Newcellon Capsule 3 mg (Rivastigmine Tartrate)

Adult dose

Administration: Rivastigmine should be administered orally twice daily with the morning and evening meals. ○ Adults: 1. Treatment of mild to moderate Alzheimer-type dementia The initial dose is rivastigmine 3mg per day, and should be increased at intervals of at least 2 weeks for each patient to the highest 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 After administering 1.5mg per dose twice daily for at least 2 weeks, the dose may be increased to 3mg per dose twice daily if well tolerated. 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 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 previously well-tolerated dose. 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 3~12mg per day was administered twice daily (1.5~6mg per dose twice daily). The initial dose is 1.5mg per dose twice daily. Depending on the patient's tolerability, subsequent doses may be increased consecutively at intervals of at least 4 weeks to 3mg per dose twice daily, then 4.5mg per dose twice daily, and then 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, these symptoms may decrease if one or more doses are withheld. If adverse reactions persist, temporarily reducing the daily dose to the previously well-tolerated dose or discontinuing treatment may be considered. 3. Maximum recommended dose Administer 6 mg per dose orally twice daily. 4. Reinitiation The incidence 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 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 contains the ingredient Rivastigmine and should not be administered to certain patients. For example, patients who are allergic to any components of this medication, those with severe liver dysfunction, and those who previously experienced skin allergic reactions while using the patch form of this medication should avoid using it. Patients with heart conditions, peptic ulcers, asthma, obstructive pulmonary disease, urinary obstruction, seizures, and extrapyramidal disorders should use this medication with caution. Common gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur with this medication, and these symptoms may occur more frequently in female patients than in male patients. Additionally, neurological and psychiatric side effects such as dizziness, headache, drowsiness, tremors, anxiety, and restlessness have also been reported. In patients with dementia associated with Parkinson's disease, symptoms like tremors or deterioration in motor functions may occur, so caution is required. This medication may interact with other drugs, especially anesthetics, cholinergic drugs, anticholinergic drugs, beta-blockers, and medications known to prolong the QT interval, so consultation with a physician or pharmacist is essential. Women who are pregnant or breastfeeding should use this medication cautiously, under medical supervision, as its safety has not been fully established. It is not recommended for children, as appropriate clinical trials have not been conducted. In cases of overdose, symptoms such as nausea, vomiting, dizziness, bradycardia, and confusion may appear, and in severe cases, emergency treatment may be necessary. This medication should be stored out of the reach of children and should not be transferred to other containers. During treatment, patients' weight, heart condition, gastrointestinal symptoms, and motor functions should be regularly monitored, and if any adverse reactions occur, medical staff should be informed immediately.

• Area
• vomiting
• dizziness
• anxiety
• confusion
• nightmares
• restlessness
• insomnia
• depression
• hallucinations

This medication should be stored in a tightly closed container to prevent air and moisture from entering. It is best to keep it at room temperature between 1 and 30 degrees Celsius.

Appearance

A hard capsule with a white powder inside, orange-colored at the bottom

Package unit

28 capsules (14 capsules/PTP packaging x 2)