Samsung Rivastigmine Capsule 3.0 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 with an allergy to its components or severe liver dysfunction. Patients with heart disease, gastric ulcers, asthma, urinary retention, seizures, and extrapyramidal disorders should exercise caution when using this medication. Gastrointestinal symptoms such as nausea, vomiting, and diarrhea may commonly occur with this medication, particularly in women who might experience these symptoms more frequently. Neurological and psychiatric side effects such as dizziness, headache, drowsiness, tremors, anxiety, and restlessness have also been reported, so patients should consult healthcare professionals if symptoms worsen. Patients with Parkinson's disease may experience worsening of motor symptoms, so careful observation of symptom changes is necessary. This medication may interact with other drugs, so if you are currently taking any other medication, it is essential to inform your healthcare provider. Patients who are about to undergo anesthesia or surgery should temporarily discontinue this medication, and caution is advised when used with other cholinergic or anticholinergic drugs. Women who are pregnant or breastfeeding should consult a physician before use, as the safety of this medication has not been adequately confirmed. It is recommended that children do not use this medication, and in the case of overdose, severe symptoms such as vomiting, dizziness, and bradycardia may occur, requiring immediate emergency treatment. This medication should be stored out of reach of children, and it is safest not to transfer it to another container. During treatment, patients' weight and changes in symptoms should be regularly monitored, and dosage adjustments or cessation may be needed in case of severe adverse reactions. Caution should be exercised when driving or operating machinery, as dizziness or drowsiness may occur.

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

This medication can be sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 degree and 30 degrees Celsius to preserve the efficacy of the medicine.

Appearance

An orange-colored hard capsule containing white to pale yellow powder

Package unit

28 capsules (14 capsules/PTP×2)