Medication info
Donepezil Hydrochloride 10 mg (Donepezil Hydrochloride Monohydrate)

Donepezil Hydrochloride 10 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10.43mg / 1 tablet
Manufacturer / importer
풍림무약(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets, 100 tablets/bottle
Approval status
Active

MFDS item code 201602670 · Approved 2016.05.16 · Insurance code 649001540

Summary

Main use
Improvement of symptoms related to Alzheimer-type dementia
Who takes it
Adults · Children
Adult dose
Administer 5 mg once daily before bedtime as Donepezil Hydrochloride. Maintain the dose of 5 mg for 4-6 weeks while assessing clinical response, after which it may be increased up to 10 mg. If increasing to 10 mg daily, monitor closely for gastrointestinal adverse reactions. Underweight female patients over 85 years should not exceed 5 mg daily and require careful monitoring.
Child dose
There is no experience of use in pediatric patients.

Ingredients

Manufacturer
풍림무약(주)

Efficacy & effects

Improvement of symptoms related to Alzheimer-type dementia

  • Symptoms of Alzheimer-type dementia
View approved original text

This medication is used to slow the progression of symptoms of Alzheimer-type dementia and improve cognitive function.

How to take

Adult dose

Administer 5 mg once daily before bedtime as Donepezil Hydrochloride. Maintain the dose of 5 mg for 4-6 weeks while assessing clinical response, after which it may be increased up to 10 mg. If increasing to 10 mg daily, monitor closely for gastrointestinal adverse reactions. Underweight female patients over 85 years should not exceed 5 mg daily and require careful monitoring.

Child dose

There is no experience of use in pediatric patients.

Precautions

This medication contains Donepezil Hydrochloride Monohydrate as its active ingredient and is used to treat Alzheimer-type dementia symptoms. This medication should not be used in certain patients. For example, individuals allergic to this medication or its components, pregnant women or women who may become pregnant, and nursing mothers should not take this medication. Additionally, this medication contains lactose and should not be given to patients with lactose intolerance or certain genetic metabolic disorders. Patients with heart diseases or specific cardiac conduction disorders should be careful when using this medication as they may experience bradycardia or arrhythmia. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcer should use this medication with caution as it may increase gastric acid secretion and accelerate gastrointestinal motility, potentially worsening ulcer symptoms. Patients with a history of asthma or obstructive lung disease should be cautious as this medication may cause bronchoconstriction or increased mucus secretion, worsening symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should use this medication with caution due to its cholinergic effects which may exacerbate symptoms. This medication contains Yellow No. 5 dye, and caution is advised for individuals allergic to this component. During the administration of this medication, adverse reactions related to the heart may include fainting, bradycardia, heart block, myocardial infarction, and heart failure, and gastrointestinal-related issues may include peptic ulcers, bleeding, liver dysfunction, cerebrovascular disorders, extrapyramidal symptoms, and severe neurological symptoms, so it is advised to consult a physician immediately if any symptoms appear. This medication has also been reported to cause various side effects such as drowsiness, dizziness, hallucinations, insomnia, nausea, vomiting, diarrhea, loss of appetite, headaches, fatigue, so if these symptoms become severe, notify medical personnel. This medication is not approved for other types of dementia or memory impairments other than Alzheimer-type dementia, and treatment should be conducted under the supervision of an experienced physician. Patients with heart conditions or electrolyte abnormalities may have an increased risk of cardiac arrhythmia and may require ECG monitoring while taking this medication. Care should be taken when driving or operating machinery as this medication may cause dizziness or fatigue. This medication is metabolized by certain liver metabolic enzymes, so there may be interactions with other medications, especially antifungals, antibiotics, antidepressants, and antiarrhythmics, requiring caution. Pregnant or nursing women are advised not to use this medication unless absolutely necessary and should consult with medical personnel beforehand. Safety in pediatric patients has not been established, hence it is not used in children. In cases of overdose, severe symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and seizures may occur, requiring immediate treatment at a medical facility. This medication should be kept out of the reach of children, and transferring it to other containers is not advisable as it may compromise quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough + fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, lightning-like headache, seizures, confusion, visual disturbances, paralysis, urination.

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headaches
  • fatigue
  • dizziness
  • insomnia
  • drowsiness
  • muscle pain
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  • rash
  • itching
  • increased blood pressure
  • palpitations
  • constipation
  • difficulty swallowing
  • fecal incontinence
  • urinary incontinence
  • frequent urination
  • fever
  • facial flushing
  • lethargy
  • weakness
  • dehydration
  • hyperlipidemia
  • weight loss
  • swelling
  • arthritis
  • arthralgia
  • muscle cramps
  • restlessness
  • anxiety
  • tremors
  • hallucinations
  • aggressive behavior
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • psychiatric symptoms.

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

Storage

This medication should be stored in an airtight container, preferably at room temperature between 1°C and 30°C. Storing it this way helps maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets, 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.