Medication info
Donepezil 10 mg (Donepezil Hydrochloride Hydrate)

Donepezil 10 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet
Ingredient · strength
Donepezil Hydrochloride Hydrate›10.43mg / 1 tablet
Manufacturer / importer
(주)서흥
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201906860 · Approved 2019.09.26 · Insurance code 679601250

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who uses it
Adults · Children
Adult dosage
As Donepezil hydrochloride, administer 5 mg once daily before bedtime. After administering the 5 mg dose for 4-6 weeks, evaluate clinical response and can increase to 10 mg. When increasing to 10 mg daily, exercise caution for gastrointestinal adverse reactions. Underweight females aged 85 or older should not exceed 5 mg per day and require careful monitoring due to potential adverse reactions.
Children's dosage
There is no experience with the use in children.

Ingredients

Manufacturer
(주)서흥

Efficacy & effects

Improvement of Alzheimer's dementia symptoms

  • Symptoms of Alzheimer's dementia
View approved original text

This medication is used to treat symptoms of Alzheimer's dementia. It helps alleviate memory decline and cognitive function impairment, enabling daily life to be smoother.

Dosage and Administration

Adult dosage

As Donepezil hydrochloride, administer 5 mg once daily before bedtime. After administering the 5 mg dose for 4-6 weeks, evaluate clinical response and can increase to 10 mg. When increasing to 10 mg daily, exercise caution for gastrointestinal adverse reactions. Underweight females aged 85 or older should not exceed 5 mg per day and require careful monitoring due to potential adverse reactions.

Children's dosage

There is no experience with the use in children.

Precautions

This medication is used for the treatment of Alzheimer’s dementia symptoms and contains Donepezil hydrochloride as its main ingredient. First, this medication should not be used in certain patients. For example, individuals who are allergic to this medication or its ingredients, women who are pregnant or may become pregnant, and nursing mothers should not take this medication. Additionally, patients with genetic conditions that prevent the breakdown of lactose should also refrain from taking this medication. Second, patients with heart diseases, a history of asthma, chronic obstructive pulmonary disease, a history of peptic ulcers, those who are on non-steroidal anti-inflammatory drugs, and patients with extrapyramidal disorders like Parkinson's disease should use this medication with caution. This medication can slow down heart rate or cause arrhythmias, and it may exacerbate gastrointestinal symptoms. Various side effects can occur with this medication, so caution is needed. Common side effects may include nausea, vomiting, diarrhea, dizziness, and insomnia, while rare but serious side effects have been reported, including severe heart problems, liver dysfunction, cerebrovascular issues, and severe muscle symptoms. If any of these symptoms appear, consulting a doctor immediately is recommended. Moreover, this medication is not approved for other forms of dementia or memory decline aside from Alzheimer's dementia, and its therapeutic effects should be evaluated regularly. If no therapeutic effect is observed, discontinuation should be considered. This medication can affect the heart, so patients with heart conditions or electrolyte imbalances may require an electrocardiogram. Additionally, patients with a history of peptic ulcers should monitor for risks such as gastrointestinal bleeding. It may affect driving or machinery operation capabilities, so caution should be exercised if experiencing fatigue or dizziness during treatment. Pregnant or nursing women are advised against using this medication without consulting a specialist if absolutely necessary. This medication may interact with other drugs, so it is essential to inform physicians or pharmacists of any currently taken medications. Special caution is required when used together with heart-related medications, antibiotics, antidepressants, and antipsychotics. In cases of overdose, symptoms like severe vomiting, bradycardia, respiratory depression, and seizures may occur, and immediate medical treatment is necessary. Antidotes like atropine may be used in cases of overdose. Finally, this medication should be stored out of reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash accompanied by high fever, blisters, peeling skin, pain in oral/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, breathing abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

Nausea, vomiting, diarrhea, loss of appetite, headache, fatigue, dizziness, insomnia, drowsiness, anxiety, depression, hallucinations, agitation, aggressive behavior, tremors, gait disturbances, involuntary movements, decreased concentration, mental dullness, thrombocytopenia, petechiae, myalgia, muscle cramps, urinary incontinence, frequent urination, fecal incontinence, increased salivation, rash, itching, facial swelling, edema, hypertension, lethargy, weight loss, hematological disorders (anemia, leukopenia

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 kept at room temperature between 1°C and 30°C. Storing it this way will help maintain its effectiveness for a longer period.

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.