Excel C Capsule 1.5 mg (Rivastigmine Tartrate)

Adult dose

Administration: Rivastigmine should be administered orally twice daily, with breakfast and dinner. 1. Treatment of mild to moderate dementia of the Alzheimer’s type The initial dose is 3mg of rivastigmine daily. For each patient, increase the dose at intervals of at least 2 weeks to the maximum tolerated dose or the maximum recommended dose of 12mg daily. Since this medicine showed greater efficacy in clinical trials at doses of 6mg daily and higher, a target dose range of 6~12mg daily is recommended for most patients. Recommended dose titration schedule Administer 1.5mg of this medicine twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3mg twice daily. Further 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 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 previous dose that was well tolerated. 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 3~12mg daily in 2 divided doses (1.5~6mg twice daily). The initial dose is 1.5mg of this medicine twice daily. Depending on the patient’s tolerability, subsequent doses may be increased consecutively at intervals of at least 4 weeks to 3mg twice daily, then 4.5mg twice daily, and then 6mg 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, withholding one or more doses may reduce these symptoms. If adverse reactions persist, the daily dose may be temporarily reduced to the previous well-tolerated dose, or discontinuation of treatment may be considered. 3. Maximum recommended dose Administer 6 mg of this medicine 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 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 therefore occur. Accordingly, take particular care when titrating the dose based on individual tolerability. 2. Do not administer to patients with severe hepatic impairment, as no studies have been conducted in these patients.

Child dose

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

This medication contains the ingredient rivastigmine and should not be administered to certain patients. For example, patients allergic to this medication's ingredients or those with severe liver impairment should not use it. Additionally, patients who have had skin allergic reactions while using the patch form of this medication should exercise caution. Patients with cardiac conditions, peptic ulcers, asthma, urinary retention, seizures, or extrapyramidal disorders should use this medication carefully. Gastrointestinal side effects may occur frequently with this medication, especially during the dosage adjustment period, including nausea, vomiting, and diarrhea. Women, especially dementia patients, may experience gastrointestinal side effects and weight loss more frequently. While taking this medication, neurological symptoms such as dizziness, headaches, drowsiness, and tremors may also occur, requiring caution. During administration, do not start with a high dose; gradually increase. If adverse reactions occur after increasing the dose, the dosage should be reduced or discontinued. If dehydration occurs due to vomiting or diarrhea, notify healthcare personnel immediately, and intravenous therapy may be administered if necessary. Furthermore, this medication may interact with other cholinergic drugs or anesthetics, so consult healthcare personnel about concomitant medications. Cardiac patients require regular monitoring for side effects, such as ECG abnormalities or bradycardia. Women who are pregnant or breastfeeding should use this medication cautiously since its safety has not been sufficiently established and it is recommended to discontinue breastfeeding if treatment is necessary. This medication is not recommended for children, and overdose may result in severe symptoms such as nausea, vomiting, bradycardia, and confusion, requiring immediate emergency treatment. Antidotes such as atropine may be used in the event of an overdose. Finally, this medication should be stored out of reach of children, and transferring to other containers should be avoided. If unusual symptoms occur while taking the medication, consult healthcare personnel immediately.

• Nausea
• vomiting
• dizziness
• headache
• drowsiness
• tremors
• fainting
• seizures
• extrapyramidal symptoms
• angina

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. The storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature. Storing it this way will help preserve the medication's efficacy.

Appearance

Hard capsule containing a white to off-white powder, colored yellow on both the upper and lower sides

Package unit

30 capsules (10 capsules/PTP X 3)