Shinshin Rivastigmine Capsule 6.0 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 medication should not be used in patients who have allergies to this drug's active ingredient or other components. It is not recommended for patients with severe liver dysfunction as safety has not been confirmed. Patients who have experienced skin allergic reactions when using the patch formulation of this drug should also not take this medication. Patients with heart disease, gastric ulcers, duodenal ulcers, asthma, obstructive pulmonary disease, urinary obstruction, seizures, or extrapyramidal disorders should use this medication carefully. This medication can cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea, so if these symptoms are severe, consultation with a physician is necessary. Weight loss may occur during dementia treatment, so it is important to regularly monitor weight changes. Dizziness or drowsiness may occur during treatment; caution should be taken when driving or operating machinery. This medication may interact with other drugs; therefore, especially when taken in combination with anesthetics, heart medications, or anticholinergics, it is essential to inform healthcare professionals. If pregnant or breastfeeding, caution is recommended as safety has not been fully established; it is advised to avoid use while breastfeeding. This medication is not recommended for use in children. In case of overdose, serious symptoms such as nausea, vomiting, dizziness, and bradycardia may occur, so immediate medical attention should be sought. This medication should be kept out of the reach of children, and transferring it to another container is not safe.

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

This medication should be stored in a sealed container to protect it from air and moisture. It is advisable to maintain a storage temperature 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 light yellow powder.

Package unit

28 capsules (14 capsules/PTP, 2 packs)