Eldaim Odi Tablets 5 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

○ Adults : Administer 5 mg of donepezil hydrochloride once daily at bedtime. If sleep disturbances such as unusual 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 escalation, administer the 5 mg dose for 4~6 weeks. After evaluating 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 for gastrointestinal adverse reactions. When this medicine is discontinued, its effects gradually diminish; no rebound effect occurs due to abrupt discontinuation. This medicine is an orally disintegrating tablet. Place it on the tongue and allow it to dissolve, then take it with or without water. ○ Female patients aged 85 years or older with low body weight : Careful monitoring is required because adverse reactions occur more frequently. Elderly female patients with low body weight should not exceed 5 mg once daily.

Child dose

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

This medicine contains Donepezil Hydrochloride and is primarily used to treat symptoms of Alzheimer’s disease. Firstly, this medicine should not be used in certain patients. For example, it should not be administered to patients who are allergic to this medicine or its components, women who are pregnant or may become pregnant, and women who are breastfeeding. Additionally, patients with heart disease should use this medicine with caution, as it can slow down the heart rate or cause arrhythmia. Patients with a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs (NSAIDs) should also be cautious, as this medicine may stimulate gastric acid secretion and increase gastrointestinal motility, potentially worsening ulcer symptoms. Patients with a history of respiratory diseases such as asthma or chronic obstructive pulmonary disease may experience worsening symptoms due to bronchoconstriction and increased mucus secretion, so caution is needed. Patients with Parkinson's disease or extrapyramidal disorders should also be carefully administered this medicine, as its cholinergic nerve stimulation can exacerbate symptoms. During treatment with this medicine, various adverse reactions may occur, including rare but serious heart issues, gastrointestinal bleeding, liver dysfunction, cerebrovascular problems, muscle abnormalities, respiratory distress, acute pancreatitis, and acute renal failure. Commonly observed symptoms may include nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, headache, fatigue, muscle pain, rashes, and so on. Since this medicine is primarily metabolized in the liver, patients with impaired liver function should use it with caution, and there are various drugs that may interact with it, so it is essential to consult a doctor or pharmacist about using it alongside other medications. In particular, when used with drugs that affect cardiac conduction, antibiotics, antidepressants, or antipsychotics, there may be an increased risk of cardiac side effects, and ECG monitoring may be required. It is generally advised not to use this medicine during pregnancy or lactation unless absolutely necessary, and careful consideration should be made after consulting professionals. Safety for children has not been established, so it should not be used in pediatric patients. In the case of overdose, dangerous symptoms such as nausea, vomiting, sweating, bradycardia, hypotension, respiratory depression, and muscle weakness may occur, requiring immediate medical attention, and atropine may be used as an antidote. This medicine is an orally disintegrating tablet that should be placed on the tongue and swallowed, and it should be stored out of reach of children and kept in its packaging to prevent discoloration from light exposure.

Syncope, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcer, perforated duodenal ulcer, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizure, cerebral hemorrhage, cerebrovascular disorder, motor dysfunction, ataxia, movement disorder, dystonia, tremor, involuntary movements, gait disturbances, abnormal posture, speech disorder, akinetic mutism, extreme muscle rigidity, dysphagia, tachycardia, blood pressure fluctuations, sweating, myalgia, weakness, dyspnea, acute pancreatitis, acute renal failure, sudden death, cold, anorexia, hallucinations, agitation, aggressive behavior, anxiety disorders, insomnia, drowsiness, increased libido, talkativeness, mania, nightmares, nervousness, nonsense, delusions, depression, confusion, apathy, hyperactivity, increased sexual desire, hypersexuality, dizziness, tremor, seizures, stupor, chest wall rigidity, bradycardia, palpitations, sinoatrial block, atrioventricular block, hypertension, hypotension, atrial fibrillation, torsades de pointes, electrocardiogram QT interval prolongation, diarrhea, nausea, vomiting, abdominal disorders, gastrointestinal bleeding, gastric and duodenal ulcer, constipation, salivation, fecal incontinence, liver dysfunction including hepatitis, rash, itching, muscle cramps, myalgia, urge incontinence, frequent 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, headaches, back pain, chest pain, bleeding, syncope, constipation, gastroenteritis, fecal incontinence, dyspepsia, increased γ-GT, gastritis, dysphagia, periodontitis, gastric ulcer, periodontal abscess, abdominal bloating, liver dysfunction, 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, hypoproteinemia, iron deficiency anemia, increased AST, increased ALT, arthritis, arthropathy, bone fracture, arthralgia, leg cramps, osteoporosis, myalgia, restlessness, anxiety, convulsions, oscillating psychosis, gait disturbances, flat affect, dizziness, delusions, dream disturbances, cerebrovascular abnormalities, increased salivation, ataxia, euphoria, vasodilation, cerebral hemorrhage, cerebral infarction, cerebral ischemia, dementia, extrapyramidal symptoms, grand mal seizures, hemiplegia, hypertonia, reduced motor activity, pharyngitis, pneumonia, increased cough, bronchitis, dyspnea, rhinitis, asthma, rash, skin ulcer, itching, psoriasis, skin discoloration, shingles, dry skin, sweating, hives, vesicular rash, conjunctivitis, glaucoma, visual disturbances, ear pain, tear abnormalities, urinary tract infection, cystitis, hematuria, diabetes, vaginitis, urinary disorders, frequent urination, proteinuria, abdominal pain, restlessness, cholecystitis, confusion, convulsions, hallucinations, heart block, hemolytic anemia, hyponatremia, neuroleptic malignant syndrome, pancreatitis

This medicine should be stored in a tightly sealed container to prevent air from entering, preferably at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medicine over time.

Appearance

White, round orally disintegrating tablet

Package unit

30 tablets (10 tablets/PTP X 3)