Albozen Rivastigmine Capsule 3mg (Rivastigmine Tartrate)

Adult dose

Administration: Rivastigmine should be 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 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 demonstrated greater efficacy at doses of 6mg daily and higher in clinical trials, a target dose range of 6~12mg daily is recommended for most patients. Recommended dose titration schedule After administering 1.5mg of this medicine twice daily for at least 2 weeks, the dose may be increased to 3mg twice daily if well tolerated. Subsequent increases may be made by administering 4.5mg twice daily and, if well tolerated, after at least 2 weeks increasing 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 a controlled clinical trial in patients with dementia associated with Parkinson's disease, rivastigmine 3~12mg daily was administered in 2 divided doses (1.5~6mg per dose 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 in sequence according to the patient's tolerability to 3mg twice daily, then 4.5mg twice daily, and then 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, these symptoms may decrease if one or more doses are withheld. If adverse reactions persist, temporarily reduce the daily dose to the previous well-tolerated dose or consider discontinuing treatment. 3. Maximum recommended dose Administer 6 mg of this medicine orally twice daily. 4. Reinitiation of treatment The incidence 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. 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 allergic to certain ingredients. It should be avoided in patients with severe liver impairment as its safety has not been confirmed. Caution is also needed for patients who have previously experienced allergic contact dermatitis due to this medication in patch form. Patients with heart disease or a history of gastric ulcers, asthma, or obstructive lung disease should use this medication carefully. Those who have experienced urinary retention or seizures, as well as patients with extrapyramidal disorders, should be cautious when using this medication. Common gastrointestinal side effects such as nausea, vomiting, and diarrhea may occur, especially during the initial treatment period or dose adjustments. Neurological adverse reactions such as dizziness, headache, drowsiness, and tremors have also been reported. A rare occurrence of cardiac rhythm disturbances or blood pressure changes should be monitored closely in patients with heart conditions. Weight loss may occur during treatment, so weight should be checked regularly. This medication may interact with other cholinergic medications, thus it is advisable to consult healthcare providers if there are concomitant medications. It may be necessary to discontinue this medication for a certain period before anesthesia. Pregnant or nursing women should consult their physician before use since the safety of this drug has not been fully established. Use in children is not recommended. In case of overdose, symptoms such as nausea, vomiting, bradycardia, and confusion may appear, requiring immediate medical attention. This medication should be stored out of reach of children and should not be transferred to other containers. Any abnormal reactions or discomfort during treatment should be reported to healthcare professionals immediately.

• nausea
• vomiting
• urinary tract infection
• agitation
• confusion
• nightmares
• anxiety
• insomnia
• depression
• hallucination

This medication may be sensitive to air and humidity, so it must be stored in a tightly sealed container. Additionally, the drug should be kept away from extreme temperatures, ideally between 1 to 30 degrees Celsius, which is considered normal room temperature.

Appearance

A hard capsule with a white to yellowish powder inside, with an orange-colored upper and lower part.

Package unit

28 capsules (14 capsules/PTP x 2)