Megarevasmin Capsule 1.5 mg (Rivastigmine Tartrate)

Adult dose

Administration: Rivastigmine is administered orally twice daily with the morning and evening meals. ○ Adults: 1. Treatment 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 up to the highest tolerated dose or the maximum recommended dose of 12mg per day. Since this medicine showed greater efficacy at doses of 6mg per day and above in clinical trials, a target dose range of 6~12mg per day is recommended for most patients. Recommended dose titration schedule 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. Further 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, reduce the daily dose to the previously well-tolerated dose. 2. Treatment 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 per dose twice daily. At intervals of at least 4 weeks between dose levels, 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 thereafter 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, these symptoms may decrease if one or more doses are withheld. 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. Restarting treatment The incidence and severity of adverse reactions generally increase at higher doses. If treatment has been 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 medicine has not been studied in children; therefore, its use in children is not recommended.

This medication should not be used in patients with allergies to certain ingredients. It should be avoided in patients with severe liver impairment as safety has not been established. Patients who previously had allergic skin reactions to this medication's patch form should also avoid using it. Patients with a history of heart disease, gastric ulcers, asthma, urinary retention, or seizures need to exercise caution when using this medication. This medication may cause gastrointestinal side effects such as nausea, vomiting, and diarrhea, especially during the initial treatment phase or when adjusting the dosage. Dizziness, drowsiness, and headaches have also been reported as neurological adverse reactions, so care should be taken when driving or operating machinery. In patients with Parkinson's disease, there may be a worsening of motor symptoms, requiring close observation of symptom changes. Weight loss may occur during treatment, so regular weight monitoring is important. Women who are pregnant or breastfeeding should only use this medication when necessary, as its safety has not been fully established, and it should be avoided while breastfeeding. Use in children is not recommended. Drug interactions may occur when used with other medications, especially muscle relaxants, cholinergic drugs, and heart-related medications, so consult a doctor before concurrent use. In cases of overdose, symptoms such as nausea, vomiting, bradycardia, and confusion may appear, and if severe, immediate medical assistance should be sought. This medication should be stored out of reach of children and should not be transferred to another container. If any adverse reactions or discomfort occur during the use of this medication, consult a healthcare professional immediately.

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

This medication must be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to ensure the medication's efficacy and safe use.

Appearance

A hard capsule with white to pale yellow powder inside and yellow outer shell

Package unit

28 capsules/box [14 capsules/PTP × 2]