Medication info
Donepezil Tablets 10 mg (Donepezil Hydrochloride Hydrate)

Donepezil Tablets 10 mg (Donepezil Hydrochloride Hydrate)

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

MFDS item code 201906830 · Approved 2019.09.25 · Insurance code 641502510

Summary

Main use
Improvement of Alzheimer's-type dementia symptoms
Who takes it
Adults · Children
Adult dose
As donepezil hydrochloride, take 5 mg once daily at bedtime. Initially, administer 5 mg for 4 to 6 weeks, and thereafter, the dosage can be increased up to 10 mg based on clinical response. When increasing the dose to 10 mg once daily, precautions should be taken for gastrointestinal adverse reactions. Underweight women aged 85 and above should not exceed 5 mg per day.
Child dose
There is no experience with the use in pediatric patients.

Ingredients

Manufacturer
맥널티제약(주)

Efficacy & effects

Improvement of Alzheimer's-type dementia symptoms

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

This medicine is used for the treatment of Alzheimer's-type dementia symptoms and helps improve memory and cognitive function. It alleviates memory deterioration and difficulties in daily life caused by dementia, enhancing the quality of life for patients. Therefore, it can be effectively used for improving Alzheimer's-type dementia symptoms.

How to take

Adult dose

As donepezil hydrochloride, take 5 mg once daily at bedtime. Initially, administer 5 mg for 4 to 6 weeks, and thereafter, the dosage can be increased up to 10 mg based on clinical response. When increasing the dose to 10 mg once daily, precautions should be taken for gastrointestinal adverse reactions. Underweight women aged 85 and above should not exceed 5 mg per day.

Child dose

There is no experience with the use in pediatric patients.

Precautions

This medication contains donepezil hydrochloride as the active ingredient and is primarily used for the treatment of Alzheimer's-type dementia. First, patients who are allergic to donepezil hydrochloride, piperidine derivatives, or any other components of this medication should not take it. It is also safer for pregnant women or those who may become pregnant, and nursing mothers not to use this medication. Additionally, since it contains lactose, individuals with lactose intolerance or related genetic disorders should not take this medication. Second, patients with heart diseases or cardiac conduction disorders should use this medication with caution. This medication can slow down heart rate or cause arrhythmias. Patients who are taking non-steroidal anti-inflammatory drugs (NSAIDs) or have a history of peptic ulcers should be cautious of gastrointestinal bleeding or ulcer exacerbation. Individuals with a history of asthma or obstructive lung disease may find their symptoms worsen while taking this medication. Patients with extrapyramidal disorders, such as Parkinson's disease, should also be cautious as their symptoms may deteriorate. Moreover, individuals allergic to the color additive Tartrazine (yellow No. 5) should use this medication carefully. Third, various side effects may occur when taking this medication. For instance, cardiac-related issues (bradycardia, heart block, myocardial infarction), gastrointestinal bleeding, liver function impairment, cerebrovascular problems, movement disorders, severe muscle issues, respiratory distress, acute pancreatitis, acute renal failure, and sudden death have been reported. Additionally, various mild symptoms such as nausea, vomiting, diarrhea, dizziness, insomnia, headaches, fatigue, rash, myalgia, and urinary incontinence may also occur. If any of these symptoms appear, consult a doctor immediately. Fourth, in clinical trials, this medication may help improve dementia symptoms, but its therapeutic effects can vary among individuals, and it is essential to regularly evaluate efficacy and discontinue treatment if necessary. Fifth, since this medication is primarily metabolized in the liver, patients with impaired liver function should exercise caution. Also, be cautious as dizziness or fatigue may occur while driving or operating machinery. Sixth, there may be interactions with other medications, especially those affecting CYP3A4 or CYP2D6 enzymes, muscle relaxants, cholinergic drugs, anticholinergic drugs, cardiac-related medications, and NSAIDs, so patients should inform their doctor or pharmacist if they are taking any of these medications. Seventh, it is advisable for pregnant or nursing women to refrain from taking this medication unless necessary, and they should consult with a specialist before making any decisions. Eighth, safety in children has not been established, so this medication is not used in pediatric patients. Ninth, in case of overdose, symptoms such as nausea, vomiting, bradycardia, respiratory depression, and seizures may occur; thus, one should seek immediate medical attention for appropriate treatment in cases of overdose. Lastly, it is safe to store this medication out of reach of children and not to transfer it into another container.

Side effects and when to seek care immediately

Serious side effects

  • Fainting
  • bradycardia
  • heart block
  • QT interval prolongation
  • myocardial infarction
  • heart failure
  • peptic ulcers
  • perforated duodenal perforation
  • gastrointestinal bleeding
  • hepatitis
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  • liver dysfunction
  • jaundice
  • cerebral convulsions
  • epilepsy
  • seizures
  • cerebral hemorrhage
  • cerebrovascular disorders
  • movement dysfunction
  • ataxia
  • movement disorders
  • dystonia
  • tremors
  • involuntary movements
  • gait disturbances
  • abnormal posture
  • speech disturbances
  • extreme rigidity
  • difficulty swallowing
  • tachycardia
  • blood pressure fluctuation

Mild side effects

  • Cold
  • loss of appetite
  • hallucinations
  • excitement
  • aggressive behavior
  • anxiety
  • insomnia
  • drowsiness
  • increased libido
  • talking too much
Show 30 more
  • mania
  • nightmares
  • irritability
  • nonsensical speech
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • excessive sexual desire
  • dizziness
  • insomnia
  • tremors
  • stupor
  • palpitations
  • high blood pressure
  • low blood pressure
  • atrial fibrillation
  • diarrhea
  • nausea
  • vomiting
  • abdominal discomfort
  • constipation
  • salivation
  • difficulty swallowing
  • fecal incontinence
  • rash
  • itching
  • muscle cramps
  • myalgia

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

Storage

This medication may be sensitive to air or moisture and should be stored in a tightly closed container. It is also recommended to store the medication in a cool room temperature, between 1 to 30 degrees Celsius.

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

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.