Rivastone Capsule 6.0 mg (Rivastigmine Tartrate)

Adult dose

Directions for use: Rivastigmine is administered orally twice daily, in the morning and evening, with meals. 1. Treatment of mild to moderate symptoms of Alzheimer-type dementia The initial dose is 3mg of rivastigmine per day. For each patient, the dose should be increased at intervals of at least 2 weeks to the maximum tolerated dose or the maximum recommended dose of 12mg per day. Because this medicine showed greater efficacy in clinical trials at doses of 6mg per day or higher, 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, to 6mg 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 last dose that was well tolerated. 2. Treatment of mild to moderate symptoms of 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, divided into 2 doses. (A dose of 1.5~6mg was administered twice daily.) The initial dose is 1.5mg of this medicine twice daily. At intervals of at least 4 weeks between each dose, depending on the patient's tolerability, the dose may then be increased consecutively to 3mg twice daily, followed by 4.5mg twice daily, and then 6mg 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, temporarily withholding one or more doses may reduce these symptoms. If adverse reactions persist, the daily dose may be temporarily reduced to the last well-tolerated dose, or discontinuation of treatment may be considered. 3. Maximum recommended dose Administer 6mg of this medicine orally twice daily. 4. Resumption 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, 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 medication should not be administered to patients with specific allergies or severe liver disease. It should be used cautiously in patients with heart disease, gastric ulcer, asthma, urinary retention, seizures, and extrapyramidal disorders. While taking the medication, gastrointestinal symptoms such as nausea, vomiting, and diarrhea may appear, so caution is necessary. Nervous system adverse reactions such as dizziness, headache, drowsiness, and tremors have also been reported, so if symptoms are severe, consult a physician. This medication may interact with other drugs, so you must inform your doctor of any other medications you are taking. Pregnant or breastfeeding women should consult their doctor before taking this medication. It is not recommended for children, and in case of overdose, symptoms such as nausea, vomiting, bradycardia, and confusion may occur, requiring immediate medical assistance. During treatment, body weight should be checked periodically, and any adverse reactions should be reported to a healthcare professional immediately. Caution is needed when driving or operating machinery, so exercise care based on your symptoms.

• Nausea
• vomiting
• urinary tract infection
• restlessness
• confusion
• nightmares
• anxiety
• insomnia
• depression
• hallucination

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is also best to avoid extremely hot or cold places and to store it at a temperature between 1 and 30 degrees Celsius, which is room temperature.

Appearance

A hard capsule with a red upper part and an orange lower part containing a white to yellowish powder.

Package unit

28 capsules/box [14 capsules/PTP×2]