Monsticap 4.5 mg (Rivastigmine tartrate)

Adult dose

Administration: Administer rivastigmine orally twice daily with the morning and evening meals. ○ Adults: 1. Treatment of mild to moderate Alzheimer-type dementia The initial dose is 3 mg of rivastigmine daily. For each patient, increase the dose at intervals of at least 2 weeks to the maximum tolerated dose or the maximum recommended dose of 12 mg daily. Because this medicine showed greater efficacy at doses of 6 mg daily and higher in clinical trials, a target dose range of 6~12mg daily is recommended for most patients. Recommended dose titration Administer 1.5mg of this medicine per dose twice daily for at least 2 weeks; if well tolerated, the dose may be increased to 3mg twice daily. For subsequent dose increases, administer 4.5mg per dose twice daily; if well tolerated, after at least 2 weeks the dose may be increased to 6mg per dose 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 was administered at 3~12mg daily in 2 doses (1.5~6mg per dose twice daily). The initial dose is 1.5mg of this medicine per dose twice daily. Depending on the patient's tolerability, subsequent doses may be increased sequentially, with a minimum interval of 4 weeks between each dose, to 3mg per dose twice daily, then 4.5mg per dose twice daily, and then 6mg per dose 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, omitting one or several doses may reduce these symptoms. 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 per dose orally twice daily. 4. Restarting treatment The incidence and severity of adverse reactions generally increase at higher doses. If treatment has been 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

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 known allergies to specific ingredients or in patients with severe liver impairment. It should be used cautiously in patients with a history of heart disease, gastric ulcers, asthma, urinary retention, or seizures. Gastrointestinal symptoms such as nausea, vomiting, and diarrhea may frequently occur, particularly at the beginning of treatment or when increasing the dose. Neurological symptoms such as dizziness, headache, drowsiness, and tremor have also been reported, so caution is advised. Heart rate may slow down, so patients with heart disease should regularly monitor their condition. This medication may worsen Parkinson's disease symptoms; if related symptoms occur, consult a doctor immediately. Women who are pregnant or breastfeeding should consult a doctor before use, as the safety of this medication has not been fully established. There are no adequate clinical trials for children; thus, it is not recommended for use in this population. Interactions may occur when taken with other medications; caution is especially needed when combined with muscle relaxants, cardiac medications, or anticholinergic drugs. Dizziness or drowsiness may occur while driving or operating machinery during treatment, so caution is necessary. In case of overdose, symptoms such as vomiting, diarrhea, dizziness, bradycardia, and confusion may appear, and severe cases may require urgent medical attention. Allergic dermatitis may develop at the site of administration; therefore, if severe skin reactions occur, stop using the medication and consult a doctor. Weight loss may occur, so regular weight monitoring during treatment is advisable. This medication should be stored out of reach of children and should not be transferred to another container for safety.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is best kept at room temperature between 1°C and 30°C.

Appearance

Hard capsule containing a white to whitish powder with a brown hard shell on the outer surface.

Package unit

30 capsules/bottle, 100 capsules/bottle