Medication info
Alzepel 5 mg (Donepezil Hydrochloride Hydrate)

Alzepel 5 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationOrally disintegrating Tablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.22mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
White round orally disintegrating tablet
Packaging
30 tablets (10 tablets/PTP packaging x 3)
Approval status
Active

MFDS item code 201903433 · Approved 2019.05.27 · Insurance code 649104450

Summary

Main use
Improvement of symptoms of Alzheimer's-type dementia
Who takes it
Adults
Adult dose
Administer 5 mg of donepezil hydrochloride once daily before bedtime. If unusual dreams, nightmares, or insomnia occurs, consider morning dosing. After 15 days, reach a steady state; evaluate clinical response after administering 5 mg for 4-6 weeks and can increase to 10 mg with caution regarding gastrointestinal adverse effects. It can be taken by placing the orally disintegrating tablet on the tongue and swallowing with water or without water.

Ingredients

Manufacturer
한국휴텍스제약(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 associated with Alzheimer's-type dementia. It helps improve cognitive function and alleviate memory decline.

How to take

Adult dose

Administer 5 mg of donepezil hydrochloride once daily before bedtime. If unusual dreams, nightmares, or insomnia occurs, consider morning dosing. After 15 days, reach a steady state; evaluate clinical response after administering 5 mg for 4-6 weeks and can increase to 10 mg with caution regarding gastrointestinal adverse effects. It can be taken by placing the orally disintegrating tablet on the tongue and swallowing with water or without water.

Precautions

This medicine contains aspartame, an artificial sweetener, and should not be used by patients with hereditary diseases such as phenylketonuria. Patients who are allergic to donepezil hydrochloride, piperidine derivatives, or other components of this medication, pregnant women, women who may become pregnant, and breastfeeding women should not take this drug. Patients with heart disease, especially those with conduction disorders, should use this medication cautiously as it may cause bradycardia or arrhythmia. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should take this medication cautiously, as increased gastric acid secretion and gastrointestinal motility may worsen symptoms. Patients with a history of asthma or chronic obstructive pulmonary disease should be cautious, as there may be increased bronchoconstriction and mucus secretion that can worsen symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should be careful with this medication, as the cholinergic effects may worsen their symptoms. During the use of this medication, adverse reactions related to the heart, gastrointestinal bleeding, liver dysfunction, neurological symptoms, musculoskeletal symptoms, and others may occur; consult a healthcare provider immediately if abnormal symptoms arise. This medication is approved for the treatment of dementia, but not for other forms of dementia or memory disorders, so it should be taken under the supervision of an experienced physician after an accurate diagnosis. As this medication may affect driving or machinery operation, caution is needed at the beginning of treatment or with dosage changes. This medication can interact with various drugs; if you are taking other medications, be sure to inform your doctor or pharmacist. Pregnant or breastfeeding women are advised not to use this medication; if absolutely necessary, they should consult a professional before use. The safety for children has not been established, so it should not be used in pediatric patients. In case of overdose, serious symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur, so seek appropriate treatment immediately at a medical institution. This medication should be taken by dissolving it on the tongue, stored out of children's reach, and should be kept in its packaging as it may discolor under light.

Side effects and when to seek care immediately

Serious side effects

Syncope, bradycardia, heart block, myocardial infarction, heart failure, gastrointestinal bleeding, peptic ulcer, hepatitis, liver dysfunction, jaundice, seizure, cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (movement dysfunctions, ataxia, motor disorders, dystonia, tremors, involuntary movements, gait disorders, speech disorders), neuroleptic malignant syndrome (stiffness, extreme rigidity, dysphagia, tachycardia, blood pressure fluctuations, sweating, fever), rhabdomyolysis.

Mild side effects

Mild to moderate side effects such as headache, dizziness, insomnia, diarrhea, nausea, vomiting, loss of appetite, fatigue, muscle pain, rash, itching, increased blood pressure, weight loss, urinary incontinence, frequent urination, dehydration, fever, malaise, lethargy, drowsiness, hallucinations, agitation, aggressive behavior, anxiety, drowsiness, insomnia, tremors, confusion, delusions, insomnia, depression, and hematological abnormalities (such as anemia, leukopenia, thrombocytopenia) have been reported.

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

Storage

This medication should be stored in a sealed container to prevent air exposure, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. By storing this way, the effectiveness of the medication can be maintained, and deterioration can be prevented.

Appearance and packaging

Appearance

White round orally disintegrating tablet

Package unit

30 tablets (10 tablets/PTP packaging x 3)

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.