Exeliba Capsule 1.5 mg (Rivastigmine Tartrate)

Adult dose

Administration: Rivastigmine is administered orally twice daily, with breakfast and the evening meal. ○ Adults: 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: 1. 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. 2. 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 used in certain patients. For instance, patients with an allergy to any component of this medication or severe liver dysfunction should not be treated with it. Additionally, patients who have had allergic reactions on their skin after using this medication should be cautious. Patients with a history of heart disease, gastric ulcers, asthma, urinary retention, seizures, or extrapyramidal disorders should use this medication with caution. This medication can cause various side effects such as gastrointestinal adverse reactions, dizziness, headache, drowsiness, and tremors, so if these symptoms occur, consult a medical professional immediately. In particular, the dosage of this medication should be adjusted slowly, and caution is required when starting or resuming treatment. Gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur, so it is important to be aware of signs of dehydration and receive appropriate treatment if necessary. This medication may interact with other drugs, so if you are taking other medications, you must inform your doctor or pharmacist. Caution is especially required when used with anesthetics, heart-related medications, and cholinergic drugs. Pregnant or breastfeeding women should consult a doctor before using this medication, and it is not recommended for children. In cases of overdose, symptoms such as severe vomiting, bradycardia, confusion, and seizures may occur, requiring immediate visit to a medical institution and appropriate emergency treatment. This medication should be kept out of reach of children and should not be transferred to another container. While taking this medication, be cautious of dizziness or drowsiness during driving or operating machinery, and it is important to continuously monitor the patient's condition during treatment.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage conditions can help maintain the effectiveness of the medication for a longer period.

Appearance

A hard yellow capsule containing a white to pale yellow powder

Package unit

28 capsules (14 capsules/ PTP X 2)