Riseton Capsule 6.0 mg (Rivastigmine Tartrate)

Adult dose

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 of rivastigmine daily, and it should be increased at intervals of at least 2 weeks for each patient up to the highest tolerated dose or the maximum recommended dose of 12 mg daily. Since this medicine showed greater efficacy at doses of 6 mg daily and above in clinical trials, a target dose range of 6~12 mg daily is recommended for most patients. Recommended dose titration Administer 1.5 mg of this medicine 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 are observed, one or more doses may be omitted. However, if adverse reactions or weight loss persist, reduce the daily dose to the dose that was previously well tolerated. 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 daily in 2 divided doses (1.5~6 mg per dose twice daily). The initial dose is 1.5 mg of this medicine twice daily. At intervals of at least 4 weeks between dose levels, the dose may be increased sequentially according to patient tolerability to 3 mg twice daily, then 4.5 mg twice daily, and then 6 mg 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, these symptoms may be reduced by omitting one or more doses. If adverse reactions persist, temporary reduction of the daily dose to the previously well-tolerated dose or discontinuation of treatment may be considered. 3. Maximum recommended dose Administer 6 mg of this medicine orally twice daily. 4. Reinitiation of treatment The frequency and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for 3 days or longer, 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 medicine has not been studied in children; therefore, its use in children is not recommended.

This medication should not be used in patients with allergies to certain ingredients. It should also not be administered to patients with severely impaired liver function. Patients who have experienced an allergic reaction to the transdermal patch formulation of this medication in the past should use it with caution. Patients with heart disease, peptic ulcers, asthma, urinary retention issues, seizures, or extrapyramidal disorders should use this medication carefully. Gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur, particularly early in treatment. These gastrointestinal symptoms and weight loss have been reported more frequently in female patients than in males. Neuropsychiatric symptoms such as dizziness, headache, drowsiness, anxiety, restlessness, and hallucinations may also occur, requiring caution. In Parkinson's disease patients, this medication may worsen symptoms, so careful observation of symptom changes is necessary. The effectiveness of this medication may be enhanced when taken with other cholinergic drugs, so caution is advised when combined. It is recommended to temporarily stop this medication before anesthesia. Patients with a history of peptic ulcers or those at high risk for peptic ulcers should be cautious, as gastrointestinal bleeding may occur during treatment with this medication. Patients with asthma or obstructive lung diseases may experience worsening respiratory symptoms during use, so it should be taken cautiously. Treatment should start with a low dose and be gradually increased. Upon re-initiation after discontinuation, treatment should also start at a low dose. If severe symptoms such as nausea, vomiting, or diarrhea occur during treatment, consult a doctor immediately to consider dosage adjustment or discontinuation. Women who are pregnant or breastfeeding should consult a physician before using this medication, and it is advisable to avoid use during breastfeeding. This medication is not recommended for children. In case of overdose, severe symptoms such as nausea, vomiting, dizziness, and bradycardia may occur, necessitating immediate contact with a healthcare institution. This medication should be stored out of reach of children and should not be transferred to other containers for safety.

• Nausea
• vomiting
• urinary tract infection
• anxiety
• confusion
• nightmares
• restlessness
• insomnia
• depression
• hallucination

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. It is important to maintain storage temperatures between 1 to 30 degrees Celsius to preserve the medication's effectiveness for an extended period.

Appearance

A hard capsule with a brown upper part and an orange lower part containing white powder.

Package unit

30 capsules/bottle, 100 capsules/bottle