Rivastigmine Capsule 3 mg (Rivastigmine Tartrate)

Adult dose

Administration: Rivastigmine is administered orally twice daily, in the morning and evening, with meals. ○ Adults: 1. Treatment of symptoms of mild to moderate Alzheimer-type dementia The initial dose is 3mg of rivastigmine per day. 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 12mg per day. Since this medicine showed greater efficacy in clinical trials at doses of 6mg per day and higher, a target dose range of 6~12mg per day is recommended for most patients. Recommended dose titration schedule Administer 1.5mg of this medicine per dose 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 per dose twice daily, and, if well tolerated, after administration for at least 2 weeks, 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, the daily dose should be reduced 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 3~12mg per day in two divided doses. (1.5~6mg per dose twice daily.). The initial dose is 1.5mg of this medicine per dose twice daily. Depending on the patient's tolerability, subsequent doses may be increased consecutively at intervals of at least 4 weeks between each dose to 3mg per dose twice daily, then to 4.5mg per dose twice daily, and subsequently to 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, omitting one or more doses may reduce these symptoms. If adverse reactions persist, the daily dose may be temporarily reduced to the previously well-tolerated dose, or discontinuation of treatment may be considered. 3. Maximum recommended dose Administer 6mg of this medicine per dose orally twice daily. 4. Reinitiation The incidence and severity of adverse reactions generally increase with 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 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 medication has not been studied in children; therefore, its use in children is not recommended.

This drug should not be used in certain patients. For example, those allergic to the active ingredient or other related components, or those with severe liver impairment should not take it. Additionally, individuals who have previously had an allergic reaction when using a patch form of this drug should exercise caution. Patients with heart disease, gastric ulcers, asthma, urinary retention, seizures, and extrapyramidal disorders should be particularly careful when using this drug. Gastrointestinal side effects are common, especially nausea, vomiting, and diarrhea during the initial dosage or during dose adjustment. If such symptoms are severe, consult a doctor. This drug can cause symptoms like mental anxiety, agitation, confusion, and hallucinations, and dizziness or drowsiness may also commonly occur. Caution is necessary as symptoms may exacerbate in patients with Parkinson's disease. When taking this drug, there may be drug interactions, so if you are currently taking other medications, be sure to inform your healthcare provider. Special caution is required when used in conjunction with muscle relaxants, heart-related medications, and other cholinergic drugs. Women who are pregnant or breastfeeding should consult a doctor before taking this drug, as its safety has not been sufficiently confirmed. Additionally, this drug is not recommended for children. In cases of overdose, symptoms such as vomiting, dizziness, bradycardia (slow heartbeat), and confusion may occur, and in severe cases, it may be life-threatening, requiring immediate medical attention. When storing this drug, keep it out of the reach of children and do not transfer it to other containers. During treatment, monitor for weight changes and immediately consult a healthcare provider if any unusual symptoms occur.

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

This drug should be stored in a tightly closed container to prevent air or moisture exposure. Also, keep the drug at room temperature between 1°C and 30°C, away from extremes of heat or cold.

Appearance

An orange hard capsule containing white powder.

Package unit

28 capsules (14 capsules/PTP packaging x 2)