropathy
  • bone fracture
  • arthralgia
  • leg cramps
  • osteoporosis
  • agitation
  • anxiety
  • convulsions
  • transient psychotic disorders
  • gait abnormality
  • apathy
  • delusions
  • dream disorder
  • cerebrovascular abnormalities
  • increased salivation
  • ataxia
  • euphoric state
  • vasodilation
  • cerebral hemorrhage
  • cerebral infarction
  • cerebral ischemia
  • dementia
  • generalized tonic-clonic seizures
  • hemiplegia
  • hypertonia
  • reduced motor activity
  • pharyngitis
  • pneumonia
  • increased cough
  • bronchitis
  • rhinitis
  • asthma
  • skin ulcer
  • psoriasis
  • skin discoloration
  • shingles
  • dry skin
  • urticaria
  • vesicular rash
  • conjunctivitis
  • glaucoma
  • visual disturbances
  • ear pain
  • tear abnormalities
  • cystitis
  • hematuria
  • vaginitis
  • urination disorders
  • proteinuria
  • abdominal pain
  • agitation
  • cholecystitis
  • hemolytic anemia
  • hyponatremia
  • neuroleptic malignant syndrome
  • pancreatitis

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

Storage

This medication should be stored in a closed container to prevent air or moisture from entering. It is also recommended to keep it at room temperature, ideally between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

This medication is a white, 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.