Medication info
Hanlim Donepezil Tablets 23mg (Donepezil Hydrochloride Hydrate)

Hanlim Donepezil Tablets 23mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Donepezil Hydrochloride Hydrate›24mg / 1 tablet
Manufacturer / importer
한림제약(주)
Appearance
Biconvex, round, reddish-brown film-coated tablet
Packaging
30 tablets/bottle
Approval status
Expired

MFDS item code 202100883 · Approved 2021.01.28 · Insurance code 645306610

This product's status changed to Expired on 2026.01.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of moderate to severe symptoms of Alzheimer's-type dementia
Who takes it
Adults
Adult dose
This medication is taken once daily just before bedtime, and can be administered regardless of food. The initial recommended dose of Donepezil Hydrochloride is 5 mg once daily. After administering 5 mg for 4 to 6 weeks, clinical response should be evaluated, and the dose may be increased to 10 mg. If increasing to 10 mg daily, attention should be given to gastrointestinal adverse reactions during administration. Continuation of 10 mg once daily is required for at least 3 months.

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

Treatment of moderate to severe symptoms of Alzheimer's-type dementia

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

This medication is used to treat moderate to severe symptoms of Alzheimer's-type dementia. It improves memory impairment and cognitive dysfunction in patients, and aids in the maintenance of daily functioning. It also alleviates behavioral and psychiatric symptoms, thus enhancing the quality of life for both patients and families. This drug helps to slow the decline in cognitive function and supports the overall management of dementia symptoms.

How to take

Adult dose

This medication is taken once daily just before bedtime, and can be administered regardless of food. The initial recommended dose of Donepezil Hydrochloride is 5 mg once daily. After administering 5 mg for 4 to 6 weeks, clinical response should be evaluated, and the dose may be increased to 10 mg. If increasing to 10 mg daily, attention should be given to gastrointestinal adverse reactions during administration. Continuation of 10 mg once daily is required for at least 3 months.

Precautions

This medication should not be taken by individuals who are allergic to specific ingredients. It is also advised that pregnant or potentially pregnant women, as well as nursing mothers, do not use this medication. This drug contains lactose, so patients with lactose intolerance or certain genetic metabolic disorders should not take it. Patients with heart disease or conduction disorders should be cautious, as bradycardia or arrhythmia may occur. Patients with peptic ulcers or those taking non-steroidal anti-inflammatory drugs (NSAIDs) should use it cautiously due to the risk of gastrointestinal bleeding. Patients with a history of asthma or obstructive pulmonary disease should be careful, as bronchoconstriction may worsen. Patients with extrapyramidal disorders, such as Parkinson's disease, may experience exacerbation of symptoms due to this drug. Serious side effects such as syncope, heart problems, gastrointestinal bleeding, liver function abnormalities, neurological issues, movement disorders, neuroleptic malignant syndrome, rhabdomyolysis, breathing difficulties, acute pancreatitis, acute renal failure, and sudden death have been reported with this medication. Additionally, various side effects such as nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, hallucinations, anxiety, drowsiness, muscle pain, and rash may occur. This medication is not approved for other forms of memory disorders outside of dementia, and it should be taken only under the diagnosis and supervision of an experienced physician. Treatment efficacy should be evaluated regularly, and if ineffective, discontinuation should be considered. This medication can affect heart rate, therefore patients with heart disease may require ECG monitoring. Patients with gastrointestinal disorders should be careful of worsening gastrointestinal symptoms and it may also impact bladder function. Neurological side effects such as seizures or extrapyramidal disorders may occur, so caution is necessary. During pregnancy, it should not be used unless in special cases, and nursing mothers are also advised to avoid its administration. Safety in pediatric patients has not been established. This medication can interact with other drugs, especially when combined with certain antibiotics, antiarrhythmics, antidepressants, and antipsychotic medications, so care is needed. Additionally, this drug may affect the ability to drive or operate machinery, so caution is advised. In case of overdose, symptoms may include nausea, vomiting, bradycardia, hypotension, respiratory depression, and convulsions, and immediate medical attention should be sought. When stored, it should be kept in a sealed container to prevent exposure to air or moisture and kept at room temperature between 1 and 30 degrees Celsius. Following these storage guidelines will help maintain the drug's effectiveness and prevent degradation.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, shedding skin, mouth/eye mucosal pain, shortness of breath or difficulty breathing, asthma attack, cough and fever accompanied respiratory abnormalities, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Loss of appetite
  • nausea
  • vomiting
  • diarrhea
  • headache
  • fatigue
  • pain
  • toothache
  • facial flushing
  • malaise
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  • lethargy
  • fever
  • decreased temperature
  • decreased hematocrit
  • leukopenia
  • anemia
  • thrombocytopenia
  • cold
  • drowsiness
  • insomnia
  • excitement
  • aggressive behavior
  • anxiety
  • talkativeness
  • mania
  • nightmares
  • nervousness
  • nonsensical speech
  • delusions
  • depression
  • confusion
  • indifference
  • hyperactivity
  • increased libido
  • excessive libido
  • dizziness
  • tremor
  • delirium
  • rigidity of the chest wall

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 ingress and is best kept at room temperature between 1 and 30 degrees Celsius. Following these storage guidelines will help maintain the effectiveness of the medication and prevent degradation.

Appearance and packaging

Appearance

Biconvex, round, reddish-brown 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.