Medication info
Donepezil Tablets 5 mg (Donepezil Hydrochloride Monohydrate)

Donepezil Tablets 5 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTabletOral
Ingredient · strength
Donepezil Hydrochloride Monohydrate›5.215mg / 1 tablet
Manufacturer / importer
Dongwha Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 200806458 · Notified 2008.06.12 · Insurance code 642704270

Summary

Main use
Treatment of symptoms of Alzheimer-type dementia
Who takes it
Adults · Children
Adult dose
○ Adults: Administer 5 mg of donepezil hydrochloride once daily before bedtime. If sleep disturbances such as unusual dreams, nightmares, or insomnia occur, taking this medication in the morning may be considered. Since donepezil reaches steady-state concentrations 15 days after administration and the frequency of adverse reactions may be affected by the rate of dose escalation, administer the 5 mg dose for 4~6 weeks. After evaluating 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 for gastrointestinal adverse reactions. If this medication is discontinued, its effects gradually diminish, and no rebound effect occurs following abrupt discontinuation. ○ Female patients aged 85 years or older who are underweight: Careful monitoring is required because adverse reactions occur more frequently. Underweight elderly women should not exceed 5 mg daily.
Child dose
○ Children: There is no experience with use in children.

Ingredients

Manufacturer
Dongwha Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of symptoms of Alzheimer-type dementia

  • Symptoms of Alzheimer-type dementia
View approved original text

This medication is used to treat symptoms of Alzheimer-type dementia. It helps alleviate various symptoms related to dementia such as memory decline, cognitive impairment, and difficulties in daily activities. It improves the patient's quality of life and has the effect of delaying the progression of symptoms. It may also contribute to the management of confusion or behavioral issues caused by dementia. Regular use has a positive impact on maintaining cognitive function.

How to take

Adult dose

○ Adults: Administer 5 mg of donepezil hydrochloride once daily before bedtime. If sleep disturbances such as unusual dreams, nightmares, or insomnia occur, taking this medication in the morning may be considered. Since donepezil reaches steady-state concentrations 15 days after administration and the frequency of adverse reactions may be affected by the rate of dose escalation, administer the 5 mg dose for 4~6 weeks. After evaluating 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 for gastrointestinal adverse reactions. If this medication is discontinued, its effects gradually diminish, and no rebound effect occurs following abrupt discontinuation. ○ Female patients aged 85 years or older who are underweight: Careful monitoring is required because adverse reactions occur more frequently. Underweight elderly women should not exceed 5 mg daily.

Child dose

○ Children: There is no experience with use in children.

Precautions

This medication contains Donepezil Hydrochloride and is used for the treatment of Alzheimer's disease symptoms. First, this medicine should not be used by individuals who are allergic to Donepezil Hydrochloride or similar substances, and by women who are pregnant, may become pregnant, or are breastfeeding. Patients with heart disease or cardiac conduction disorders should use this medication with caution, as it may slow the heart rate or cause arrhythmias. Additionally, patients with a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs should be cautious as gastrointestinal symptoms may worsen. Patients with asthma or obstructive pulmonary disease should also exercise caution as this medication may cause bronchospasm, worsening their symptoms. Patients with extrapyramidal disorders such as Parkinson's disease may require careful observation as this medication might exacerbate their symptoms. This medication can cause various side effects, and in severe cases, may lead to fainting, heart block, gastrointestinal bleeding, liver dysfunction, seizures, motor disorders, muscle abnormal symptoms, and more. Common mild side effects reported include nausea, vomiting, diarrhea, appetite loss, dizziness, insomnia, headache, and fatigue. Patients with heart disease or a history of prolonged QT interval may be at risk for arrhythmias and may require an electrocardiogram. This medication can affect driving or operating machinery, so caution should be applied during the initial dosing or dosage adjustments. Women who are pregnant or breastfeeding should avoid using this medication if possible, and use it only after consulting a healthcare professional if absolutely necessary. This medication may affect liver and kidney function, and regular testing may be required. In case of overdose, severe symptoms such as nausea, vomiting, bradycardia, respiratory depression may arise, and immediate medical attention should be sought. Atropine can be used as an antidote. Finally, this medication should be stored out of the reach of children and should not be transferred to other containers.

Side effects

  • Syncope
  • bradycardia
  • heart block
  • prolonged QT interval
  • myocardial infarction
  • heart failure
  • peptic ulcer
  • perforated duodenal ulcer
  • gastrointestinal bleeding
  • hepatitis
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  • liver dysfunction
  • jaundice
  • cerebral spasm
  • cerebral hemorrhage
  • cerebrovascular disorders
  • motor function disorders
  • ataxia
  • movement disorders
  • dystonia
  • tremor
  • involuntary movements
  • gait disturbance
  • abnormal posture
  • speech disorders
  • akinetic mutism
  • severe rigidity
  • dysphagia
  • tachycardia
  • blood pressure fluctuations
  • sweating
  • myalgia
  • weakness
  • dyspnea
  • acute pancreatitis
  • acute renal failure
  • cardiac arrest
  • cold
  • loss of appetite
  • hallucinations
  • agitation
  • aggressive behavior
  • anxiety disorders
  • insomnia
  • drowsiness
  • increased libido
  • talkativeness
  • mania
  • nightmares
  • nervousness
  • gibberish
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • hypersexuality
  • dizziness
  • tremor
  • seizures
  • delirium
  • chest rigidity
  • palpitations
  • sinoatrial block
  • atrioventricular block
  • hypertension
  • hypotension
  • atrial fibrillation
  • torsades de pointes
  • diarrhea
  • nausea
  • vomiting
  • abdominal disorders
  • gastric and duodenal ulcers
  • constipation
  • saliva secretion
  • fecal incontinence
  • liver disorders including hepatitis
  • rashes
  • pruritus
  • muscle spasms
  • myalgia
  • urinary incontinence
  • polyuria
  • urinary retention
  • headache
  • fatigue
  • pain
  • toothache
  • facial flushing
  • malaise
  • lethargy
  • edema
  • fever
  • decreased body temperature
  • decreased hematocrit
  • leukopenia
  • anemia
  • thrombocytopenia
  • petechiae
  • abnormal dreams
  • accidents
  • back pain
  • chest pain
  • bleeding
  • increased CPK
  • dehydration
  • hyperlipidemia
  • hypotension
  • abnormal ECG
  • heart failure
  • angina
  • congestive heart failure
  • peripheral vascular disease
  • supraventricular extrasystole
  • ventricular extrasystole
  • cardiac hypertrophy
  • constipation
  • gastroenteritis
  • fecal incontinence
  • dyspepsia
  • increased γ-GT
  • gastritis
  • dysphagia
  • periodontitis
  • gastric ulcer
  • periodontal abscess
  • abdominal distension
  • abnormal liver function
  • belching
  • esophagitis
  • hemorrhoidal bleeding
  • diabetes
  • anemia
  • leukocytosis
  • weight loss
  • peripheral edema
  • edema
  • increased LDH
  • increased 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 fractures
  • arthralgia
  • leg cramps
  • osteoporosis
  • anxiety
  • tremor
  • convulsions
  • episodic psychosis
  • gait abnormalities
  • apathy
  • delusions
  • dream disorders
  • cerebrovascular anomalies
  • increased salivation
  • ataxia
  • euphoric feelings
  • vasodilation
  • cerebral hemorrhage
  • cerebral infarction
  • cerebral ischemia
  • dementia
  • extrapyramidal symptoms
  • generalized tonic-clonic seizures
  • hemiplegia
  • hypertonia
  • hypokinesia
  • pharyngitis
  • pneumonia
  • increased cough
  • bronchitis
  • rhinitis
  • asthma
  • skin ulcers
  • psoriasis
  • skin discoloration
  • shingles
  • dry skin
  • urticaria
  • vesicular rash
  • conjunctivitis
  • glaucoma
  • visual disturbances
  • ear pain
  • tear abnormalities
  • urinary tract infections
  • cystitis
  • hematuria
  • vaginitis
  • dysuria
  • proteinuria
  • anxiety
  • 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 tightly closed container that prevents air entry and it is recommended to keep it at room temperature between 1 degree Celsius and 30 degrees Celsius. This will help maintain the efficacy of the medication for a longer duration.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 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.