Oselon Capsule 1.5 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 administered to patients with known allergies to certain components. It should be avoided in patients with severe liver dysfunction, as safety has not been established. Patients who have experienced allergic contact dermatitis after using this medication should be advised against its use. Patients with heart disease, gastric ulcers, duodenal ulcers, asthma, obstructive pulmonary disease, urinary retention, seizures, or extrapyramidal disorders should use this medication with caution. Gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur when starting treatment or increasing the dose, and these symptoms can be alleviated by adjusting the dose. This medication may cause neurological adverse reactions such as dizziness, drowsiness, headache, and tremors; therefore, care should be taken when driving or operating machinery. It may affect heart rhythm, so patients with heart disease should use it only under medical supervision. Women who are pregnant or breastfeeding should carefully consider the use of this medication, as its safety has not been sufficiently confirmed. This medication is not recommended for children due to a lack of appropriate clinical trials. In cases of overdose, symptoms such as vomiting, dizziness, bradycardia, and confusion may occur, requiring immediate medical assistance. This medication may interact with other drugs; therefore, patients should inform their healthcare provider of any other medications they are taking. During treatment, weight changes should be monitored regularly, and if any adverse reactions are severe or persistent, consultation with a physician is necessary. Keep this medication out of reach of children and do not transfer it to another container.

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

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the medication's efficacy.

Appearance

A hard capsule with a white to light yellow powder in an upper part and a yellow lower part

Package unit

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