Demenli Capsule 6.0 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 drug should not be used in patients who are allergic to certain components or have severe liver dysfunction. Patients with a history of heart disease, gastric ulcers, asthma, urinary retention, or seizures should use this drug cautiously. When taking this drug, gastrointestinal symptoms such as nausea, vomiting, and diarrhea may frequently occur, so caution is needed. Neurological symptoms like dizziness, drowsiness, and headache can also commonly occur, so care should be taken when driving or operating machinery. Patients with Parkinson's disease may experience worsening symptoms with this drug, so changes in symptoms should be closely monitored. Weight loss may occur during treatment, so it is important to regularly monitor weight. This drug's effectiveness may increase when used with other cholinergic drugs, so caution should be exercised when combining it with other medications. When receiving anesthesia, this drug should be discontinued for a certain period, and potential interactions with other drugs should be discussed with the attending physician. Women who are pregnant or breastfeeding should consult a doctor before using this drug. The safety and efficacy of this drug have not been established in children, so it is not recommended for pediatric use. In case of overdose, serious symptoms such as vomiting, bradycardia, and seizures may occur, so the dosage should be strictly followed, and if abnormal symptoms arise, medical personnel should be notified immediately. This drug should be stored out of reach of children, and it is recommended not to transfer it to another container.

• nausea
• vomiting
• dizziness
• headache
• drowsiness
• tremors
• fainting
• seizures
• extrapyramidal symptoms
• angina

This drug should be stored in a tightly sealed container away from air or moisture, at a cool room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the drug's effectiveness and prevents deterioration.

Appearance

A hard capsule with a red upper part and an orange lower part containing white to light yellow powder.

Package unit

28 capsules (14 capsules/PTP × 2)