Medication info
Espel Tablet 10 mg (Donepezil Hydrochloride Hydrate)

Espel Tablet 10 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10mg / 1 tablet
Manufacturer / importer
(주)텔콘알에프제약
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201706736 · Approved 2017.08.22 · Insurance code 625500530

Summary

Main use
Improvement of symptoms of Alzheimer’s type dementia
Who takes it
Adults · Children
Adult dose
As donepezil hydrochloride, administer 5 mg once daily before bedtime. For 4 to 6 weeks, administer the 5 mg dose and evaluate clinical response during this period before increasing to 10 mg. Caution should be taken for gastrointestinal adverse reactions when increasing to 10 mg daily. Underweight elderly women should not exceed 5 mg per day.
Child dose
There is no clinical experience with pediatric use.

Ingredients

Manufacturer
(주)텔콘알에프제약

Efficacy & effects

Improvement of symptoms of Alzheimer’s type dementia

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

This medication is used for the treatment of symptoms of Alzheimer's type dementia.

How to take

Adult dose

As donepezil hydrochloride, administer 5 mg once daily before bedtime. For 4 to 6 weeks, administer the 5 mg dose and evaluate clinical response during this period before increasing to 10 mg. Caution should be taken for gastrointestinal adverse reactions when increasing to 10 mg daily. Underweight elderly women should not exceed 5 mg per day.

Child dose

There is no clinical experience with pediatric use.

Precautions

This medication contains donepezil hydrochloride hydrate as its active ingredient and is used to improve symptoms of Alzheimer's type dementia. This medication should not be used in certain patients. For example, individuals with allergies to this medication or its components, pregnant women or those who may become pregnant, breastfeeding women, and those with lactose intolerance or specific genetic lactose metabolism disorders should not take this medication. Patients with heart disease or arrhythmias should take this medication with caution since it can slow down heart rate or cause arrhythmias. Those with a history of peptic ulcers or those taking nonsteroidal anti-inflammatory drugs should closely monitor gastrointestinal symptoms while using this medication, as it may increase gastric acid secretion and stimulate gastrointestinal motility, potentially exacerbating gastrointestinal issues. Patients with a history of asthma or chronic obstructive pulmonary disease may also experience bronchoconstriction or increased mucus secretion, so caution is advised while taking this medication. Furthermore, patients with extrapyramidal disorders, such as Parkinson's disease, should use this medication with caution as it may exacerbate symptoms. Possible side effects that may occur while taking this medication include serious heart issues, gastrointestinal bleeding, liver function impairment, cerebrovascular problems, movement disorders, severe muscle problems, difficulty breathing, acute pancreatitis, kidney failure, and sudden death. Commonly reported side effects include nausea, vomiting, diarrhea, dizziness, insomnia, headache, fatigue, and decreased appetite. Some patients may also experience psychiatric symptoms or cardiac arrhythmias. This medication is approved only for use in Alzheimer's type dementia and should not be used for other types of dementia or memory decline. Treatment should be conducted under the guidance of a specialist, and discontinuation should be considered if there is no effectiveness. Patients with heart disease or electrolyte imbalances may require ECG monitoring during treatment due to the risk of cardiac arrhythmias. This medication may interact with other drugs. In particular, caution should be exercised when taken with drugs that inhibit or induce the enzymes that metabolize this medication in the liver, as its effects may change. Moreover, co-administration with muscle relaxants or certain neuromuscular blockers may enhance its effects, while anticholinergic drugs may have opposing effects. It is advisable not to use this medication during pregnancy, and breastfeeding women are recommended to discontinue breastfeeding while taking this medication. The safety of this medication in children has not been established, and it should not be used in pediatric patients. In case of overdose, severe nausea, vomiting, sweating, bradycardia, hypotension, respiratory depression, and seizures may occur, and immediate medical attention is required, with atropine used as an antidote. This medication should be stored out of the reach of children, and transferring it to another container can compromise its quality.

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, peeling skin, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty in breathing, asthma attack, cough accompanying respiratory difficulties with fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and very severe headache, thunderclap headaches, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Cold
  • decreased appetite
  • hallucinations
  • agitation
  • aggressive behavior
  • anxiety
  • insomnia
  • drowsiness
  • increased libido
  • talkativeness
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  • mania
  • nightmares
  • nervousness
  • rambling
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • excessive libido
  • dizziness
  • tremor
  • diarrhea
  • nausea
  • vomiting
  • abdominal discomfort
  • constipation
  • salivation
  • difficulty swallowing
  • fecal incontinence
  • rash
  • itching
  • muscle cramps
  • myalgia
  • urinary incontinence
  • frequent urination
  • headache
  • fatigue

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 entry and should be kept at a temperature between 1 and 30 degrees Celsius for safety. Storing this way will help maintain the efficacy of the medication and prevent degradation.

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.