Medication info
Donepezil Hydrochloride 5 mg Tablets (Donepezil Hydrochloride Hydrate)

Donepezil Hydrochloride 5 mg Tablets (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.215mg / 1 tablet
Manufacturer / importer
(주)마더스제약
Appearance
White round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201501030 · Approved 2015.02.27 · Insurance code 622802340

Summary

Main use
Improvement of Alzheimer's-type dementia symptoms
Who takes it
Adults · Children
Adult dose
Adult: Administer Donepezil Hydrochloride 5 mg once daily before bedtime. If unusual dreams, nightmares, or sleep disturbances occur, consider taking this medication in the morning. Donepezil's concentration reaches a steady state after 15 days of administration, and the frequency of adverse reactions may be influenced by the rate of dosage increase; therefore, administer 5 mg for 4 to 6 weeks. After evaluating the clinical response during this period, the dosage may be increased to 10 mg. When increasing to a daily dosage of 10 mg, be cautious of gastrointestinal adverse reactions. When discontinuing this medication, effects gradually diminish, and rebound effects due to abrupt withdrawal do not occur. ○ For underweight women aged 85 years and older: Careful monitoring is necessary as adverse reactions are more likely to occur. Underweight elderly women should not exceed 5 mg per day.
Child dose
Pediatric: There is no experience in using this medication in children.

Ingredients

Manufacturer
(주)마더스제약

Efficacy & effects

Improvement of Alzheimer's-type dementia symptoms

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

This medication is used for the treatment of Alzheimer's-type dementia symptoms. It aims to improve symptoms such as memory decline and cognitive function impairment to assist patients in their daily activities. Consistent use can slow the progression of symptoms and improve quality of life.

How to take

Adult dose

Adult: Administer Donepezil Hydrochloride 5 mg once daily before bedtime. If unusual dreams, nightmares, or sleep disturbances occur, consider taking this medication in the morning. Donepezil's concentration reaches a steady state after 15 days of administration, and the frequency of adverse reactions may be influenced by the rate of dosage increase; therefore, administer 5 mg for 4 to 6 weeks. After evaluating the clinical response during this period, the dosage may be increased to 10 mg. When increasing to a daily dosage of 10 mg, be cautious of gastrointestinal adverse reactions. When discontinuing this medication, effects gradually diminish, and rebound effects due to abrupt withdrawal do not occur. ○ For underweight women aged 85 years and older: Careful monitoring is necessary as adverse reactions are more likely to occur. Underweight elderly women should not exceed 5 mg per day.

Child dose

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

Precautions

This medication contains Donepezil Hydrochloride as the active ingredient and is used for treating Alzheimer's-type dementia symptoms. First, do not use this medication in patients who are allergic to it or have shown hypersensitivity to the components, as well as in pregnant women or those who may become pregnant, and in nursing mothers. Additionally, since it contains lactose, patients with genetic disorders such as galactose intolerance, lactase deficiency, and glucose-galactose malabsorption should not take this medication. Patients with heart diseases, especially conditions like sick sinus syndrome or heart conduction disorders, should exercise caution, as this medication may slow down heart rate or induce arrhythmia. Patients currently taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should be cautious due to the potential risk of gastrointestinal bleeding or worsening of ulcers. Patients with a history of asthma or chronic obstructive pulmonary disease may experience worsening of symptoms due to bronchoconstriction and increased mucus secretion, and should be careful. Patients with extrapyramidal disorders, such as Parkinson's disease, are at risk of worsening symptoms due to the cholinergic effects of this medication. While taking this medication, serious side effects such as heart-related symptoms, gastrointestinal bleeding symptoms, liver function abnormalities, seizures, muscle-related symptoms, and difficulty breathing may occur; if symptoms arise, consult your healthcare provider immediately. Moreover, various side effects such as dizziness, nausea, vomiting, diarrhea, insomnia, hallucinations, anxiety, fatigue, and headaches may occur, and careful observation is required. This medication should be used under the supervision of a physician experienced in diagnosing and treating Alzheimer's dementia, and treatment efficacy should be regularly evaluated. Patients with cardiovascular diseases or electrolyte abnormalities may require ECG monitoring due to the risk of cardiac arrhythmia. Caution is necessary while driving or operating machinery due to the possibility of dizziness or fatigue. It is generally advised that pregnant or nursing women do not use this medication, and if absolutely necessary, consult a specialist. Safety in pediatric patients has not been established, so it is not used in this population. This medication may interact with various drugs, so inform your healthcare provider of any other medications you are taking. In the case of overdose, there is a risk of severe nausea, vomiting, bradycardia, and respiratory depression, so adhere to the prescribed dosage, and seek emergency treatment immediately in case of overdose. Lastly, this medication should be stored out of reach of children and should not be transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

  • Fainting
  • bradycardia
  • heart block
  • QT interval prolongation
  • myocardial infarction
  • heart failure
  • peptic ulcer
  • duodenal perforation
  • gastrointestinal bleeding
  • hepatitis
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  • liver dysfunction
  • jaundice
  • cerebral seizure
  • intracerebral hemorrhage
  • cerebrovascular disorder
  • extrapyramidal disorders
  • neuroleptic malignant syndrome
  • rhabdomyolysis
  • respiratory distress
  • acute pancreatitis
  • acute renal failure
  • unexplained sudden death
  • cardiac arrest
  • difficulty breathing
  • hives
  • severe swelling
  • or urination abnormalities.

Mild side effects

  • Nausea
  • vomiting
  • dizziness
  • diarrhea
  • insomnia
  • loss of appetite
  • headache
  • fatigue
  • drowsiness
  • rash
Show 10 more
  • itching
  • muscle pain
  • urinary incontinence
  • blood pressure fluctuations
  • sweating
  • fever
  • swelling
  • pain
  • changes in blood values
  • etc. are common adverse reactions.

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 ingress, and it is advisable to store it at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

White round film-coated tablets

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.