Shinshin Rivastigmine Capsule 3.0 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

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

This drug contains rivastigmine and is used to improve cognitive function in patients with Alzheimer's type dementia or dementia related to Parkinson's disease. This drug should not be administered to certain patients. For instance, individuals who are allergic to the components of this drug, those with severe liver dysfunction, and patients who previously experienced skin allergic reactions from the patch form of this drug should avoid using it. Patients with a history of heart disease, gastric ulcers, asthma, urinary retention, seizures, or extrapyramidal disorders should exercise greater caution when using this drug. While taking this drug, side effects such as nausea, vomiting, diarrhea, dizziness, headache, fatigue, and weight loss may occur, especially during dosage adjustment periods when these symptoms may be more common. In cases of overdose, severe symptoms like nausea, vomiting, increased salivation, bradycardia, and seizures can manifest; immediate consultation with medical personnel is necessary. This drug may interact with other cholinergic or anticholinergic medications, so it is essential to inform your doctor or pharmacist of any other medications you are currently taking. Women who are pregnant or breastfeeding should use this drug cautiously after discussing it with their doctor, as safety has not been fully established. The safety and efficacy of this drug in children have not been confirmed; hence, it is not recommended for pediatric use. During treatment, dizziness or drowsiness may occur, necessitating caution while driving or operating machinery. It is also advisable to regularly monitor the patient's weight. Store this drug out of reach of children and maintain it in its original packaging for safety. If you experience any unusual symptoms while taking this drug, it is crucial to consult your doctor or pharmacist immediately to receive appropriate action.

• Area
• vomiting
• urinary tract infection
• irritability
• confusion
• nightmares
• anxiety
• insomnia
• depression
• hallucinations

This drug should be stored in a tightly sealed container to prevent air or moisture exposure, ideally between 1 to 30 degrees Celsius. Storing it this way helps maintain its efficacy and safety.

Appearance

A hard capsule with white to pale yellow powder, with an orange-colored lower half

Package unit

28 capsules (14 capsules/PTP × 2 packs)