Albozen Rivastigmine Capsule 1.5 mg (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 medicine should not be used in patients with allergies to certain components. Its safety is not confirmed in patients with severe liver dysfunction, so it should not be administered to them. Patients who previously experienced skin allergic reactions while using this medicine's patch should not use this medication. Caution should be exercised in patients with heart disease, gastric ulcers, asthma, urinary retention, seizures, or extrapyramidal disorders. Gastrointestinal disturbances such as nausea, vomiting, and diarrhea may occur, especially during the initial treatment or dose adjustments. This medicine may cause neurological adverse reactions such as dizziness, drowsiness, tremors, and headaches, so caution is necessary. In patients with Parkinson's disease, symptoms may worsen, so changes in symptoms should be monitored. Weight loss may occur during treatment, so regular weight checks are necessary. If pregnant or breastfeeding, this medicine should be used carefully as its safety has not been sufficiently confirmed. It is not recommended for children as there have been no adequate clinical trials in pediatric populations. In case of overdose, symptoms like nausea, vomiting, bradycardia, confusion, and seizures may appear, and medical attention should be sought immediately. Interactions may occur with other medications, so consultation with a physician or pharmacist before use is required. This medicine should be kept out of reach of children and should not be transferred to another container.

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

This medication should be stored in a tightly closed container to avoid exposure to air or moisture and kept at room temperature between 1 °C and 30 °C. Storing in this way will help maintain the medication's effectiveness for a longer period.

Appearance

A hard capsule with white to pale yellow powder inside, and a yellow lower part.

Package unit

28 capsules (14 capsules/PTP × 2)