Medication info
Donepezil Tablet 10 mg (Donepezil Hydrochloride Hydrate)

Donepezil Tablet 10 mg (Donepezil Hydrochloride Hydrate)

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

MFDS item code 201902737 · Approved 2019.04.29 · Insurance code 657503390

Summary

Main use
Improvement of symptoms of Alzheimer-type dementia
Who takes it
Adults · Children
Adult dose
Adults: Administer 5 mg of Donepezil Hydrochloride once daily before bedtime. The dosage should be started at 5 mg for 4 to 6 weeks. After assessing clinical response during this period, it may be increased to 10 mg. If increasing to 10 mg daily, caution should be exercised regarding gastrointestinal adverse reactions. For underweight women aged 85 and older, do not exceed 5 mg daily.
Child dose
Pediatric: There is no experience using this medication in children.

Ingredients

Manufacturer
미래바이오제약(주)

Efficacy & effects

Improvement of symptoms of Alzheimer-type dementia

  • Alzheimer-type dementia symptoms
View approved original text

This medication is used for the treatment of symptoms of Alzheimer-type dementia. It alleviates symptoms associated with memory decline and helps improve cognitive function of patients. This contributes to enhancing the quality of daily life.

How to take

Adult dose

Adults: Administer 5 mg of Donepezil Hydrochloride once daily before bedtime. The dosage should be started at 5 mg for 4 to 6 weeks. After assessing clinical response during this period, it may be increased to 10 mg. If increasing to 10 mg daily, caution should be exercised regarding gastrointestinal adverse reactions. For underweight women aged 85 and older, do not exceed 5 mg daily.

Child dose

Pediatric: There is no experience using this medication in children.

Precautions

This drug is primarily composed of Donepezil Hydrochloride Hydrate and is used to treat symptoms of Alzheimer-type dementia. Firstly, this medication should not be administered to certain patients. For example, it should not be used in individuals who are allergic to this medication or its components, women who are pregnant or may become pregnant, breastfeeding women, and patients with genetic lactose intolerance. Additionally, it should be used cautiously in patients with heart disease, a history of peptic ulcer, those taking non-steroidal anti-inflammatory drugs, patients with a history of asthma or obstructive pulmonary disease, patients with extrapyramidal disorders such as Parkinson's disease, and patients allergic to certain dyes contained in this medication. During the use of this medication, various adverse reactions may occur. Serious side effects reported include heart-related issues, gastrointestinal bleeding, liver function abnormalities, cerebrovascular problems, motor dysfunction, severe muscle symptoms, respiratory distress, acute pancreatitis, renal failure, and sudden death. Furthermore, various symptoms such as nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, depression, muscle pain may also occur, and if any unusual symptoms arise, it is important to consult a physician immediately. This medication can affect heart rhythm, so patients with heart disease may require regular electrocardiogram checks. Additionally, it can increase gastric acid secretion, which may exacerbate symptoms of peptic ulcers, so attention should be paid to gastrointestinal health. It may also affect driving or machinery operation abilities, so caution is advised during the initial dosing period or when changing doses. This medication can interact with other medications. In particular, its efficacy may change when taken with drugs that inhibit or induce enzymes metabolizing drugs in the liver, and the risk of side effects may increase when combined with other heart-affecting medications. Pregnant or breastfeeding women are advised not to use this medication, and if necessary, they should consult with a specialist. Safety in children has not been confirmed, so it should not be used in pediatric patients. In case of overdose, serious side effects such as nausea, vomiting, bradycardia, hypotension, and seizures can occur, and immediate medical attention is necessary. Finally, this medication should be kept out of the reach of children, and transferring it to another container should be avoided as it can cause deterioration in quality or accidents.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by coughing and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, coma

Mild side effects

  • Nausea
  • vomiting
  • appetite loss
  • diarrhea
  • headache
  • fatigue
  • drowsiness
  • insomnia
  • dizziness
  • anxiety
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  • hallucinations
  • agitation
  • aggressive behavior
  • nightmares
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental sluggishness
  • blood pressure fluctuations
  • sweating
  • skin rash
  • itching
  • eczema
  • petechiae
  • muscle pain
  • urinary incontinence
  • frequent urination
  • fecal incontinence
  • pain
  • toothache
  • facial flushing
  • lethargy
  • weakness
  • edema
  • fever
  • decreased body temperature
  • thrombocytopenia

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

Storage

Store this medication in a tightly sealed container to prevent air or moisture from entering, and keep it at room temperature between 1 and 30 degrees Celsius. Proper storage will maintain the medication's efficacy and ensure safe use.

Appearance and packaging

Appearance

Yellow 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

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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.