Samsung Rivastigmine Capsule 1.5 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 contains the ingredient rivastigmine and should not be administered to certain patients. For example, patients with an allergy to this medication's ingredients or severe liver dysfunction, and those who have previously had skin allergic reactions to this medication in patch form should not use it. Patients with a history of heart disease, peptic ulcer, asthma, urinary retention, seizures, extrapyramidal disorders, etc. should use this medication with special caution. This medication may commonly cause gastrointestinal side effects such as nausea, vomiting, and diarrhea. These side effects may occur more frequently in female patients. This medication can also affect the nervous system, leading to symptoms like dizziness, headache, drowsiness, and tremors; in rare cases, it may cause irregular heartbeats. Additionally, systemic symptoms such as skin rashes, itching, fatigue, and weight loss have been reported. There is a possibility of interactions with other medications, so special caution is necessary when used with anesthetics or other cholinergic drugs. Patients with heart disease or abnormalities in electrocardiograms should consult medical professionals before administration. Women who are pregnant or breastfeeding should be cautious about using this medication, and it is advisable to avoid its use during breastfeeding. Safety in children has not been sufficiently established, so it is not recommended. In case of overdose, symptoms such as nausea, vomiting, bradycardia, and confusion may occur, so if these symptoms appear, immediate medical attention should be sought. When storing, it is safe to keep it in a sealed container out of the reach of children and not to transfer it to other containers. During the course of this medication, it is important to closely observe for any side effects, and if any abnormal symptoms persist or worsen, medical consultation should be sought.

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

This medication should be stored in a sealed container to prevent exposure to air or moisture, and it is advisable to store it at room temperature between 1°C and 30°C. This storage method helps maintain the effectiveness of the medication for an extended period.

Appearance

Hard capsule containing white to yellowish powder with yellow lower part

Package unit

28 capsules (14 capsules/PTP×2)