Medication info
Donepezil 5 mg Tablets (Donepezil Hydrochloride Hydrate)

Donepezil 5 mg Tablets (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.22mg / 1 tablet
Manufacturer / importer
한국유나이티드제약(주)
Appearance
White, round, film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202002346 · Approved 2020.04.03 · Insurance code 644309450

Summary

Main use
Improvement of symptoms of Alzheimer's type dementia
Who takes it
Adults · Children
Adult dose
Administer 5 mg of donepezil hydrochloride once daily before bedtime. If strange dreams, nightmares, or insomnia occur, consider morning administration. The concentration of donepezil reaches a normal state 15 days after administration, so administer the 5 mg dosage for 4 to 6 weeks. After evaluating the clinical response during this period, it can be increased to 10 mg. When increasing to 10 mg per day, caution should be exercised regarding gastrointestinal adverse reactions.
Child dose
No experience of use in children.

Ingredients

Manufacturer
한국유나이티드제약(주)

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

Administer 5 mg of donepezil hydrochloride once daily before bedtime. If strange dreams, nightmares, or insomnia occur, consider morning administration. The concentration of donepezil reaches a normal state 15 days after administration, so administer the 5 mg dosage for 4 to 6 weeks. After evaluating the clinical response during this period, it can be increased to 10 mg. When increasing to 10 mg per day, caution should be exercised regarding gastrointestinal adverse reactions.

Child dose

No experience of use in children.

Precautions

This medication should not be used by women who are allergic to certain ingredients, pregnant, or breastfeeding. Patients with genetic issues such as lactose intolerance should also not take this medication. Patients with heart disease or cardiac rhythm problems need special caution when using this medication. Patients currently taking non-steroidal anti-inflammatory drugs or having a history of peptic ulcers may face gastrointestinal problems, thus should exercise caution. Patients with asthma or obstructive lung disease should use this medication with care as it may worsen symptoms. Patients with extrapyramidal disorders like Parkinson's disease may have worsened symptoms when taking this medication, again requiring caution. This medication contains a pigment called Yellow No. 5, so patients allergic to it should be cautious. During treatment, serious side effects such as fainting, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, seizures, muscle issues, difficulty breathing, etc., may occur, so immediate consultation with a healthcare provider is necessary if any symptoms arise. This medication may also cause gastrointestinal disturbances, nausea, vomiting, diarrhea, loss of appetite, headache, dizziness, insomnia, etc. It is not an approved treatment for other memory disorders other than dementia, so it should be used under the diagnosis and supervision of a specialist. Patients with heart disease or electrolyte abnormalities may be at risk for arrhythmias and may require an electrocardiogram. Caution is necessary as it may affect the ability to drive or operate machinery. There may be interactions with other medications, so especially if taking heart medications, antibiotics, antidepressants, or antipsychotics, consultation with a physician or pharmacist is mandatory. Women who are pregnant or breastfeeding should avoid this medication or stop breastfeeding, and the safety for children has not been established. In case of overdose, there is a risk of severe nausea, vomiting, bradycardia, respiratory depression, so immediate emergency treatment is required. Keep this medication out of the reach of children and be careful not to transfer it to another container.

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 oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

Loss of appetite, hallucinations, agitation, aggressive behavior, anxiety, insomnia, drowsiness, increased libido, talkativeness, mania, nightmares, nervousness, talking nonsense, delusions, depression, confusion, apathy, hyperactivity, increased libido, hypersexuality, dizziness, insomnia, tremors, delirium, chest tightness (pseudocyesis syndrome), palpitations, hypertension, hypotension, atrial fibrillation, diarrhea, nausea, vomiting, abdominal discomfort (including abdominal pain), constipation, salivation, difficulty swallowing,

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container that is well ventilated and kept at a temperature between 1 degree and 30 degrees Celsius (room temperature). Storing it this way helps maintain the effectiveness of the medication for a long time.

Appearance and packaging

Appearance

White, round, film-coated tablet

Package unit

30 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.