HiSept 5 mg Tablet (Donepezil Hydrochloride Hydrate)

Adult dose

As Donepezil Hydrochloride, it is administered once daily at a dose of 5 mg before bedtime. After 4 to 6 weeks of administration at 5 mg, the dosage may be increased to 10 mg based on clinical response assessment. If the dosage is increased to 10 mg per day, attention should be paid to gastrointestinal adverse reactions. For underweight female patients aged over 85 years, the dose should not exceed 5 mg per day.

Child dose

There is no experience in pediatric use.

This medication contains Donepezil Hydrochloride as its main ingredient and is primarily used for the treatment of Alzheimer's disease symptoms. Firstly, this medication should not be used in patients who are allergic to Donepezil Hydrochloride or any other components of this medication, in pregnant women or women who may become pregnant, and in nursing mothers. Patients with heart conditions, especially those with bradycardia or arrhythmias, should use this medication cautiously and may require regular monitoring of their cardiac status. Additionally, patients with a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs (NSAIDs) should be cautious due to the risk of gastrointestinal bleeding or exacerbation of ulcers. Patients with respiratory diseases such as asthma or chronic obstructive pulmonary disease may also experience worsening of symptoms while taking this medication, so caution is needed. Patients with extrapyramidal disorders such as Parkinson's disease should use this medication cautiously due to the potential exacerbation of symptoms from its cholinergic effects. Adverse cardiac reactions such as fainting, bradycardia, heart block, and myocardial infarction may occur with this medication, as well as serious side effects including gastrointestinal bleeding, liver dysfunction, cerebrovascular disorders, extrapyramidal symptoms, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, and sudden death. Common side effects may include nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, headache, fatigue, rash, myalgia, urinary incontinence, increased frequency of urination, dehydration, weight loss, edema, increased blood pressure, drowsiness, anxiety, hallucinations, aggressive behavior, confusion, delusions, incoherence, congestive heart failure, palpitations, atrial fibrillation, heart failure, heart block, syncope, thrombocytopenia, anemia, leukopenia, dyspepsia, abdominal pain, constipation, fecal incontinence, and teeth issues. This medication may interact with other drugs, especially those affecting CYP3A4 or CYP2D6 enzymes, drugs affecting cardiac conduction, and cholinergic or anticholinergic medications, so caution is needed when co-administering these. Pregnant or nursing women should not take this medication and must consult a specialist if necessary. The safety of this medication in children has not been established, thus it should not be used in pediatric patients. This medication can affect driving or machine operating abilities, hence caution should be exercised during initial dosing or when increasing the dosage. In case of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and seizures may occur, necessitating immediate medical attention. Lastly, this medication must be kept out of reach of children, and transferring it to another container can compromise its quality, so care should be taken.

Serious side effects

Hives, severe swelling (edema), chest tightness, shortness of breath, cold sweat, paleness, severe rash accompanied by high fever, blisters, skin peeling, pain in mouth/eye mucosa, difficulty breathing or shortness of breath, asthma attack, cough with fever and respiratory abnormalities, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and very severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary issues

Mild side effects

• Nausea
• vomiting
• diarrhea
• loss of appetite
• headache
• fatigue
• dizziness
• insomnia
• fever
• tremors

This medication should be stored in a tightly closed container to prevent exposure to air and moisture, preferably at room temperature between 1°C and 30°C. By storing it this way, the efficacy of the medication can be maintained for a longer period.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle