Shinshin Rivastigmine Capsule 4.5 mg (Rivastigmine Tartrate)

Adult dose

Dosage and administration: Rivastigmine is administered orally twice daily, in the morning and evening, with meals. ○ Adults: 1. Treatment of symptoms of mild to moderate Alzheimer-type dementia The initial dose is 3mg of rivastigmine per day, and 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 per day. Because 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 twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3mg twice daily. Subsequent increases may be made to 4.5mg twice daily, and if well tolerated, after at least 2 weeks, the dose may be increased to 6mg twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or loss of 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 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 per day in 2 divided doses. (1.5~6mg per dose, twice daily.). The initial dose is 1.5mg of this medicine twice daily. Depending on the patient's tolerability, subsequent doses may be increased in increments at intervals of at least 4 weeks, first to 3mg twice daily, then to 4.5mg twice daily, and then to 6mg twice daily. If adverse reactions (for example, nausea, vomiting, abdominal pain, or loss of appetite), weight gain, or extrapyramidal symptoms (for example, tremor) occur during treatment, withholding 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 orally twice daily. 4. Reinitiation of treatment The frequency and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for more than 3 days, restart treatment 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, particular care should be taken 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 drug should not be used in patients with allergies to specific components. It is also safe not to administer to patients with severely impaired liver function or those who have experienced allergic skin reactions due to this drug's patch form. It should be used with caution in patients with heart diseases, gastric ulcers, asthma, urinary retention, seizures, or extrapyramidal disorders. This drug can commonly cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea, which may worsen, especially at the initial start of treatment or when increasing the dosage. Neurological symptoms such as dizziness, headache, drowsiness, and tremor may also frequently occur, requiring attention. In Parkinson's patients, symptoms may worsen, so careful monitoring of symptom changes is necessary. Regular examinations are required for patients with heart disease as heart rate may slow down or arrhythmia may occur. The effectiveness may be increased or side effects may worsen when this drug is used in combination with other cholinergic drugs, so consultation with a physician is necessary. This drug should be discontinued for a certain period before anesthesia, and caution should be taken regarding interactions with concurrent medications. Women who are pregnant or breastfeeding should consult a physician before use as the safety of this drug has not been fully established. It is not recommended for children, and serious side effects can occur in cases of overdose, so prescribed dosages must be strictly followed. Weight loss or dehydration symptoms may occur while taking this drug, so it is important to regularly monitor your health status. Caution should be exercised as dizziness or drowsiness may occur when driving or operating machinery. If a skin rash or severe allergic reaction occurs at the administration site, discontinue use immediately and consult a physician. If any abnormal symptoms occur while taking this drug, inform the healthcare provider immediately for appropriate measures.

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

This drug must be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to store it at room temperature, that is, between 1 degree and 30 degrees Celsius.

Appearance

A hard capsule containing white to yellowish powder with red color at the bottom.

Package unit

28 capsules (14 capsules/PTPX2)