Megarevastigmine Capsule 3mg (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

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

This drug contains the ingredient rivastigmine and should not be administered to certain patients. For example, patients who are allergic to this drug or similar medications, those with severely impaired liver function, and those who experienced skin allergic reactions when using this drug’s patches should not use it. Patients with certain conditions such as heart disease, gastric ulcers, asthma, urinary retention, seizures, and extrapyramidal disorders should use this drug cautiously. This drug commonly causes gastrointestinal side effects, especially nausea, vomiting, and diarrhea, which can occur frequently in the early stages of treatment. Such side effects and weight loss have been reported more frequently in female patients. Additionally, neurological side effects such as dizziness, headache, drowsiness, and tremors may occur, and less commonly, cardiac-related side effects, skin rash, and fatigue may also appear. Particularly in Parkinson’s disease patients, worsening symptoms or movement disorders may occur, so if such symptoms arise, a physician should be consulted. During treatment with this drug, it is important to regularly monitor weight changes, which can help reduce the risk of side effects during dosage adjustments. This medication may interact with other cholinergic drugs or anesthetics and drugs affecting the heart; therefore, patients taking other medications should inform their healthcare provider or pharmacist. Pregnant or breastfeeding women should consult a healthcare professional before taking this drug, and it is recommended to avoid its use while breastfeeding. Safety and efficacy in children have not been sufficiently established, so it is recommended not to use it in children. In case of overdose, symptoms such as nausea, vomiting, bradycardia, and confusion may appear, and immediate medical assistance should be sought. This drug should be stored out of reach of children and not transferred to other containers to ensure safety.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

A hard capsule containing a white to light yellow powder with an orange-colored lower section.

Package unit

28 capsules/box [14 capsules/PTP × 2]