Medication info
Donerin 5 mg (Donepezil Hydrochloride Monohydrate)

Donerin 5 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTabletOral
Ingredient · strength
Donepezil Hydrochloride Monohydrate›5mg / 1 tablet
Manufacturer / importer
Huons Life Science Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201900923 · Approved 2019.02.14 · Insurance code 052701310

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, morning administration of this medicine 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 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 attention to gastrointestinal adverse reactions. Upon discontinuation, the effect of this medicine gradually decreases, and no rebound effect occurs with abrupt discontinuation. Female patients aged 85 years and older who are underweight: Careful monitoring is required because adverse reactions occur more frequently. Elderly women who are underweight should not exceed 5 mg daily.
Child dose
Pediatric patients: There is no experience with use in pediatric patients.

Ingredients

Manufacturer
Huons Life Science Co., Ltd.

Efficacy & effects

Treatment of symptoms of Alzheimer-type dementia

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

This medication is used to treat symptoms of Alzheimer's type dementia. It helps improve memory decline, cognitive dysfunction, and difficulties in daily life. It is effective in enhancing the patient's quality of life and slowing the progression of symptoms. Therefore, it is beneficial for patients with Alzheimer's type dementia.

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, morning administration of this medicine 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 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 attention to gastrointestinal adverse reactions. Upon discontinuation, the effect of this medicine gradually decreases, and no rebound effect occurs with abrupt discontinuation. Female patients aged 85 years and older who are underweight: Careful monitoring is required because adverse reactions occur more frequently. Elderly women who are underweight should not exceed 5 mg daily.

Child dose

Pediatric patients: There is no experience with use in pediatric patients.

Precautions

This medication contains Donepezil Hydrochloride and is primarily used for the treatment of symptoms of Alzheimer's type dementia. First, this medication should not be administered to specific patient populations. For example, individuals allergic to this medication or its ingredients, pregnant women or women who may become pregnant, and patients with a genetic lactose intolerance issue should not take this medication. Additionally, patients with cardiac conditions or conduction disorders, those with a history of peptic ulcers or currently taking non-steroidal anti-inflammatory drugs, patients with asthma or obstructive pulmonary disease, and patients with extrapyramidal disorders, such as Parkinson's disease, should be particularly cautious when using this medication. This medication can slow the heart rate or cause arrhythmias and may increase the risk of gastrointestinal bleeding or worsen existing ulcers. It may also exacerbate asthma symptoms and has the potential to worsen or cause new symptoms in Parkinson's disease patients. Various side effects may occur during the use of this medication. Common symptoms include nausea, vomiting, diarrhea, dizziness, insomnia, and fatigue, while rare but severe issues include serious cardiac problems, liver function abnormalities, cerebrovascular accidents, muscle problems, acute pancreatitis, and acute renal failure. This medication is approved specifically for use in patients with Alzheimer's type dementia and is not to be used for other types of dementia or memory disorders. Treatment should be initiated and regularly evaluated for efficacy and side effects by a qualified physician. Care should be taken with driving or operating machinery while taking this medication, especially during the initial stages or when adjusting the dosage, as dizziness or fatigue may occur. This medication is metabolized in the liver, so caution is advised in patients with compromised liver function or those taking other medications that affect the liver. Moreover, it can interact with various medications, so it is crucial to consult with a physician or pharmacist regarding other medications currently being taken. Women who are pregnant or breastfeeding should refrain from using this medication unless absolutely necessary and after careful consultation with a specialist. In case of overdose, severe symptoms such as persistent nausea, vomiting, bradycardia, hypotension, respiratory depression, and seizures may occur, necessitating immediate medical attention, with atropine available as an antidote. Finally, this medication should be stored out of the reach of children, and it is preferable not to transfer it to another container for safety and quality maintenance.

Side effects

  • Syncope
  • bradycardia
  • heart block
  • prolongation of QT interval
  • myocardial infarction
  • heart failure
  • peptic ulcer
  • perforated duodenal perforation
  • gastrointestinal bleeding
  • hepatitis
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  • liver dysfunction
  • jaundice
  • cerebral seizure
  • epilepsy
  • convulsion
  • cerebral hemorrhage
  • cerebrovascular disorder
  • movement dysfunction
  • ataxia
  • motor disturbance
  • dystonia
  • tremor
  • involuntary movement
  • gait disturbance
  • abnormal posture
  • speech disorder
  • akinetic mutism
  • extreme rigidity
  • dysphagia
  • tachycardia
  • blood pressure variability
  • sweating
  • myoglobinuria
  • renal dysfunction
  • myalgia
  • fatigue
  • dyspnea
  • acute pancreatitis
  • acute renal failure
  • sudden death
  • cold
  • appetite loss
  • hallucination
  • agitation
  • aggressive behavior
  • anxiety disorder
  • insomnia
  • drowsiness
  • increased libido
  • verbosity
  • mania
  • nightmares
  • nervousness
  • delirium
  • delusion
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • hypersex
  • dizziness
  • tremor
  • stupor
  • chest wall rigidity
  • bradycardia
  • palpitations
  • sinoatrial block
  • atrioventricular block
  • hypertension
  • hypotension
  • atrial fibrillation
  • torsades de pointes
  • diarrhea
  • nausea
  • vomiting
  • abdominal disorder
  • gastrointestinal bleeding
  • gastric and duodenal ulcer
  • constipation
  • salivation
  • fecal incontinence
  • liver disorder including hepatitis
  • rash
  • pruritus
  • muscle cramps
  • myalgia
  • urinary incontinence
  • polyuria
  • urinary retention
  • headache
  • fatigue
  • pain
  • toothache
  • facial flushing
  • lethargy
  • asthenia
  • edema
  • fever
  • temperature drop
  • decrease in hematocrit
  • leukopenia
  • anemia
  • thrombocytopenia
  • petechiae
  • abnormal dreams
  • accident
  • infection
  • headache
  • pain
  • back pain
  • fever
  • chest pain
  • hypertension
  • bleeding
  • syncope
  • decreased appetite
  • urinary tract infection
  • increased CPK
  • dehydration
  • hyperlipidemia
  • insomnia
  • hostility
  • irritability
  • drowsiness
  • depression
  • confusion
  • emotional instability
  • personality disorder
  • dermatitis
  • urinary incontinence
  • abdominal pain
  • weakness
  • fungal infection
  • influenza-like illness
  • allergy
  • soft tissue infection
  • lethargy
  • sepsis
  • facial edema
  • hernia
  • hypotension
  • ECG abnormalities
  • heart failure
  • myocardial infarction
  • angina
  • atrial fibrillation
  • congestive heart failure
  • peripheral vascular disease
  • supraventricular ectopic beats
  • ventricular ectopic beats
  • cardiac hypertrophy
  • constipation
  • gastroenteritis
  • fecal incontinence
  • dyspepsia
  • increased γ-GT
  • gastritis
  • dysphagia
  • 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
  • increased BUN
  • B12 deficiency anemia
  • cachexia
  • increased creatinine
  • gout
  • hyponatremia
  • hypoproteinemia
  • iron deficiency anemia
  • increased AST
  • increased ALT
  • arthritis
  • arthrosis
  • bone fracture
  • arthralgia
  • leg cramps
  • osteoporosis
  • myalgia
  • agitation
  • anxiety
  • convulsion
  • delusional disorder
  • gait disturbance
  • apathy
  • delusion
  • dream disorder
  • cerebrovascular abnormality
  • increased salivation
  • ataxia
  • abnormal euphoria
  • vasodilation
  • cerebral hemorrhage
  • cerebral infarction
  • cerebral ischemia
  • dementia
  • extrapyramidal symptoms
  • grand mal seizure
  • hemiplegia
  • hypertonia
  • reduced movement
  • 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 abnormalities
  • urinary tract infection
  • cystitis
  • hematuria
  • vaginitis
  • urination disorders
  • proteinuria
  • abdominal pain
  • agitation
  • cholecystitis
  • confusion
  • convulsion
  • heart block
  • hemolytic anemia
  • hyponatremia
  • neuroleptic malignant syndrome
  • pancreatitis
  • rash

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 exposure to air or moisture. It is best to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

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

No questions yet.

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.