Excel C Capsule 6 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

○ Children: This drug has not been studied in children; therefore, its use is not recommended in children.

This medication should not be used in certain patients. For instance, patients allergic to the active substance or other ingredients, patients with severe liver impairment, and patients who have experienced allergic reactions from the patch formulation should avoid this medication. Care should be taken when administering this medication to patients with heart diseases, peptic ulcers, asthma, urinary retention, seizures, or extrapyramidal disorders. Gastrointestinal disturbances such as nausea, vomiting, and diarrhea may commonly occur while taking this medication, particularly during the initial stage of treatment or when increasing the dosage. If these symptoms are severe, consult a physician to consider dosage adjustment or discontinuation. Neurological symptoms such as dizziness, drowsiness, headache, and tremors may also occur; therefore, caution is needed when driving or operating machinery. This medication may interact with other drugs, so it is important to inform healthcare professionals of any medications being taken. Special caution is necessary if combined with anesthetics, heart-related medications, anticholinergics, or muscle relaxants. Women who are pregnant or breastfeeding should consult a physician before taking this medication, as its safety has not been fully established. It is advisable to avoid taking this medication while breastfeeding. This medication is not recommended for children, and in cases of overdose, severe symptoms such as nausea, vomiting, bradycardia, and confusion may occur, and medical institutions should be contacted immediately. Store this medication out of reach of children, and do not transfer it to other containers. Additionally, it is essential to regularly monitor the patient’s weight and any adverse reactions during treatment.

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

This medication may be sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. Additionally, avoid storing the medication in areas that are too hot or too cold, ideally between temperatures of 1 and 30 degrees Celsius.

Appearance

A hard capsule with a red upper part and an orange lower part containing a white to off-white powder

Package unit

30 capsules (10 capsules/PTP x 3)