Riceltone Capsule 4.5 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

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, those who are allergic to the active ingredients or excipients of this medication, those with severe liver dysfunction, and those who have had allergic dermatitis from using this transdermal patch should not use it. Patients with heart disease, peptic ulcers, duodenal ulcers, asthma, chronic obstructive pulmonary disease, urinary retention, seizures, or extrapyramidal disorders should use this medication cautiously. Gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur when taking this medication, especially at the beginning of treatment or when increasing the dose. If these symptoms are severe, it may be necessary to reduce the dose or discontinue the treatment. This medication may cause neurological and psychiatric symptoms such as dizziness, drowsiness, headache, tremors, anxiety, insomnia, and therefore caution is needed while driving or operating machinery. Patients with heart disease may need regular electrocardiogram tests as this medication may affect heart rate. Since this medication may interact with other drugs, caution is especially needed when taking it with anesthetics, other cholinergic drugs, anticholinergic drugs, beta-blockers, and drugs that prolong the QT interval. Women who are pregnant or nursing may not be safe to use this medication, so the need and risk should be carefully considered. There is insufficient experience with this medication in children, and it is not recommended for use in this age group. In case of overdose, symptoms may include nausea, vomiting, diarrhea, dizziness, bradycardia, and confusion, and immediate medical attention is required. This medication should be kept out of reach of children and should not be transferred to other containers.

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

This medication may be sensitive to air or moisture, so it must be stored in a tightly closed container. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius. This will help maintain the effectiveness of the medication and prevent deterioration.

Appearance

A brown hard capsule containing white powder

Package unit

30 capsules/bottle, 100 capsules/bottle