Medication info

Darim Donepezil 5 mg Tablets (Donepezil Hydrochloride Monohydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.22mg / 1 tablet
Manufacturer / importer
(주)다림바이오텍
Appearance
Yellow round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201903119 · Approved 2019.05.14

This product's status changed to Expired on 2024.05.14. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who takes it
Adults · Children
Adult dose
Adults: Take 5 mg of Donepezil Hydrochloride once daily before bedtime. For 4 to 6 weeks, maintain the dosage at 5 mg. After evaluating the clinical response during this period, it may be increased to 10 mg. When increasing to 10 mg daily, administer with caution regarding gastrointestinal side effects. For underweight women aged 85 and over, do not exceed 5 mg daily as adverse reactions may increase.
Child dose
Children: No experience with pediatric use.

Ingredients

Manufacturer
(주)다림바이오텍

Efficacy & effects

Improvement of Alzheimer's dementia symptoms

  • Symptoms of Alzheimer's dementia
View approved original text

Used for the treatment of Alzheimer's dementia symptoms.

How to take

Adult dose

Adults: Take 5 mg of Donepezil Hydrochloride once daily before bedtime. For 4 to 6 weeks, maintain the dosage at 5 mg. After evaluating the clinical response during this period, it may be increased to 10 mg. When increasing to 10 mg daily, administer with caution regarding gastrointestinal side effects. For underweight women aged 85 and over, do not exceed 5 mg daily as adverse reactions may increase.

Child dose

Children: No experience with pediatric use.

Precautions

This medicine contains Donepezil Hydrochloride Monohydrate as the active ingredient and is used for the treatment of Alzheimer's dementia symptoms. First, it should not be used in patients who have allergies to Donepezil Hydrochloride or piperidine derivatives, or to any other components of this drug. Additionally, pregnant women or women who may become pregnant, as well as nursing mothers, should not take this medication. Since it contains lactose, patients with hereditary lactose intolerance or related disorders should also avoid it. Caution is required when administering this drug to patients with heart diseases, especially those with bradycardia or heart conduction disorders, as it may lower heart rate or induce arrhythmia. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcer disease should closely monitor their gastrointestinal condition. Patients with a history of asthma or obstructive pulmonary disease should also be careful, as bronchospasm and increased mucus secretion may occur. Patients with extrapyramidal disorders such as Parkinson’s disease should exercise caution, as symptoms may worsen. Furthermore, caution is advised for those allergic to Tartrazine (Yellow No. 5). Serious side effects such as cardiovascular adverse reactions (bradycardia, heart block, myocardial infarction, etc.), gastrointestinal bleeding, liver dysfunction, cerebrovascular issues, movement disorders, neuroleptic malignant syndrome, rhabdomyolysis, acute renal failure, acute pancreatitis, respiratory distress, and sudden death may occur. If these symptoms arise, discontinue the medication immediately and consult a healthcare professional. More common side effects include nausea, vomiting, diarrhea, appetite loss, dizziness, insomnia, headache, fatigue, muscle pain, which are mostly mild and temporary. However, if symptoms are severe or persist, consult a doctor. Patients with heart conduction disorders or prolonged QT interval are at risk of cardiac arrhythmias; therefore, an electrocardiogram may be necessary. Additionally, this medication may interact with several drugs, so inform healthcare providers if taking other medications. This drug should not be used during pregnancy unless under special circumstances, and nursing mothers are advised to discontinue breastfeeding while taking this medication. Safety in children has not been established, so it is not administered to pediatric patients. In case of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and convulsions may occur, and immediate medical attention should be sought. Atropine may be used as an antidote, so follow medical advice. Store this medication out of the reach of children, and be cautious not to transfer it to other containers, as this could lead to a decrease in quality or accidents.

Side effects and when to seek care immediately

Serious side effects

Syncope, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcer, perforated duodenal ulcer, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizures, epilepsy, convulsions, cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (motor function disorders, ataxia, movement disorders, dystonia, tremors, involuntary movements, gait disturbances, abnormal postures, speech disorders), neuroleptic malignant syndrome (akinesia, mutism, intense muscular rigidity)

Mild side effects

  • Cold
  • appetite loss
  • hallucinations
  • agitation
  • aggressive behavior
  • anxiety
  • insomnia
  • drowsiness
  • increased libido
  • talkativeness
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  • mania
  • nightmares
  • nervousness
  • nonsense speech
  • delusions
  • depression
  • disorientation
  • apathy
  • hyperactivity
  • excessive libido
  • dizziness
  • tremors
  • confusion
  • chest tightness
  • palpitations
  • hypertension
  • hypotension
  • atrial fibrillation
  • diarrhea
  • nausea
  • vomiting
  • abdominal discomfort
  • gastrointestinal bleeding
  • constipation
  • salivation
  • difficulty swallowing
  • fecal incontinence
  • rash
  • itching
  • muscle pain

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 room temperature between 1 and 30 degrees Celsius. This will help maintain the efficacy of the drug and prevent deterioration.

Appearance and packaging

Appearance

Yellow 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.