Exelon 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 symptoms of mild to moderate Alzheimer-type dementia The initial dose is 3mg of rivastigmine per day. The dose 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 drug showed greater efficacy in clinical trials at doses of 6mg per day and above, a target dose range of 6~12mg per day is recommended for most patients. Recommended dose titration schedule Administer 1.5mg of this drug twice daily for at least 2 weeks; if well tolerated, the dose may be increased to 3mg twice daily. 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 loss of appetite) or weight loss occur, 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 symptoms 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 3~12mg per day in 2 divided doses. (1.5~6mg per dose, twice daily.). The initial dose is 1.5mg of this drug twice daily. At intervals of at least 4 weeks between each dose, subsequent doses may be increased according to the patient's tolerability, first to 3mg twice daily, then to 4.5mg twice daily, and thereafter to 6mg twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or loss of appetite), weight gain, or extrapyramidal symptoms (e.g., tremor) occur during treatment, temporarily withholding one or more doses may reduce these symptoms. If adverse reactions persist, the daily dose may be temporarily reduced to the previously well-tolerated dose, or discontinuation of treatment may be considered. 3. Maximum recommended dose Administer 6mg of this drug orally twice daily. 4. Restarting treatment The frequency and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for 3 days or more, restart at the lowest daily dose and titrate as described above. ○ Patients with hepatic or renal impairment: 1. Since exposure is increased in patients with moderate renal impairment and mild to moderate hepatic impairment, 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

This medication has not been studied in children; therefore, its use in children is not recommended.

This medication should not be used in certain patients. For example, patients allergic to the active ingredient or other components, those with severe liver impairment, and those who have had skin allergic reactions from the patch form of this medication should not take it. Patients with heart disease or conditions such as peptic ulcer, asthma, urinary retention, seizures, or extrapyramidal disorders should use this medication with caution. Gastrointestinal symptoms such as nausea, vomiting, and diarrhea are common when taking this medication, and if symptoms are severe, it may be necessary to consult a doctor to adjust the dose or discontinue use. Additionally, this medication may cause neurological side effects such as dizziness, drowsiness, tremors, anxiety, depression, so caution is advised while driving or operating machinery. In Parkinson's disease patients, this medication may exacerbate symptoms, so regular monitoring of symptom changes is necessary. The effects may be enhanced, or side effects may increase when used in combination with other cholinergic medications, so it is essential to consult a doctor before use. Women who are pregnant or breastfeeding should use this medication only when clearly necessary, as its safety is not sufficiently confirmed, and it is recommended to avoid use during breastfeeding. This medication is not recommended for children, and caution is needed as overdose may lead to serious symptoms such as nausea, vomiting, bradycardia, seizures, etc. This medication should be stored out of reach of children and should not be transferred to other containers for safety.

• Dizziness
• vomiting
• vertigo
• agitation
• confusion
• nightmares
• anxiety
• insomnia
• depression
• hallucinations

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is also advisable to keep it at room temperature, avoiding extreme heat or cold.

Appearance

A hard yellowish capsule containing a pale gray to light yellow powder

Package unit

28 capsules (14 capsules/PTP packaging x 2)