Medication info
Dopet 10 mg (Donepezil Hydrochloride Hydrate)

Dopet 10 mg (Donepezil Hydrochloride Hydrate)

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

MFDS item code 201707538 · Approved 2017.10.20 · Insurance code 055800160

Summary

Main use
Improvement of symptoms of Alzheimer's type dementia
Who takes it
Adults · Children
Adult dose
Adults: Administer 5 mg once daily before bedtime as donepezil hydrochloride. If unusual dreams, nightmares, or sleep disturbances occur, consider switching the medication to the morning dose. Donepezil reaches a steady-state concentration 15 days after administration, and the frequency of adverse reactions may be influenced by the rate of dosage increase; hence, administer 5 mg for 4 to 6 weeks. After evaluating clinical responses during this period, the dosage may be increased to 10 mg. When increasing to 10 mg daily, caution is required regarding gastrointestinal adverse reactions. If the medication is discontinued, its effects gradually decrease, and rebound effects due to abrupt discontinuation do not occur. Low body weight women over 85 years: Close monitoring is necessary due to a higher occurrence of adverse reactions. Low body weight elderly women should not exceed 5 mg daily.
Child dose
Children: There is no experience of use in pediatric patients.

Ingredients

Manufacturer
(주)셀비온

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 Alzheimer's type dementia symptoms. It helps alleviate cognitive decline and memory loss, improving the patient's ability to perform daily activities.

How to take

Adult dose

Adults: Administer 5 mg once daily before bedtime as donepezil hydrochloride. If unusual dreams, nightmares, or sleep disturbances occur, consider switching the medication to the morning dose. Donepezil reaches a steady-state concentration 15 days after administration, and the frequency of adverse reactions may be influenced by the rate of dosage increase; hence, administer 5 mg for 4 to 6 weeks. After evaluating clinical responses during this period, the dosage may be increased to 10 mg. When increasing to 10 mg daily, caution is required regarding gastrointestinal adverse reactions. If the medication is discontinued, its effects gradually decrease, and rebound effects due to abrupt discontinuation do not occur. Low body weight women over 85 years: Close monitoring is necessary due to a higher occurrence of adverse reactions. Low body weight elderly women should not exceed 5 mg daily.

Child dose

Children: There is no experience of use in pediatric patients.

Precautions

This medication contains donepezil hydrochloride hydrate as its active ingredient and is used for the treatment of symptoms of Alzheimer's type dementia. Patients with allergies to certain components, pregnant or breastfeeding women, and patients with genetic metabolic disorders such as lactose intolerance should not take this medication. Patients with heart disease or a history of stomach ulcers, as well as those with asthma or obstructive pulmonary disease, should use this medication with caution, and those allergic to any colorants included in the medication should also be cautious. While taking this medication, serious side effects such as fainting, heart arrhythmias, gastrointestinal bleeding, liver dysfunction, seizures, muscle abnormalities, and breathing difficulties may occur, so if these symptoms arise, immediate consultation with healthcare professionals is necessary. Common side effects may include nausea, vomiting, diarrhea, dizziness, insomnia, and fatigue, and rarely, cardiovascular issues or neurological symptoms may appear. This medication should not be used for types of dementia or memory disorders other than Alzheimer's type dementia, and the therapeutic effects and side effects should be evaluated regularly. Patients with heart conditions should be on the lookout for bradycardia or heart block, and it is advisable to undergo an electrocardiogram if necessary. Caution is needed while driving or operating machinery during treatment, especially at the beginning of treatment or when changing doses, as dizziness or muscle cramps may occur. This medication is metabolized in the liver, so patients with compromised liver function should use it cautiously and must inform healthcare providers about other medications they are taking due to possible interactions. Pregnant or breastfeeding women are advised not to use this medication; if necessary, decisions should be made after consultation with a specialist. Safety in pediatric use has not been established, so it is better not to use it in children. Overdosage may result in hazardous symptoms such as nausea, vomiting, bradycardia, and respiratory suppression, so strict adherence to the prescribed dosage is essential, and immediate medical assistance should be sought in case of overdose. This medication should be kept out of the reach of children, and transferring it to other containers should be avoided.

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 high fever, blisters, skin peeling, pain in mouth/eyes mucous membranes, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Nausea
  • vomiting
  • dizziness
  • diarrhea
  • insomnia
  • abdominal pain
  • loss of appetite
  • headache
  • fatigue
  • drowsiness
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  • anxiety
  • hallucinations
  • agitation
  • drowsiness
  • irritability
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • excessive sexual desire
  • insomnia
  • tremors
  • seizures
  • stupor
  • palpitations
  • hypertension
  • hypotension
  • atrial fibrillation
  • diarrhea
  • constipation
  • dysphagia
  • fecal incontinence
  • rash
  • itching
  • muscle cramps
  • myalgia
  • urinary incontinence
  • empty

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

Storage

This medication should be stored in a tightly sealed container that does not allow air to pass through, and it is advisable to keep it at room temperature between 1°C and 30°C. Storing it this way helps maintain the medication's effectiveness and prevents degradation.

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.