Medication info

Donepezil Tablet 23 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›24mg / 1 tablet
Manufacturer / importer
(주)보령바이오파마
Appearance
Red, biconvex, round film-coated tablets
Packaging
Bottle - 30 tablets per bottle
Approval status
Active

MFDS item code 202103130 · Approved 2021.04.15

Summary

Main use
Treatment of symptoms of moderate to severe Alzheimer's type dementia
Who takes it
Adults
Adult dose
This medication is to be taken once daily just before bedtime, and it can be administered regardless of food. The initial recommended dose of Donepezil Hydrochloride is 5 mg once daily. Normal state is reached after 15 days of administration, and 5 mg should be given for 4 to 6 weeks. After clinical response, the dose may be increased to 10 mg. When increasing to 10 mg once daily, attention should be paid to gastrointestinal adverse reactions. It should be administered for a minimum of 3 months.

Ingredients

Manufacturer
(주)보령바이오파마

Efficacy & effects

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

  • Symptoms of Alzheimer’s type dementia
View approved original text

This medication is used to treat symptoms of moderate to severe Alzheimer’s type dementia.

How to take

Adult dose

This medication is to be taken once daily just before bedtime, and it can be administered regardless of food. The initial recommended dose of Donepezil Hydrochloride is 5 mg once daily. Normal state is reached after 15 days of administration, and 5 mg should be given for 4 to 6 weeks. After clinical response, the dose may be increased to 10 mg. When increasing to 10 mg once daily, attention should be paid to gastrointestinal adverse reactions. It should be administered for a minimum of 3 months.

Precautions

This medicine contains Donepezil Hydrochloride Hydrate as its main ingredient, and is primarily used to alleviate symptoms of Alzheimer’s type dementia. First, this medication should not be taken by individuals who are allergic to Donepezil Hydrochloride, piperidine derivatives, or any of the ingredients in this medicine. Additionally, it is advisable for women who are pregnant or may become pregnant and those who are breastfeeding to avoid using this medication. This medication contains lactose, so individuals with genetic issues such as galactose intolerance, lactose enzyme deficiency, or glucose-galactose malabsorption should not take it. Individuals with heart disease or arrhythmias should use this medication cautiously as it may slow the heart rate or cause arrhythmias. Those taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should carefully monitor their gastrointestinal status. Individuals with asthma or obstructive pulmonary disease should be cautious as bronchoconstriction or increased mucous secretion may occur. Those with extrapyramidal disorders such as Parkinson's disease should be careful, as symptoms may worsen. This medication contains Yellow No. 4 (tartrazine), and individuals allergic to this substance should also exercise caution. Side effects may include heart-related issues, gastrointestinal bleeding, liver dysfunction, cerebrovascular problems, movement disorders, neuroleptic malignant syndrome, and rhabdomyolysis; if any unusual symptoms appear, immediate consultation with a physician is necessary. Moreover, various symptoms such as nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, headache, and fatigue may occur, although these symptoms are generally mild or transient. This medication is not approved for use in other types of dementia or memory disorders other than Alzheimer's type dementia, and treatment should be conducted under the supervision of an experienced physician. Individuals with heart disease or electrolyte imbalances may require electrocardiogram testing, and this medication may increase gastric acid secretion, potentially worsening peptic ulcers, so gastrointestinal status should be closely monitored. As a cholinesterase inhibitor, this medication may cause bronchoconstriction, so those with respiratory diseases should exercise caution. Women who are pregnant or breastfeeding are advised not to take this medication; if it must be taken, breastfeeding should be discontinued. Safety for pediatric use has not been established, so it should not be used in children. This medication may affect liver and kidney function, so regular testing may be necessary. In cases of overdose, symptoms such as nausea, vomiting, decreased heart rate, respiratory suppression, and seizures may occur, and immediate medical attention is required. This medication may interact with some drugs, so it is essential to consult a physician or pharmacist if taking other medications.

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 fever, blisters, skin peeling, pain in mouth/eyes mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, altered consciousness, vision problems, paralysis, urination.

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • lethargy
  • dizziness
  • drowsiness
  • insomnia
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  • sweating
  • rash
  • itching
  • muscle pain
  • urinary incontinence
  • frequent urination
  • weight loss
  • blood pressure fluctuations
  • tremors
  • anxiety
  • confusion
  • drowsiness
  • talkativeness
  • nightmares
  • hallucinations
  • agitation
  • aggressive behavior
  • increased libido
  • mania
  • delusions
  • depression
  • apathy
  • hyperactivity
  • thrombocytopenia
  • petechiae
  • abnormal dreams
  • fatigue
  • dental pain
  • facial flushing.

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 from entering. It is best to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature. Proper storage can help maintain the medication's efficacy for a longer duration.

Appearance and packaging

Appearance

Red, biconvex, round film-coated tablets

Package unit

Bottle - 30 tablets per 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.