Donepezil Tartrate Capsule 1.5 mg

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’s disease 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 highest tolerated dose or the maximum recommended dose of 12 mg/day. Because this drug showed greater efficacy at doses of 6 mg/day and higher in clinical trials, a target dose range of 6~12 mg/day is recommended for most patients. Recommended dose titration schedule After administering 1.5 mg per dose twice daily for at least 2 weeks, the dose may be increased to 3 mg twice daily if well tolerated. Subsequent increases may be made to 4.5 mg per dose twice daily and, if well tolerated for at least 2 weeks, to 6 mg per dose twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite) or weight loss are observed, one or more doses may be omitted. However, if adverse reactions or weight loss persist, the daily dose should be reduced to the previously well-tolerated dose. 2. Treatment of symptoms of mild to moderate dementia associated with Parkinson’s disease In a controlled clinical trial in patients with dementia associated with Parkinson’s disease, rivastigmine was administered at 3~12 mg/day in two divided doses. (1.5~6 mg per dose was administered twice daily.) The initial dose is 1.5 mg per dose twice daily. At intervals of at least 4 weeks between dose levels, the dose may be increased successively according to the patient’s tolerability, first to 3 mg per dose twice daily, then to 4.5 mg per dose twice daily, and subsequently to 6 mg per dose twice daily. If adverse reactions (for example, nausea, vomiting, abdominal pain, or decreased appetite), weight gain, or extrapyramidal symptoms (for example, tremor) are observed during treatment, these symptoms may decrease if one or more doses are withheld. If adverse reactions persist, the daily dose may be temporarily reduced to the previously well-tolerated dose, or discontinuation of treatment may be considered. 3. Maximum recommended dose Administer 6 mg per dose orally twice daily. 4. Re-administration 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, use particular caution 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

○ Pediatric patients: This drug has not been studied in pediatric patients; therefore, its use is not recommended in children.

This medication should not be used in patients with allergies to specific ingredients. Patients with severely impaired liver function should also avoid taking this medication. Patients with a history of heart disease, gastric ulcers, asthma, urinary retention, or seizures should use this medication with caution. Additionally, patients with movement disorders need to be careful. While taking this medication, gastrointestinal problems such as nausea, vomiting, and diarrhea, as well as symptoms such as dizziness, headache, and drowsiness may occur. Particularly, female patients may experience gastrointestinal issues and weight loss more frequently. In Parkinson's disease patients, this medication may exacerbate symptoms, necessitating dosage adjustments and symptom monitoring. This medication may interact with other drugs; therefore, consultations with a physician are necessary, especially when using it with anesthetics, cardiovascular medications, or other cholinergic drugs. Pregnant or breastfeeding women should consult with a doctor before use, as the safety of this medication has not been established. It is not recommended for children, and overdose may result in serious side effects; thus, the dosage must be strictly adhered to. When storing this medication, it should be kept out of reach of children and not transferred to other containers. Lastly, while on this medication, be cautious of dizziness or drowsiness when driving or operating machinery, as there is a risk of accidents.

• dizziness
• vomiting
• headache
• drowsiness
• tremor
• fainting
• convulsion
• extrapyramidal symptoms
• angina
• myocardial infarction

This medication should be stored in a tightly closed container to protect from air and moisture. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve the efficacy and safety of the medication.

Appearance

A hard capsule with white to pale yellow powder.

Package unit

28 capsules/box [14 capsules/PTP × 2]