Exelon 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 symptoms of mild to moderate Alzheimer-type dementia The initial dose is 3 mg of rivastigmine per day. For each patient, the dose should be increased at intervals of at least 2 weeks to the highest tolerated dose or the maximum recommended dose of 12 mg per day. Because this medicine showed greater efficacy in clinical trials at doses of 6 mg per day and higher, 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 last dose that was well tolerated. 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 3~12 mg per day in two divided doses (1.5~6 mg twice daily). The initial dose is 1.5 mg of this medicine twice daily. Depending on the patient's tolerability, subsequent doses may be increased consecutively, with a minimum interval of 4 weeks between each dose, first to 3 mg twice daily, then to 4.5 mg twice daily, and subsequently to 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, omitting 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 6 mg of this medicine orally twice daily. 4. Restarting treatment The incidence 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 or mild to moderate hepatic impairment, and more adverse reactions may occur. Therefore, exercise 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.

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 by certain patients. For example, patients who are allergic to any component of this medication or have severe liver dysfunction, and patients who had a skin allergic reaction when using the transdermal patch of this medication, should not be administered this drug. This drug should be used cautiously in patients with heart disease, peptic ulcers, asthma, urinary retention, seizures, or extrapyramidal disorders. Such patients require special attention when taking this medication. This drug may commonly cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea, especially at the beginning of treatment or when increasing the dose. If these symptoms are severe, the dose may be reduced or treatment may be discontinued. Additionally, neurological and psychiatric symptoms such as dizziness, drowsiness, headache, tremors, anxiety, insomnia, etc. may occur. Care should be taken as Parkinson's disease symptoms may worsen in patients with Parkinson's disease. This medication may interact with other drugs, therefore, especially when used in conjunction with anesthetics, other cholinergic medications, anticholinergics, beta-blockers, QT prolonging drugs, etc., it is important to consult a healthcare provider. Women who are pregnant or breastfeeding should consult a physician before taking this medication, and it is recommended to avoid using this drug while breastfeeding. This medication is not recommended for use in children. In case of overdose, symptoms such as nausea, vomiting, diarrhea, dizziness, bradycardia, and confusion may arise, and in severe cases, immediate medical attention should be sought. This medication should be kept out of reach of children and should not be transferred to another container as a safety measure. Finally, it is important to regularly monitor the patient's condition while taking this medication and immediately inform the healthcare provider if any adverse reactions occur.

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

This medication may be sensitive to air and moisture, so it must be stored in a sealed container. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. Proper storage will ensure the medication's efficacy is safely maintained.

Appearance

A hard capsule with a white powder, the lower part is orange.

Package unit

28 capsules (14 capsules/PTP packaging x 2)