Demenris Capsule 4.5 mg (Rivastigmine Tartrate)

Adult dose

Dosage: Rivastigmine is administered orally twice daily, with breakfast and the evening meal. ○ Adults: 1. Treatment of symptoms of mild to moderate Alzheimer-type dementia The initial dose is 3mg/day of rivastigmine. The dose should be increased at intervals of at least 2 weeks for each patient to the highest tolerated dose or the maximum recommended dose of 12mg/day. Because this medicine showed greater efficacy in clinical trials at doses of 6mg/day or higher, a target dose range of 6~12mg/day is recommended for most patients. Recommended dose titration Administer 1.5mg per dose twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3mg per dose twice daily. 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 the adverse reactions or weight loss persist, reduce the daily dose to the previous dose that was well tolerated. 2. Treatment of symptoms 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/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 dose levels, based on the patient’s tolerability, the dose may then be increased sequentially 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, omitting one or more doses may reduce these symptoms. If adverse reactions persist, temporarily reduce the daily dose to the previous well-tolerated dose or consider discontinuing treatment. 3. Maximum recommended dose Administer 6 mg per dose orally twice daily. 4. Resumption of treatment 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 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 this population.

Child dose

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

This medication should not be used in patients who are allergic to certain ingredients. It should not be administered to patients with severely impaired liver function. Caution is required for patients who have had skin allergic reactions to this medication's patch version. Patients with a history of heart disease, peptic ulcer, asthma, urinary retention, seizures, or extrapyramidal disorders should use this medication with caution. Taking this medication can commonly cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea, so consult a doctor if symptoms are severe. Dizziness, headache, drowsiness, and tremors may also occur, so caution is necessary when driving or operating machinery. This medication may worsen Parkinson's disease symptoms, so patients with Parkinson's disease should be particularly careful. There is a risk of slow heart rate or arrhythmia, so patients with heart disease should undergo regular check-ups. The effects may be enhanced when used with other cholinergic drugs, so caution is needed with concomitant administration. Patients scheduled for anesthesia may need to discontinue this medication for a certain period. Pregnant or breastfeeding women should only take this medication after consulting a doctor, as its safety has not been thoroughly confirmed. Use in pediatric patients is not recommended. In case of overdose, symptoms such as vomiting, diarrhea, dizziness, or in severe cases, seizures or difficulty breathing may occur, so immediate medical attention is required. This medication should be kept out of reach of children and should not be transferred to another container. During treatment, it is important to regularly monitor the patient's weight and any abnormal reactions.

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

This medication must be stored in a tightly closed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

A red hard capsule containing white to pale yellow powder

Package unit

28 capsules (14 capsules/PTP x 2)