Dimentis Capsule 3.0 mg (Rivastigmine Tartrate)

Adult dose

Administration: Rivastigmine should be 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 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 12mg per day. Since this medicine showed greater efficacy at doses of 6mg per day and higher in clinical trials, a target dose range of 6~12mg per day is recommended for most patients. Recommended dose titration schedule Administer 1.5mg of this medicine 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 loss of appetite) or weight loss occur, one or more doses may be omitted. However, if adverse reactions or weight loss persist, reduce the daily dose to the previously well-tolerated dose. 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 per day in 2 divided doses (1.5~6mg per dose twice daily). The initial dose is 1.5mg of this medicine 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, then 4.5mg per dose twice daily, and then 6mg per dose twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or loss of appetite), weight gain, or extrapyramidal symptoms (e.g., tremor) occur during treatment, omitting one or more doses may reduce these symptoms. If adverse reactions persist, the daily dose may be temporarily reduced to the previously well-tolerated dose, or discontinuation of treatment may be considered. 3. Maximum recommended dose Administer 6mg of this medicine per dose orally twice daily. 4. Re-administration 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 these patients.

Child dose

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

This medicine should not be used in certain patients. For example, patients who are allergic to the ingredients of this medicine, have severe liver dysfunction, or have experienced skin allergic reactions when using the patch should not take it. Patients with heart disease, gastric ulcer, duodenal ulcer, asthma, obstructive lung disease, urinary retention, seizures, or extrapyramidal disorders should use this medicine with caution. Gastrointestinal side effects such as nausea, vomiting, and diarrhea are common, especially during the initial period when adjusting dosages. Female patients may experience gastrointestinal side effects and weight loss more frequently than male patients. Also, central nervous system and psychiatric side effects such as dizziness, headaches, drowsiness, tremors, anxiety, insomnia, depression, and hallucinations may occur. Rarely reported cardiac side effects include bradycardia, angina, and myocardial infarction. This medicine may interact with other drugs; caution is required, especially when used with anesthetics, other cholinergic drugs, anticholinergics, beta-blockers, and QT interval prolonging drugs. Women who are pregnant or breastfeeding should carefully consider the risks to the fetus or newborn when using this medicine and it is advisable to avoid use while nursing. Safety and efficacy in children have not been established, and it is recommended not to use it in children. In case of overdose, symptoms such as nausea, vomiting, diarrhea, dizziness, tremors, bradycardia, and confusion may occur; in severe cases, it can be life-threatening, and immediate medical attention should be sought. During treatment with this medicine, weight changes should be monitored regularly, and if any adverse reactions occur, medical consultation should be sought immediately. Finally, this medicine should be kept out of reach of children and should not be transferred to other containers for safety.

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

This medicine may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is recommended to keep the storage temperature between 1°C and 30°C at room temperature. This will help maintain the effectiveness of the medicine for a longer period.

Appearance

A hard capsule with white to yellowish powder, the upper portion is orange.

Package unit

28 capsules (14 capsules/PTP x 2)