Tdisep Tablet 10mg (Donepezil Hydrochloride Monohydrate)

Adult dose

○ Adults: Administer donepezil hydrochloride 5 mg 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 frequency of adverse reactions may be affected by the rate of dose increase, 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. When treatment with this medicine is discontinued, its effect gradually decreases, 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 daily.

Child dose

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

This medication contains donepezil hydrochloride, which is used for the treatment of Alzheimer's type dementia symptoms. First, this medication should not be administered to certain patients. For instance, individuals allergic to this medication or its components, pregnant women or women who may become pregnant, and breastfeeding women should avoid using this drug. Also, patients with a genetic issue that prevents the breakdown of lactose should not take this medication. This drug should be used with caution in patients with heart diseases. There is a risk of bradycardia or arrhythmia, so those with heart-related conditions should consult a doctor. Patients with a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs should closely monitor their gastrointestinal condition, and individuals with a history of asthma or obstructive lung disease should take care that symptoms do not worsen while using this drug. This medication may also exacerbate symptoms in patients with extrapyramidal disorders, such as Parkinson's disease, and should be administered with caution. This medication contains a dye called Yellow No. 5, so individuals allergic to this ingredient should also be careful. During use, various adverse reactions may occur. Cardiovascular issues can lead to fainting, bradycardia, and heart block, while gastrointestinal bleeding or ulcers, liver dysfunction, cerebrovascular issues, and movement disorders have also been reported. Serious symptoms such as neuroleptic malignant syndrome and rhabdomyolysis can rarely occur, so patients experiencing muscle pain, weakness, or respiratory distress should consult a doctor immediately. Since this medication affects brain function, it may also present psychiatric symptoms such as hallucinations, anxiety, insomnia, depression, and confusion. Gastrointestinal disturbances like nausea, vomiting, diarrhea, and abdominal pain are frequently reported, as well as rash, itching, muscle cramps, urinary incontinence, and others. Since this medication may require ECG monitoring in patients with heart diseases, those with a history of cardiac conduction abnormalities or QT interval prolongation should be particularly cautious. Additionally, this drug increases gastric acid secretion and enhances gastrointestinal motility, which may worsen peptic ulcer symptoms, so patients with a history of gastrointestinal diseases should carefully observe their conditions while taking it. It may also affect driving or machinery operation ability, so initial use or dosage increase may result in fatigue, dizziness, or muscle cramps that require caution. This drug may interact with other medications, especially those affecting the CYP3A4 and CYP2D6 enzymes; thus, patients should follow their doctor's instructions when taking them. Caution is required when used with muscle relaxants, anticholinergic drugs, antiarrhythmics, certain antidepressants, antibiotics, etc., as side effects may increase or therapeutic effects may change. Pregnant or breastfeeding women should preferably avoid using this medication, and if absolutely necessary, must consult their doctor. The safety of this drug in children has not yet been established, hence it should not be used in pediatrics. In case of overdose, symptoms such as nausea, vomiting, sweating, bradycardia, hypotension, respiratory suppression, and seizures may occur. Immediate medical attention should be sought. Atropine may be used as an antidote, and appropriate treatment is necessary. Finally, this medication should be kept out of reach of children, and it is advisable not to transfer it to another container.

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 movement, gait disorder, abnormal posture, speech disorder, akinetic mutism, severe muscle rigidity, dysphagia, tachycardia, blood pressure fluctuations, sweating, renal dysfunction accompanied by myoglobinuria, rhabdomyolysis, myalgia, weakness, increased CK in blood and urine, dyspnea, acute pancreatitis, acute renal failure, unexplained sudden death, cold, loss of appetite, hallucination, agitation, aggressive behavior, anxiety disorder, insomnia, drowsiness, increased libido, chatter, mania, nightmares, hyperexcitability, nonsense speech, delusion, depression, confusion, apathy, hyperactivity, increased libido, hypersexuality, dizziness, tremor, seizure, stupor, chest rigidity, bradycardia, palpitations, sinoatrial block, atrioventricular block, hypertension, hypotension, atrial fibrillation, torsades de pointes, QT interval prolongation on ECG, diarrhea, nausea, vomiting, abdominal disorder, gastrointestinal bleeding, gastric and duodenal ulcer, constipation, salivation, dysphagia, fecal incontinence, rash, itching, muscle cramps, myalgia, urinary incontinence, polyuria, urinary retention, headache, fatigue, pain, toothache, facial flushing, malaise, 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 disorder, eczema, urinary incontinence, abdominal pain, weakness, fungal infection, influenza-like syndrome, allergies, soft tissue infection, malaise, sepsis, facial edema, hernia, hypotension, ECG abnormalities, heart failure, myocardial infarction, angina, atrial fibrillation, congestive heart failure, peripheral vascular disease, supraventricular ectopic beats, ventricular ectopic beats, cardiac hypertrophy, constipation, gastroenteritis, fecal incontinence, dyspepsia, increased γ-GT, gastritis, 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, vitamin B12 deficiency anemia, cachexia, increased creatinine, gout, hyponatremia, hypoalbuminemia, iron deficiency anemia, increased AST, increased ALT, arthritis, arthropathy, bone fracture, arthralgia, leg cramps, osteoporosis, myalgia, anxiety, agitation, spasms, psychotic symptoms, gait abnormalities, apathy, delusions, abnormal dreams, cerebrovascular abnormalities, increased salivation, ataxia, euphoric state, vasodilation, cerebral hemorrhage, cerebral infarction, cerebral ischemia, dementia, extrapyramidal symptoms, grand mal seizures, hemiplegia, hypertonia, decreased motor activity, pharyngitis, pneumonia, increased cough, bronchitis, dyspnea, rhinitis, asthma, rash, skin ulcer, itching, psoriasis, skin discoloration, herpes zoster, dry skin, sweating, hives, vesicular rash, conjunctivitis, glaucoma, visual disturbances, ear pain, tear abnormalities, urinary tract infection, cystitis, hematuria, diabetes, vaginitis, urination difficulties, polyuria, proteinuria, abdominal pain, anxiety, cholecystitis, confusion, spasms, hallucination, heart block, hemolytic anemia, hyponatremia, neuroleptic malignant syndrome, pancreatitis, rash, severe nausea, vomiting, hypersalivation, hypotension, respiratory depression, weakness, spasms, muscular weakness symptoms, respiratory muscle relaxation

This medication should be kept in a tightly closed container to prevent air or moisture from entering, and it is recommended to store it at room temperature between 1°C and 30°C. Storing it this way will help maintain the drug's effectiveness.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle