Donepezil Tartrate 6 mg Capsules

Adult dose

Dosage and administration: Rivastigmine is administered orally twice daily with the morning and evening meals. ○ Adults: 1. Treatment of symptoms of mild to moderate Alzheimer-type dementia The initial dose is 3 mg/day of rivastigmine. For each patient, the dose should be increased at intervals of at least 2 weeks to the maximum tolerated dose or the maximum recommended dose of 12 mg/day. Because greater efficacy was observed in clinical trials at doses of 6 mg/day or higher, a target dose range of 6~12 mg/day is recommended for most patients. Recommended dose titration schedule Administer 1.5 mg twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3 mg twice daily. Subsequent increases may be made to 4.5 mg twice daily and, if well tolerated, after at least 2 weeks to 6 mg twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite) or weight loss occur, one or more doses may be omitted. However, if adverse reactions or weight loss persist, reduce the daily dose to the previous dose that was well tolerated. 2. Treatment of symptoms of mild to moderate dementia associated with Parkinson's disease In controlled clinical trials in patients with dementia associated with Parkinson's disease, rivastigmine was administered at 3~12 mg/day in 2 divided doses. (1.5~6 mg per dose twice daily.) The initial dose is 1.5 mg twice daily. Depending on the patient's tolerability, subsequent doses may be increased at intervals of at least 4 weeks to 3 mg twice daily, then to 4.5 mg twice daily, and then to 6 mg twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite), weight gain, or extrapyramidal symptoms (e.g., tremor) occur during treatment, omitting one or more doses may reduce these symptoms. If adverse reactions persist, the daily dose may be temporarily reduced to the previous well-tolerated dose, or discontinuation of treatment may be considered. 3. Maximum recommended dose Administer 6 mg orally twice daily. 4. Reinitiation of treatment The frequency and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for more than 3 days, restart at the lowest daily dose and titrate as described above. ○ Patients with hepatic or renal impairment: 1. Exposure is increased in patients with moderate renal impairment and mild to moderate hepatic impairment, and more adverse reactions may occur. Therefore, take particular care when titrating the dose according to individual tolerability. 2. Do not administer to patients with severe hepatic impairment, as no studies have been conducted in these patients.

Child dose

○ Children: This medication has not been studied in children; therefore, its use in children is not recommended.

This medication should not be used in certain patients. For example, patients allergic to the active ingredient or other components of this medication, patients with severe liver impairment, and those who have experienced allergic dermatitis from the patch form of this medication should not take it. Additionally, patients with heart disease or peptic ulcer, duodenal ulcer, asthma, obstructive lung disease, urine retention, seizures, and extrapyramidal disorders should use this medication with caution. Gastrointestinal adverse effects such as nausea, vomiting, and diarrhea may commonly occur when taking this medication, especially during the dose adjustment period. Female patients may experience gastrointestinal adverse effects and weight loss more frequently than male patients. Symptoms of mental agitation or confusion, anxiety, insomnia, depression, and hallucinations may occur, and neurological adverse effects such as dizziness, headache, drowsiness, tremors, fainting, and seizures have also been reported. Heart-related issues such as bradycardia, angina, and myocardial infarction can occasionally occur. This medication may interact with other drugs; caution is required, especially when used with muscle relaxants, cholinergic drugs, anticholinergic drugs, beta-blockers, and drugs that prolong the QT interval. Pregnant or nursing women should take this medication with caution due to the lack of established safety, and it is advisable to avoid use during breastfeeding. There are no adequate clinical studies for children, so it is not recommended for pediatric use. In case of overdose, symptoms may include nausea, vomiting, diarrhea, dizziness, bradycardia, and confusion, which may require emergency treatment in severe cases. This medication should be stored out of reach of children, and it is safe not to transfer it to another container. When starting treatment or adjusting the dosage, adjustments should be made slowly considering the possibility of adverse reactions, and the patient's condition should be monitored closely. Monitoring is particularly important for patients with Parkinson's disease, as their symptoms may worsen. Also, it is necessary to periodically check for weight changes while taking this medication.

• Nausea
• vomiting
• urinary tract infection
• agitation
• confusion
• nightmares
• anxiety
• insomnia
• depression
• hallucinations

This medication must be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius.

Appearance

A hard capsule with a red upper part and an orange lower part containing a white to pale yellow powder

Package unit

28 capsules/box [14 capsules/PTP x 2]