Prometax Capsule 3.0 mg (Rivastigmine Tartrate)

Adult dosage

Directions for use: Rivastigmine is administered orally twice daily with breakfast and dinner. ○ Adults: 1. Treatment of mild to moderate Alzheimer-type dementia The initial dose is 3mg of rivastigmine daily. Increase the dose for each patient at intervals of at least 2 weeks to the maximum tolerated dose or the maximum recommended dose of 12mg daily. Since this medicine showed greater efficacy at doses of 6mg daily and higher in clinical trials, a target dose range of 6~12mg daily is recommended for most patients. Recommended dose titration After administering 1.5mg of this medicine twice daily for at least 2 weeks, the dose may be increased to 3mg twice daily if well tolerated. Subsequent increases may be made to 4.5mg twice daily, and, if well tolerated, after 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 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 daily was administered in 2 divided doses. (1.5~6mg per dose was administered twice daily.). The initial dose is 1.5mg of this medicine twice daily. At intervals of at least 4 weeks between dose levels, the dose may then be increased sequentially according to patient tolerability 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 more doses may reduce these symptoms. If adverse reactions persist, consider temporarily reducing the daily dose to the previously well-tolerated dose or discontinuing treatment. 3. Maximum recommended dose Administer 6 mg of this medicine orally twice daily. 4. Resumption of treatment The incidence 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, so more adverse reactions may occur. Therefore, use particular caution 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.

Children's dosage

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

This medicine should not be administered to specific patients. For example, patients who are allergic to the active ingredient or other components of this medication, patients with severe liver impairment, and those who have previously had a skin allergic reaction to this medication in patch form should not take it. Additionally, patients with heart diseases, those with a history of gastric ulcers or duodenal ulcers, asthmatics or those with chronic obstructive pulmonary disease, patients with urinary retention or seizure history, and those with extrapyramidal syndromes should use this medication cautiously. Gastrointestinal side effects such as nausea, vomiting, and diarrhea may commonly occur when taking this medication, especially during the initial period of dosage adjustment. Female patients may experience these side effects and weight loss more frequently than male patients. Furthermore, neurological and psychiatric side effects such as dizziness, headache, drowsiness, anxiety or confusion, and, rarely, hallucinations have been reported. Cardiac-related side effects such as bradycardia or atrial fibrillation may occur infrequently. This medication can interact with other drugs, so caution is necessary, particularly when used with anesthetics, muscle relaxants, beta-blockers, or other cholinergic agents. Some drug combinations may increase efficacy or heighten the risk of side effects. Pregnant or breastfeeding women should only take this medication under the doctor's judgment, as its safety has not been sufficiently established, and it is advisable to avoid taking it during breastfeeding. This medication is not recommended for children, and in case of overdose, serious side effects may occur, so immediate consultation with a medical professional is necessary. During administration, the patient's weight and occurrence of adverse reactions should be monitored regularly, and particularly for dementia patients related to Parkinson's, motor function deterioration should also be closely monitored. Lastly, this medication should be stored out of the reach of children and should not be transferred to another container for safety.

• Nausea
• vomiting
• dizziness
• headache
• drowsiness
• tremors
• fainting
• seizures
• extrapyramidal symptoms
• angina

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly closed container. It should also be kept away from direct sunlight and stored at room temperature.

Appearance

A capsule containing a grayish-white to yellowish powder: hard capsule in orange color

Package unit

28 capsules (14 capsules/PTP packaging x 2)