Donepezil Rivastigmine Tartrate Capsule 4.5 mg

Adult dose

Administration: Rivastigmine should be administered orally twice daily with breakfast and dinner. ○ Adults: 1. Treatment of mild to moderate dementia of the Alzheimer's type The initial dose is rivastigmine 3mg daily, 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 daily. Since this medicine showed greater efficacy in clinical trials at doses of 6mg daily and higher, a target dose range of 6~12mg daily is recommended for most patients. Recommended dose titration 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, followed, if well tolerated for at least 2 weeks, by an increase to 6mg 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 previous dose that was well tolerated. 2. Treatment of mild to moderate dementia associated with Parkinson's disease In controlled clinical trials in patients with dementia associated with Parkinson's disease, rivastigmine 3~12mg daily was administered in 2 divided doses. (1.5~6mg per dose, administered twice daily.) The initial dose is 1.5mg of this medicine twice daily. At intervals of at least 4 weeks between doses, the dose may subsequently be increased according to the patient's tolerability, first to 3mg twice daily, then to 4.5mg twice daily, and then to 6mg 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, the daily dose may be temporarily reduced to the previous well-tolerated dose, or discontinuation of treatment may be considered. 3. Maximum recommended dose Administer 6 mg of this medicine orally twice daily. 4. Restarting 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. No studies have been conducted in patients with severe hepatic impairment; do not administer this medicine.

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 certain patients. For example, patients who are allergic to the active ingredient or any of the components, those with severe liver impairment, and those who have had a skin allergic reaction to this drug's patch formulation should not take it. Additionally, caution should be exercised when administering to patients with heart disease, a history of gastric or duodenal ulcers, asthma or obstructive lung disease, urinary retention, a history of seizures, and those with extrapyramidal disorders. When taking this medication, gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur frequently, so the dosage should be adjusted, or use should be stopped if symptoms are severe. Neurological adverse reactions, such as dizziness, drowsiness, and headache, may also occur, so caution is required. In particular, patients with Parkinson's disease may experience exacerbation of symptoms or movement disorders, so if such symptoms occur, consultation with a doctor is important. If this drug is combined with other cholinergic medications, its effects may increase or side effects may occur, so informing healthcare providers of any other medications being taken is essential. The safety of this medication has not been fully confirmed in pregnant women or nursing mothers, so if there is a possibility of pregnancy or while nursing, it should be taken after consulting with a healthcare provider. Use is not recommended for children, and in case of overdose, serious symptoms such as nausea, vomiting, bradycardia, and seizures may appear, making it necessary to visit a medical institution immediately. When storing this medication, it should be kept out of reach of children and should not be transferred to another container. Finally, while taking this medication, dizziness or drowsiness may occur during driving or operating machinery, so caution is required, and regular evaluations by a physician are important.

• Nausea
• vomiting
• diarrhea
• loss of appetite
• abdominal pain
• indigestion
• gastric ulcer
• duodenal ulcer
• gastrointestinal bleeding
• pancreatitis

This medication should be stored in a tightly sealed container to protect it from air and moisture, ideally at room temperature between 1 degree and 30 degrees Celsius. Storing it in this way will help maintain its effectiveness and prevent deterioration.

Appearance

Hard capsule with red upper and lower parts containing white to pale yellow powder

Package unit

28 capsules/box [14 capsules/PTP × 2]