Risetlon Capsule 1.5 mg (Rivastigmine Tartrate)

Adult dose

Administration: Administer rivastigmine orally twice daily with breakfast and dinner. ○ Adults: 1. Treatment of mild to moderate dementia of the Alzheimer type The initial dose is 3 mg of rivastigmine per day, and the dose should be increased at intervals of at least 2 weeks for each patient to the maximum tolerated dose or the maximum recommended dose of 12 mg per day. Since this medicine showed greater efficacy in clinical trials at doses of 6 mg per day and above, a target dose range of 6~12 mg per day is recommended for most patients. Recommended dose titration schedule Administer 1.5mg of this medicine twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3mg twice daily. Subsequent increases may be made to 4.5mg twice daily, and, if well tolerated for at least 2 weeks, to 6mg 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 controlled clinical trials in patients with dementia associated with Parkinson's disease, rivastigmine was administered at 3~12mg per day in 2 divided doses. (1.5~6mg per dose twice daily.) The initial dose is 1.5mg of this medicine twice daily. Thereafter, depending on the patient's tolerability, the dose may be increased sequentially, with a minimum interval of 4 weeks between dose levels, to 3mg twice daily, then 4.5mg twice daily, and then 6mg 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, omitting one or several doses may reduce these symptoms. If adverse reactions persist, the daily dose may be temporarily reduced to the previous well-tolerated dose, or discontinuation of treatment may be considered. 3. Maximum recommended dose Administer 6 mg of this medicine 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 and renal impairment: 1. Exposure is increased in patients with moderate renal impairment and mild to moderate hepatic impairment, which may result in more adverse reactions. 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 certain patients. For example, patients with allergies to the main ingredient or components of this medication, patients with severe liver disease, and those who have had skin allergic reactions to the patch form of this medication should not be administered this drug. This medication should be used with caution in patients with heart disease, peptic ulcers, asthma, chronic obstructive pulmonary disease, urinary retention, seizures, and extrapyramidal disorders. This is because these patients may have a higher risk of side effects from this medication. During the use of this medication, gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur. These symptoms may be more frequent at the beginning of treatment or when increasing the dose, so caution is necessary. Additionally, this medication can cause neurological adverse reactions such as dizziness, drowsiness, and headaches, so patients should be careful when driving or operating machinery. This medication may worsen symptoms such as tremors or worsening motor function in Parkinson's disease patients, so these patients should closely monitor for any side effects. Women who are pregnant or breastfeeding should consult a doctor before using this medication, as its safety has not been sufficiently established. Especially during lactation, it is recommended not to administer this medication. This medication may interact with other drugs, hence caution is necessary when taken in conjunction with anesthetics, cholinergic drugs, anticholinergic drugs, beta-blockers, and medications that prolong the QT interval. In case of overdose, serious symptoms such as nausea, vomiting, diarrhea, dizziness, bradycardia, and confusion may arise, requiring immediate medical assistance, and an antidote such as atropine may be used if necessary. This medication is not recommended for children and should be stored out of reach of children. While taking this medication, adverse reactions such as weight loss or skin rashes may occur, so if symptoms persist or worsen, patients should consult with medical personnel.

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

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. Additionally, it is important to store it at room temperature between 1°C and 30°C to maintain the drug's effectiveness.

Appearance

A hard capsule with white powder, yellow upper and lower parts

Package unit

30 capsules/bottle, 100 capsules/bottle