Medication info
Adone Tablet 5 mg (Donepezil Hydrochloride Monohydrate)

Adone Tablet 5 mg (Donepezil Hydrochloride Monohydrate)

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

MFDS item code 201800773 · Approved 2018.02.09 · Insurance code 649701650

Summary

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

Ingredients

Manufacturer
GL Pharma Co., Ltd.

Efficacy & effects

Treatment of symptoms of Alzheimer-type dementia

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

This medicine is used for the treatment of symptoms of Alzheimer's-type dementia. It helps improve the patient's memory decline and cognitive function and supports a smoother daily life. Additionally, it contributes to the gradual progression of symptoms, enhancing the quality of life for both the patient and their family.

How to take

Adult dose

○ Adults: Administer donepezil hydrochloride 5 mg once daily at bedtime. If sleep disturbances such as unusual dreams, nightmares, or insomnia occur, taking this medicine in the morning may be considered. Since donepezil concentrations reach steady state 15 days after administration and the incidence of adverse reactions may be affected by the rate of dose escalation, 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, use with caution regarding gastrointestinal adverse reactions. If this medicine is discontinued, its effects gradually diminish; no rebound effect occurs with abrupt discontinuation. ○ Women aged 85 years and older who are underweight: Careful monitoring is required because adverse reactions occur more frequently. Underweight elderly women should not exceed 5 mg per day.

Child dose

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

Precautions

This medicine contains Donepezil Hydrochloride as its main component, primarily used for improving symptoms of Alzheimer's-type dementia. First, this medicine should not be used by individuals who are allergic to Donepezil Hydrochloride or any other components of this medicine, pregnant women or women who may become pregnant, and nursing mothers. Additionally, those with lactose intolerance or specific genetic metabolic disorders should also avoid taking this medicine. Patients with heart diseases must exercise caution when taking this medicine. This medicine may slow heart rate or cause arrhythmias. Those taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should use it carefully considering the risk of gastrointestinal bleeding or worsening ulcers. Patients with asthma or obstructive pulmonary diseases may also experience worsening of symptoms when taking this medicine, so caution is required. Patients with extrapyramidal disorders such as Parkinson’s disease should also be careful as symptoms may worsen. If severe adverse reactions appear, such as fainting, cardiac abnormalities, gastrointestinal bleeding, liver function anomalies, seizures, movement disorders, severe muscle pain, shortness of breath, acute pancreatitis, acute renal failure, or sudden death, discontinue use immediately and consult a physician. Additionally, common side effects may include nausea, vomiting, diarrhea, dizziness, insomnia, decreased appetite, headache, and fatigue. If these symptoms persist or worsen, it is important to consult a professional. This medicine has not been approved for other forms of dementia or memory decline other than Alzheimer's-type dementia and should only be taken under the diagnosis and supervision of a specialist. Caution is necessary during the initial period of use or when changing doses as it may affect driving or machine operation abilities. This medicine is metabolized in the liver, so patients with impaired liver function should use it cautiously, and interactions with other drugs are possible, so it's essential to inform the healthcare provider of any other medications being taken. In particular, caution is needed when used in combination with drugs affecting CYP3A4 or CYP2D6 enzymes as the efficacy may change. Pregnant or nursing women should generally avoid using this medicine unless necessary and after thorough consultation with a specialist. The safety of this medicine in children has not been established, hence it's not used in pediatric patients. In case of overdose, serious symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and seizures may appear, requiring immediate emergency treatment, and atropine may be used as an antidote. Finally, this medicine should be stored out of the reach of children, and it is advised not to transfer it to other containers.

Side effects

  • Syncope
  • bradycardia
  • heart block
  • prolonged QT interval
  • myocardial infarction
  • heart failure
  • peptic ulcer
  • perforated duodenal perforation
  • gastrointestinal bleeding
  • hepatitis
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  • liver dysfunction
  • jaundice
  • cerebral seizures
  • epilepsy
  • convulsion
  • cerebral hemorrhage
  • cerebrovascular disorders
  • motor dysfunction
  • ataxia
  • movement disorders
  • dystonia
  • tremors
  • involuntary movements
  • gait disturbance
  • abnormal posture
  • speech disorders
  • akinetic mutism
  • severe muscle rigidity
  • dysphagia
  • tachycardia
  • blood pressure fluctuations
  • sweating
  • myoglobinuria
  • renal dysfunction
  • myalgia
  • weakness
  • dyspnea
  • acute pancreatitis
  • acute renal failure
  • sudden death
  • cold
  • loss of appetite
  • hallucinations
  • agitation
  • aggressive behavior
  • anxiety disorders
  • insomnia
  • drowsiness
  • increased libido
  • talkativeness
  • mania
  • nightmares
  • nervousness
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • hypersexuality
  • dizziness
  • insomnia
  • tremors
  • seizures
  • stupor
  • chest wall rigidity
  • bradycardia
  • palpitations
  • sinoatrial block
  • atrioventricular block
  • hypertension
  • hypotension
  • atrial fibrillation
  • torsades de pointes
  • prolonged QT interval on ECG
  • diarrhea
  • nausea
  • vomiting
  • abdominal disorders
  • gastrointestinal bleeding
  • gastric and duodenal ulcers
  • constipation
  • saliva secretion
  • dysphagia
  • fecal incontinence
  • rashes
  • itching
  • muscle spasms
  • myalgia
  • urinary incontinence
  • frequent urination
  • urinary retention
  • headache
  • fatigue
  • pain
  • toothache
  • facial flushing
  • lethargy
  • weakness
  • edema
  • fever
  • decreased body temperature
  • decreased hematocrit
  • leukopenia
  • anemia
  • thrombocytopenia
  • petechiae
  • abnormal dreams
  • decreased appetite
  • urinary tract infections
  • increased CPK
  • dehydration
  • hyperlipidemia
  • insomnia
  • hostility
  • irritability
  • drowsiness
  • depression
  • confusion
  • emotional instability
  • personality disorders
  • eczema
  • urinary incontinence
  • abdominal pain
  • weakness
  • fungal infections
  • influenza-like syndrome
  • allergies
  • soft tissue infections
  • malaise
  • sepsis
  • facial edema
  • hernia
  • hypotension
  • abnormal ECG
  • heart failure
  • constipation
  • gastroenteritis
  • fecal incontinence
  • dyspepsia
  • increased γ-GT
  • gastritis
  • periodontitis
  • gastric ulcers
  • periodontal abscess
  • abdominal bloating
  • 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
  • increased BUN
  • vitamin B12 deficiency anemia
  • cachexia
  • increased creatinine
  • gout
  • hyponatremia
  • hypoproteinemia
  • iron deficiency anemia
  • increased AST
  • increased ALT
  • arthritis
  • arthrosis
  • bone fractures
  • arthralgia
  • leg cramps
  • osteoporosis
  • anxiety
  • restlessness
  • convulsions
  • transient mental disorders
  • gait abnormalities
  • apathy
  • delusions
  • dream abnormalities
  • cerebrovascular abnormalities
  • increased saliva secretion
  • ataxia
  • euphoric state
  • vasodilation
  • cerebral hemorrhage
  • cerebral infarction
  • cerebral ischemia
  • dementia
  • grand mal seizures
  • hemiplegia
  • tension hypertension
  • 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
  • urination disorders
  • proteinuria
  • anxiety
  • cholecystitis
  • hemolytic anemia
  • hyponatremia

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

Storage

This medicine should be stored in a tightly closed container to keep out air, and it is best kept in a temperature range between 1 to 30 degrees Celsius at room temperature. Proper storage can help maintain the efficacy of the medication for a longer time.

Appearance and packaging

Appearance

This medicine is a 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.