Oselon Capsule 3.0 mg (Rivastigmine Tartrate)

Adult dose

Administration: Rivastigmine is administered orally twice daily, in the morning and evening, with meals. ○ Adults: 1. Treatment of mild to moderate Alzheimer-type dementia The initial dose is 3 mg/day of rivastigmine. For each patient, increase the dose at intervals of at least 2 weeks to the highest tolerated dose or the maximum recommended dose of 12 mg/day. Since this medicine showed greater efficacy at doses of 6 mg/day and higher in clinical trials, a target dose range of 6~12 mg/day is recommended for most patients. Recommended dose titration Administer 1.5 mg per dose twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3 mg per dose twice daily. Subsequent increases may be made to 4.5 mg per dose twice daily; if well tolerated, after at least 2 weeks the dose may be increased to 6 mg 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, 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 was administered at 3~12 mg/day in 2 divided doses. (1.5~6 mg per dose twice daily.) The initial dose is 1.5 mg per dose twice daily. At intervals of at least 4 weeks between dose levels, and according to the patient's tolerability, the dose may subsequently be increased in sequence to 3 mg per dose twice daily, then 4.5 mg per dose twice daily, and then 6 mg 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 lessen if one or more doses are withheld. If adverse reactions persist, temporarily reduce the daily dose to the previously well-tolerated dose or consider discontinuing treatment. 3. Maximum recommended dose Administer 6 mg per dose orally twice daily. 4. Re-administration The frequency and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for more than 3 days, restart treatment 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 should not be used in patients with allergies to specific ingredients. Patients with severely impaired liver function should also not take this medication. Patients who have previously experienced allergic contact dermatitis while using this medication should exercise caution. Patients with a history of cardiac disease or peptic ulcers, asthma, or chronic obstructive pulmonary disease must use this medication carefully. Patients with a history of urinary retention or seizures should also be cautious. Furthermore, patients with movement disorders related to Parkinson's disease should be careful when taking this medication. Nausea, vomiting, and diarrhea, which are gastrointestinal side effects, can occur frequently while taking this medication, especially at the beginning of treatment or when increasing the dosage. Female patients may experience more gastrointestinal side effects and weight loss than male patients. Nervous system and psychiatric side effects such as dizziness, headache, drowsiness, anxiety, and agitation have also been reported. Cardiovascular abnormalities such as bradycardia or arrhythmia, which exhibit a slow heartbeat, may occur rarely, so caution is advised. This medication may interact with other drugs; therefore, especially when used with anesthetics, muscle relaxants, or cholinergic medications, consulting a physician is necessary. Pregnant or nursing women must consult their doctor before taking this medication. The safety and efficacy in children have not been established, so it is not recommended. In case of overdose, symptoms such as nausea, vomiting, diarrhea, dizziness, tremors, bradycardia, and confusion may appear, and in severe cases, it may be life-threatening, requiring immediate medical attention. During the course of this medication, weight changes should be monitored regularly, and if any unusual symptoms appear, the medical staff should be notified immediately. Store out of reach of children and avoid transferring to other containers.

nausea, vomiting, urinary tract infection, agitation, confusion, nightmares, anxiety, insomnia, depression, hallucinations, dizziness, headache, drowsiness, tremors, syncope, seizures, extrapyramidal symptoms, angina, myocardial infarction, deep vein thrombosis, hypertension, diarrhea, loss of appetite, abdominal pain, dyspepsia, gastric ulcer, duodenal ulcer, gastrointestinal bleeding, pancreatitis, esophageal rupture, increased sweating, rash, itching, fatigue, weakness, lethargy, falls, weight loss, abnormal liver function test results, mucous membrane hypersensitivity syndrome, tremors, bradykinesia, movement disorders, cogwheel rigidity, hypokinesia, bradycardia, atrial fibrillation, heart block, decreased appetite, dehydration, increased sweating, gait disturbance, hypertension, hypotension, urinary incontinence, cerebrovascular accident, delirium, erythema, urticaria, blisters, allergic dermatitis, tremors, somnolence, confusion, salivation, hypotension, respiratory depression, muscle weakness, syncope, lethargy, aggression, restlessness, dysautonomia, hepatitis, allergic dermatitis, sensory disturbances, personality disorders, inability to sit still, delirium, confusion, pneumonia, sepsis

This medication is sensitive to air and moisture and should be stored in a sealed container. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. Storing it this way can help maintain the efficacy and safety of the medication for a long time.

Appearance

A hard capsule with white to light yellow powder inside, with an orange bottom.

Package unit

28 capsules/box [(14 capsules/PTP*2)]