Medication info
Daewon Donepezil Hydrochloride Tablets 10 mg (Donepezil Hydrochloride Monohydrate)

Daewon Donepezil Hydrochloride Tablets 10 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTabletOral
Ingredient · strength
Donepezil Hydrochloride Monohydrate›10.43mg / 1 tablet
Manufacturer / importer
Daewon Pharmaceutical Co., Ltd.
Appearance
Yellow round film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 200806368 · Notified 2008.06.09 · Insurance code 671804130

Summary

Main use
Treatment of symptoms of Alzheimer-type dementia
Who takes it
Adults · Children
Adult dose
○ Adults: Take 5 mg of donepezil hydrochloride once daily at bedtime. If sleep disturbances such as abnormal dreams, nightmares, or insomnia occur, taking this medicine in the morning may be considered. Since donepezil concentrations reach steady state 15 days after administration and the incidence of adverse reactions may be affected by the rate of dose increase, administer the 5 mg dose for 4~6 weeks. After assessing the clinical response during this period, the dose may be increased to 10 mg. When increasing the dose to 10 mg once daily, administer with caution regarding gastrointestinal adverse reactions. If administration of this medicine is discontinued, its effects gradually diminish; no rebound effect occurs after abrupt discontinuation. ○ Women aged 85 years or older with low body weight: Adverse reactions occur more frequently, so careful monitoring is required. Elderly women with low body weight should not exceed 5 mg once daily.
Child dose
○ Children: There is no experience with use in children.

Ingredients

Manufacturer
Daewon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of symptoms of Alzheimer-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. It helps improve symptoms such as memory decline and cognitive dysfunction, aiding the patient's daily life. It is effective in slowing down or alleviating the progression of symptoms. Consequently, it can contribute to enhancing the patient's quality of life.

How to take

Adult dose

○ Adults: Take 5 mg of donepezil hydrochloride once daily at bedtime. If sleep disturbances such as abnormal dreams, nightmares, or insomnia occur, taking this medicine in the morning may be considered. Since donepezil concentrations reach steady state 15 days after administration and the incidence of adverse reactions may be affected by the rate of dose increase, administer the 5 mg dose for 4~6 weeks. After assessing the clinical response during this period, the dose may be increased to 10 mg. When increasing the dose to 10 mg once daily, administer with caution regarding gastrointestinal adverse reactions. If administration of this medicine is discontinued, its effects gradually diminish; no rebound effect occurs after abrupt discontinuation. ○ Women aged 85 years or older with low body weight: Adverse reactions occur more frequently, so careful monitoring is required. Elderly women with low body weight should not exceed 5 mg once daily.

Child dose

○ Children: There is no experience with use in children.

Precautions

This drug contains Donepezil Hydrochloride, which is used to alleviate symptoms of Alzheimer's-type dementia. This medication should not be used by individuals who are allergic to Donepezil Hydrochloride or any component of this medication, pregnant women or those who may become pregnant, nursing mothers, and patients with hereditary lactose intolerance. Patients with heart disease or heart conduction disorders should use this drug with caution, as it may stimulate the vagus nerve leading to bradycardia or arrhythmias. Patients taking non-steroidal anti-inflammatory drugs or those with a history of peptic ulcers should be cautious as increased gastric acid secretion and enhanced gastrointestinal motility may exacerbate ulcer symptoms. Patients with a history of asthma or obstructive lung disease should be careful as bronchoconstriction and mucus secretion may worsen symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should be cautious as this drug may exacerbate symptoms. Serious side effects such as fainting, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, seizures, muscle pain, shortness of breath, acute pancreatitis, and acute renal failure may occur during the use of this medication, so if symptoms arise, consult a doctor immediately. Additionally, various adverse reactions such as nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, anxiety, fatigue, headache, muscle cramps, urinary incontinence, frequent urination, urination difficulties, elevated blood pressure, palpitations, hypotension, hypertension, dry skin, itching, rash, urticaria, dehydration, talkativeness, drowsiness, nightmares, confusion, stupor, mental dullness, aggressive behavior, hallucinations, delusions, anxiety disorders, depression, insomnia, mania, neuroirritability, and tremors have been reported, so if any abnormal symptoms occur, inform medical personnel. This medication should only be used for patients with Alzheimer's-type dementia and has not been approved for other types of dementia or memory decline, hence diagnosis and treatment should be carried out under the supervision of an experienced physician. Patients with cardiovascular diseases or electrolyte abnormalities may require regular electrocardiograms due to the risk of cardiac arrhythmias. Since this drug can affect driving or machine operation ability, caution is needed during the initial dosage or when increasing the dose. This medication is metabolized by specific enzymes, so interactions with other drugs may occur, especially caution is necessary when taken with antibiotics, antidepressants, antiarrhythmics, etc. Pregnant or nursing women should avoid using this medication, and it should only be used after consulting a specialist when absolutely necessary. Safety for children has not been established, thus it should not be used in pediatric patients. In case of overdose, severe symptoms such as nausea, vomiting, bradycardia, hypotension, seizures may occur, and immediate emergency treatment is required. This medication should be stored out of the reach of children, and it is advisable to avoid transferring it to other containers as it may negatively affect the quality.

Side effects

Fainting, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcer, perforated duodenal perforation, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizure, cerebral hemorrhage, cerebrovascular disorder, motor impairment, ataxia, movement disorders, dystonia, tremors, involuntary movements, gait disturbances, abnormal posture, speech disorders, akinetic mutism, extreme rigidity, dysphagia, tachycardia, blood pressure fluctuations, sweating, muscle pain, weakness, dyspnea, acute pancreatitis, acute renal failure, sudden death, cold, loss of appetite, hallucinations, agitation, aggressive behavior, anxiety disorder, insomnia, drowsiness, increased libido, talkativeness, mania, nightmares, neuroexcitability, nonsense, delusions, depression, confusion, apathy, hyperactivity, increased libido, hypersexuality, dizziness, tremors, seizures, stupor, thoracic stiffness, bradycardia, palpitations, sinoatrial block, atrioventricular block, hypertension, hypotension, atrial fibrillation, torsades de pointes ventricular tachycardia, QT interval prolongation on ECG, diarrhea, nausea, vomiting, abdominal disorders, gastrointestinal bleeding, gastric and duodenal ulcers, constipation, salivation, dysphagia, fecal incontinence, rash, itching, muscle spasms, muscle pain, urinary incontinence, frequency of urination, urinary retention, headache, fatigue, pain, toothache, facial flushing, malaise, lethargy, edema, fever, decreased body temperature, decreased hematocrit, leukopenia, anemia, thrombocytopenia, petechiae, abnormal dreams, accidents, headache, pain, back pain, fever, chest pain, hypertension, bleeding, fainting, constipation, gastroenteritis, fecal incontinence, dyspepsia, increased γ-GT, gastritis, dysphagia, periodontal disease, gastric ulcer, periodontal abscess, abdominal bloating, abnormal liver function, belching, esophagitis, anal bleeding, diabetes, anemia, leukocytosis, weight loss, peripheral edema, edema, increased LDH, increased alkaline phosphatase, hypercholesterolemia, hypokalemia, hypoglycemia, weight gain, hyperbilirubinemia, increased BUN, B12 deficiency anemia, cachexia, increased creatinine, gout, hyponatremia, hypoalbuminemia, iron deficiency anemia, increased AST, increased ALT, arthritis, arthrosis, bone fractures, arthralgia, leg cramps, osteoporosis, muscle pain, anxiety, agitation, spasms, migratory psychosis, gait abnormalities, apathy, delusions, dream abnormalities, cerebrovascular abnormalities, increased salivation, ataxic syndrome, altered euphoria, vasodilation, cerebral hemorrhage, cerebral infarction, cerebral ischemia, dementia, extrapyramidal symptoms, grand mal seizures, hemiplegia, hypertonia, decreased mobility, pharyngitis, pneumonia, increased cough, bronchitis, dyspnea, rhinitis, asthma, rash, skin ulcer, itching, psoriasis, skin discoloration, shingles, dry skin, sweating, urticaria, vesicular rash, conjunctivitis, glaucoma, visual disturbances, ear pain, tear abnormalities, urinary tract infection, cystitis, hematuria, diabetes, vulvovaginitis, urination disorders, frequency of urination, proteinuria, abdominal pain, anxiety, cholecystitis, confusion, spasms, hallucinations, heart block, hemolytic anemia, hepatitis, hyponatremia, neuroleptic malignant syndrome, pancreatitis, rash, nausea, vomiting, excessive salivation, sweating, hypotension, respiratory depression, weakness, spasms

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 and moisture from entering, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the drug's effectiveness for a long time.

Appearance and packaging

Appearance

Yellow round film-coated tablets

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.

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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.