Exceleva Capsule 3 mg (Rivastigmine Tartrate)

Adult dose

Administration: Rivastigmine is administered orally twice daily, with breakfast and the evening meal. 1. Treatment of mild to moderate dementia of the Alzheimer’s type The initial dose is 3 mg of rivastigmine per day. For each patient, increase the dose at intervals of at least 2 weeks to the maximum tolerated dose or the maximum recommended dose of 12 mg per day. Since 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. For subsequent increases, administer 4.5 mg twice daily; if well tolerated, after at least 2 weeks the dose may be increased 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 dose that was previously well tolerated. 2. Treatment of mild to moderate dementia associated with Parkinson’s disease In a controlled clinical trial in patients with dementia associated with Parkinson’s disease, rivastigmine was administered at 3~12 mg per day, divided into two daily 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 sequentially at intervals of at least 4 weeks 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, interrupting administration once or several times may reduce these symptoms. 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. Reinitiation of 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: Because 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. Do not administer to patients with severe hepatic impairment, as no studies have been conducted in these patients.

Child dose

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

This medication should not be taken by certain patients. For example, patients who are allergic to the active ingredient or any other ingredients, patients with severe liver disease, and those who have previously experienced allergic skin reactions from this medication's patch form should avoid its use. Additionally, patients with a history of heart disease, gastric ulcers, asthma, urinary retention, seizures, or extrapyramidal disorders should use this medication with caution, as these patients may experience more severe side effects. Common gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur after taking this medication, especially when starting treatment or increasing the dosage. If these symptoms are severe, consult a doctor to adjust the dosage or discontinue use. Neurological symptoms such as dizziness, headaches, and drowsiness may also occur, so caution is needed when driving or operating machinery. This medication may affect heart rate, so patients with heart conditions require regular testing, and when taken with other medications, there may be interactions, so it is essential to consult a doctor or pharmacist. Pregnant or breastfeeding women must consult a physician before taking this medication, especially during breastfeeding when avoidance is advised. This medication is not recommended for children as its safety and efficacy have not been sufficiently established. In case of overdose, severe symptoms such as nausea, vomiting, bradycardia, and confusion may occur, requiring immediate medical attention, with treatment to be tailored to symptoms. This medication should be kept out of reach of children, and transferring it to other containers should be avoided to prevent quality degradation or accidental risks. Lastly, during treatment, the patient's condition should be periodically monitored, and any adverse reactions should be reported to healthcare professionals immediately.

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

This medication may be sensitive to air and moisture, so it should be stored in an airtight container. It is best to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. This will safely preserve the medication's effectiveness.

Appearance

Orange hard capsule containing white to yellowish powder

Package unit

28 capsules (14 capsules/PTP x 2)