Shinshin Rivastigmine Capsule 1.5 mg (Rivastigmine Tartrate)

Adult dose

Administration: Rivastigmine is administered orally twice daily, with breakfast and the evening meal. ○ Adults: 1. Treatment of mild to moderate Alzheimer-type dementia The initial dose is 3mg of rivastigmine per day. For each patient, increase the dose at intervals of at least 2 weeks to the maximum tolerated dose or the maximum recommended dose of 12mg per day. Since this medicine showed greater efficacy at doses of 6mg per day or higher in clinical trials, a target dose range of 6~12mg per day is recommended for most patients. Recommended dose titration Administer 1.5mg per dose twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3mg twice daily. For subsequent increases, administer 4.5mg per dose twice daily; if well tolerated, after at least 2 weeks increase to 6mg 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, reduce the daily dose to the previous dose that was well tolerated. 2. Treatment 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 3~12mg per day, twice daily (1.5~6mg per dose twice daily). The initial dose is 1.5mg per dose twice daily. At intervals of at least 4 weeks between dose levels, and depending on the patient's tolerability, the dose may be increased sequentially to 3mg per dose twice daily, then 4.5mg per dose twice daily, and then 6mg per dose twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite), weight gain, or extrapyramidal symptoms (e.g., tremor) are observed during treatment, temporarily withholding one or more doses may reduce these symptoms. If adverse reactions persist, temporarily reduce the daily dose to the previous well-tolerated dose or consider discontinuing treatment. 3. Maximum recommended dose Administer 6 mg per dose orally twice daily. 4. Resumption of treatment The incidence and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for more than 3 days, restart treatment 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

This medicine has not been studied in pediatric patients; therefore, its use is not recommended in children.

This medication should not be used in patients with known allergies to specific ingredients. Its safety has not been established in patients with severely impaired liver function, so it should not be administered. Patients who have previously experienced skin allergic reactions while using the patch form of this medication should avoid using it. Patients with heart disease, gastric ulcers, asthma, urinary retention, seizures, or extrapyramidal symptoms should use this medication cautiously. Gastrointestinal side effects, such as nausea, vomiting, and diarrhea, may commonly occur, so caution is needed during early dosing or dose adjustments. Female patients may experience gastrointestinal side effects and weight loss more frequently than male patients. In dementia patients, neurological adverse reactions such as dizziness, headache, drowsiness, and tremors may occur. Bradycardia or cardiac arrhythmias, which slow the heart rate, may occur rarely, requiring regular observation in patients with heart disease. This medication may interact with other drugs, so caution is advised, especially when used with anesthetics, beta-blockers, and certain heart medications. Pregnant or breastfeeding women should consult a doctor before taking this medication. The safety and efficacy of this medication in children have not been established, so it is not recommended. In case of overdose, symptoms such as nausea, vomiting, bradycardia, and confusion may appear, requiring immediate medical attention; in some cases, antidotes such as atropine may be used. During the course of taking this medication, it is important to regularly monitor weight changes, and caution should be taken when driving or operating machinery due to potential dizziness or drowsiness. This medication should be stored out of reach of children and not transferred to other containers. If skin rash or severe allergic reactions occur during use, discontinue use immediately and consult a doctor.

• nausea
• vomiting
• urinary tract infection
• anxiety
• confusion
• nightmares
• anxiety
• insomnia
• depression
• hallucinations

This medication should be stored in a tightly sealed container to avoid exposure to air and moisture, and it is best kept at room temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness over time.

Appearance

A hard capsule filled with white to pale yellow powder, with a yellow lower part.

Package unit

28 capsules (14 capsules/PTP × 2 units)