Medication info
Hanwha Donepezil Tablets 5mg (Donepezil Hydrochloride Monohydrate)

Hanwha Donepezil Tablets 5mg (Donepezil Hydrochloride Monohydrate)

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

MFDS item code 201905692 · Approved 2019.08.13 · Insurance code 651602550

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 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 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 for gastrointestinal adverse reactions. If this medicine is discontinued, its effects gradually diminish, and no rebound effect occurs following 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
Hanwha Pharmaceutical 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 and cognitive function impairment caused by dementia.

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, 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 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 for gastrointestinal adverse reactions. If this medicine is discontinued, its effects gradually diminish, and no rebound effect occurs following 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 is used to treat symptoms of Alzheimer's-type dementia with the ingredient Donepezil Hydrochloride. First, this medication should not be used in certain patients. For example, it should not be administered to individuals with allergies to this medication or its components, pregnant women, or women who may become pregnant, and patients with lactose intolerance or certain genetic issues. Additionally, caution is required for individuals with heart diseases, as this medication may slow down heart rate or cause arrhythmias. Those with a history of peptic ulcers or who are taking nonsteroidal anti-inflammatory drugs should also be careful due to the risk of gastrointestinal bleeding. Patients with asthma or chronic obstructive pulmonary disease may experience exacerbation of symptoms due to increased bronchoconstriction or mucus secretion. Those with extrapyramidal disorders such as Parkinson's disease should also use this medication cautiously as it may worsen their symptoms. Various side effects may occur during the use of this medication. Commonly reported side effects include nausea, vomiting, diarrhea, dizziness, insomnia, bradycardia, and cardiac arrhythmias. Rarely, serious heart issues, liver dysfunction, cerebrovascular disorders, or muscle abnormalities may occur, so if any unusual symptoms arise, consult a healthcare professional immediately. This medication can interact with other drugs, so it is essential to inform your doctor or pharmacist if you are currently taking any other medications, especially heart-related medications, antibiotics, antidepressants, and antipsychotic drugs. Women who are pregnant or breastfeeding should not use this medication unless absolutely necessary, and if it must be used, discontinuation of breastfeeding is recommended after consulting a specialist. Safety in children has not been established; therefore, this medication is not used in pediatric patients. This medication may affect driving or operating machinery, so caution is advised at the beginning of treatment or when changing doses. In cases of overdose, severe symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur, so immediate emergency treatment is required if suspected, and atropine can be used as an antidote. Finally, this medication should be stored out of reach of children, and transferring to another container may cause quality issues, so care is advised.

Side effects

  • Syncope
  • bradycardia
  • heart block
  • prolonged QT interval
  • myocardial infarction
  • heart failure
  • peptic ulcer
  • perforated duodenal perforation
  • gastrointestinal bleeding
  • hepatitis
Show 233 more
  • liver dysfunction
  • jaundice
  • cerebral seizure
  • epilepsy
  • convulsions
  • cerebral hemorrhage
  • cerebrovascular disorders
  • motor dysfunction
  • ataxia
  • abnormal movements
  • dystonia
  • tremors
  • involuntary movements
  • gait disturbances
  • abnormal posture
  • speech disorders
  • psychomotor retardation
  • extreme muscle rigidity
  • dysphagia
  • tachycardia
  • blood pressure fluctuations
  • sweating
  • rhabdomyolysis
  • myalgia
  • weakness
  • dyspnea
  • acute pancreatitis
  • acute renal failure
  • sudden death
  • common cold
  • anorexia
  • hallucinations
  • agitation
  • aggressive behavior
  • anxiety disorders
  • insomnia
  • drowsiness
  • increased libido
  • talkativeness
  • mania
  • nightmares
  • irritability
  • delirium
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • hypersexuality
  • dizziness
  • tremors
  • stupor
  • thoracic rigidity
  • bradycardia
  • palpitations
  • sinoatrial block
  • atrioventricular block
  • hypertension
  • hypotension
  • atrial fibrillation
  • torsades de pointes
  • ECG QT interval prolongation
  • diarrhea
  • nausea
  • vomiting
  • abdominal disorders
  • gastrointestinal bleeding
  • gastric and duodenal ulcers
  • constipation
  • saliva secretion
  • fecal incontinence
  • liver disorders including hepatitis
  • rash
  • pruritus
  • muscle spasms
  • myalgia
  • urinary incontinence
  • polyuria
  • urinary retention
  • headache
  • fatigue
  • pain
  • dental pain
  • flushing
  • malaise
  • lethargy
  • edema
  • fever
  • decreased body temperature
  • decreased hematocrit
  • leukopenia
  • anemia
  • thrombocytopenia
  • petechiae
  • abnormal dreams
  • decreased appetite
  • urinary tract infection
  • increased CPK
  • dehydration
  • hyperlipidemia
  • insomnia
  • hostility
  • irritability
  • drowsiness
  • depression
  • confusion
  • emotional instability
  • personality disorder
  • eczema
  • urinary incontinence
  • hypotension
  • abnormal ECG
  • heart failure
  • constipation
  • gastroenteritis
  • fecal incontinence
  • dyspepsia
  • increased γ-GT
  • gastritis
  • dysphagia
  • periodontal disease
  • gastric ulcers
  • periodontal abscess
  • abdominal distension
  • abnormal liver function
  • 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
  • myalgia
  • anxiety
  • agitation
  • convulsions
  • transient psychotic disorders
  • gait disturbances
  • flatness of affect
  • delusions
  • dream disturbances
  • cerebrovascular abnormalities
  • increased salivation
  • ataxia
  • euphoric state
  • vasodilation
  • cerebral hemorrhage
  • cerebral infarction
  • cerebral ischemia
  • dementia
  • extrapyramidal symptoms
  • generalized seizures
  • hemiplegia
  • heightened tension
  • hypokinesia
  • pharyngitis
  • pneumonia
  • increased cough
  • bronchitis
  • dyspnea
  • rhinitis
  • asthma
  • rash
  • skin ulcers
  • itching
  • psoriasis
  • skin discoloration
  • herpes zoster
  • dry skin
  • sweating
  • urticaria
  • vesicular rash
  • conjunctivitis
  • glaucoma
  • visual disturbances
  • ear pain
  • tear abnormalities
  • urinary tract infection
  • cystitis
  • hematuria
  • diabetes
  • vaginitis
  • dysuria
  • polyuria
  • proteinuria
  • abdominal pain
  • anxiety
  • cholecystitis
  • confusion
  • convulsions
  • hallucinations
  • heart block
  • hemolytic anemia
  • hepatitis
  • hyponatremia
  • neuroleptic malignant syndrome
  • pancreatitis
  • rash
  • nausea
  • vomiting
  • hypersecretion of saliva
  • sweating
  • hypotension
  • respiratory depression
  • weakness
  • convulsions
  • muscular weakness symptoms

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

Storage

This medication should be stored in a sealed container to prevent air or moisture from entering, and it is best kept at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

White round film-coated tablets

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.

Related searches

Search tags

Suggested searches

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.