Donepezil Hydrochloride 5 mg Tablets

Adult dose

○ Adults : Administer 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. As donepezil concentrations reach steady state 15 days after administration and the frequency 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 daily, administer with caution for gastrointestinal adverse reactions. If administration of this medicine is discontinued, its effect gradually declines, and no rebound effect occurs following abrupt discontinuation. ○ Female patients aged 85 years or older with low body weight : Careful monitoring is required because adverse reactions occur frequently. Elderly women with low body weight should not exceed 5 mg daily.

Child dose

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

This medication contains the ingredient Donepezil Hydrochloride and is primarily used to improve symptoms in patients with Alzheimer's disease. Before taking this medication, individuals allergic to Donepezil Hydrochloride or any of the ingredients in this drug should not use it. Furthermore, women who are pregnant, potentially pregnant, or breastfeeding should also refrain from taking this medication. Patients with lactose intolerance or specific genetic lactose degradation disorders should avoid this drug. Patients with heart disease should be cautious as this medication may cause problems such as bradycardia or arrhythmia during its use. Patients currently taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should be careful of potential gastric bleeding or worsening of ulcers. Individuals with asthma or obstructive pulmonary disease should use this medication cautiously as it may lead to bronchoconstriction and increased mucus secretion, worsening their symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should also exercise caution due to potential worsening of symptoms. This medication can cause various side effects, particularly cardiovascular reactions (fainting, bradycardia, heart block, etc.), gastrointestinal bleeding, liver dysfunction, cerebrovascular issues, extrapyramidal symptoms, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, and acute renal failure have been reported. Common side effects may include nausea, vomiting, diarrhea, dizziness, insomnia, headaches, fatigue, and loss of appetite. Some patients have also reported neuropsychiatric symptoms such as hallucinations, agitation, and aggressive behavior. This medication is approved only for Alzheimer's disease and should not be used for other forms of dementia or memory impairment. Regular assessments of treatment effects and side effects are essential while on medication, and dosage adjustments or cessation should be made under a physician's instructions. Patients with cardiovascular diseases need regular monitoring of heart function, especially if they have a history of QT interval prolongation or are taking related medications. This medication may affect driving or operating machinery, so caution is needed if symptoms such as fatigue, dizziness, or muscle cramps occur during the initial phase of treatment. Interactions with other medications may occur, particularly with drugs that affect CYP3A4 or CYP2D6 enzymes, muscle relaxants, anticholinergics, antiarrhythmics, antidepressants, and antibiotics; therefore, it is advisable to consult with a physician or pharmacist. Women who are pregnant or breastfeeding are advised against taking this medication, and if it must be used, breastfeeding should be discontinued. Safety for pediatric use has not been established, so it is recommended not to use it. In case of overdose, symptoms may include nausea, vomiting, sweating, bradycardia, respiratory depression, and seizures, requiring immediate medical attention. This medication should be kept out of reach of children and should not be transferred to other containers as it may compromise quality.

Syncope, bradycardia, heart block, prolonged QT interval, myocardial infarction, heart failure, peptic ulcer, perforated duodenal ulcer, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizure, epilepsy, convulsions, cerebral hemorrhage, cerebrovascular disorders, movement dysfunction, ataxia, motor disorders, dystonia, tremors, involuntary movements, gait disturbances, abnormal posture, language disorders, akinetic mutism, extreme muscle rigidity, dysphagia, tachycardia, blood pressure fluctuations, sweating, myoglobinuria, renal dysfunction, myalgia, malaise, dyspnea, acute pancreatitis, acute renal failure, sudden death, cold, decreased appetite, hallucinations, excitement, aggressive behavior, anxiety disorders, insomnia, drowsiness, increased libido, talkativeness, mania, nightmares, hyperosmia, delusions, depression, confusion, apathy, hyperactivity, increased libido, hypersexuality, dizziness, tremors, stupor, chest tightness, bradycardia, palpitations, sinoatrial block, atrioventricular block, hypertension, hypotension, atrial fibrillation, torsades de pointes ventricular tachycardia, diarrhea, nausea, vomiting, abdominal disorders, gastrointestinal bleeding, gastric and duodenal ulcers, constipation, salivation, fecal incontinence, liver dysfunction including hepatitis, rash, pruritus, muscle cramps, myalgia, urinary incontinence, frequent urination, urinary retention, headache, fatigue, pain, toothache, facial flushing, lethargy, asthenia, edema, fever, decreased body temperature, decreased hematocrit, leukopenia, anemia, thrombocytopenia, petechiae, abnormal dreams, decreased appetite, urinary tract infection, elevated CPK, dehydration, hyperlipidemia, insomnia, hostility, irritability, drowsiness, depression, confusion, emotional instability, personality disorder, eczema, urinary incontinence, abdominal pain, weakness, fungal infection, influenza-like syndrome, allergies, soft tissue inflammation, lethargy, sepsis, facial edema, hernia, hypotension, ECG abnormalities, heart failure, constipation, gastroenteritis, fecal incontinence, dyspepsia, increased γ-GT, gastritis, dysphagia, periodontitis, gastric ulcer, periodontal abscess, abdominal distension, liver dysfunction, belching, esophagitis, rectal bleeding, diabetes, anemia, leukocytosis, weight loss, peripheral edema, edema, elevated LDH, increased alkaline phosphatase, hypercholesterolemia, hypokalemia, hypoglycemia, weight gain, hyperbilirubinemia, elevated BUN, B12 deficiency anemia, cachexia, elevated creatinine, gout, hyponatremia, hypoproteinemia, iron deficiency anemia, elevated AST, elevated ALT, arthritis, arthrosis, bone fractures, arthralgia, leg cramps, osteoporosis, myalgia, anxiety, restlessness, convulsions, psychotic disorders, gait abnormalities, apathy, delusions, abnormal dreams, cerebrovascular abnormalities, increased salivation, ataxia, euphoric states, vasodilation, cerebral hemorrhage, cerebral infarction, cerebral ischemia, dementia, extrapyramidal symptoms, generalized tonic-clonic seizures, hemiplegia, hypertonia, decreased activity, 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 infections, cystitis, hematuria, diabetes, vulvovaginitis, urination disorders, frequent urination, proteinuria, abdominal pain, restlessness, cholecystitis, confusion, convulsions, hallucinations, heart block, hemolytic anemia, hepatitis, hyponatremia, neuroleptic malignant syndrome, pancreatitis, rash, nausea, vomiting, excessive salivation, sweating, hypotension, respiratory depression, weakness, convulsions, muscular weakness.

This medication should be stored in a tightly sealed container to prevent air exposure and kept at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the drug's effectiveness and safety.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle