Exelon Capsule 3.0 mg (Rivastigmine Tartrate)

Adult dose

Directions for use: Rivastigmine should be administered orally twice daily, with breakfast and the evening meal. ○ Adults: 1. Treatment of symptoms of mild to moderate Alzheimer’s dementia The initial dose is 3mg/day of rivastigmine. For each patient, the dose should be increased at intervals of at least 2 weeks to the highest tolerated dose or the maximum recommended dose of 12mg/day. Because this medicine showed greater efficacy at doses of 6mg/day and higher in clinical trials, a target dose range of 6~12mg/day is recommended for most patients. Recommended dose titration schedule Administer 1.5mg per dose twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3mg per dose twice daily. Subsequent increases may be made to 4.5mg per dose twice daily and, if well tolerated, after 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 occur, one or more doses may be omitted. However, if adverse reactions or weight loss persist, reduce the daily dose to the previous well-tolerated dose. 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/day, divided into two doses. (1.5~6mg per dose was administered twice daily.). The initial dose is 1.5mg per dose twice daily. Depending on the patient’s tolerability, subsequent doses may be increased sequentially at intervals of at least 4 weeks, first to 3mg per dose twice daily, then to 4.5mg per dose twice daily, and then 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) occur during treatment, temporarily withholding one or more 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 6mg per dose orally twice daily. 4. Restarting treatment 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 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 with dose titration according to individual tolerability. 2. Do not administer to patients with severe hepatic impairment, as no studies have been conducted in this population.

Child dose

○ Children: This medicine has not been studied in children; therefore, administration to children is not recommended.

This drug should not be used in patients with allergies to certain ingredients or severe liver disorders. Caution is required for patients with a history of heart disease, gastric ulcer, asthma, urinary retention, seizures, or extrapyramidal disorders before using this drug. During treatment, gastrointestinal adverse reactions such as nausea, vomiting, and diarrhea may occur, especially when starting or increasing the dose. In female patients, gastrointestinal adverse reactions and weight loss may occur more frequently than in males. Neurological symptoms such as dizziness, headache, drowsiness, and tremors have also been reported, and Parkinson's disease patients should be cautious as symptoms may worsen. Cardiac adverse reactions such as bradycardia, angina, and myocardial infarction may occur rarely, so careful observation of cardiac condition is necessary. This drug may interact with anesthetics or other cholinergic drugs, so consultation with a specialist is necessary when used in combination. Women who are pregnant or breastfeeding should consult their doctor before use as the safety of this drug has not been sufficiently confirmed. There are no adequate clinical trials in children, so it is not recommended. In case of overdose, symptoms such as nausea, vomiting, bradycardia, and confusion may occur, and in severe cases, emergency treatment may be required. During the use of this drug, weight changes should be checked periodically, and if adverse reactions are severe, the healthcare provider should be notified immediately. Keep out of reach of children, and avoid transferring to other containers. This drug may cause dizziness or drowsiness when driving or operating machinery, so caution is needed. There may be gastrointestinal bleeding or skin allergic reactions during treatment, so if abnormal symptoms occur, discontinue immediately and consult a healthcare provider. The use of this drug must be done under the diagnosis and supervision of an experienced physician, and patients and caregivers should closely monitor the patient's condition.

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

This drug may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be at room temperature, which means maintaining a normal room temperature that is not too hot or too cold.

Appearance

An orange-colored hard capsule filled with a grayish-white to light yellow powder

Package unit

28 capsules (14 capsules x 2 PTP packaging)