Exeliva Capsule 6mg (Rivastigmine Tartrate)

Adult dose

Administration: Take rivastigmine orally twice daily with breakfast and the evening meal. ○ Adults: 1. Treatment of mild to moderate dementia of the Alzheimer type The initial dose is 3 mg of rivastigmine per day. For each patient, increase the dose at intervals of at least 2 weeks up to the highest tolerated dose or the maximum recommended dose of 12 mg per day. Since this medicine showed greater efficacy at doses of 6 mg per day and higher in clinical trials, a target dose range of 6–12 mg per day is recommended for most patients. Recommended dose titration Administer 1.5 mg of this medicine twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3 mg twice daily. Subsequent increases may be made to 4.5 mg twice daily and, if well tolerated, after at least 2 weeks, to 6 mg 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, 3–12 mg of rivastigmine per day was administered in 2 divided doses (1.5–6 mg per dose twice daily). The initial dose is 1.5 mg of this medicine twice daily. At intervals of at least 4 weeks between each dose level, the dose may be increased sequentially according to the patient's tolerability to 3 mg twice daily, then 4.5 mg twice daily, and then 6 mg 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 omitted. 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 of this medicine orally twice daily. 4. Resumption of 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 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 this population.

Child dose

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

This drug should not be used by patients who are allergic to certain components or those with severe liver impairment. Additionally, caution is required for patients with a history of heart disease, stomach ulcers, asthma, or seizures. Gastrointestinal disturbances such as nausea, vomiting, and diarrhea may occur while taking this medication. Neurological adverse reactions such as dizziness, drowsiness, and tremors may also arise, so caution is advised during driving or machinery operation. Patients with Parkinson's disease should carefully adjust dosages according to their doctor's instructions to avoid symptom exacerbation. Safety during pregnancy or breastfeeding has not been adequately established, thus usage should be cautious. There may be interactions with other medications, so consultation with a physician or pharmacist is necessary. Severe symptoms may occur in case of overdose, so adherence to prescribed dosages is essential. This medication is not recommended for children, and it should be stored out of reach of children. If any unusual reactions including weight changes occur while taking this drug, immediate consultation with a healthcare provider is necessary.

• nausea
• vomiting
• dizziness
• headache
• drowsiness
• tremor
• fainting
• convulsions
• angina pectoris
• myocardial infarction

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. The recommended storage temperature is between 1°C and 30°C. This way, the efficacy and safety of the drug can be maintained for an extended period.

Appearance

Opaque red capsule with an orange bottom containing white to pale yellow powder.

Package unit

28 capsules (14 capsules/PTP X 2)