Exel C Capsule 4.5 mg (Rivastigmine Tartrate)

Adult dose

Administration: Rivastigmine is administered orally twice daily with the morning and evening meals. ○ Adults: 1. Treatment of symptoms of mild to moderate Alzheimer-type dementia The initial dose is 3mg/day of rivastigmine, and the dose should be increased at intervals of at least 2 weeks for each patient, up to the highest tolerated dose or the maximum recommended dose of 12mg/day. Since this drug showed greater efficacy in clinical trials at doses of 6mg/day and above, a target dose range of 6~12mg/day is recommended for most patients. Recommended dose titration After administering 1.5mg per dose twice daily for at least 2 weeks, the dose may be increased to 3mg twice daily if well tolerated. Subsequent increases may be made to 4.5mg per dose twice daily and, if well tolerated, after at least 2 weeks to 6mg per dose 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, the daily dose should be reduced to the dose that was previously well tolerated. 2. Treatment of symptoms 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 3~12mg/day in two divided doses. (1.5~6mg per dose twice daily.). The initial dose is 1.5mg per dose twice daily. At intervals of at least 4 weeks between doses, the dose may then be increased sequentially according to the patient's tolerability to 3mg per dose twice daily, followed by 4.5mg per dose twice daily, and then 6mg per dose 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 one or more doses 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 per dose orally twice daily. 4. Resumption 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. Exposure is increased in patients with moderate renal impairment and mild to moderate hepatic impairment, and 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

Not recommended for children.

This medicine should not be used in certain patients. Individuals allergic to the active ingredient or other components of this medication, those with severe liver dysfunction, and those who have experienced skin allergic reactions while using this medication's patch should not take it. Patients with heart disease, those with a history of peptic ulcer or duodenal ulcer, individuals with asthma or obstructive lung disease, those with urinary retention or seizure history, and those with extrapyramidal disorders should exercise caution when using this medication. Common gastrointestinal adverse reactions include nausea, vomiting, and diarrhea, particularly more frequently at the beginning of treatment or during dosage adjustments. Female patients may experience these gastrointestinal adverse reactions and weight loss more often than males. Various adverse reactions have been reported, including dizziness, headache, drowsiness, anxiety, agitation, hallucinations, tremors, and arrhythmia. Notably, in patients with dementia related to Parkinson's disease, neurological adverse reactions such as tremors or worsening motor functions may occur, necessitating careful observation. This medication may interact with other drugs, so careful management is required, especially when co-administered with anesthetics, other cholinergic medications, anticholinergics, beta-blockers, and drugs that prolong the QT interval. Women who are pregnant or breastfeeding should use this medication cautiously as the effects on the fetus or newborn are unclear, and it is recommended not to use it while breastfeeding. The safety and efficacy of this medication have not been established in children, thus it is not recommended. In case of overdose, symptoms such as nausea, vomiting, diarrhea, dizziness, bradycardia, and confusion may occur, and in severe cases, emergency treatment may be necessary. This medication should be kept out of reach of children and should not be transferred to other containers for safety. During treatment, the patient's weight and occurrence of adverse reactions should be continuously monitored, and if adverse reactions are severe, dosage should be adjusted or treatment discontinued. Particularly during the use of this medication, caution is advised when driving or operating machinery due to possible dizziness or drowsiness.

• 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 important to maintain storage temperatures between 1 and 30 degrees Celsius. This helps keep the medication's efficacy and safety over time.

Appearance

A hard capsule with reddish upper and lower parts containing a white to off-white powder

Package unit

30 capsules (10 capsules/PTP×3)