Samsung Rivastigmine Capsule 4.5 mg (Rivastigmine Tartrate)

Adult dose

Administration: Rivastigmine is administered orally twice daily with breakfast and the evening meal. ○ Adults: 1. Treatment of mild to moderate dementia of the Alzheimer's type The initial dose is 3mg of rivastigmine per day. For each patient, increase the dose at intervals of at least 2 weeks 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 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. The next increase is to 4.5mg twice daily; 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 last 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 was administered at 3~12mg per day in two divided doses (1.5~6mg twice daily). The initial dose is 1.5mg of this medicine twice daily. Depending on the patient's tolerability, subsequent doses may be increased consecutively, with a minimum interval of 4 weeks between each dose level: 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 loss of 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 last 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 frequency and severity of adverse reactions generally increase with 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 who have allergies to specific components. It is not safe for patients with severely impaired liver function, so it should be avoided in these cases. Patients who experienced skin allergic reactions while using patch formulations should also avoid this medication. Patients with heart disease, gastric ulcers, asthma, chronic obstructive pulmonary disease, urinary retention, seizures, or extrapyramidal disorders should use this medication cautiously. Gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur at the beginning of treatment or when increasing the dosage; these symptoms can be alleviated by dosage adjustments. This medication can cause neurological symptoms like dizziness, drowsiness, tremors, and headaches, so caution is required when driving or operating machinery. In Parkinson's disease patients, symptoms may worsen, so it should be used according to a doctor's direction. Weight loss may occur during treatment, so regular weight checks are important. When used in combination with other cholinergic medications, the effect may be enhanced, or side effects may increase, so caution should be exercised. Before anesthesia, this medication may need to be stopped for a period; patients should inform medical staff. Patients with heart rhythm abnormalities should have their condition monitored through ECG tests while on this medication. Pregnant or breastfeeding women should consult a doctor before taking this medication, and it is recommended to avoid use while breastfeeding. Safety and efficacy in pediatric patients have not been established, thus it should not be used in children. In case of overdose, symptoms such as nausea, vomiting, bradycardia, and confusion may occur, and immediate medical attention should be sought. This medication should be kept out of reach of children and it is advisable not to change the storage container.

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

This medication should be stored in a tightly closed container to protect it from exposure to air and moisture. It is best to maintain the storage temperature between 1 and 30 degrees Celsius. This helps to preserve the effect of the medication and prevent deterioration.

Appearance

A hard capsule with white to light yellow powder, with a red upper and lower part.

Package unit

28 capsules (14 capsules/PTP×2)