Medication info
Adone Tablet 10 mg (Donepezil Hydrochloride Monohydrate)

Adone Tablet 10 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTabletOral
Ingredient · strength
Donepezil Hydrochloride Monohydrate›10.43mg / 1 tablet
Manufacturer / importer
GL Pharm Co., Ltd.
Appearance
Yellow round film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201800772 · Approved 2018.02.09 · Insurance code 649701640

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 Pharm Co., Ltd.

Efficacy & effects

Treatment of symptoms of Alzheimer-type dementia

  • Alzheimer's type dementia symptoms
View approved original text

This medication is used for the treatment of Alzheimer's type dementia symptoms.

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 medication contains Donepezil Hydrochloride and is used for the treatment of Alzheimer's type dementia. Firstly, this medication should not be used in patients with hypersensitivity to Donepezil Hydrochloride or any component of this medication, women who are pregnant or may become pregnant, and nursing mothers. Patients with heart disease, especially those with bradycardia or cardiac conduction disorders, should use this medication with caution as bradycardia or arrhythmia may occur. Patients on nonsteroidal anti-inflammatory drugs or with a history of peptic ulcers should be cautious, as increased gastric acid secretion and enhanced gastrointestinal motility may worsen symptoms. Patients with a history of asthma or obstructive pulmonary disease should be careful, as bronchoconstriction and increased mucus secretion may worsen symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should be cautious with this medication, as cholinergic effects may exacerbate their symptoms. This medication contains Yellow No. 5 dye, so patients with allergies to this component should be careful. During treatment, severe side effects such as cardiac-related adverse reactions, gastrointestinal bleeding, liver function abnormalities, cerebrovascular accidents, extrapyramidal disorder symptoms, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute kidney failure, and sudden death may occur. If any unusual symptoms arise, immediately discontinue the medication and consult a healthcare professional. Common side effects may include nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, headache, fatigue, and muscle pain, which are generally transient and mild. This medication is approved only for use in patients with Alzheimer's type dementia and should not be used for other forms of dementia or memory disorders. Treatment should be conducted under the diagnosis and supervision of an experienced physician, regularly assessing the effectiveness and considering discontinuation if necessary. Patients with heart conditions may experience bradycardia, heart block, QT interval prolongation, and may require an electrocardiogram. This medication may increase gastric acid secretion and enhance gastrointestinal motility, so patients with a history of gastric ulcers should be carefully monitored for worsening symptoms. Neuropsychiatric side effects may include hallucinations, agitation, aggressive behavior, anxiety, and depression, and adjustment of the dosage or cessation of treatment may be necessary if symptoms are severe. This medication may affect driving or operating machinery, so caution is advised at the beginning of treatment or when changing the dosage. It is advised that pregnant or nursing women do not use this medication, and if necessary, treatment should be conducted after consultation with a specialist. This medication may interact with various drugs, especially those that affect CYP3A4 or CYP2D6 enzymes, and caution is advised when used in combination with those medications. In cases of overdose, symptoms may include nausea, vomiting, bradycardia, hypotension, respiratory depression, and seizures, and treatment with an antidote such as atropine should be administered. This medication has not been established to be safe for children and should not be used; it should be stored out of reach of children.

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
  • seizures
  • epilepsy
  • convulsions
  • cerebral hemorrhage
  • cerebrovascular disorders
  • motor dysfunction
  • ataxia
  • movement disorders
  • dystonia
  • tremor
  • involuntary movements
  • walking difficulties
  • abnormal posture
  • speech disorders
  • akinetic mutism
  • extreme muscle rigidity
  • dysphagia
  • tachycardia
  • blood pressure fluctuations
  • sweating
  • myoglobinuria
  • renal dysfunction
  • myalgia
  • weakness
  • dyspnea
  • acute pancreatitis
  • acute renal failure
  • sudden death
  • cold
  • decreased appetite
  • hallucinations
  • agitation
  • aggressive behavior
  • anxiety disorders
  • insomnia
  • drowsiness
  • increased libido
  • talkativeness
  • mania
  • nightmares
  • neurogenic irritability
  • nonsense
  • delusions
  • depression
  • confusion
  • apathy
  • hyperkinesia
  • increased sexual desire
  • hypersexuality
  • dizziness
  • tremor
  • stupor
  • chest stiffness
  • palpitations
  • sinoatrial block
  • atrioventricular block
  • hypertension
  • hypotension
  • atrial fibrillation
  • paroxysmal ventricular tachycardia
  • diarrhea
  • nausea
  • vomiting
  • abdominal disorders
  • gastric-duodenal ulcer
  • constipation
  • salivation
  • fecal incontinence
  • rash
  • itching
  • muscle spasms
  • myalgia
  • urinary incontinence
  • frequent urination
  • urinary retention
  • headache
  • fatigue
  • pain
  • toothache
  • facial flushing
  • malaise
  • lethargy
  • edema
  • fever
  • decreased body temperature
  • decreased hematocrit
  • leukopenia
  • anemia
  • thrombocytopenia
  • petechiae
  • abnormal dreams
  • appetite suppression
  • urinary tract infection
  • increased CPK
  • dehydration
  • hyperlipidemia
  • insomnia
  • hostility
  • irritability
  • drowsiness
  • depression
  • confusion
  • emotional instability
  • personality disorders
  • eczema
  • urinary incontinence
  • accidents
  • infections
  • headache
  • pain
  • back pain
  • fever
  • chest pain
  • hypertension
  • bleeding
  • syncope
  • constipation
  • gastroenteritis
  • fecal incontinence
  • dyspepsia
  • increased γ-GT
  • gastritis
  • dysphagia
  • periodontitis
  • gastric ulcer
  • 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
  • B12 deficiency anemia
  • cachexia
  • increased creatinine
  • gout
  • hyponatremia
  • hypoproteinemia
  • iron deficiency anemia
  • increased AST
  • increased ALT
  • arthritis
  • arthrosis
  • bone fractures
  • arthralgia
  • leg cramps
  • osteoporosis
  • restlessness
  • anxiety
  • convulsions
  • transient mental disorders
  • gait abnormalities
  • apathy
  • delusions
  • dream disorders
  • cerebrovascular abnormalities
  • increased salivation
  • ataxia
  • euphoria
  • vasodilation
  • cerebral hemorrhage
  • cerebral infarction
  • cerebrovascular ischemia
  • dementia
  • generalized tonic-clonic seizures
  • hemiplegia
  • increased tension
  • decreased physical activity
  • pharyngitis
  • pneumonia
  • increased cough
  • bronchitis
  • rhinitis
  • asthma
  • skin ulcers
  • psoriasis
  • skin discoloration
  • shingles
  • dry skin
  • hives
  • vesicular rash
  • conjunctivitis
  • glaucoma
  • visual disturbances
  • ear pain
  • tear abnormalities
  • urinary tract infection
  • cystitis
  • hematuria
  • vaginitis
  • urinary voiding disorders
  • proteinuria
  • restlessness
  • cholecystitis
  • hemolytic anemia
  • hyponatremia

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

Storage

This medication should be stored in a tightly closed container to prevent air and moisture from entering, and it is best to keep it at room temperature between 1 and 30 degrees Celsius. This will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

Yellow round film-coated tablets

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.