Donetine 10 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

○ Adults: Administer 5 mg of donepezil hydrochloride once daily at bedtime. If sleep disturbances such as abnormal dreams, nightmares, or insomnia occur, morning administration of this medicine may be considered. Since 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 assessing 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 treatment with this medicine is discontinued, its effects gradually diminish, and no rebound effect occurs with abrupt discontinuation. ○ Women aged 85 years or older with low body weight: Careful monitoring is necessary because adverse reactions occur more frequently. Elderly women with low body weight should not exceed 5 mg per day.

Child dose

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

This medicine contains donepezil hydrochloride and is used to alleviate symptoms of Alzheimer's type dementia. First, this medication should not be taken by those who are allergic to donepezil hydrochloride, piperidine derivatives, or any other components of this medication. It is also not safe for women who are pregnant or may become pregnant, as well as those who are breastfeeding. Additionally, individuals with lactose intolerance or certain genetic lactose metabolism disorders should not take this medication. Patients with heart disease or problems such as conduction disorders or bradycardia should use this medication cautiously and may need to periodically check their heart condition. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should be cautious as gastrointestinal symptoms may worsen. Patients with asthma or obstructive pulmonary disease should also be careful as bronchoconstriction and increased mucus secretion may occur with this medication. Patients with extrapyramidal disorders such as Parkinson's disease should be cautious as symptoms may worsen. This medication contains Yellow No. 5, and those allergic to this dye should use it with caution. During the use of this medication, serious adverse reactions such as fainting, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, seizures, extrapyramidal symptoms, muscle pain, and shortness of breath may occur; if these symptoms arise, immediate consultation with a physician is necessary. Additionally, various side effects such as nausea, vomiting, diarrhea, dizziness, insomnia, headache, and fatigue may occur, so symptoms should be closely monitored during use. This medication is not approved for use in other forms of dementia or memory disorders outside of Alzheimer-type dementia, thus diagnosis and treatment should occur under the supervision of experienced physicians. Caution is needed when driving or operating machinery while taking this medication, especially during the initial treatment or changes in dosage, as feelings of fatigue or dizziness may occur. As this medication is metabolized in the liver, patients with reduced liver function may require dosage adjustment and monitoring. Furthermore, there may be interactions with certain medications, so if taking other medications, be sure to inform your healthcare provider. Pregnant or breastfeeding women are advised to avoid this medication, and if it must be taken, breastfeeding should be discontinued. Safety for children has not been established, so it is not used in pediatric populations. In cases of overdose, symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur, and appropriate treatment should be sought immediately from a medical facility. Finally, this medication should be stored out of the reach of children and should not be transferred to another container.

Fainting, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcer, perforated duodenal perforation, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, encephalopathy, cerebral hemorrhage, cerebrovascular disorders, motor function disorders, ataxia, movement disorders, dystonia, tremor, involuntary movements, gait disorders, abnormal posture, speech disorders, akinetic mutism, extreme muscle rigidity, dysphagia, tachycardia, blood pressure fluctuations, sweating, myalgia, malaise, dyspnea, acute pancreatitis, acute renal failure, sudden death, cold, loss of appetite, hallucinations, agitation, aggressive behavior, anxiety disorders, insomnia, drowsiness, increased libido, talkativeness, mania, nightmares, neuroexcitability, nonsensical speech, delusions, depression, confusion, apathy, hyperactivity, increased libido, hypersexuality, dizziness, tremor, 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, fecal incontinence, liver disorders including hepatitis, rash, itching, 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, increased CPK, dehydration, hyperlipidemia, insomnia, hostility, irritability, drowsiness, depression, confusion, emotional instability, personality disorders, eczema, urinary incontinence, abdominal pain, weakness, fungal infection, influenza-like illness, allergy, soft tissue infection, malaise, 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, 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, agitation, anxiety, tremor, convulsions, psychotic disorders, gait disturbance, numbness, delusions, dream disorders, cerebrovascular abnormalities, increased salivation, ataxia, euphoric state, vasodilation, cerebral hemorrhage, cerebral infarction, cerebral ischemia, dementia, extrapyramidal symptoms, grand mal convulsions, hemiplegia, hypertonia, reduction in physical activity, pharyngitis, pneumonia, increased cough, bronchitis, respiratory distress, rhinitis, asthma, rash, skin ulcer, itching, psoriasis, skin discoloration, herpes zoster, dry skin, sweating, urticaria, vesicular rash, conjunctivitis, glaucoma, visual disturbances, ear pain, tear abnormalities, urinary tract infection, cystitis, hematuria, diabetes, vaginitis, urination disorders, frequent urination, proteinuria, abdominal pain, agitation, cholecystitis, confusion, convulsions, hallucinations, heart block, hemolytic anemia, hepatitis, hyponatremia, neuroleptic malignant syndrome, pancreatitis, rash

This medication should be stored in a tightly closed container that is well-ventilated. Storage temperature should be maintained at room temperature between 1 degree and 30 degrees Celsius. Proper storage helps maintain the effectiveness of the medication for a longer time.

Appearance

Yellow, round, film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle