Medication info
Alzheimer's Tablet 10mg (Donepezil Hydrochloride)

Alzheimer's Tablet 10mg (Donepezil Hydrochloride)

Prescription medicationOrally disintegrating Tablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10.43mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
Yellow round orally disintegrating tablet
Packaging
30 tablets (10 tablets/PTP packaging × 3)
Approval status
Active

MFDS item code 201903434 · Approved 2019.05.27 · Insurance code 649104460

Summary

Main use
Improvement of symptoms of Alzheimer's-type dementia
Who takes it
Adults
Adult dose
Administer 5 mg once daily before bedtime as donepezil hydrochloride. For 4 to 6 weeks, administer the 5 mg dose. After evaluating clinical responses during this period, it may be increased to 10 mg. Caution should be exercised regarding gastrointestinal adverse reactions when increasing to 10 mg daily. This medication is an orally disintegrating tablet that can be placed on the tongue to dissolve and taken with or without water.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

Improvement of symptoms of Alzheimer's-type dementia

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

This medication is used in the treatment of Alzheimer's-type dementia symptoms. It helps improve memory decline or cognitive impairment due to dementia.

How to take

Adult dose

Administer 5 mg once daily before bedtime as donepezil hydrochloride. For 4 to 6 weeks, administer the 5 mg dose. After evaluating clinical responses during this period, it may be increased to 10 mg. Caution should be exercised regarding gastrointestinal adverse reactions when increasing to 10 mg daily. This medication is an orally disintegrating tablet that can be placed on the tongue to dissolve and taken with or without water.

Precautions

This medication contains the artificial sweetener aspartame and should not be used by patients with the hereditary condition phenylketonuria. The maximum daily intake of aspartame included in this medication is limited to 40mg per kg of body weight, so care should be taken not to exceed 2.4g per day for adults. Patients who are allergic to this medication or have hypersensitivity to donepezil hydrochloride or piperidine derivatives should not take it. It is safer for pregnant women, women who may become pregnant, and breastfeeding women to avoid using this medication. Patients with heart disease or heart rhythm problems should use this medication cautiously, as it may stimulate the vagus nerve and cause bradycardia or arrhythmia. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcer disease should exercise caution due to the risk of gastrointestinal bleeding or worsening of ulcers. Those with asthma or obstructive pulmonary disease should be careful, as this medication may cause bronchoconstriction and worsen symptoms. Patients with extrapyramidal disorders such as Parkinson's disease may experience worsening symptoms with this medication and should use it cautiously. This medication contains Yellow No. 4 dye, so caution is needed for patients with an allergy to this ingredient. Serious side effects such as fainting, heart problems, gastrointestinal bleeding, liver function abnormalities, cerebral hemorrhage, symptoms of extrapyramidal disorders, acute pancreatitis, and acute renal failure may occur during use, so if any unusual symptoms arise, medical personnel should be notified immediately. This medication may have various mild side effects such as diarrhea, nausea, vomiting, loss of appetite, dizziness, insomnia, headache, and muscle pain, so symptoms should be monitored. It is not approved for use in other memory disorders aside from dementia and should only be administered under the diagnosis and supervision of an experienced physician. This medication may affect heart rhythm, so patients with heart disease or a history of prolonged QT interval may require an EKG. Caution is necessary when driving or operating machinery while taking this medication, as fatigue, dizziness, muscle cramps, etc. may occur. There may be interactions with other medications, so especially when taken with antibiotics, antidepressants, antiarrhythmics, antipsychotics, and anti-inflammatory pain medications, it is essential to consult with medical personnel. Pregnant or breastfeeding women should avoid using this medication, and if it must be taken, breastfeeding should be discontinued. Safety in children has not been established, and its use is not recommended. In cases of overdose, serious symptoms such as nausea, vomiting, bradycardia, respiratory depression, and seizures may occur, and immediate emergency treatment should be received, with atropine being a possible antidote. This medication should be taken by dissolving it in the mouth and it is preferable to swallow it with water or saliva. When storing, it should be kept in a sealed container to prevent air or moisture exposure, and it should be stored unopened away from light as it may discolor.

Side effects and when to seek care immediately

Serious side effects

Fainting, bradycardia, heart block, prolonged QT interval, myocardial infarction, heart failure, peptic ulcer, perforated duodenal perforation, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizures (epilepsy, convulsions, etc.), cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (motor dysfunction, ataxia, movement disorders, dystonia, tremors, involuntary movements, gait abnormalities, abnormal posture, speech disorders), neuroleptic malignant syndrome.

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • drowsiness
  • dizziness
  • insomnia
  • muscle pain
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  • rash
  • itching
  • swelling
  • elevated blood pressure
  • urinary incontinence
  • frequent urination
  • anxiety
  • aggressive behavior
  • involuntary movements
  • gait disturbance
  • decreased concentration
  • mental dullness
  • drowsiness
  • nervousness
  • irritability
  • hallucinations
  • depression
  • confusion
  • delusions
  • talkativeness
  • mania
  • nightmares
  • lethargy
  • weakness
  • pain
  • toothache
  • facial flushing
  • fever
  • decreased body temperature
  • blood

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture ingress. It is best stored at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round orally disintegrating tablet

Package unit

30 tablets (10 tablets/PTP packaging × 3)

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.